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Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Limited [2010] FCA 108 (22 February 2010)
Last Updated: 24 February 2010
FEDERAL COURT OF AUSTRALIA
Inverness Medical Switzerland GmbH v MDS Diagnostics Pty
Limited
[2010] FCA 108
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Citation:
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Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Limited [2010] FCA
108 |
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Parties:
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INVERNESS MEDICAL SWITZERLAND GMBH
v MDS DIAGNOSTICS PTY
LIMITED
(ACN 090 764 702), MDS DIAGNOSTICS LIMITED (NEW ZEALAND
COMPANY NO 1000571), PRAKASH APPANNA, AUSTRALIAN MEDICAL TESTING PTY LIMITED
(ACN 101 245 176), FLAMUR KRASNIQI
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File number:
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NSD 1722 of 2006
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Judge:
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BENNETT J
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Date of judgment:
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Catchwords:
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PATENTS – devices for assays
involving specific binding – alleged infringement by respondents’
pregnancy testing devices
– construction of claims – validity
– utility – whether product within the claims not useful –
claim
leaves reader to select appropriate specific binding reagents –
novelty – whether applicant’s earlier patent anticipates
its later
patent – whether additional feature in later patent disclosed in earlier
patent – construction of “carrier”
propounded by applicant for
purposes of infringement applies on consideration of anticipation –
whether divisional patent takes
priority date of priority documents, parent or
own filing date – whether divisional patent fairly based on parent patent
or
priority documents – sufficiency – clarity
PATENTS – personal liability of director for infringement by
companies – joint tortfeasor – relevant test –
relevance of director’s knowledge that acts constitute patent infringement
– director’s involvement in managing
companies and procuring and
distributing infringing products – meaning of “authorise”
under s 13 of the Patents
Act – whether analogous to copyright law –
whether applicable to directors – sanction, approve or countenance
EVIDENCE – admissibility – exception to hearsay rule
– whether representation obtained in connection with proceeding
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Words and phrases:
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“specific binding reagent”,
“dry porous carrier”, “within said casing”,
“authorise”
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Legislation:
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Cases cited:
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26, 30, 31 March 2009, 1, 8 April 2009, 13 May 2009
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Date of last submissions:
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15 June 2009
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Place:
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Sydney
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Division:
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GENERAL DIVISION
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Category:
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Catchwords
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Number of paragraphs:
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205
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Counsel for the Applicant:
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Ms K Howard SC, Mr P Flynn
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Solicitor for the Applicant:
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Addisons Lawyers
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Counsel for the First,
Second and Third Respondents: |
Mr A Franklin SC, Mr A Fox
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Solicitor for the First, Second and Third Respondents:
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Breens Lawyers until 27 November 2009, Douros Lawyers thereafter
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Counsel for the Fourth and Fifth Respondents:
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The Fourth and Fifth Respondents did not appear.
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IN THE FEDERAL COURT OF AUSTRALIA
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NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
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INVERNESS MEDICAL SWITZERLAND
GMBHApplicant
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AND:
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MDS DIAGNOSTICS PTY LIMITED (ACN 090 764
702)First Respondent
MDS DIAGNOSTICS LIMITED
(NEW ZEALAND COMPANY NO
1000571)
Second Respondent
PRAKASH APPANNA
Third Respondent
AUSTRALIAN MEDICAL TESTING PTY LIMITED
(ACN 101 245
176)
Fourth Respondent
FLAMUR KRASNIQI
Fifth Respondent
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DATE OF ORDER:
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WHERE MADE:
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THE COURT DIRECTS THAT:
- The
parties submit proposed orders within 14 days to give effect to these
reasons.
- The
parties file and serve any submissions on costs within 14 days.
Note: Settlement and entry of orders is dealt with in Order 36 of
the Federal Court Rules.
The text of entered orders can be located using
eSearch on the Court’s website.
IN THE FEDERAL COURT OF AUSTRALIA
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NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
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NSD 1722 of 2006
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BETWEEN:
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INVERNESS MEDICAL SWITZERLAND GMBH
Applicant
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AND:
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MDS DIAGNOSTICS PTY LIMITED (ACN 090 764 702)
First
Respondent
MDS DIAGNOSTICS LIMITED
(NEW ZEALAND COMPANY NO
1000571)
Second Respondent
PRAKASH APPANNA
Third Respondent
AUSTRALIAN MEDICAL TESTING PTY LIMITED
(ACN 101 245
176)
Fourth Respondent
FLAMUR KRASNIQI
Fifth Respondent
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JUDGE:
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BENNETT J
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DATE:
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22 FEBRUARY 2010
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PLACE:
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SYDNEY
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REASONS FOR JUDGMENT
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[3]
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THE PATENTS
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[7]
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PRINCIPLES OF CLAIM
CONSTRUCTION
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[12]
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THE SKILLED
ADDRESSEE
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[16]
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BACKGROUND CHEMISTRY AND
TERMINOLOGY
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[21]
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CONSTRUCTION OF TERMS IN THE
PATENTS
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[29]
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“Specific Binding
Reagent”
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[30]
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The positions of Inverness and
MDS
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[32]
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The evidence of the
experts
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[38]
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Consideration of the meaning of
“specific binding reagent for an analyte” in the first
patent
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[44]
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GENERALLY
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[44]
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EMBODIMENTS AND EXAMPLES OF THE
INVENTION
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[51]
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THE CLAIMS
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[65]
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Summary of the main reasons for
the conclusion that the meaning of “specific binding reagent for an
analyte” is not a
reagent that binds only the target analyte but one that
binds the analyte in a specific binding reaction
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[69]
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The second, third and fourth
patents
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[70]
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“Dry porous
carrier”
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[74]
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Bibulous sample liquid receiving
member “within said casing”
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[82]
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Porous material backed with
transparent moisture-impervious material
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[88]
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INFRINGEMENT GENERALLY, APART FROM
CONSIDERATION OF VALIDITY
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[93]
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The first and second
patents
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[93]
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The third patent
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[94]
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The fourth patent
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[96]
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Electron micrograph
evidence
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[97]
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Email from the manufacturer of
macroporous body in the MDS devices
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[106]
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VALIDITY
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[114]
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Applicable law
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[114]
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Utility
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[115]
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Sufficiency
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[130]
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Clarity
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[135]
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Priority date of the third
patent
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[140]
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Disclosures in the first patent
and the Parent Priority Documents
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[146]
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Fair basing on the Parent
Priority Documents
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[149]
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Fair basing on the first
patent
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[152]
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Novelty – third and fourth
patents
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[156]
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Legal
principles
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[156]
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Third patent
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[157]
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Fourth
patent
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[159]
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LIABILITY OF DR
APPANNA
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[176]
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Joint tortfeasor
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[179]
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Authorising conduct of MDS - s
13(1) of the 1990 Act
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[193]
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MDS’ CROSS CLAIM UNDER S 128
OF THE 1990 ACT
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[204]
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CONCLUSION
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[205]
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- The
applicant (Inverness) is the owner of four patents (together, the
patents). The inventions described and claimed in the patents relate to
assays involving specific binding, especially immunoassays. The
device
described in the patents is an analytical device suitable for home use as a
single step device for, but not limited to, pregnancy
testing.
- Inverness
alleges that pregnancy testing devices marketed under the names of QuickStream
(QuickStream) and QuickCard (QuickCard) infringe various claims in
its four patents. The proceedings relate to questions of infringement and
validity of the patents.
Issues of liability and quantum have been
separated.
THE RESPONDENTS
- The
application seeks orders against five respondents. Only the first three
respondents have filed a notice of appearance. The
first respondent (MDS
Aus) is the sponsor under the Therapeutic Goods Act 1989 (Cth) of,
and the second respondent (MDS NZ) is the New Zealand and Australian
distributor of, QuickStream and QuickCard (together the MDS devices).
- The
third respondent, Dr Appanna, is a director of both MDS Aus and MDS NZ.
Inverness alleges that Dr Appanna is personally
liable as a joint tortfeasor for
the infringement by the MDS companies and also for authorising the same
infringement. When referring
to the submissions made by the first to third
respondents, I will refer to the three respondents together as MDS,
unless I need to refer to them individually.
- The
fourth respondent was deregistered on 5 November 2008. The proceedings as
against the fourth respondent have been brought
to an end, as the fourth
respondent has ceased to exist on deregistration (s 601AD(1) of the
Corporations Act 2001 (Cth)). The proceedings against the fourth
respondent should be dismissed with no order as to costs.
- Inverness
informs me that on 21 September 2007 the fifth respondent entered into a
personal insolvency agreement under the Australian Bankruptcy Act 1966
(Cth) such that the proceedings against him have been stayed.
Inverness has taken no further steps in the proceedings against him since
that
time. As requested by Inverness, I will grant leave for Inverness to file a
notice of discontinuance of the proceedings against
the fifth respondent. The
fifth respondent has not filed an appearance. There will be no order as to
costs as between Inverness
and the fifth respondent.
THE PATENTS
- Australian
Patent No. 626207 is a PCT application (the first patent). There is no
challenge to the fact that the invention there described involves an inventive
step. From that parent patent, two divisional patents, Australian Patent
No. 656966 (the second patent) and Australian Patent No. 656967 (the
third patent) were granted. Questions of the priority date have been raised
in respect of the third patent. Australian Patent No. 643430 (the fourth
patent) was filed separately. There is no dispute the invention described
in the fourth patent involves an inventive step. The fourth patent
is not a
divisional and takes its own filing date, 16 February 1990, as its priority
date. The first, second and third patents expired
on 26 April 2008.
- The
parties have presented the infringement issues by reference to claim 1 of each
patent with the proviso that, if claim 1 of the
third patent is anticipated, it
will be necessary to consider claims 9 and 10 of that patent. As to the third
patent, Inverness
initially claimed infringement of claims 1, 2, 3 and 4. Those
claims then formed the basis of MDS’ attack on validity. Inverness
now
claims infringement also of claims 9 and 10. MDS says that it is not in a
position to deal with the validity of those claims.
- MDS
challenges the validity of all four patents on the grounds of lack of utility
and sufficiency. If its argument on the priority
date of the third patent is
accepted, MDS also challenges claims 1 to 4 of the third patent on the basis of
lack of novelty. It
further challenges the validity of the claims of the fourth
patent on the basis of lack of novelty and challenges particular claims
in the
second and fourth patents on the basis of lack of clarity.
- A
key issue is the meaning of certain terms used in the claims, specifically:
- “specific
binding reagent for an analyte/ the same analyte” as it appears in the
claims of the first patent and the second
patent;
- “specific
binding reagent” as it appears in the claims of the third patent and the
fourth patent;
- “dry
porous carrier” or “carrier”, as they appear in the claims of
the patents;
- “bibulous
sample liquid receiving member within said casing” in sub-paragraph (b) of
claim 1 of the third patent; and
- “porous
material backed with a layer of transparent moisture-impervious material”
in claim 9 of the third patent.
- During
the course of the hearing MDS accepted that if either QuickStream and QuickCard
are found to infringe any of the four patents,
MDS NZ (as well as MDS Aus)
exploited that patent in Australia within the definition of
“exploit” in the Patents Act 1990 (Cth) (the 1990
Act). Relevantly to the claimed infringement, MDS also admitted during the
hearing that the reagent in the detection zone of the MDS
devices is
“permanently immobilised” and that the label used in the labelled
reagent is a “particulate direct label”
within the meaning of the
claims of the patents.
PRINCIPLES OF CLAIM CONSTRUCTION
- There
is no issue between the parties as to the principles to be applied in the
construction of patents, drawn from Welch Perrin and Company Proprietary
Limited v Worrell [1961] HCA 91; (1961) 106 CLR 588, Minnesota Mining and Manufacturing
Company v Beiersdorf (Australia) Limited [1980] HCA 9; (1980) 144 CLR 253 and
Kimberly-Clark Australia Pty Limited v Arico Trading International Pty
Limited [2001] HCA 8; (2001) 207 CLR 1.
- It
is of particular importance to keep in mind that the question is what the person
skilled in the art would have understood the
patentee to be using the language
of the claim to mean (Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46; [2005]
1 All ER 667; (2004) 64 IPR 444 at [34] per Lord Hoffman; H Lundbeck A/S v
Alphapharm Pty Ltd (2009) 177 FCR 151 at [118] per Bennett J
(Middleton J agreeing)). It is necessary to read the whole of the patent,
including the claims,
and to construe the terms in dispute through the eyes of
the skilled addressee. The complete specification is to be construed in
the
light of the common general knowledge as at the priority date
(Kimberly-Clark at [24]).
- The
claims are construed in the context, and not in isolation, of the specification.
That is not to say that the clear meaning of
a claim can be varied by reference
to the body of the specification, although terms which are unclear may be
clarified by reference
to the body of the specification (Kimberly-Clark
at [15]). As noted by Sheppard J in Décor Corporation Pty Ltd v Dart
Industries Inc (1988) 13 IPR 385 at 410, the claim should be understood and
interpreted in the context of the specification as a whole. As Sheppard J
went on
to say, there are two specific circumstances in which the body of the
specification may be referred to. One is where there is ambiguity.
The other is
where the specification discloses an intention that words used elsewhere are to
have a particular meaning, in which
case that meaning should be given effect
because the draftsman of the patent has used his or her own dictionary
(Décor at 410-41; Flexible Steel Lacing Company v Beltreco Ltd
[2000] FCA 890; (2000) 49 IPR 331 at [76] per Hely J).
- An
essential part of the process of construction involves understanding the nature
of the invention described and claimed and the
way in which the patentee has
used words or phrases in describing and then claiming that invention. Sometimes
the patentee provides
a clear dictionary in the body of the specification for
words and phrases. However, that is not always the case. While a patent
is a
public instrument which must define a monopoly in such a way that it is not
reasonably capable of being misunderstood, it is
also appropriate to try to
understand what the patentee seeks to convey by the words used, especially where
those words convey matters
of biological or technological complexity (see
generally Welch Perrin). The body of the specification may be used to
resolve ambiguities or to clarify what is uncertain in meaning. It may not be
used
to restrict, expand or qualify what appears in the claim (Interlego AG v
Toltoys Proprietary Limited [1973] HCA 1; (1973) 130 CLR 461 at [16]). However, as stated
in Sachtler GmbH and Co KG v RE Miller Pty Ltd [1916] HCA 49; (2005) 22 ALR 373 at [42]
per Bennett J, there is a fine line between, on the one hand, reading down the
words of a patent claim to reflect how a person skilled
in the art would
understand it in a practical and common sense way and, on the other,
impermissibly limiting the clear words of a
claim because a reader skilled in
the art would be likely to apply those wide words only in a limited range of all
the situations
they describe (citing Stanway Oyster Cylinders Pty Ltd v
Marks (1996) 66 FCR 577 at 585 per
Drummond J).
THE SKILLED ADDRESSEE
- Neither
Inverness nor MDS has objected to the evidence of the expert witnesses. There
is a slight difference between the parties
in the characterisation of the
skilled addressee. Inverness contends that such a person is one with a
practical interest in immunoassays
and immunoassay kits. MDS’
characterisation is a person experienced in the area of assay development,
particularly immunoassays
and in generating, working with and characterising
antibodies. Both parties accept that the person may either have a PhD in
Science
or have otherwise gained such experience.
- Inverness
relies on the evidence of Ms Boscato, who leads the manual immunoassay team
at St Vincent’s Hospital in Sydney.
Ms Boscato is a person who works
at a bench in a laboratory rather than being a theoretical researcher. She has
designed and
made immunoassays, uses them routinely and has a “practical
interest” in the subject matter of the invention.
- MDS
relies on the evidence of Dr Sinosich, the Scientific Director of the
Prenatal Testing and Molecular Genetics Divisions
of Sonic Clinical Institute in
Sydney. He supervises Australia-wide prenatal screening and molecular testing
and accreditation of
assays as provided by the Sonic Clinical Institute. In
summary, Dr Sinosich has worked in the field of immunoassay development,
including immunoassays for a range of fertility, pregnancy and non-pregnancy
associated analytes. He has generated both polyclonal
and monoclonal
antibodies; all of his research activity has been antibody-based.
Dr Sinosich has primarily undertaken development
of quantitative
immunoassays for detection of pregnancy-associated analytes (a competitive
immunoassay). The fundamental principles
utilised in that work are equally
applicable to qualitative immunoassays (such as a sandwich design). Inverness
does not challenge
Dr Sinosich’s qualifications but says that he is
more of a theoretical researcher.
- Dr
Sinosich states that, in his opinion, in relation to the test strip aspect of
the inventions, the patents are addressed to a person
experienced in the area of
assay development (specifically immunoassays) who generates, works with and
characterises antibodies.
Other persons would become involved to develop the
casing associated with the strip and commercialise the product.
- While
the respective experts differ in their qualifications and experience, each of
MDS and Inverness accept that both of the experts,
Dr Sinosich and
Ms Boscato, are skilled addressees able to give evidence of terms of art
and of the understanding of the
person skilled in the art of the language of the
specifications and the claims.
BACKGROUND CHEMISTRY AND TERMINOLOGY
- The
background chemistry is not in dispute. Inverness stresses, however, that as at
the priority date of the first patent in 1987,
some of the knowledge was not as
advanced as it is now.
- Immunoassays
are a type of analytical technique used to detect, either quantitatively or
qualitatively, a hormone or marker of some kind. Hormones are molecules
that are released in one area of an organism to exert their action in another
area of the organism. A marker is a molecule that has particular
attributes associated with a function or physiological state. The hormone or
marker that is the
subject of the immunoassay is known as the analyte. In the
context of immunoassays, the antigen is referred to interchangeably as
the
analyte. The key reactants in an immunoassay are the analyte (antigen) and the
antibody.
- The
analyte is the target molecule that is sought to be detected or measured.
Some of the most common target molecules are the four trophic hormones
(the
glycoprotein hormones): luteinising hormone (LH), follicle
stimulating hormone (FSH), thyroid stimulating hormone (TSH) and
human chorionic gonadotropin (hCG). Of these, only hCG is pregnancy
derived; that is, it is a peptide hormone produced in pregnancy. LH, for
example, would normally
be present in a non-pregnant woman’s urine in
varying concentrations, usually peaking at ovulation. hCG is heterodimeric,
which means that it has two different parts: an α-subunit and a
ß-subunit. The α-subunit is common to all four glycoprotein
hormones
which may be present in human urine: LH, FSH, TSH and hCG. Each is
distinguished by its unique ß-subunit. In a pregnancy
test, the analyte
is hCG.
- The
antibody, also referred to as a binding reagent, may be used to identify
the presence of the analyte. It is usually produced by the organism
or host in
response to immunisation with the antigen (analyte), that is, the introduction
of the analyte to the organism or host.
Immunisation is required to stimulate
antibody production; a particular antigen induces the production of antibodies
which can bind
to it. The antibody can then be used in assays to measure or
detect the analyte. Each antibody binds to a different part of the
analyte
which is termed the epitope or the antigenic determinant. There are one
or more specific binding sites at which this binding occurs. If the epitope or
a similar
structure is present in another molecule, then the antibody could also
bind to that molecule. These substances are then said to
cross-react
with the antibody. The antibody binds to a limited but defined number of
substances. The number of cross–reactants and the
degree of binding of the
cross-reactants compared to the analyte determine the degree of
specificity of the antibody.
- Antibodies
can be either polyclonal or monoclonal. Monoclonal antibodies are
a single, pure, homogeneous type of antibody, produced by a single clone of
cells, which react with a single epitope on the analyte.
Polyclonal
antibodies are a mixture of monoclones and therefore generally bind, with
different affinities, to multiple epitopes on an analyte. Different
antibodies
may have different affinities for an epitope, so that there may be different
strengths of binding. Immunoassays can use
monoclonal or polyclonal antibodies.
- Immunoassays
can be either competitive or sandwich assays. As Dr Sinosich accepted, the
development of those assays was still
evolving as at the priority date. Both
types of immunoassays use labelled reagents which may be either the antibody
(sandwich) or
the analyte (competitive). Labels used for tagging the analyte in
competitive immunoassays are small molecules, such a, radioactive
isotopes or
metals. Labels for tagging the antibody in sandwich immunoassays can include
small and large molecules, such as radioactive
isotopes, metals or enzymes.
Labelling enables detection and/or quantification of analyte-antibody complexes
(immunecomplex) and, accordingly, the presence of the analyte. An
immunoglobulin participates in an antigen/antibody reaction, in which
there is binding to particular sites.
- A
competitive assay involves the use of a labelled analyte or analyte
analogue which is physico-chemically identical to the unlabelled target analyte.
The labelled analyte competes with the unlabelled target analyte for limited
binding sites on the antibody. Competitive assays are
used to determine the
concentration of an analyte in a biological specimen. The strength of the
signal from the label, whether it
is colour or radioactivity, is inversely
related to the analyte concentration.
- A
sandwich assay (which is a non-competitive assay) usually involves the
use of two antibodies, with specificities directed at two distinct epitopes
on
the target analyte. One antibody is immobilised on an inert stationary surface
to serve as capture. The other antibody is labelled.
When the sample
containing the analyte is added, the labelled antibody binds to it and forms an
immunecomplex. The immunecomplex
is then captured by the immobilised antibody,
so that the analyte is sandwiched between the two antibodies. A sandwich assay
can
be used for detecting the presence of an analyte and also its concentration.
In contrast to a competitive assay, the signal generated
from the label is
proportional to the amount of analyte present in the
sample.
CONSTRUCTION OF TERMS IN THE PATENTS
- The
parties agree that, save where dependent claims are specifically referred to,
questions of construction can be determined by
reference to claim 1 in each
patent.
“Specific Binding Reagent”
- The
primary issue in these proceedings is the construction of ‘specific
binding reagent for an analyte’ in claim 1 of the first and second
patents and of ‘specific binding reagent’ in claim 1 of the
third and fourth patents. The parties agree that:
(a) It is an
essential integer of claim 1 of the first and second patents that the analytical
test device must have a ‘labelled specific binding reagent for an
analyte’ and an ‘unlabelled specific binding reagent
for the same analyte’.
(b) It is an essential integer of claim 1 of the third patent that the
analytical test device must have a ‘labelled specific binding
reagent’.
(c) It is an essential integer of claim 1 of the fourth patent that the
analytical test device must have a ‘labelled specific binding
reagent’ and an ‘unlabelled specific binding
reagent’.
- The
MDS devices are devices for pregnancy tests where the analyte is hCG. These
devices contain a labelled anti-ß hCG antibody
in the first zone and an
unlabelled anti-α hCG antibody immobilised in the detection zone. MDS
accepts that the labelled anti-ß
hCG antibody is a specific binding
reagent within the meaning of the patents. MDS denies that the unlabelled
anti-α hCG antibody
is a specific binding reagent within the meaning of the
patents. Accordingly, MDS submits that the MDS devices do not contain an
unlabelled specific binding reagent, which is an essential integer of the claims
of the first, second and fourth patents.
The positions of Inverness and MDS
- Both
parties have analysed the meaning of the expression “specific binding
reagent” by reference to the first patent,
the parent patent of the second
and third patents. The substance of the difference between the parties as to
the meaning of this
term is whether this expression means that the reagent may
bind not only to the analyte that is sought to be detected but also to
other
molecules related to the analyte (Inverness’ position) or
whether it means that the reagent will preferably bind only to the analyte and
to no other molecule in the sample (MDS’ position).
- MDS
characterises “specific” in the term “specific binding
reagent” as the adjective applied to a binding
reagent. Inverness does
not dispute that “specific” alone can be used as an adjective.
However, Inverness says that
“specific binding reagent” as used in
the patents is a composite phrase, in effect equated with “specific
binding
reaction”. That is, a reagent can be specific in that it is able
to bind to the hormone in a specific binding reaction but
not totally specific,
as it can bind other hormones as well. An anti-α hCG antibody is thus a
specific binding reagent for
the glycoprotein hormones but not totally specific
for any one of them.
- Inverness’
position is that a specific binding reagent is something that binds to the
analyte, in that it has an inherent specificity
for the analyte, but may also
bind to other molecules. That is, there may be cross-reactivity with other
molecules. Inverness contends
that the expression “specific binding
reagent for an analyte” means ‘a binding reagent which
binds to the analyte in a specific binding reaction’. When
used in the manner described in the claims of the first and second patents, it
enables the presence of the analyte, or target
molecule, to be determined.
Inverness maintains that a specific binding reagent may bind to other molecules
that are related to
the analyte and still be a specific binding reagent for the
analyte as long as it enters into a specific binding reaction with the
analyte.
It is not necessary that it be specific only for one analyte. The parties
accept that if Inverness’ construction
is adopted, the anti-α hCG
antibody in the MDS devices is a specific binding reagent.
- MDS
says that, in ordinary English, the word “specific” relevantly means
‘[s]pecially or peculiarly pertaining to a certain thing or class of
things’ so that a specific binding reagent is capable of
discriminating between analytes. This capability is, MDS says, the meaning
of
the term in immunology now and before the priority date. Therefore, it says,
the word “specific” imports the requirement
that the reagent should
bind to the target molecule and not to any other molecule. MDS says that this
would be and would have been
the understanding of skilled workers in the field.
MDS says that “specific” equates with “absolute” but
accepts that there may be a slight degree of cross-reactivity of the reagent
with another protein, of the order of less than 1% and
still be a specific
binding reagent for an analyte. For the purpose of discussion, this property
can be referred to as the reagent
being “mono-specific”.
MDS says that simply because the antibody can bind
to the analyte does not mean that it is specific for the analyte.
Otherwise, MDS asks rhetorically, why include the word
“specific” in the expression “specific binding reagent for
an
analyte”?
- There
is no dispute that the
anti-α and anti-ß hCG
antibodies used in the MDS devices both bind to hCG or that the combination of
anti-α and anti-ß
antibodies enable the specific detection of hCG
from among the glycoprotein hormones. MDS says that the requirement imported by
the expression “specific binding reagent” in the patents is that the
reagent must bind only to hCG. Under this construction,
claim 1 of the first,
second and fourth patents would require both the labelled and unlabelled
specific binding reagents to be mono-specific
for hCG. This would require an
anti-ß antibody in each case. The anti-α hCG antibody is not a
specific binding reagent
for hCG under this construction because it also binds
to the other glycoprotein hormones.
- MDS
denies that the competing constructions are merely a matter of semantics. It
points to the decreased likelihood of false positives
in a testing device where
the reagents will not bind to other molecules in the sample. It also points to
the problem of false negative
results in a device such as its own, where one of
the two reagents, the anti-α hCG antibody, can bind the other glycoprotein
hormones, such as LH and FSH, which can then compete with hCG and “fill
up” the available anti-α antibodies such
that hCG present in the
sample may not be detected. MDS points to evidence that, where the reagents
lack the required specificity,
scavenger molecules (not part of the invention in
the patents) are used to remove unwanted antigens or hormones such as LH to
address
cross-reactivity that could interfere with the assay. MDS says that
without such scavenger molecules, devices which use binding
reagents which can
cross-react with other molecules in the sample are non-useful because of
problems of false positive and false
negative results.
The evidence of the experts
- MDS
relies on Dr Sinosich to support its submission that, to those skilled in
the art of immunoassay in Australia before the
priority date, the adjective
“specific” used in relation to a reagent was a term of art meaning
that the reagent will
preferentially bind to the analyte in the immunoassay with
no binding to any other molecule in the sample. Dr Sinosich emphasised
that, otherwise, the immunoassay will not be able to detect the presence of the
analyte to the exclusion of other molecules in the
sample. Dr Sinosich was
firmly of the view that, in the context of antibodies, “specific” in
the phrase “specific
binding reaction for an analyte”, means that
the reagent will bind the target molecule and no other: it is
mono-specific.
- I
formed the clear impression that, while Dr Sinosich gave his opinion
honestly and impartially, his approach was, as he conceded
in evidence,
influenced by his own specific area of expertise and his own rigorous approach
to the relevant terminology. It was
apparent during cross-examination when Dr
Sinosich was taken to different parts of the specification that the patentee did
not adopt
the same limited use of terminology. This may be explained in part by
the fact that the application of the patent is not limited
to antigen-antibody
reactions, or to pregnancy kits.
- Dr
Sinosich construed the patent as an expert in immunology interested in pregnancy
testing. The patents are not based solely on
the use of antibodies in an
immunoassay to detect pregnancy or fertility. While the claimed invention
especially relates to immunoassays,
it is not so limited. Dr Sinosich accepted
that, for other analytes referred to in the specification such as some hormones
and proteins,
a mono-specific reagent may not have been available, especially as
at the priority date and he acknowledged that other skilled workers
in the field
may use words or expressions of relative specificity. Despite this,
Dr Sinosich said that he applied his interpretation
of
“specific” and “specific binding reagent” uninfluenced
by the way in which the terms were used in the
specification or the context of
the specification. His use of terminology which does not allow for relative
specificity or degrees
of specificity does not accord with
Ms Boscato’s evidence, or with much of the literature as at the
priority date, or
with the specification, which has broader application. Dr
Sinosich’s use of the terminology may well reflect his own experience
and
practice but the evidence suggests that it is not and was not the common use of
others in the art to which the specification
relates.
- On
the other hand, Ms Boscato agreed that, in the context of immunoassays,
“specificity” means the ability to measure
the analyte without
interference from other substances which would cause a false positive response,
or interference from other substances
causing an inaccurate result. Some
confusion was introduced into the evidence by the use of the word
“specific” on its
own, in questions concerning whether or not a
reagent would bind only to hCG and therefore be specific. This term then
introduced
concepts of “totally specific” or “highly
specific”. Ms Boscato adopted and used these terms. However,
she
drew a distinction between the use of “specificity” and
“specific” as stand-alone words and the use of
“specific” in the phrase “a specific binding reagent for an
analyte” which, she repeated, means that the
reagent has to be able to
bind the analyte of interest in a specific binding reaction, but not necessarily
exclusively. Ms Boscato’s
understanding of the phrase
“specific binding reagent for an analyte” is that it describes a
reagent as ‘a component used in an assay...for [an] analyte that
is able to bind the analyte in a reaction that is particular to that reagent and
analyte’. As used in the specification, Ms Boscato says that the
phrase is used as a generic term for a broad range of molecules
that are able to
bind to the analyte of interest. Put shortly, as the evidence of
Ms Boscato explained it, a reagent that participates
in a specific binding
reaction with an analyte or analytes may have different degrees of specificity
for different analytes.
- Ms
Boscato explained that a specific binding reagent binds in a specific binding
reaction, in contrast to binding that may be non-specific.
Dr Sinosich
also explained that a specific binding reaction is only one way of an analyte
becoming bound.
- Ms Boscato
pointed to literature that formed part of the art as at the priority date,
including papers by Dr Ekins who,
she said, was regarded as the person who
introduced specific binding assays. His articles were considered to be very
important in
the field at the time. Throughout the Ekins article in evidence,
the phrase “specific binding reagent” is used as a
composite phrase.
This provides support for Inverness’ submission that the expression
“specific binding reagent for an
analyte” as used in the
specification, reflects and describes the prior art as of the priority date.
This may explain why
the phrase is used in the specification, although its use
as a composite phrase does import redundancy in the use of
“specific”:
Ms Boscato accepted that every binding reagent that
binds to an analyte will bind in accordance with a specific binding reaction.
Consideration of the meaning of “specific binding reagent for an
analyte” in the first patent
GENERALLY
- The
expression “specific binding reagent for an analyte” is not
self-explanatory. It is open to different interpretations
and is an expression
as to which the parties’ experts differ. What are the indicia in the
specification as to whether the
specific binding reagent for the analyte binds
exclusively to that analyte? The question is whether the expression
“specific
binding reagent for an analyte” in claim 1 of the first
patent means, where the analyte is hCG, a reagent that binds with hCG
in a
specific binding reaction but may also bind with other hormones containing the
α-subunit, or whether it means a reagent
that binds with and only with hCG,
that is, with its unique ß-subunit. The language of the specification is
not rigorous.
- The
definitions of “specific” in ordinary English and immunology
highlighted by MDS support both MDS’ and Inverness’
constructions of
“specific binding reagent”. On Inverness’ construction, the
reagent must engage in a specific
binding reaction with the analyte of interest,
which means that there must be a special binding site on the analyte capable of
binding
to that reagent. In that sense, it specifically binds with the analyte
and is capable of discriminating between analytes. On MDS’
construction,
it binds only to the analyte of interest; it does discriminate between analytes.
- The
title of the specification of the first patent is ‘Immunoassays and
devices therefor’. The field of the invention is said to concern
assays involving “specific binding”, especially immunoassays.
The
background section of the specification refers to “specific binding
assays, such as immunoassays”. Previously proposed
specific binding
assays are described as involving the use of a specific binding reagent for the
analyte which is immobilised and
can therefore bind the analyte in the detection
zone where the extent of binding can be determined with the aid of labelled
reagents.
The invention of the first patent is not to new reagents or new assay
techniques. Rather, the invention improves and adapts known
assay techniques in
terms of the configuration, arrangement and labelling of reagents to operate in
a test device suitable for home
use.
- A
reading of pages 1 and 2 of the first patent discloses, inter alia, the
following:
- The assays to
which the invention relates involve specific binding especially, but not limited
to, immunoassays or pregnancy tests.
- The invention
also relates to “analytical devices” suitable for home, clinic, or
surgery use. The devices are intended
to give an analytical result which is
rapid and which requires the minimum degree of skill and involvement from the
user.
- The stated
improvement is that these devices do not require the user to perform a sequence
of operations to obtain an observable test
result.
- The device is
contacted with a sample, such as a urine stream, and no further action by the
user is required.
- Prior methods
are described, including the use of reagent-impregnated test strips in specific
binding assays such as immunoassays.
In such procedures, the sample is
applied to one portion of the test material, usually with the aid of an eluting
solvent such as water. The sample progresses
into or through a detection zone
where ‘a specific binding reagent for an analyte’ suspected
of being in the sample is immobilised. Analyte present in the sample can
therefore become bound within the detection
zone. The extent of binding can be
determined with the aid of labelled reagents.
- The promise of
the invention is to provide diagnostic test devices especially suitable for home
use which are quick and convenient
to use and which require the user to perform
as few actions as possible.
- The device can
be applied to different analytes (also on page 17).
- The
specification describes different embodiments of the invention. In one
embodiment (at page 4):
- The labelled
reagent is a specific binding partner for the analyte.
- The labelled
reagent, the analyte (if present) and the immobilised unlabelled specific
binding reagent cooperate together in a “sandwich”
reaction.
- This results in
the labelled reagent being bound in the second zone if analyte is present in the
sample.
- The two binding
reagents must have specificities for different epitopes on the
analyte.
- The
specification seems to draw a distinction between specificity and a specific
binding reagent. The former is the characteristic
that defines the ability of
the reagent to identify only that analyte, the latter is the characteristic that
ensures that the reagent
does bind with the analyte in a specific binding
reaction. There is repeated reference to “specific binding”. MDS
points
out that any reagent which binds to an analyte binds in a specific
binding reaction, so that the word “specific” is either
redundant or
imports a requirement of mono-specificity. Inverness’ response is that,
in context, “specific” refers
to the type of binding: the binding
reagent must bind to the analyte in a specific binding reaction, being one where
it is known
which particular sites are bound, standing in contrast to a
non-specific binding reaction. Under this construction, examples of
specific
binding reagents are antibodies, receptors and binding proteins. Inverness
submits that examples of non-specific binding
would be the non-specific binding
of the reagent to the preferred carrier material, nitrocellulose, and of the
label to the reagent,
as described in the specification. This can be contrasted
with the specific binding that occurs between reagent and analyte, for
example
by recognition of an epitope.
- I
do not accept MDS’s contention that “specific” in the phrase
“specific binding reagent” and “specificity”
have
equivalent meanings in the specification. The Oxford Dictionary defines
“specificity” as used in medicine and biology
to mean: ‘the
narrowness of the range of substances with which an antibody, enzyme, or other
agent acts or is effective’. Ms Boscato agreed that
“specificity” means the graded ability to measure the analyte
without interference
from other substances causing an inaccurate result. High
specificity means low cross-reactivity. Ms Boscato also said that
the
references in the specification to the range of specific, highly specific and
monoclonal antibodies indicate that the patentee
accepts that specificity,
reflected in the word “specific” as used in the specification and
the claims, is a relative
term.
EMBODIMENTS AND EXAMPLES OF THE INVENTION
- The
embodiments of the invention utilise the sandwich reaction and the competition
reaction. In the sandwich reaction, the labelled
reagent is a specific binding
partner for the analyte. The labelled reagent, the analyte and the immobilised
unlabelled specific
binding reagent cooperate together in a
“sandwich”. Binding occurs because of the recognition of the
reagent for an
epitope (or binding site) on the analyte. In the embodiment
involving a sandwich reaction (at page 4), it states that the two binding
reagents must have specificities for different epitopes on the analyte. This
suggests that the reagents should bind preferably to
the analyte. However, in
the embodiment involving the competition reaction (at page 4), the labelled
reagent is the analyte itself,
or an analyte analogue with identical specific
binding characteristics to the analyte. That labelled reagent binds with the
immobilised
reagent. If the analyte is present in the sample, there will be
competition between the analyte and the labelled reagent in binding
to the
immobilised reagent, so that there is a decrease in the intensity of the signal
in comparison with the situation where there
is no analyte. This does not
import a requirement for the reagent to be mono-specific. In a competition
reaction, the labelled
reagent does not bind to the analyte. This requires
specificity of the immobilised reagent but does not involve a concept of
mono-specificity.
In either reaction, the immobilised specific binding reagent
in the second zone is said to be preferably a highly specific
antibody and, more preferably, a monoclonal antibody. If the specific
binding reagent for the analyte were necessarily mono-specific,
it would not be
necessary to state a preference for a highly specific antibody.
- There
are references in the specification to an “important embodiment” (at
pages 7 and 8) where the carrier contains
in the first zone a labelled
highly-specific anti-hCG antibody and has immobilised in the second zone
an unlabelled highly-specific anti-hCG antibody. The labelled and
unlabelled antibodies are to have specificities for different hCG epitopes. If
a specific binding
reagent must be mono-specific, there is no room for degrees
of specificity. Further, an “important alternative” in the
same
important embodiment is ‘a fertile period device, essentially as
described for hCG except that the analyte is LH’.
- In
an embodiment of the invention (at page 16) a labelled antibody having
specificity for an epitope and a second antibody having
specificity for a
different epitope on the same analyte are used. As a given example of an
analysis to which this can be applied,
the analyte can be hCG and the
reagents can be monoclonal antibodies to hCG. The specification goes on
to state that an assay based on these principles can be used to determine
a wide
variety of analytes by choice of appropriate specific binding reagents. The
analytes can be, for example, proteins, immunoglobulins,
hormones, drugs or
infectious diseases agents.
- The
specification describes how to produce certain examples of the invention. In the
section describing the preparation of labelled
reagents, the specification
describes the process for coupling an anti-α hCG antibody to the dye sol
label (at page 34). It
goes on to state that:
Due to the structural homology between the alpha subunits of hCG and LH,
[an] anti-α hCG antibody can be used to detect LH in a
cross-reactive immunoassay (at page 34). Thus, a labelled antibody may be
prepared for use in an LH assay in an identical manner to that described for
Example 1, using an anti-alpha hCG antibody.
In the section describing the preparation of the reagent strip (at page 35),
the specification provides that the immobilised protein
can be a suitably
selected antibody preparation such as anti-ß hCG, using a second
(labelled) anti-hCG antibody in a sandwich
format. However, the specification
later provides (at page 36) that sandwich-type reactions may be performed for
the detection of
hCG in a liquid sample using an anti-hCG antibody as described
earlier in the specification, that is, using an anti-α hCG antibody
linked
to dye sols, gold sols or coloured latex particles. It further provides that a
similar embodiment can be prepared using LH
instead of hCG.
- As
Inverness points out, the only difference between the MDS kits and this example
in the first patent is that the antibodies are
reversed in the MDS kits in that
the anti-α hCG antibody is the unlabelled reagent and the anti-ß hCG
antibody is the
labelled reagent. Inverness says that the reverse use of the
antibodies makes no difference in terms of determining whether or not
there are
two specific binding reagents in the MDS kits.
- In
the context of sandwich assays, the specification repeatedly uses the term
specific binding reagent to describe the labelled reagent,
for
example:
In one embodiment of the invention, the labelled reagent is a specific
binding partner for the analyte. The labelled reagent, the
analyte (if present)
and the immobilised unlabelled reagent cooperate together in a
“sandwich” reaction (at page 4).
Another important preferred embodiment of the invention is the use of so
called “direct labels”, attached to one of the
specific binding
reagents. Direct labels such as gold sols and dye sols, are already known per
se (at page 5).
The only description in the specification of the preparation of a labelled
reagent for hCG detection for use in a sandwich assay utilises
an
anti-α hCG antibody. It
describes how an anti-α hCG antibody can be labelled with dye sol for use
in a sandwich assay.
The most obvious conclusion is that the specification
describes an anti-α hCG
antibody as a specific binding reagent for hCG within the meaning of claim 1.
This use of this expression to describe
a reagent which binds to the
α-subunit of hCG, which it shares with the other glycoprotein hormones,
argues against a meaning
of mono-specificity. The anti-α antibody is
specific for hCG in that it will bind to hCG in a specific binding reaction; it
has specificity for hCG but it is not exclusively specific for that analyte. It
will also bind to the α-subunit of LH and to
the other proteins with that
subunit. It has specificity for LH, as well as FSH and TSH and may be used to
detect those hormones.
Indeed, the specification states that the anti-α
hCG antibody can be used to detect LH in a cross-reactive immunoassay. The
specification recognises the existence of cross-reactive immunoassays and makes
reference to antibodies that will cross-react with
molecules other than the
target antigen. That is, the reagents are not absolutely specific.
- MDS
seeks to overcome this exemplification of the anti-α hCG antibody by
arguing that it was not provided as an example of a
specific binding reagent.
MDS argues that the body of the specification, consistently with the parent
priority documents, does not
limit the labelled reagent in the first zone to a
specific binding reagent, although it always limits the unlabelled immobilised
reagent to a specific binding reagent. It finds support for this from the use
in the specification and parent priority documents
of the phrase “labelled
reagent”, without using the word “specific” while the phrase
“specific binding
reagent” is always used to describe the unlabelled
reagent. This, MDS says, is a deliberate differentiation between any binding
reagent and a specific binding reagent, the latter meaning one that is
mono-specific for the analyte. MDS says that the anti-α
hCG antibody is an
example of a labelled reagent which is not a specific binding reagent. It says
that claim 1 is narrower than
the specification in that it requires both the
labelled specific binding reagent in the first zone and the permanently
immobilised
unlabelled specific binding reagent in the detection zone to be
mono-specific.
- In
essence, MDS argues that claim 1 is not satisfied by the use of the exemplified
assay involving the labelled anti-α hCG antibody.
That is, of course,
possible. However, it is equally likely, in my view, that the claim includes
rather than excludes an exemplified
embodiment of the invention. As there is an
available construction that would include the exemplified use of anti-α hCG
antibody
as a specific binding reagent, the exemplification supports that
construction. I do not accept MDS’ submission that the specification
deliberately differentiates between “labelled reagent” and
“labelled specific binding reagent” with only
the latter meaning a
reagent mono-specific for the analyte. Rather, I accept Ms Boscato’s
evidence on the parent priority
documents of the first patent, that the
references to a “labelled reagent” in the context of a sandwich
reaction is a
reference to a labelled specific binding reagent such that the
example of the labelled anti-α hCG antibody is an example of
a labelled
specific binding reagent.
- The
examples in the specification assist in clarifying the invention and the
application of the terminology. The specification states
that an assay based on
the principles described can be used to determine a wide variety of analytes by
choice of the appropriate
specific binding reagent. The assays can be sandwich
assays, for example for hCG, or competition assays. The reference in one
embodiment
to the fact that the analyte can be hCG and the reagents
can be monoclonal antibodies to hCG suggests that the reagents are not
necessarily monoclonal antibodies.
- MDS
looks to the efficacy of the device in identifying, exclusively, hCG. It points
out that unless one of the binding reagents
is specific only for hCG, the system
will not differentiate between hCG and the other glycoprotein hormones. That
is, the reagent
must bind with the ß-subunit of hCG. MDS points to the
definition of “specific” of ‘capability of discriminating
between analytes’. It says that, unless such a mono-specific reagent
is used, the reagent is not so capable of distinguishing between hCG and
other
analytes in the sample.
- The
specification is not limited in its description to a test device for hCG. As
examples of certain preferred test strip materials
and reagents, the
specification exemplifies the anti-α hCG antibody as an appropriate
labelled reagent and the anti-ß
hCG antibody as an appropriate immobilised
unlabelled reagent for use in a sandwich assay for hCG. There is no example in
the first
patent which utilises two reagents each mono-specific for hCG.
- The
specification explains (at page 11) that ‘the immobilised specific
binding reagent in the second zone is preferably a highly specific
antibody, and more preferably a monoclonal antibody. In the embodiment of the
invention involving the sandwich reaction, the labelled
reagent is also
preferably a highly specific antibody, and more preferably a monoclonal
antibody’ (emphasis added). Highly specific does not mean
mono-specific. It recognises that, while the reagent is thought specifically
to
target the analyte of choice, there is a possibility that it may also bind to
another analyte. By directing the use of a highly
specific reagent, the
likelihood of cross-reaction is reduced. The patentee has used an expression
that allows for a degree of specificity.
- The
degree of specificity concerns the number of different analytes with which a
reagent will bind. If “specific binding reagent”
already meant
mono-specific, such as a monoclonal antibody, this description would be
unnecessary and contradictory. Dr Sinosich
acknowledged that, if
“specific binding reagent” does mean exclusive specificity as
advanced by MDS, a qualification
that an antibody is “highly
specific” is redundant.
- MDS
submits that “highly specific” contemplates analytes that will not
have binding reagents that are mono-specific but
this is negated by the use of
the expression in the context of the detection of hCG, which has the unique
ß-subunit. If the
description in the specification is designed to encompass analytes that do and
analytes that do not have
mono-specific binding reagents, the repeated use of
“specific binding reagent for the analyte” in that context is more
likely to mean a reagent that binds the analyte in a specific binding reaction
than a mono-specific reagent. Not all reagents will
be antibodies or highly
specific antibodies. As described in the specification, they are subclasses of
“specific binding reagents”.
THE CLAIMS
- Claim
1 does not differentiate in language between the “specific binding
reagent” in each of the two zones, other than
to specify that one is
labelled and one unlabelled. MDS says that if the same expression or
terminology is used for the binding
reagent in each zone of the device, they
must both have the same characteristics of mono-specificity.
- The
language of the specification is not consistent or rigorous. For example, the
patentee has used the expressions “labelled
reagent” and
“labelled binding reagent”. The specification seems to use
“reagent”, “binding
reagent” and “specific binding
reagent” somewhat interchangeably. In a sandwich assay a “labelled
reagent”
which does not bind to the analyte would be ineffective in
carrying out the purpose of enabling detection of the analyte-reagent
complex in
the detection zone. It is apparent that the former expression is shorthand for
the latter. This is reinforced by the
language of claim 2. Claim 1 refers to a
labelled specific binding reagent and an unlabelled specific binding reagent.
Claim 2,
which is dependent on claim 1, uses the expressions “labelled
reagent” and “unlabelled reagent”, clearly
referring to the
labelled and unlabelled specific binding reagents of claim 1. Other dependent
claims include the shorthand description.
This does not support MDS’s
submission that the specific binding reagent is a sub-class of the broader class
of labelled and
unlabelled reagents.
- The
way in which these expressions and “labelled specific binding
reagent” and “unlabelled specific binding reagent
having specificity
for the analyte” are used in the patent provide support for
Inverness’ interpretation, supported by
Ms Boscato, that the
expressions are not used to describe a mono-specific reagent but one that binds
with the analyte in a specific
binding reaction. That is, the reagent is one
that binds to that analyte, in the sense of pairing with the analyte. Inverness
contends
that “specific” is used to distinguish the kind of binding
and that “specific binding” indicates just that:
specific binding
as distinct from non-specific binding. This is supported by the statement in
page 1 of the patent that ‘the present invention relates to assays
involving specific binding, especially immunoassays’, that is, assays
involving specific binding reactions between the reagent and the analyte. This
is in contrast to non-specific
binding, with the example of that binding given
in the patent of a reagent to nitrocellulose. The extra words “having
specificity
for the analyte” may denote an extra requirement for
the reagent in the detection zone, that it not only binds in a specific binding
reaction but also
that it has a degree of specificity for the analyte and, in
that way, has the capability to distinguish between analytes.
- It
follows that claim 1 of the first patent requires the presence in each zone of a
reagent that will bind to hCG in a specific binding
reaction. That requirement
is fulfilled by the labelled anti-ß hCG antibody and the unlabelled
anti-α hCG antibody in
the detection zone of the MDS
devices.
Summary of the main reasons for the conclusion that the meaning of
“specific binding reagent for an analyte” is not a
reagent that
binds only the target analyte but one that binds the analyte in a specific
binding reaction
- A
first, untutored, lay construction might be to look to the word
“specific” as an adjective describing the kind of binding
reagent.
This would be consistent with MDS’ construction that the reagent is one
that binds specifically to and only to that
analyte. However, there are a
number of important reasons to reject this untutored approach, which
include:
- The
specification uses the expression “specific binding reagent”, in
context, compendiously.
- The
interpretation of the expression must take account of the range of subject
matter of the specification and of the claimed invention.
- The
link in meaning and expression of “specific binding reaction” and
“specific binding reagent” as used in
the specification and by
Ms Boscato.
- The
distinction between specific binding where a reagent binds to a specific site on
the analyte (a specific binding reaction) and
non-specific binding.
- The
concept, recognised in the specification, of degrees of specificity which is
inconsistent with a meaning of mono-specific and
the inconsistency between a
mono-specific binding reagent and the references in the specification of the
degree of specificity of
that reagent for an analyte.
- Examples
in the specification of the claimed invention include anti-α hCG
antibodies, which are not mono-specific for hCG, as
labelled reagents to be used
in sandwich assays. The labelled reagent in sandwich assays is consistently
described as a specific
binding reagent for the analyte elsewhere in the
specification.
- The
evidence of and explanation by Ms Boscato as to the meaning of the
expression, which I accept.
- The
use in the literature, as at the priority date, of the expression
“specific binding reaction” as a compendious phrase,
which supports
Ms Boscato’s construction.
- The
more limited construction of Dr Sinosich is one that may be appropriate in
his particular area of expertise and in his own
experience but that is not
necessarily the construction adopted by other skilled workers, either in
immunology or more broadly.
The second, third and fourth patents
- The
additional integer of the claimed device of the second patent does not affect
the specific binding reagent or the construction
of the term. Claim 1 of the
second patent makes it clear that the labelled specific binding reagent can also
participate in a competition
reaction in the presence of an analyte.
Grammatically, the claim is not well constructed in the expression ‘the
device also containing a labelled specific binding reagent for an analyte, or
which can participate in a competition reaction
in the presence of an
analyte’. I accept Ms Boscato’s evidence that the skilled
reader would read this to mean that the labelled specific binding
reagent can
bind in a specific binding reaction with the analyte, that is, “be”
for an analyte or can participate in
a competition reaction in the presence of
the analyte. As discussed above, the labelled analyte in a competition reaction
can be
the analyte itself. In the case of hCG being the labelled specific
binding reagent, it can bind to both an anti-α antibody
via its
α-subunit and to an anti-ß hCG antibody via its ß-subunit.
That is, it binds to more than one molecule
and is not mono-specific.
- This
reinforces, for the purposes of the second patent, the meaning contended for by
Inverness. The expression “specific binding
reagent for an analyte”
has the same meaning in the second patent as in the first patent.
- The
third patent, like the second patent, states that it incorporates the disclosure
of the specification of the first patent. Claim
1 of the third patent requires a
“reagent-impregnated carrier” and a labelled specific binding
reagent and provides for
the labelled reagent to become bound if the sample
liquid contains the analyte. The claim does not specify the means by which the
labelled specific binding reagent becomes bound. MDS accepts that the
anti-ß hCG antibody used in the MDS devices is a labelled
specific binding
reagent within the meaning of the third patent.
- The
fourth patent cites the United Kingdom equivalent of the first patent as prior
art. The fourth patent explains that the use
of reagent-impregnated test strips
in specific binding assays such as immunoassays has previously been proposed and
that analyte
present in the sample can participate in a sandwich or a
competition reaction within the detection zone, with a labelled reagent.
The
invention of the fourth patent is described in terms of a mobile labelled
specific binding reagent and an immobilised unlabelled
specific binding reagent,
which reagents are capable of participating in either a sandwich or competition
reaction in the presence
of the analyte. An additional integer is a macroporous
body. The fourth patent uses the same meaning of the expression “specific
binding reagent” as in the first patent, in that the reagent may bind not
only to the analyte but also to other molecules.
No different meaning to that
of the first patent is suggested and the context makes it apparent that the same
meaning is used, as
supported by the explanation of Ms Boscato.
“Dry porous carrier”
- The
construction of the phrase “dry porous carrier” contained in the
claims of all four patents is also in issue and
is relevant to whether the MDS
devices infringe the four patents. Claim 1 of the first patent defines the
invention as containing
‘a dry porous carrier which communicates
directly or indirectly with the exterior of the casing such that a liquid test
sample
can be applied to the porous carrier...’. Claim 1 of the
second and fourth patents also includes the essential integer of a dry porous
carrier and claim 1 of the
third patent includes the essential integer of
‘a dry porous reagent-impregnated carrier, such as an assay
strip’.
- I
shall consider the specification of the first patent. It is not suggested that
there is any relevant difference in meaning in
the specifications of the other
patents. Inverness accepts that the claims of the second patent and the third
patent do not regard
the ‘bibulous sample liquid receiving
member’ as part of the carrier and says that the fourth patent does
not regard the ‘macroporous body’ or the ‘porous
receiving member’ as part of the carrier. The main issue for the
purposes of infringement is whether the dry porous carrier is limited to a
single continuous piece of material.
- Inverness’
construction of the expression is simple: a dry and porous carrier is a carrier
which carries, conveys or transports
the liquid sample, whether it is a single
strip or a number of strips stuck together, whether it is a single body or a
number of
discrete bodies. Inverness says that the specification focuses on the
function of the carrier in carrying the reagent rather than
on the physical form
of the carrier. As described in the specification of first patent, in summary,
the dry porous carrier:
- receives the
sample, either directly or indirectly;
- carries within
it the labelled specific binding reagent which is mobile when in the moist
state;
- carries the
immobilised unlabelled specific binding reagent; and
- contains the
reagents positioned such that a liquid sample applied to the carrier can pick up
the labelled reagent and thereafter
permeate into the detection
zone.
- MDS
contends that “a dry porous carrier” is a single continuous piece of
material which:
- is dry and
porous; and
- can carry
(meaning support or bear) “within” it a labelled specific binding
reagent and “on” it an unlabelled
specific binding reagent; and
- can carry
(meaning transport or convey) a liquid sample through the carrier when the
sample is applied to it.
- The
MDS devices contain a number of dry and porous discrete pieces which, together,
receive the liquid sample and carry the labelled
and unlabelled reagents. There
is porous material that receives the liquid sample, a separate
“conjugate pad” (a small pink pad) being a dry porous body in
which the labelled anti-ß hCG antibody is carried, and a separate
nitrocellulose
test strip on which the unlabelled anti-α hCG antibody is
permanently immobilised. The sample permeates through these discrete
pieces.
Together, the discrete pieces work as described in the specification. A sample
is applied, any analyte in the sample binds
to the labelled specific binding
reagent at one part of a carrier and the analyte/reagent complex is then carried
to another part
of the carrier where it is detected.
- The
specification does refer to the carrier material in the form of a strip or a
sheet but only as a preferred embodiment or example
(for example at pages 6, 12,
14), which suggests that it contemplates that a device according to the
invention can incorporate a
carrier consisting of two or more discrete bodies of
porous phase material. For example, an important aspect of the invention is
said to enable a directly labelled specific binding reagent to be used in a
carrier-based analytical device, such as one based on
a strip format, to give a
quick and clear result (at page 6). Claim 9 of the first patent is a dependent
claim which limits the
dry porous carrier of claim 1 to a device in which
‘the dry porous carrier comprises a strip or sheet of porous
material’. Claim 1 is not so limited.
- I
consider it clear from the specification and the claims of the first patent that
the phrase “a dry porous carrier”
in the claims other than claim 9
is not limited to a single continuous piece of material, although a carrier in
the form of a single
strip may be a preferred embodiment of the invention as
described in the specification. As used in claim 1, the dry porous carrier
describes that part of the device which works to receive the sample and carry it
through the two zones for labelling and detection.
While a preferred embodiment
of that carrier is a single strip or sheet, the claim is not so limited.
- Accordingly,
I find that the MDS devices contain a dry porous carrier within the meaning of
claim 1 of the first patent. For the
same reasons, I find that the MDS devices
contain a dry porous carrier within the meaning of claim 1 of the second, third
and fourth
patents.
Bibulous sample liquid receiving member “within said casing”
- Only
the claims of the third patent contain the integer of a ‘bibulous
sample liquid receiving member within said casing to receive sample liquid
applied to said application aperture’. In issue is whether
“within” in this integer means only “wholly within” as
contended by MDS or also
“partly within” as contended by Inverness.
It is agreed between the parties that if MDS’ construction is correct,
this integer is absent from QuickStream but present in QuickCard.
- MDS
relies on the Oxford English Dictionary meaning of the word
“within”, namely: ‘in the inner part or interior, or on the
inner side (of a receptacle or other material thing); inside,
internally’ to contend that the QuickStream sample receiving member is
not “within” the casing because it protrudes from it.
In answer, to
support its construction that, in the context of the specifications,
“within” does not require the sample
receiving member to be wholly
within the casing, Inverness relies on figures 8 and 9 in the specification
depicting an embodiment
of the invention with the sample receiving member
protruding from the casing.
- Relevant
dictionary definitions of “within” provide for a meaning that
includes penetration into the interior of an enclosed
space (see Macquarie
Dictionary online, Oxford English Dictionary online, Black’s
Law Dictionary (6th ed, West Publishing Co, 1990)).
They also include definitions that necessitate being inside and not beyond the
boundaries or limits
of a space. As was said in
Texas State Commission for
the Blind v the United States [1986] USCAFED 690; 796 F2d 400 (Fed Cir 1986) at [92], the word
is not without some ambiguity and can mean “a part of” as well as
“inside”.
- An
embodiment of the invention at pages 7 and 8 of the specification and another
embodiment at pages 22 to 26 (see also figures 8
and 9) both clearly involve a
sample receiving member which protrudes from the casing, that is, partly within
and partly outside
the casing. However, that does not necessarily mean that the
claims, by using the expression ‘bibulous sample liquid receiving
member within said casing’ include those embodiments. The claims can
be narrower than the description in the specification.
- In
describing the position of the porous sample receiving member 506 depicted in
figures 8 and 9, which protrudes from the casing,
the specification does not use
the word “within” (at pages 22-26). However, in describing
the same embodiment, the patentee uses the word “within” to describe
the position
of the carrier strip 510 which is depicted in figures 8 and 9 as
wholly within the casing, for example:
...as long as the strip is held firmly in place within the
housing... (at page 23)
Member 506 therefore provides the sole route of access for the sample to the
strip within the housing... (at page
25)
In another embodiment where there is no protruding sample receiving member,
the specification uses the words ‘within the body’ to
describe a test strip which is depicted in figure 3 as wholly within the casing
of the device (at page 20).
- The
use of the word “within” in the specification supports the
definition contended by MDS that “within”
means “wholly
within” and the bibulous receiving member of the claims of the third
patent must be wholly within the casing.
Accordingly, the integer of a
‘bibulous sample liquid receiving member within said casing to receive
sample liquid applied to said application aperture’ is present in
QuickCard but not in QuickStream.
Porous material backed with transparent moisture-impervious material
- Inverness
alleges that QuickStream infringes claims 9 and 10 of the third patent. Claim 9
contains the integer:
[the] porous carrier is a strip or sheet of porous material backed with a
layer of transparent moisture-impervious material, said transparent
layer being
in contact with the inside of said casing adjacent said result observation
aperture to inhibit ingress of moisture or
sample
liquid.
- MDS
contends that QuickStream does not contain this integer for the following
reasons:
- It
does not have a single “strip or sheet of porous material” but a
test strip made up of individual components.
- It
is not backed with a layer of “transparent moisture-impervious
material”, but rather with a strip of white vinyl which
is not
transparent. This white vinyl strip is also not adjacent to the observation
apertures but is against the casing on the other
side, opposite the
apertures.
- A
very small transparent piece of material (the clear plastic strip)
covers only the pink conjugate pad. However, the clear plastic strip is not
adjacent the apertures, in that it is not directly
beneath the apertures when
the casing is closed, and also does not perform the function of inhibiting
ingress of moisture or sample.
In QuickStream, inhibition of moisture is
achieved in a completely different way, by external plastic windows that form
part of
the casing.
- Inverness
contends that the clear plastic strip, which is in contact with the casing on
the same side as the apertures, constitutes
the integer in question. It submits
that the word “backed” means no more than “coated” so
that the impervious
layer can be on top of or underneath the porous carrier
because it has a functional meaning. I do not accept this contention. The
claim uses “backed” which has a different meaning to
“coated”.
- The
white vinyl strip is not transparent and does not fulfil the requirements of the
claim. The opposite side of the casing to the
observation aperture does not
equate to and is not encompassed by the words of the claim. In QuickStream, the
clear plastic strip
does not perform the function of inhibiting ingress of
moisture or sample liquid through the aperture, as this function is achieved
through the clear plastic windows built into the casing. The fact that,
functionally but by different means, the MDS device achieves
a similar result is
not to the point. The patentee has specified the means by which its claimed
device functions.
- QuickStream
is, in this respect, outside the scope of and does not infringe claim 9 of the
third patent. As claim 10 is dependent
upon claim 9, QuickStream does not
infringe claim 10.
INFRINGEMENT GENERALLY, APART FROM CONSIDERATION OF VALIDITY
The first and second patents
- The
parties agree that claim 1 of the first patent is infringed by the MDS devices
and claim 1 of the second patent is infringed
by QuickStream if Inverness’
constructions of “specific binding reagent for an analyte” and
“dry porous carrier”
are accepted. Based on my findings above,
claim 1 of the first patent is infringed by QuickStream and QuickCard and claim
1 of the
second patent is infringed by QuickStream.
The third patent
- It
follows from the meaning of “dry porous carrier” and “bibulous
sample liquid receiving member within said casing”
that claim 1 of the
third patent is infringed by QuickCard but not by QuickStream.
- It
follows from the meaning of “porous material backed with a layer of
transparent moisture-impervious material” that
claims 9 and 10 of the
third patent are not infringed by QuickStream.
The fourth patent
- Claim
1 of the fourth patent contains an integer which is not contained in any of the
other three patents, namely that the particulate-labelled
specific binding
reagent is retained in a ‘macroporous body having a pore size of not
less than 10 times greater than the maximum particle size of the particulate
label’. Inverness says that the conjugate pad in each of the MDS
devices constitutes the macroporous body within this claim. MDS
does not
dispute that the MDS devices contain a “macroporous body” per se
but has put Inverness to proof of establishing the relationship between the
pore size of the macroporous body and the particle size
of the label. MDS did
not adduce evidence of the pore size or the particle size of its
devices.
Electron micrograph evidence
- Inverness
instructed Mr Furzeland, an electron-microscopist, to examine the MDS
devices under an electron microscope and produce
and examine the resulting
electron micrographs. Mr Furzeland’s evidence is that the maximum
particle size of the direct
label was of the order of 45 nanometres in QuickCard
and of the order of 65 nanometres in QuickStream. This evidence is not
challenged
by MDS.
- Mr
Furzeland also gave evidence that from the images taken of the conjugate pad in
the MDS devices he estimated that, although he
saw smaller pores, the majority
of the pores on the conjugate pad were greater than 200 microns (2.00 x
10-4 metres) in size. If this is correct, the average
pore size would be greater than 200 microns. Ms Boscato read the same
micrographs
and gave evidence that the top view and the cross section view in
combination allowed her to calculate the pores to be 50-150 microns
for
QuickCard and 40-110 microns for QuickStream. Inverness relies on this evidence
to prove that the direct labels in the MDS devices
are smaller, by a factor of
about 1,000, than the average pore size of the conjugate pad, amply meeting the
requirement in the fourth
patent that they be at least 10 times smaller (a
nanometre is 10-9 metres; a micron is
10-6 metres). Inverness says that any errors inherent
in the estimate of pore sizes are amply compensated by the orders of magnitude
in difference between the two figures.
- MDS
submits that Inverness’ evidence fell short of proving that the MDS
devices incorporate a macroporous body as defined in
the claims. It challenges
the evidence of Mr Furzeland on the basis that his use of Scanning Electron
Microscope (SEM) images to calculate pore size is inaccurate and that a
different device, a porometer, should have been used instead. MDS points
to Mr
Furzeland’s concession in cross-examination that SEMs, unlike porometers,
cannot give any accurate indication in three
dimensions of the mean pore
diameter in a material and that his use of a scalpel to cut the sample before he
took the SEM images
could have caused the fibres to move and possibly separate
and thus affect the true measurements.
- In
reply, Inverness contends that although SEM images are not three-dimensional,
pore size can be ascertained by the micrographs
of the top view and
cross-section views in combination, as Ms Boscato did. It further contends
that the porometer is a “red
herring” because there is no evidence
that a porometer was widely available at the priority date of the fourth patent
or that
the measurements should be made by an instrument that was then
available. Inverness further points out that MDS chose not to adduce
any
evidence as to pore size, which could have been easily proved using the
manufacturer’s specification for its material.
Inverness submits that the
Court can infer that MDS could adduce no evidence that would support its
argument that there was no macroporous
body as defined in the claims in the MDS
devices.
- Inverness
is alleging infringement. It is therefore for Inverness to establish that the
MDS devices fall within the scope of the
claims said to be infringed.
- Claim
1 of the fourth patent provides for the relative pore size of the macroporous
body without reference in the claims or the specification
to the means of
measurement. The criterion is objective. There is no reason to import a
requirement that the measurement must be
with any specific instrument. If an
electron microscope image can used satisfactorily to establish pore size, then
it is acceptable.
This is a matter for evidence.
- While
Mr Furzeland accepted some error and some deficiencies of three dimensional
measurements under an SEM, the claim does
not specify three-dimensional
measurement. Mr Furzeland and Ms Boscato measured the pore size in
two dimensions from the
micrographs. While that does not measure pore size along
the length of the fibres, MDS has not established the degree of error, if
any,
to which these measurements should be subjected, nor that the skilled reader
would understand pore size as referred to in the
claim as other than a
combination of top view and cross section view. Ms Boscato’s
understanding of the claim and her presentation
of her evidence of pore size for
the purposes of the claim as the skilled reader were not effectively challenged.
I accept her evidence.
- Inverness
has not provided statistical evidence of acceptable error. Neither has MDS.
The order of magnitude of the difference
between the measured pore size and the
maximum particle size is sufficiently greater than the 10-fold difference
required by the
claim to provide for the unquantified error that may be involved
in Mr Furzeland’s preparation for SEM imaging. Mr Furzeland
maintained
that the average pore size was 200 microns.
- I
am satisfied that the MDS devices contain a macroporous body having a pore size
of not less than 10 times greater than the maximum
particle size of the
particulate label, within claim 1 of the fourth patent. It follows from this
finding and my earlier findings
on the construction of “specific binding
reagent” and “dry porous carrier” that claim 1 of the fourth
patent
is infringed by QuickStream and QuickCard.
Email from the manufacturer of macroporous body in the MDS devices
- Apart
from the evidence of Mr Furzeland and Ms Boscato, Inverness seeks to
rely on a representation contained in an email
to prove the pore size of the
macroporous body in the MDS devices. MDS objects to the admissibility of the
representation. In light
of my findings based on the SEM evidence, it is not
necessary to consider the representation but I will nonetheless deal with its
admissibility.
- There
is evidence that the macroporous body in the MDS devices (that is, the conjugate
pad) is composed of a certain glass fibre
grade specified in a confidential
exhibit. I will refer to the grade as grade X. That was manufactured by
a specified manufacturer (the manufacturer). Inverness’ lawyers,
through a Mr Raj, made enquiries to the general sales manager of the
manufacturer regarding the
pore size of glass fibre grade X. The sales manager
replied by an email dated 28 February 2009 (the Email).
- MDS
objects to the admissibility of the Email as hearsay. Inverness seeks to rely
on the business record exception to the hearsay
rule in s 69 of the Evidence
Act 1995 (Cth) (the Evidence Act). Section 69 relevantly
provides:
(1) This section applies to a document
that:
(a) either:
(i) is or forms part of the records belonging to or kept by a person, body or
organisation in the course of, or for the purposes of,
a business;
or
(ii) at any time was or formed part of such a record;
and
(b) contains a previous representation made or recorded in the document in
the course of, or for the purposes of, the
business.
(2) The hearsay rule does not apply to the document (so far as it contains
the representation) if the representation was
made:
(a) by a person who had or might reasonably be supposed to have had personal
knowledge of the asserted fact; or
(b) on the basis of information directly or indirectly supplied by a person
who had or might reasonably be supposed to have had personal
knowledge of the
asserted fact.
(3) Subsection (2) does not apply if the
representation:
(a) was prepared or obtained for the purpose of conducting, or for or in
contemplation of or in connection with, an Australian or
overseas
proceeding;
- The
Email is as follows:
Hi Raj,
Please find here below the technical information received from our Mount
Holly mill.
The information received from the Lab is as
follows:
Roughly 10+ years ago when we were looking into entering the hydraulic glass
market, [grade X] was to be part of the product line we offered. Because
the flow is so high on this glass grade, we gave it a micron rating of 40
– 50. This was based on porometer testing and multi-pass testing performed
on this grade. I still feel confident stating that
the retention of [grade
X] is in the range of 40 – 50 microns.
(the representation for the purposes of
s 69)
All the best,
[Sales manager]
- It
does not seem to be disputed that the representation was made for the purposes
of the manufacturer’s business as it was
a purpose of that business to
answer enquiries made about their products. MDS’ objection is that the
representation was obtained
in connection with an Australian proceeding for the
purposes of s 69(3)(a) of the Evidence Act. Inverness submits that
Mr Raj, who elicited the response from the manufacturer, did not cause the
representation from “the
Lab” ‘to be made in the form which
it takes’ (Australian Competition and Consumer Commission v
Advanced Medical Institute Pty Ltd [2005] FCA 1357; (2005) 147 FCR 235 at [27] per Lindgren
J) and, as he had no input into the form of the representation, Mr Raj was
not relevantly the person who “obtained”
it. Inverness says that
the sales manager of the manufacturer was the relevant person who
“obtained” the representation
but that he clearly did not do so in
connection with the present proceedings as he had no knowledge of these
proceedings.
- The
Email is dated 28 February 2009. It was clearly elicited and sent in connection
with the Australian proceedings. The representation
contained in the Email is
not a laboratory report of results of testing. It is the general sales
manager’s report of the recollection
of someone in “the Lab”
of test results of over 10 years ago. The information from the Lab was sought
and obtained as
a direct result of the request from Mr Raj made in
connection with and for the purposes of these proceedings.
- The
exception to the hearsay rule provided for in s 69(2) of the Evidence Act
does not apply by reason of s 69(3). The representation contained in the
Email is not admissible for proving the pore size of the macroporous body in the
MDS devices.
The form of the representation is a summary of recollection and
opinion also made in connection with the proceedings. Further,
in its form and
content, it accords with the rationale of unreliability which underlies
subsection (3) (Advanced Medical Institute at [27] per Lindgren J). Even
if it were admissible, it has in my view little or no probative value in view of
its form and lack
of detail.
- Inverness
further asks me to exercise my discretion under s 190(3) of the Evidence
Act to order that the hearsay rule does not apply to the representation because
the matter to which the representation relates is not
genuinely in dispute.
Inverness says that the matter is not genuinely in dispute because MDS has not
put an affirmative case against
it on the pore size of the macroporous body.
MDS has put the proof of the pore size in dispute. Section 190(3) does not
apply.
VALIDITY
Applicable law
- The
first and fourth patents were filed under the Patents Act 1952 (Cth)
(the 1952 Act) and granted under the 1990 Act. The second and third
patents were filed and granted under the 1990 Act. It is not disputed that
the
validity of the first and fourth patents is governed by the 1952 Act
(s 234(1) of the 1990 Act; Regulation 23.26(2) of the Patents
Regulations 1991 (Cth)). It is not disputed that the validity of the second
and third patents is governed by the 1990 Act.
Utility
- The
ground of lack of utility is couched in the same terms in the 1952 Act and the
1990 Act. The parties did not contend that a
different test of utility should
be applied to the different patents and made submissions on the utility of all
four patents compendiously.
Section 18(1)(c) of the 1990 Act requires that a
patentable invention, so far as claimed in any claim, must be useful. It is for
MDS, which asserts a lack of utility, to establish the ground of
invalidity.
- One
test of utility is whether the claimed invention fulfils the promises of the
specification, in that it does what was intended
and claimed by the patentee,
and whether the end obtained is itself useful (Advanced Building Systems Pty
Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19; (1998) 194 CLR 171 at 187 for the
first limb, Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC [2008] FCAFC 82; (2008) 77
IPR 449 at [144] for both limbs). MDS contends that both these limbs must be
satisfied for an invention to be useful. Inverness contends that the
only
practical way to test utility is to determine whether the invention as claimed
attains the result promised by the patentee,
rather than to seek to assess
general usefulness in a vacuum.
- A
principle has been expressed that all within the scope of a claim must be useful
if the claim is not to fail for want of utility,
so that a claim is bad if it
covers something that will not produce the desired result, even if a skilled
person would know which
means to avoid it (WM Wrigley Jr Co v Cadbury
Schweppes Pty Ltd [2005] FCA 1035; (2006) 66 IPR 298 at [138] per Heerey J and
authorities there cited). This was the test applied by the primary judge in
Lundbeck and the parties did not dispute this test in the appeal in that
case (Lundbeck at [217]). However, this principle does not mean that a
specification should be construed in a way that any sensible person would
appreciate would lead to unworkability when by construction it could be given a
more limited meaning (Welch Perrin at 602 per Menzies J). The
claims should be construed as they would be by the person skilled in the art
desirous of making use of
the invention (Martin Engineering Co v Trison
Holdings Pty Ltd (1989) 14 IPR 330 at 338 per Burchett J; see also Austal
Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805; (2006) 66 IPR 420 at [227]- [239]).
It has also been said that a claim does not need to specify a limitation that
was common knowledge in the art for that limitation
to apply in construing a
claim to avoid want of utility (Austal Ships at [236] per Bennett J,
citing Washex Machinery Corporation v Roy Burton & Co Pty Ltd (1974)
49 ALJR 12 at 18 per Stephen J). In Lundbeck (at [217]),
Bennett J, with whom Middleton J agreed, affirmed the test as set out in
Ranbaxy and Austal Ships.
- The
claims of the patents allow the reader to select which specific binding reagents
to use in the device, although the specifications
express preference for
reagents such as highly specific antibodies and monoclonal antibodies. Where a
claim omits a feature which,
on a proper construction of the claim, is left for
the reader to supply, the claim will not be invalid for want of utility if the
feature is one that the skilled addressee could reasonably be expected to supply
and the claimed invention is useful after the feature
is supplied (Bodkin C,
Patent Law in Australia (Lawbook Co, 2008) at [6080]; Rescare Ltd v
Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 143 per Gummow J;
appeal allowed but the Full Court did not consider utility). A similar approach
should be adopted where
a claim leaves a choice to the skilled reader to select
features to include in the invention. In such circumstances, the fact that
it
is possible to make a purposeful selection of inappropriate features with the
intention of making something useless does not imply
that the claim lacks
utility (Bodkin at [6070]; Martin Engineering at 338 per
Burchett J).
- In
NV Philips Gloeilampenfabrieken v Mirabella
International Pty Ltd [1992] FCA 333; (1992) 24 IPR 1, the claims of a patent for a lamp did
not identify any particular phosphor to use when many phosphors within the
claims, and phosphors
improperly prepared, would not be useful for the stated
purpose. Justice Wilcox, in obiter (at 37-38), considered that this did
not
render the claims invalid for want of utility because he found that a skilled
addressee would know which phosphors have the necessary
qualities to make them
worth testing and would appreciate the necessity for proper preparation
(affirmed in NV Philips Gloeilampenfabrieken v Mirabella International Pty
Ltd [1993] FCA 404; (1993) 44 FCR 239 at 267 per Lockhart J, with whom Northrop J and, on
this aspect of the case, Burchett J agreed). The subject matter of the
invention
is also important. In Abbott Laboratories v Corbridge Group Pty
[2002] FCAFC 314; (2003) 57 IPR 432, the Full Court upheld a claim which included combinations
of mediator compound, enzymes and substances of interest which do not
work
because the invention of the patent was a device (a sensor), not a chemical
reaction or process. The Full Court considered
that it was sufficient for the
requirement of utility if the invention was effective in relation to some
substances of interest.
- In
order to determine whether a claim is bad for lack of utility, it is necessary
to construe the claim, understand the specification
and consider any evidence on
the usefulness, or lack thereof, of the invention.
- The
first patent asserts that the invention relates to analytical devices which:
- are suitable for
use in the home, clinic or doctor’s surgery;
- give a rapid
analytical result requiring a minimum degree of skill; and
- adapt and
improve known techniques, which enable determination of an analyte in a sample
using labelled reagents and immobilised specific
binding reagents, to provide
diagnostic test devices suitable for home use which are quick and
convenient.
- The
first patent describes features which enable a quick and clear result ideally
discernable by the eye and which increase the probability
of an observable
result (at page 6). As to the “important embodiment” of a pregnancy
testing device, the specification
describes the use of a highly specific
anti-hCG antibody in each of the first and second zones, with specificities for
different
hCG epitopes (at pages 7-8). The specification then states that
‘the presence or intensity of the signal from the label which becomes
bound in the second zone can provide a qualitative or quantitative
measurement of analyte in the sample’ (emphasis added) (at page 11).
It also states that, by choice of appropriate specific binding reagents, an
assay can be used
to determine a wide variety of analytes (at page 17). The
word “can” is repeatedly used to describe what the device
can
achieve. The specification also states that, by using the test strip materials
and reagents as described, a device can be produced
‘which is eminently
suitable for use as a pregnancy test kit or fertile period test kit for use in
the home or clinic’ (at page 25). The fertile period test kit tests
for LH. The specification also explains that, ‘due to the structural
homology between the alpha subunits of hCG and LH, alpha hCG antibody can be
used to detect LH in a cross-reactive
immunoassay’ (at page 34). At
a broader level, the invention achieves its purpose if the specific binding
reagents are chosen such that,
in combination, they are selective for the
desired analyte. They must both bind with the analyte in a specific binding
reaction
but do not both need to be highly specific or mono-specific for that
analyte. Ms Boscato considered that she and anyone skilled
in art would be
capable of selecting appropriate specific binding reagents to set up an assay
which effectively detects the targeted
analyte.
- That
is, the claimed invention of the first patent is an improved diagnostic test
device, with the improvement not being in the ability
to detect the analyte with
greater certainty or with less cross-reactivity of the reagent, but in the speed
and convenience of the
test. The specification recognises that the operations
involved in the prior art devices involve time and introduce the possibility
of
error and it is apparent that the devices of the first patent are intended to
reduce the steps involved and thereby reduce error.
There is no statement that
error will be eliminated. There is no evidence that the known techniques which
were to be adapted were
of any particular sensitivity, that the specific binding
reagents of the prior art devices were mono-specific or otherwise, or that
there
was no degree of cross-reactivity of those reagents. The first patent promises
convenience of use. If the analyte is present,
it will be bound; if sufficient
analyte is bound, it will be detectable. The specification says nothing about
false positives, false
negatives, cross-reaction, accuracy or commercial
success.
- MDS
contends that the test for utility has two parts: fulfilling the promise of the
patent in that the claimed invention must do
what was intended and the end
result must be useful. MDS says that what is promised in the first patent and
claimed in claim 1 is
an analytical test device which will function as an
analytical test device for the targeted analyte and, from that, accuracy is
necessarily
a promise. Without conceding whether some inaccuracy must be
imported in any test device, MDS says that the degree of cross-reactivity
by use
of reagents in both the first zone and the detection zone that bind not only
with hCG but also with hormones with the same
α-subunit gives rise to
unacceptable and non-useful inaccuracy in the detection of hCG that does not
accord with the promise
of the specification.
- MDS
also says a device that yields false positives and false negatives is not useful
and that this is the case if “specific
binding reagent” permits the
use of a reagent that is not mono-specific to the analyte to be detected. False
positive results
may occur in a sandwich assay if neither the labelled reagent
nor the unlabelled reagent is mono-specific for the analyte, so that
another
molecule in the sample can bind to both reagents and be detected. If the
labelled reagent in the first zone is specific
only for hCG, then only hCG will
be labelled and able to be detected in detection zone. However, if the
unlabelled reagent in the
detection zone is not specific only for hCG, other
hormones with equal or higher affinity, such as LH, will bind to it. The
unlabelled
reagent, having bound the LH, will not be available to bind with the
labelled hCG which will then not be detected, giving a false
negative. MDS says
that its devices use scavenger molecules to bind with the LH to prevent this
occurring. MDS says that the construction
of “specific” for which
Inverness contends and I accept, means that the claimed invention is useless in
testing for the
presence of hCG.
- Both
experts accepted in affidavit evidence that for a pregnancy test, it would not
be clinically useful to have both antibodies
in a sandwich assay, or the
antibody in a competition assay, binding to the α-subunit of hCG, as that
subunit is common to the
other glycoprotein hormones, although Ms Boscato
reconsidered this position during the hearing. The experts also agreed that it
would be clinically useful to have the antibody of a competitive assay, or one
antibody of a sandwich assay, that binds to sites
other than the α-subunit
of hCG, such as the ß-subunit of hCG which is unique for each glycoprotein
hormone. They agreed
that it is the ß-subunit that confers biological
specificity and allows detection of the individual hormone.
- However,
during cross-examination, Ms Boscato said that a device constructed with
anti-α antibodies in both zones would not
be completely clinically useless
because although there could well be a false positive result, there would be
some utility as there
would not be a false negative result. An absence of
detection would correctly indicate an absence of pregnancy. While Ms Boscato
accepted that, theoretically, there could be a false negative if there were high
concentrations of the non-hCG glycoprotein hormones
and insufficient reagent she
said, and I accept, that the skilled worker would not devise an assay with
insufficient reagent, to
allow for that possibility. Ms Boscato conceded
that use of the anti-ß antibody would result in a device that was more
clinically useful but did not accept that a device using only anti-α
antibodies lacked utility.
- Further,
even some anti-ß antibodies may bind to both hCG and LH as there are sites
on the ß-subunits of hCG and LH which
are common. That is, anti-ß
antibodies may cross-react. It is apparent that there are degrees of
cross-reactivity with the
use of different reagents and that the possibility of
a false positive or false negative result is inherent in the nature of the
analytical tests. The patents do not contend otherwise. Further, the claims
are not restricted to pregnancy testing devices but
include devices to test for
other reagents which may not have unique binding sites and for which
cross-reactivity is a greater possibility.
Dr Sinosich accepted that such
test devices can still be useful in clinical or research work.
- A
test device constructed according to the claims and as understood by the skilled
addressee has not been shown to lack utility.
The fact that, in theory, one
could construct a device according to the claims that, in certain circumstances,
would not detect the
analyte is insufficient to render the invention so far as
claimed in the claims invalid for want of utility.
Sufficiency
- The
parties have proceeded on the basis that the test for sufficiency is the same
under the 1952 Act and the 1990 Act. The test
for sufficiency is whether the
disclosure in each of the patents enables the skilled addressee to produce
something within each claim
without new inventions or additions or prolonged
study of matters presenting initial difficulty (Kimberly-Clark at
[25]).
- MDS
contends that, on the construction of “specific binding reagent for an
analyte” that I have accepted, the first,
second and fourth patents are
invalid for insufficiency. It also contends that the third patent is invalid
for insufficiency by
virtue of the lack of limitation in claim 1 to a binding
reagent in the detection zone that is a ‘specific binding reagent for
the same analyte’.
- MDS
contends that if the permanently immobilised reagent in the detection zone is
not “specific” in the sense of being
capable of distinguishing
between analytes and preferably binding only to the target molecule with limited
or no cross-reactivity
with other molecules, scavenger molecules need to be used
to remove or clean-up unwanted antigens or hormones which would otherwise
bind
to the immobilised reagent. Scavenger molecules would “soak up”
molecules in the sample that are not to be tested,
enabling the specific binding
reagent to bind to and enable detection only of the desired analyte.
Dr Sinosich gave evidence
on the use of scavenger molecules to address the
problems of cross-reactivity and false positives which would otherwise affect a
device using reagents not mono-specific for the analyte. It is not disputed
that, at the relevant priority dates, the use of scavenger
molecules would have
involved new invention or addition or prolonged study of matters presenting
initial difficulty. MDS submits,
in effect, that the claimed device of each of
the patents is to test for an analyte with no cross-reactivity and no false
positive
or false negative results, so that a device within the claims is not
possible in the absence of scavenger molecules.
- The
claims of the patents are not limited to devices which give no false positives
and no false negatives. The test is not whether
the specifications are
sufficient to enable the production of such a device. The claims include
devices which may give a false positive
for hCG and may give a false negative
for hCG. The specifications are sufficient to enable the production of such a
device, which
is useful even without the use of scavenger molecules. There is
no evidence that the skilled worker could not make the inventions
as claimed or
that he or she would make a device that failed to detect an analyte.
Ms Boscato said that she could set up an
assay within the claims from what
she was told by the patentee. Further, for the reasons given in respect of the
claimed lack of
utility, I reject the underlying premise in MDS’
submissions that a lack of cross-reactivity is a necessary part of the
invention.
- MDS
has failed to establish that the patents are invalid for a want of
sufficiency.
Clarity
- MDS
contends that claim 1 of the second patent and claim 22 of the fourth patent are
invalid for lack of clarity. Claims are required
to define the invention
clearly and succinctly so that readers can ascertain the precise extent of
monopoly claimed. If a claim is
ambiguous, the ambiguity may be resolved by
reference to the body of the specification, failing which the claim is invalid
(Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1998) 39 IPR 56 at
94–95 per Lindgren J).
- MDS
contends that claim 1 of the second patent fails to comply with s 40(3) of
the 1990 Act as the following words in bold are
not clear or capable of any
sensible meaning:
the device also containing a labelled specific binding reagent for an
analyte, or which can participate in a competition reaction in the presence
of an analyte....
[emphasis added]
- Inverness
explains that this passage refers to two types of labelled specific binding
reagents: a labelled specific binding reagent
for an analyte, and a labelled
specific binding reagent which can participate in a competition reaction in the
presence of an analyte,
such as a labelled analyte or a labelled analogue of the
analyte. Ms Boscato gave evidence that she understood the words in that
way.
This explanation appears sensible and is consistent with the disclosures in the
specification regarding competition reactions.
- MDS
also contends that claim 22 of the Fourth Patent fails to comply with
s 40(2) of the 1952 Act as the word “having”
is not clear in
the following passage:
the labelled antibody having freely mobile within the macroporous body
and the porous carrier when in the moist
state.
[emphasis added]
- In
an almost identical passage in the body of the specification, the word
“having” is replaced by “being”.
The sentence in claim
22 does not make sense and clearly contains a mistake. A reader wishing to
clarify the meaning of the passage
would go to the specification and immediately
see that the word “having” should be read as “being”.
There
is no relevant lack of clarity.
Priority date of the third patent
- The
third patent was filed as a divisional of the first patent. Accordingly, it
takes the priority date of the first patent if it
is fairly based on matter
disclosed in the priority documents from which the first patent takes priority
(s 79B of the 1990
Act; Reg 3.12(1)(c) and (2C) of the Patents
Regulations 1991 (Cth)). If fairly based on the first patent but not on the
priority documents, the third patent will take as its priority date the
filing
date of the first patent. The first patent claims priority from two Great
Britain applications (GB 8709873 and GB 8800322)
(Parent Priority
Documents) with priority dates of 27 April 1987 and 30 October 1987
respectively. The filing date of the first Patent is 26 April 1988.
- MDS
contends that the third patent is not fairly based on the Parent Priority
Documents or on the first patent such that the priority
date of the third patent
is its own date of filing, 21 May 1992. MDS asserts lack of novelty of the
third patent by reason
of a publication of 29 June 1989. This ground of
invalidity can only succeed if the priority date of the third patent is its own
date of filing.
- In
Lockwood Security Products v Doric Products Pty Limited [2004] HCA 58; (2004) 217 CLR
274, the High Court stated at [69] that the fair basing requirement in
s 40(3) of the 1990 Act requires a ‘real and reasonably clear
disclosure’ of what is then claimed. The High Court said that it is
wrong to apply an ‘over meticulous verbal analysis’ and the
comparison is not analogous to that between a claim and an alleged anticipation
or infringement (at [68]). The correct
analysis is whether ‘the
invention is broadly, that is to say in a general sense, described in the body
of the specification’ or whether it ‘travel[s] beyond
the matter disclosed’ (Rehm Pty Ltd v Websters Security Systems
(International) Pty Ltd (1988) 81 ALR 79 at 95 per Gummow J, quoted
with approval in Lockwood at [69]; Synthetic Turf Development Pty Ltd
v Sports Technology International Pty Ltd [2005] FCAFC 270; (2005) 67 IPR 475 at [26];
Lockwood at [57]). Disclosure is not limited to preferred embodiments
set out in the specifications (Lockwood at [69]). These principles are
equally applicable to determining whether the claims in a divisional patent are
fairly based on matter
disclosed in a parent patent or a priority document.
- MDS
asserts that claim 1 of the third patent and consequently each of the relevant
dependent claims are not fairly based on the Parent
Priority Documents or the
first patent because they do not include the limitation that the unlabelled
immobilised reagent of the
detection zone be a specific binding reagent for the
analyte. MDS submits that in each of the Parent Priority Documents and the
first patent, the labelled reagent in the first zone is not limited to a
specific binding reagent although a preferred embodiment
contains that
limitation, but the unlabelled immobilised reagent of the second zone is always
required to be a specific binding reagent.
- Claim
1 of the third patent relevantly requires the device to
contain:
a labelled specific binding reagent in the dry state in said device prior to
use and which is released into mobile form by applied
sample liquid...said
porous carrier conveys said labelled reagent to said test result zone of said
carrier wherein said labelled
reagent becomes bound if said sample liquid
contains said analyte.
- That
is, the claim provides for a labelled specific binding reagent in the first
zone. A labelled specific binding reagent comes
within the class of a labelled
reagent and is fairly based. However, in the “test result zone”,
the claim of the third
patent only requires that the labelled reagent
“becomes bound” if the analyte is present in the sample and does not
specify
binding by a specific binding reaction between reagent and
analyte.
Disclosures in the first patent and the Parent Priority Documents
- Inverness
contends that the specifications of the first patent and the Parent Priority
Documents generally disclose a process whereby
the labelled reagent becomes
bound in the detection zone. Inverness refers to the sentences in bold in the
following extracts from
the specifications of the first patent, among others, as
examples of such disclosure:
The use of reagent-impregnated test strips in specific binding assays, such
as immunoassays, has previously been proposed. In such
procedures a sample is
applied to one portion of the test strip and is allowed to permeate through the
strip material, usually with
the aid of an eluting solvent such as water. In so
doing, the sample progresses into or through a detection zone in the test strip
wherein a specific binding reagent for an analyte suspected of being in the
sample is immobilised. Analyte present in the sample can therefore become
bound within the detection zone. The extent to which the analyte becomes
bound in that zone can be determined with the aid of labelled
reagents... [emphasis is mine] (page 2)
In one embodiment of the invention, the labelled reagent is a specific
binding partner for the analyte. The labelled reagent, the
analyte (if present)
and the immobilised unlabelled specific binding reagent cooperate together in a
“sandwich” reaction”.
This results in the labelled reagent
being bound in the second zone if the analyte is present in the
sample...[emphasis is mine] (page 4)
- The
sentences preceding the sentences relied on by Inverness clearly refer to the
immobilisation of a specific binding reagent for
the analyte. Inverness argues
that the reference in each preceding sentence to a specific binding reagent
merely indicates one means
by which the analyte can become bound in the
detection zone and does not limit the general disclosure in the subsequent
sentence.
Read in context, it is clear that it is the immobilised specific
binding reagent which causes or results in the labelled reagent
binding within
the detection zone if an analyte is present. Inverness refers to evidence that
at the priority date, ways for an
analyte to become bound other than by use of a
specific binding reagent were known in the field. However, Inverness has not
referred
to any parts of the first patent or the Parent Priority Documents which
disclose another way for the labelled reagent to bind in
the detection zone.
- Inverness
relies on the following passages from the Parent Priority Documents to provide a
fair basis for claim 1 of the third patent:
This results in the labelled reagent being bound in the second zone if the
analyte is present in the sample... (Page 2 of
GB8709873)
...the presence of the analyte in the sample being determined by observing
the extent (if any) to which the labelled reagent becomes
bound in the second
zone... (Pages 1 and 2 of GB8725457)
Read in context, however, it is again clear that it is the immobilised
specific binding reagent which causes or results in the labelled
reagent being
bound in the second zone as set out in these passages.
Fair basing on the Parent Priority Documents
- Inverness
says that the Parent Priority Documents are provisional specifications, which
merely need to describe the invention generally
and fairly and can be in a rough
state and that the details of the invention may be developed to some degree in
the final specifications
(Anaesthetic Supplies Pty Ltd v Rescare [1994] FCA 1065; (1994)
50 FCR 1 at 20 per Lockhart J). It argues that such development includes
amending terms to describe broadly various embodiments already considered
and
described.
- The
Parent Priority Documents do not contain a real and reasonably clear disclosure
of any way by which the labelled reagent may
bind in the detection zone other
than by use of a specific binding reagent for the analyte immobilised in the
detection zone (Synthetic Turf at [28]–[29]). Unlike in
Delnorth Pty Limited v Dura Post (Aust) Pty Limited [2008] FCA 1225; (2008) 78 IPR 463,
the method by which the labelled reagent binds to the detection zone is
fundamental to the operation of the invention. The first
sentence in all three
priority documents states that the invention relates to “assays involving
specific binding”.
- The
Parent Priority Documents do not envisage or disclose a device that binds the
labelled reagent/analyte complex in the detection
zone by other than a specific
binding reagent for the analyte. Claim 1 of the third patent is broader than
the disclosure of the
Parent Priority Documents. It follows that the claims of
the third patent are not fairly based on the Parent Priority Documents
and are
not entitled to the dates of their filing. The earliest filing date available
for the third patent is then the filing date
of the first patent, if fairly
based upon that specification.
Fair basing on the first patent
- The
third patent was filed prior to the expiry of three months since the publication
of the acceptance of the first patent. Therefore,
the question is whether the
third patent is disclosed in the specification of the first patent as a whole
(s 79B(1)(a) of the
1990 Act).
- Claim
1 of the first patent requires a specific binding reagent for the analyte to be
present in the detection zone as the unlabelled
immobilised reagent. The
specification makes repeated reference to the unlabelled specific binding
reagent in the detection zone.
It describes preferred embodiments in terms of
the degree of specificity of that reagent. Read as a whole, the specification
of
the first patent is concerned with, discloses and describes devices in which
the immobilised reagent of the detection zone is a specific
binding reagent; the
way in which the analyte becomes bound is by a specific binding reaction.
- Claim
1 of the third patent does not contain that limitation. The class of devices of
the third patent is wider than or, put another
way, the invention as claimed in
the third patent travels beyond, the disclosures and description of the
specification of the first
patent.
- It
follows that the earliest priority date of the third patent is the date of its
own filing.
Novelty – third and fourth patents
Legal principles
- MDS
attacks claims of the third and fourth patents on the ground of lack of novelty.
For a claim to lack novelty, a prior publication
must disclose all of the
essential integers of the relevant claim. It must supply enough information to
enable a person of proper
skill in the art to apply the discovery without the
need to conduct further experiments, other than ordinary methods of trial and
error which involve no inventive step (Nicaro Holdings Pty Ltd v Martin
Engineering Co (1990) 91 ALR 513 at 530 per Gummow J; Lundbeck at
[173] per Bennett J,
Middleton J agreeing). For the purposes of practical utility, the
information given in the prior publication
must also be equal to that given by
the subsequent patent (Nicaro at 530 per Gummow J). Commonly, the
only question is whether the prior publication describes the claimed invention
with sufficient
clarity and something less than a full description may be
sufficient to establish want of novelty (Lundbeck at
[173]).
Third patent
- Inverness
accepts that if the third patent takes priority from its filing date, Australian
Patent No 619231 (the Abbott patent) is relevant prior art for the
purposes of novelty of the third patent. MDS contends that the Abbott patent
anticipates claims
1 to 4 of the third patent.
- Inverness
does not contend that claims 1 to 4 of the third patent are novel over the
Abbott Patent. Those claims should be revoked
for want of novelty. Inverness
submits that claim 9 is novel over the Abbott Patent but MDS did not have the
opportunity to address
the validity of this claim as Inverness only alleged
infringement of claim 9 at the hearing. I have found above that claim 9 (and
its dependent claim 10) is not infringed by the MDS
devices.
Fourth patent
- MDS
alleges that claims 1 and 22 of the fourth patent are invalid for lack of
novelty in light of the prior art information contained
in the first patent. It
is agreed that the validity of the fourth patent is governed by the Patents
Act 1952 (Cth). In the amended particulars of invalidity filed on the last
day of the hearing, MDS amended its particulars to rely only on
anticipation by
the first patent, which was fully argued, including in rounds of written
submissions after the hearing. Inverness
accepts that, in considering
anticipation, the specification of the first patent is available under the 1952
Act to cite against
the fourth patent on novelty.
- The
main contention regarding claim 1 of the fourth patent is whether the first
patent makes sufficient disclosure of the following
essential integer of that
claim (the extra integer):
Wherein prior to the application to the device of the liquid sample, the
particle-labelled specific binding reagent is retained in
the dry state in a
macroporous body having a pore size not less than 10 times greater than the
maximum particle size of the particulate
label, through which macroporous body
the applied liquid sample must pass en route to the porous carrier material,
thus facilitating
uptake of the particle-labelled specific binding reagent by
the applied liquid sample.
- Claim
22 is an independent claim which include the following integers:
- A bibulous urine
receiving member; and
- A macroporous
body, linking the porous nitrocellulose carrier and the urine receiving member,
which contains a highly-specific anti-hCG
antibody bearing a coloured
particulate direct label.
- MDS
relies on the following passages in the specification of the first patent as
disclosing the extra integer:
Another important aspect of the invention is the use of a directly labelled
specific binding reagent on a carrier material comprising
nitrocellulose.
Preferably, the nitrocellulose has a pore size of at least one micron.
Preferably the nitrocellulose has a pore
size not greater than about 20 microns.
In a particularly preferred embodiment, the direct label is a coloured latex
particle of
spherical or near-spherical shape and having a maximum diameter of
not greater than about 0.5 micron. An ideal size range for such
particles is
from about 0.05 to about 0.5 microns (page 6 lines 16 to 26) (the page 6
passage).
If desired, a device according to the invention can incorporate two or more
discrete bodies of porous solid phase material, e.g. separate
strips or sheets,
each carrying mobile and immobilised reagents (page 12 lines 7 –
10).
Inverness points to the continuation of this passage in the specification:
These discrete bodies can be arranged in parallel, for example, such that a
single application of liquid sample to the device initiates
sample flow in the
discrete bodies simultaneously. The separate analytical results that can be
determined in this way can be used
as control results, or if different reagents
are used on the different carriers, the simultaneous determination of a
plurality of
analytes in a single sample can made. Alternatively, multiple
samples can be applied individually to an array of carriers and analysed
simultaneously (page 12 lines 10 – 20) (together, the page 12
passage).
- The
fourth patent describes and claims a separate macroporous body. The macroporous
body is a porous body of specified pore size.
In order to understand the
parties’ positions on the meaning and scope of the expression “dry
porous carrier”
in the specifications it should be remembered that the MDS
devices use as a carrier a series of dry and porous strips and, as part
of the
carrier, there is a pink conjugate pad which retains the labelled specific
binding reagent in a dry state. Inverness alleges
infringement of the first
patent by reason of the functioning of the series of strips, including the
conjugate pad, as a carrier
and submits that it makes no difference whether the
carrier is in a single strip or a series of strips, in one body or more than
one
discrete body. Inverness also asserts for the purposes of infringement of the
fourth patent that the conjugate pad is a macroporous
body within claim 1.
- Inverness
alleges infringement of the fourth patent by the MDS devices. In its
submissions on infringement, Inverness has emphasised
that the carrier material
functions to permit the sample to travel from application to the device to the
location of the labelled
specific binding reagent (in the macroporous body) and
then to the immobilised specific binding reagent for detection.
- The
parties adduced little expert evidence addressed to this aspect. Inverness
contends that nowhere in the first patent does it
disclose the extra integer of
the fourth patent. It says that the page 6 passage neither discloses a
macroporous body as a separate
element nor says anything about the relationship
between the pore size of the macroporous body and the particle size of the
label.
Inverness compares figures 9 and 10 in the first patent and figures 2
and 3 of the fourth patent, which are similar except that
the latter discloses
an extra rectangle representing the macroporous body, which is missing in the
former. Inverness also contends
that the page 12 passage does not assist MDS
because it discloses a device containing two or more different carriers,
each carrying a mobile and an immobilised reagent, such that the
sample may flow simultaneously through each carrier, whereas the macroporous
body in the fourth
patent is a separate piece containing only the labelled
reagent through which the sample passes before it reaches the detection zone.
- Inverness
submits that neither the macroporous body of claim 1 of the fourth patent nor
the macroporous body and the bibulous urine
receiving member of claim 22 of the
fourth patent form part of the dry porous carrier. Inverness says that the
first patent does
not describe the macroporous body as a separate element and
disclaims the macroporous body as part of the dry porous carrier in the
fourth
patent. Inverness relies on this disclaimer to deny anticipation of the fourth
patent but for the purposes of infringement
of the patents including the fourth
patent, presses a functional characterisation of the carrier. In those
submissions, Inverness
said that the dry porous carrier included carriage of the
labelled specific binding reagent. If the macroporous body is not a dry
porous
carrier, or part thereof, then the conjugate pad in the MDS devices is not part
of the carrier. Both the macroporous body
and the conjugate pad form an
integral part of the carriage of the sample from application to detection.
- MDS
says that Inverness is “on the horns of a dilemma” because it seeks
to argue that the MDS devices infringe both the
first and fourth patents. To
argue that the devices infringe the first patent, Inverness says that the pink
conjugate pad found
in the MDS devices which contains the labelled reagent is
within the scope of the claims of the first patent. To argue infringement
of
the fourth patent, Inverness says that the pink conjugate pad is the macroporous
body. MDS contends that this demonstrates that
the macroporous body of the
fourth patent is covered by disclosure in the first patent. MDS relies on the
page 12 passage for the
“broader statement” that the device can
contain two or more discrete bodies of porous material, whether arranged in
parallel
or in sequence, and thereby discloses the separate macroporous body of
the fourth patent.
- It
is possible for a device to infringe both a broader claim in an earlier patent
and a narrower claim in a later patent without
the earlier claim anticipating
each of the integers of the later claim. The narrower claim may include
additional features not disclosed
in the earlier patent. The relevant question
is whether the first patent sufficiently discloses the macroporous body in the
fourth
patent.
- I
have concluded that the “dry porous carrier” containing the labelled
and unlabelled specific binding reagents referred
to in the claims of the first
patent is described in functional terms and is not limited to a single
continuous strip, so that the
integer of “a dry porous carrier” is
satisfied by the pink conjugate pad containing the labelled specific reagent and
the separate nitrocellulose test strip containing the immobilised unlabelled
specific binding reagent which, in the MDS devices,
function together to carry
the sample.
- I
have accepted that the first patent contemplates a carrier made up of discrete
bodies which together function to receive and carry
the sample through the zones
containing the labelled and unlabelled reagents. The page 6 passage, in setting
out preferred pore
sizes for the carrier and particle sizes for the label,
discloses a carrier with a pore size not less than 10 times greater than
the
maximum particle size of the particulate label. The first patent also discloses
a device, for example in claim 2, in which the
labelled reagent is contained in
a first zone of the carrier and the unlabelled reagent is immobilised in a
detection zone spatially
distinct from the first zone, the two zones being
arranged such that liquid sample applied to the porous carrier can permeate via
the first zone into the detection zone.
- The
macroporous body of the fourth patent forms part of the dry porous carrier. It
is that part of the carrier containing the labelled
specific binding reagent and
through which the sample passes or is “carried”. The dry porous
carrier of the first patent
is not limited to a single, continuous strip or
sheet. The example in the page 12 passage in which separate strips each carry
both
the mobile and immobilised reagents does not limit the general disclosure
of one or more discrete bodies forming the dry porous carrier,
nor is it
applicable to the macroporous body of the fourth patent or the conjugate pad of
the MDS devices, as they contain only the
labelled reagent and not the
immobilised reagent. If Inverness relied on such a limited disclosure, the MDS
devices would not infringe
claim 1 of the first patent. Inverness relies on a
‘wide, functional definition’ of the carrier as being that
which conveys or transports the sample along its entire length and which carries
in the first zone the
labelled reagent and in the second zone the immobilised
reagent. It does not matter that the specification of the first patent does
not
disclose the macroporous body as a separate and distinct part of the carrier.
It is encompassed within and sufficiently disclosed
by the description of a dry
porous carrier made up of more than one discrete part. It is in part for that
reason that the MDS devices’
pink conjugate pad, which is a distinct and
separate part of the MDS device carrier, infringes claim 1 of the first
patent.
- Claim
1 of the fourth patent describes the macroporous body as the location wherein
the labelled specific binding reagent is retained
in the dry state prior to
application of the liquid sample. The sample then must pass through the
macroporous body “en route”
to the porous carrier material, where
the labelled reagent is freely mobile. That is, functionally, the sample is
carried through
the macroporous body where it is binds with the labelled reagent
and then carried through to the second, detection zone. If Inverness’
submissions as to the meaning of dry porous carrier for the purposes of
infringement are accepted, the macroporous body is part of
the dry porous
carrier which functions to convey or provide a carrier for the sample from
application to detection. The fact that
it is a separate, discrete body does
not affect this any more than does the presence of a number of discrete carrier
pieces or the
conjugate pad of the MDS devices. As MDS says, Inverness cannot
have it both ways.
- Inverness
submits that the first patent makes no reference to the relationship between the
pore size of the carrier and the particle
size of the label. That is not so.
At page 6, the specification of the first patent describes as an important part
of the invention
the use of a directly labelled specific binding reagent on a
carrier material comprising nitrocellulose with a pore size of at least
one
micron and preferably not greater than about 20 microns. A preferred embodiment
describes a direct label with a maximum diameter
of not greater than 0.5
microns, with an ideal size range from about 0.05 to about 0.5 microns.
Choosing a carrier within the pore
size and a label within the particle size
recommended in the first patent would encompass a carrier that satisfies the
requirement
in claim 1 of the fourth patent that the macroporous body has a pore
size at least 10 times greater than the particle size of the
label.
- Claim
22 of the fourth patent contains a similar integer of a separate macroporous
body, containing only a highly-specific anti-hCG
antibody bearing a coloured
particulate direct label. Inverness argues that the first patent does not
disclose this integer, again
because it does not disclose a separate macroporous
body. Inverness did not raise an additional basis for novelty of claim 22.
MDS
provided detailed submissions identifying disclosures in the first patent of
each integer in claim 22. I accept that all of
the other integers of that claim
are disclosed on pages 7, 8, 23, 24 and 26 of the first patent.
- The
first patent discloses a device with all of the integers of claim 1 and of claim
22 of the fourth patent. The disclosures of
the first patent anticipate claim 1
and claim 22 of the fourth patent which, accordingly, lack
novelty.
LIABILITY OF DR APPANNA
- The
third respondent, Dr Appanna, is a director of both MDS NZ and MDS Aus. On
the MDS website, he is described as the “Managing
Director” and
“Founder” of MDS, having founded MDS NZ in 1999. Dr Appanna
also works as a family physician
in Auckland, New Zealand.
- At
issue is whether Dr Appanna is personally liable for the infringement by
MDS:
- on
the basis of being a joint tortfeasor; or
- under
s 13(1) of the 1990 Act on the basis that he “authorised” the
conduct of MDS.
- MDS
accepts that if Dr Appanna is liable as a joint tortfeasor or pursuant to
s 13(1) for the infringing acts of MDS NZ,
it follows that similar findings
should be made in respect of his role as a director of MDS
Australia.
Joint tortfeasor
- The
parties have referred to the following three tests from the authorities which
may be applied in determining whether a director
is liable as a joint tortfeasor
for acts committed by the company:
- The
test propounded by Lindgren J in Microsoft Corporation v Auschina Polaris Pty
Ltd (1996) 71 FCR 231 at 246, namely whether the director ‘directed
or procured the infringing act’ (the Auschina test) (applying
Performing Right Society Ltd v Ciryl Theatrical Syndicate Ltd [1924] 1 KB
1 at 15 per Lord Aitkin).
- The
test first suggested by Finkelstein J in an obiter remark in Root Quality Pty
Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; (2000) 177 ALR 231 at [146], namely
whether the director’s conduct is ‘such that it can be said of
him that he was so personally involved in the commission of the unlawful act
that it is just that he should
be rendered liable’ (the Root
Quality test).
- The
test propounded in the Canadian case Mentmore Manufacturing Co Limited v
National Merchandising Manufacturing Co In (1978) 89 DLR (ED) 195, namely
whether ‘the director made the infringing conduct his own in the sense
that the director deliberately, wilfully or knowingly pursue[d] a course
of conduct that was likely to constitute infringement or that reflected
indifference to the risk of infringement’ (the Mentmore
test).
- The
Full Court has considered these tests but has not found it necessary to
determine which test is the correct one (Allen Manufacturing Co Pty Limited v
McCallum & Co Pty Limited [2001] FCA 1838; (2001) 53 IPR 400 where both the Auschina and
Mentmore tests were satisfied; Cooper v Universal Music Australia Pty Limited
(2006) [2006] FCAFC 187; (2006) 156 FCR 380 where none of the three tests were satisfied). In
Allen, the Full Court commented that the difference between the Auschina
test and the Mentmore test may be more apparent than real as it
was not aware of
any cases in which the Auschina test was met but the Mentmore test was not met
(at [43]). Justice Sundberg noted
in Pioneer Electronics Australia Pty Ltd v
Lee [2000] FCA 1926; (2001) 108 FCR 216 at [46] that the ‘clear preponderance of
authority’ favoured the Auschina test. After discussing the
authorities at length, Redlich J of the Supreme Court of Victoria decided
in
favour of the Auschina test in Johnson Matthey (Aust) Ltd v Dascorp Pty
Ltd [2003] VSC 291; (2003) 9 VR 171 at [200]- [201].
- MDS
contends that the Mentmore test should be applied as it avoids the generality of
the Auschina test which, it says, would render
every active director personally
liable for infringement by the company whether or not the director knows that
the conduct directed
or procured is infringing conduct. MDS submits that the
Mentmore test should be applied because it is the only one of the three
tests
which truly has its genesis in a patent infringement case in which the question
of the personal liability of a company director
on the basis of joint
tortfeasorship was fully ventilated and determined. It submits that the correct
approach from Mentmore is that for personal liability to be found, there
must be circumstances where ‘the purpose of the director...was not the
direction of the manufacturing and selling activity of the company in the
ordinary course
of his relationship to it but the deliberate, wilful and knowing
pursuit of a course of conduct that was likely to constitute infringement
or
reflected an indifference to the risk of it’ (Mentmore at 204
per Le Dain J as cited in King v Milpurrurru (1996) 66 FCR 474 at 496 per
Beazley J). Under this test, directors would not be personally liable
merely by imparting to the
company the practical, business, financial and
administrative policies which resulted in the selling of infringing articles;
there
must be that degree or kind of personal involvement by the director to
make the tortious act his or her own (Milpurrurru at 495 per
Beazley J). In Milpurrurru, Beazley J found the Mentmore test
to be a more satisfactory approach to the question of personal liability of a
director, at
least in the case of a tort that involves a mental element (at
500).
- For
patent infringement, there is no necessary mental element. It is not necessary
to show that a director, to be liable, knows
that the acts which he or she
procures or directs constitute patent infringement, as such a condition does not
exist for patent infringement
generally. The parties agree that even under the
Mentmore test there is no requirement that the director knows or has reason to
know that the acts which he or she directed or procured constituted infringement
of another party’s patent (Allen at [43]).
- The
apparent inconsistency is resolved if the mental element in the Mentmore test of
‘the deliberate, wilful and knowing pursuit of a course of conduct that
was likely to constitute infringement or reflected an indifference
to the risk
of it’ relates to the pursuit of the course of the conduct and not to
its characterisation. The question is whether Dr Appanna
knowingly pursued
a course of conduct which, judged objectively, led to infringement or was likely
to constitute infringement, or
reflected indifference to the risk of
infringement.
- The
shares in MDS NZ are held by trustees for the benefit of Dr Appanna, his
wife and their children. The shares in MDS Aus
are held by a company of which
Dr Appanna is the sole director. The shares in that company are held by
Dr Appanna and
his wife. I do not accept that the fact that
Dr Appanna controls the MDS companies as shareholder, or the mere
description
of Dr Appanna as Managing Director are, alone, sufficient to
establish that he directed or procured the infringing acts of the
MDS companies.
Dr Appanna’s liability should be determined by reference to his
involvement in the management and operations
of MDS concerning the MDS devices.
His shareholding of itself is insufficient to establish liability either as a
joint tortfeasor
or under s 13. Something more is necessary.
- MDS’s
submissions are that while Dr Appanna played an important role in the day
to day operations of MDS, he did not at
any relevant time possess the acumen,
ability or skill to determine by himself the strategic and business decisions
adopted by MDS
NZ. MDS points to Dr Appanna’s qualifications as a
general medical practitioner and emphasises that the expertise that
he brought
to the Board of Directors was his ability to understand the nature of the
medical products to be sold by MDS. It was,
MDS says, other directors of MDS
NZ, being Mr Hills (a chartered accountant) and Mr Vallant (a
solicitor) who brought critical
and necessary skills to the management of the
company. In addition, the day to day activities were managed by an Operations
Manager
until about March 2004 and thereafter by a General Manager. MDS
emphasises that Mr Hills and Mr Vallant each attended
board meetings
and took actions within their relative areas of responsibility. While Mr Hills
provided an affidavit in New Zealand
proceedings, it is only
Dr Appanna’s affidavit that was read on this issue in the Australian
proceedings. No evidence
was called from Mr Hills or Mr Vallant. MDS
points out that the strategic plan for MDS was not prepared by Dr Appanna
and was determined by the Board. That plan outlined proposed responsibilities
in the proposed business model and allocated certain
responsibilities to Dr
Appanna. Dr Appanna denies taking all of those proposed responsibilities,
which included sponsorship,
supplier relations, imports/exports, regulatory
affairs and product sourcing. He says that his responsibilities as Manager
Director
have been to liaise with the General Manager on behalf of the Board and
that he had occasionally been involved in supply relations
and product sourcing.
Dr Appanna says that he did not have responsibility for regulatory affairs,
which was the responsibility
of the Operations Manager and then the General
Manager. Dr Appanna has been the director responsible for MDS’ defence of
the
litigation commenced by Inverness in Australia and New Zealand and has, in
part, personally funded that litigation.
- MDS
says that the evidence establishes that Dr Appanna ‘was part of a
suite of appropriately skilled personnel who managed and supervised the
operations of MDS, both its day to day activities
and the “higher
level” strategic and business decisions’. MDS relies on Red
Bull Australia Pty Ltd v Sydneywide Distributors Pty Ltd [2001] FCA 1228; (2001) 53 IPR 481.
At first instance, Conti J held that a director, although self-styled as the
managing director and accepted by his Honour to be
the decision maker of
Sydneywide, was not liable as a joint tortfeasor with Sydneywide for passing
off. In that case, Conti J
accepted at [75] that the director was
personally involved in such capacity in the process of design and the ultimate
choice of design
of the impugned packaging and was closely involved in the
company’s contravention of s 52 of the Trade Practices Act 1974
(Cth). His Honour found that not sufficient to render the director liable
at common law as a joint tortfeasor, apparently on the
basis that the company
was a family company involving the director’s two brothers and father in
varying capacities. It was
not, his Honour said, a “one man
company” in the sense described in Auschina. On appeal ((2002) [2002] FCAFC 157; 55
IPR 354), Weinberg and Dowsett JJ at [160] described Auschina as a case
concerned not with joint tortfeasors but with circumstances in which a director
of a corporation will be held liable for
its tort. Their Honours did not
consider the director’s liability because there was no pleading of the
Auschina basis for liability nor an allegation that the director procured
or directed the passing off by the company. Their Honours did observe
at [164],
however, that the evidence justified the inference that the director was
knowingly concerned in the breach of s 52 and the inference that the
director procured the passing off by the company. Red Bull does not
assist MDS.
- Even
if Dr Appanna’s explanation that the five responsibilities listed in the
organisational chart in the business plan were
only proposed responsibilities
for him as Managing Director is accepted, Dr Appanna was the person to whom
the General Manager
reported within the organisational structure. Board minutes
were prepared by Dr Appanna, often in his own handwriting and not
distributed to the other Board members for approval. This shows a degree of
informality consistent with a family business run by
Dr Appanna. In the
absence of evidence from Mr Hills and Mr Vallant of their roles on the
Board of MDS NZ, the inference
is open that they are limited to those of
professional advisers within the areas of their expertise of law and
accountancy. Dr Appanna’s
evidence is that they each carried out
activities linked to their professions. Mr Vallant and Mr Hill are not
directors of
MDS Aus. There is no evidence that any director of MDS Aus other
than Dr Appanna played an active role in the management of
that
company.
- MDS
did not develop QuickCard or QuickStream. They were supplied by an overseas
manufacturer. From 2000, MDS acquired pregnancy
testing devices from the
product manufacturer, Phamatech and there is no evidence that Phamatech informed
MDS of any allegations
of patent infringement by its products.
- Dr Appanna
was aware of competitive products that were on the market, such awareness being
at least since 1993. Dr Appanna’s
evidence is to the effect that he
did not take an interest in the patents related to the products and was not
familiar with patents
in that field of activity. He was apparently not aware
that those products bore a reference to the Inverness patents and I am not
satisfied, from the evidence, that Dr Appanna was actually aware of
Inverness’ first three patents by reason of package
warnings on either of
the Inverness products “Clearblue” or “Clearview”.
Dr Appanna said that the question
whether the products that MDS was
intending to purchase from the manufacturer were covered by patents
‘was something we never considered at the time’.
- Dr Appanna
was, however, the person directly involved in obtaining the distribution rights
for MDS NZ to sell Phamatech products
in Australia. Dr Appanna was
directly and personally involved in obtaining regulatory clearance of the MDS
devices in Australia
as Managing Director of MDS and in correspondence with the
Therapeutic Goods Administration. He was similarly involved in correspondence
with Medsafe in New Zealand and was one of the “responsible persons”
listed in an application for a Medsafe licence under
New Zealand’s
Medicine Act 1981. He continued to be involved in the sourcing,
supply and sale of QuickCard and QuickStream in Australia. Dr Appanna
developed
relationships with wholesalers and medical distributors on behalf of
MDS NZ. He signed the document being an agreement with Apothecary
Sales Brokers
which granted Apothecary Sales Brokers a right to obtain orders for QuickStream
and QuickCard from Australian customers
on behalf of MDS NZ. Although
Dr Appanna gave evidence that distribution in Australia was through the
fourth respondent, the
evidence does not support the fourth respondent being an
arms-length distributor in so far as Dr Appanna was concerned. The
fifth
respondent, who was a co-director of MDS Aus with Dr Appanna until 2006, was
also the sole director and shareholder of the
fourth respondent.
- Some
of the actions of Dr Appanna took place prior to the actual importation, offer
for sale and sale of infringing MDS devices in
Australia. However, those
actions enabled and procured the infringement of MDS. They were necessary
preparatory acts to, and part
of the process of, the importation and offer for
sale of the MDS devices and the using of the devices for the purposes of sale.
They are, therefore, relevant to Dr Appanna’s liability.
- I
am satisfied that Dr Appanna’s position as the Managing Director of
MDS NZ and his participation in the procurement
and distribution of the MDS
devices in New Zealand and Australia are sufficient to establish that he
deliberately, wilfully or knowingly
pursued a course of conduct that resulted in
MDS selling products that infringed the Inverness patents. Further, he was
aware of
competing products on the market and was indifferent as to whether or
not those products were protected by patents. In taking part
in the activities
of MDS NZ and MDS Aus as a director and in the management of those companies,
Dr Appanna directed or procured
the obtaining of and the selling of the
products that infringed Inverness’ patents. Accordingly, he is liable
under both the
Mentmore test and the Auschina test.
Authorising conduct of MDS - s 13(1) of the 1990 Act
- The
“exclusive rights” of the patentee are the rights to
“exclude” others from exploiting the invention or
authorising
another person to exploit the invention (Grain Pool of Western Australia v
Commonwealth of Australia (2000) 202 CLR 479 at [83]–[85]).
Infringement of the right to authorise exploitation in s 13 looks to
whether the product being exploited
infringes the claimed invention and not
whether the person authorising that conduct intends to authorise infringement or
knows that
the product will infringe. There is no requirement that the person
knows that the authorisation is of an infringement of a patent.
- It
is an infringement of the patentee’s exclusive rights not only to exploit
an invention but also to authorise another person
to exploit it (s 13 of
the 1990 Act). The word “authorise” in s 13 has the meaning in
the comparable context
of the Copyright Act (Bristol-Myers Squibb Company v F
H Faulding & Co Ltd [2000] FCA 316; (2000) 97 FCR 524 at [97] per Black CJ and
Lehane J; see also Rescare at 155 per Gummow J). A person
authorises an infringement if he or she “sanctions, approves or
countenances’” the
infringement (University of New South Wales v
Moorhouse [1975] HCA 26; (1975) 133 CLR 1 at 12 per Gibbs J, at 20-21 per Jacobs J
(McTiernan ACJ agreeing); Cooper at [137]-[140] per Kenny J (French J
agreeing)). As Burchett J said in Kimberly-Clark Australia Pty Ltd v
Arico Trading International Pty Ltd (1998) 42 IPR 111 at 129 (appeal allowed
on validity, but not on infringement), s 13 at least embraces the case
where a person ‘made himself a party to the act of
infringement’ (Walker v Alemite Corp [1933] HCA 39; (1933) 49 CLR 643 at 658
per Dixon J).
- MDS
submits that the meaning of “authorises” in s 101 of the
Copyright Act 1968 (Cth) (the Copyright Act) is irrelevant and not
analogous to “authorise” in s 13(1) of the 1990 Act. MDS says
that as s 101 of the Copyright Act defines a species of infringement of
authorising another to perform an infringing act, “authorise” means
‘sanction, approve, or countenance’ because it is the
infringer who is authorising another to perform the relevant acts although it
has no legal right to do so.
On the other hand, as the purpose of s 13(1)
of the 1990 Act is to define the rights of the patentee, MDS contends that
“authorise”
in that section means ‘to give legal or formal
warrant to (a person) to do something’ (one of several definitions
from the Oxford English Dictionary Online) as this is what only the
patentee has the right to do.
- In
Bristol-Myers Squibb Company v F H Faulding & Co Ltd (1998) 41 IPR
467 at 488, Heerey J, at first instance, discussed the meaning of
“authorise” in s 13 of the 1990 Act. Justice Heerey considered
that
“authorise” in s 13 does not have the same meaning as
“authorise” in the Copyright Act but rather has the meaning:
- ‘To
give authority or legal power to; empower (to do something)’
from the Macquarie Dictionary; or
- ‘To
give legal or formal warrant to (a person) to do; to empower, permit
authoritatively’ from the Shorter Oxford
Dictionary.
Although Black CJ and Lehane J
expressly disagreed on this point on appeal at [97] in obiter, MDS relies on the
reasoning of
Heerey J.
- The
latter aspects of the definitions in the Macquarie and Shorter Oxford Dictionary
of “empower (to do something)” and
“empower, permit
authoritatively” do not support MDS’s submission that
“authorise” in s 13 is limited to the giving of legal
authority. In any event, it is unlikely that s 13 can have that restricted
meaning. The patentee has the right to exclude all others from authorising
another to infringe the rights
of the patentee. If authorisation required the
legal right in the patent, then only the patentee has that right and there could
be no infringement by authorisation by any person.
- Interestingly,
in Bristol-Myers Heerey J concluded, based on the definition he
adopted, that mere supply of an infringing product with instructions for use
did
not constitute infringement but that the lease of a factory containing machinery
the use of which infringed the patent did constitute
infringement by
authorisation. This does not support MDS. The acts of Dr Appanna relied
on by Inverness go beyond mere provision
of the opportunity to infringe and are
analogous to the example that Heerey J gave of an act that did amount to
infringement
by authorisation. Dr Appanna’s actions, in the context
of his position with MDS, empowered the infringement.
- MDS
submits that the word “authorise” in s 13(1) is not relevant to
the alleged liability of a director for infringing acts by a company and is not
a concept that defines any infringing
act by a third party. MDS submits that
the different contexts of s 13(1) of the 1990 Act and s 101 of the
Copyright Act have not been argued before and so were not properly considered by
Gummow J in Rescare, by Burchett J in Kimberly-Clark or by the
Full Court in Bristol-Myers. I do not accept MDS’ argument
that the different statutory contexts justify different meanings for the word
“authorise”
in patent and copyright law. As Inverness points out,
the 1990 Act, unlike the Copyright Act, does not separately define the exclusive
rights of the intellectual property owner and the acts which constitute
infringement of
those rights. Those acts which trespass on the patentee’s
exclusive rights under s 13 of the 1990 Act constitute infringement.
Further, s 13(2) of the Copyright Act uses the word “authorise”
in a similar way to s 13 of the 1990 Act to describe the exclusive right of
the copyright
owner to authorise a person to do particular acts.
- MDS
contends that a director can never be held liable for patent infringement on the
“authorisation” ground because only
the company can give the
requisite warrant to invoke liability. It submits that a director cannot give
such warrant to the company
because of the distinction between the company as a
separate, distinct entity and its directors who have an internal role in the
management of the company.
- Put
together, MDS’ submissions amount to saying that there can be no
infringement by authorisation unless the authoriser is
in such a position or
such a relationship with the person being authorised that the authoriser has
formal authority, in a technical
sense, to authorise that person to do the
infringing act. If that submission is that only the patentee has the right to
authorise
exploitation of a patent, it would follow that no person or company
other than the patentee can grant the legal right to another to exploit
the invention. This construction of “authorise” does not accord, in
my view, with s 13
or the scheme of the 1990 Act, including s 117, or
the meaning of “authorise”. To the extent that MDS is arguing
that
Dr Appanna could not have authorised MDS NZ or MDS Aus to infringe as he was a
director without proper authority formally to
authorise actions of the company,
I reject such a submission. Section 13 does not carry that limitation.
- I
do not accept MDS’ proposition that the position stated in each of
Rescare, Kimberly-Clark and by the Full Court in
Bristol-Myers should not be followed. I see no reason to construe
“authorise” in s 13 in the narrower way contended for by MDS.
That is not to say that a director of a company, by reason only of that
position, authorises any act of infringement by the company.
It is still
necessary to show actions that demonstrate that the person did sanction, approve
or countenance the act of infringement.
- There
can be no dispute that Dr Appanna knew that the infringing act of the sale of
the MDS devices would occur. He had the power
to prevent those acts and some
duty to interfere. Express or formal permission is not essential and inactivity
or indifference may
reach a degree from which authorisation or permission may be
inferred (Australasian Performing Right Association Ltd v Metro on George Pty
Ltd (2004) 61 IPR 575 at [19] per Bennett J). Dr Appanna authorised
MDS to sell the infringing products. I am satisfied that he had the power to
prevent the companies from committing the acts of exploitation (Metro on
George at [18]). He arranged for the sourcing of the products and
personally participated in the distribution of those products. Dr Appanna
sanctioned, approved and countenanced the sale of products that infringed
Inverness’ exclusive right to exploit the invention
of the first patent
and the second patent.
MDS’ CROSS CLAIM UNDER S 128 OF THE 1990 ACT
- MDS
has cross claimed under s 128 of the 1990 Act alleging unjustified threats
of infringement proceedings. The parties agreed
that the cross claim only
arises if the MDS devices do not infringe any of the patent claims or the patent
claims are found to be
invalid. It follows that there is no need to deal
further with the cross claim.
CONCLUSION
- In
summary, based on my findings above:
- Claim
1 of the first patent is infringed by QuickStream and QuickCard.
- Claim
1 of the second patent is infringed by QuickStream.
- Claims
1 to 4 of the third patent are invalid for lack of novelty. The third patent
has expired.
- Claims
1 and 22 of the fourth patent are invalid for lack of novelty and should be
revoked.
- Dr
Appanna is personally liable for the infringement of MDS Aus and MDS NZ as a
joint tortfeasor.
- Dr
Appanna is liable under s 13(1) of the 1990 Act for authorising the infringement
of MDS Aus and MDS NZ.
I will direct parties to submit
proposed orders to give effect to these reasons and any submissions on
costs.
I certify that the preceding two hundred and
five (205) numbered paragraphs are a true copy of the Reasons for Judgment
herein of
the Honourable Justice Bennett. |
Associate:
Dated: 22 February 2010
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URL: http://www.austlii.edu.au/au/cases/cth/FCA/2010/108.html
