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Medrad Inc v Alpine Medical Pty Ltd [2009] FCA 949 (25 August 2009)
Last Updated: 26 August 2009
FEDERAL COURT OF AUSTRALIA
Medrad Inc v Alpine Medical Pty Ltd
[2009] FCA 949
PATENTS – syringes for use with medical
injector systems – alleged infringement of patent – application for
interlocutory
injunction – alleged invalidity of patent on ground of
obviousness – construction of claims – whether serious question
to
be tried – balance of convenience – interlocutory relief granted
PRACTICE AND PROCEDURE – application for leave to further amend
statement of claim and application – leave granted
Therapeutic Goods Act 1989
(Cth)
Patents Act 1990 (Cth)
Australian Broadcasting Corporation v
O’Neill [2006] HCA 46; (2006) 227 CLR 57 referred to
Beecham Group Ltd v
Bristol Laboratories Pty Ltd [1968] HCA 1; (1968) 118 CLR 618 discussed
AB Hassle v
Pharmacia (Australia) Pty Ltd (1995) 33 IPR 63 referred to
Genrx Pty
Ltd v Sanofi-Aventis [2007] FCA 1485; (2007) 73 IPR 502 referred to
Interpharma Pty Ltd
v Commissioner of Patents [2008] FCA 1498; (2008) 79 IPR 261 referred
to
American-Cyanamid Co v Ethicon Ltd [1975] UKHL 1; [1975] AC 396 cited
Sigma
Pharmaceuticals (Australia) Pty Ltd v Wyeth [2009] FCA 595 cited
Wake
Forest University Health Sciences v Smith & Nephew Pty Ltd [2009] FCA
630 referred to
Tidy Tea Ltd v Unilever Australia Ltd (1995) 32 IPR
405 referred to
Pharmacia Italia SpA v Interpharma Pty Ltd (2005) 67
IPR 397 referred to
MEDRAD INC and IMAXEON PTY LTD v ALPINE MEDICAL
PTY LTD
VID 529 of 2009
KENNY J
25 AUGUST 2009
MELBOURNE
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IN THE FEDERAL COURT OF AUSTRALIA
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VICTORIA DISTRICT REGISTRY
GENERAL DIVISION
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MEDRAD INCFirst Applicant
IMAXEON PTY LTD Second Applicant
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AND:
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ALPINE MEDICAL PTY
LTDRespondent
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DATE OF ORDER:
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WHERE MADE:
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THE COURT ORDERS THAT:
- A
trial in the proceeding be fixed for 10.15 am on 22 February 2010, with an
estimated duration of 4 days.
- On
or before 4 pm on 27 August 2009:
(a) the applicants file and serve
short minutes of orders in conformity with these reasons; and
(b) the parties file and serve short submissions on costs.
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
|
|
|
VICTORIA DISTRICT REGISTRY
GENERAL DIVISION
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VID 529 of 2009
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BETWEEN:
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MEDRAD INC First Applicant
IMAXEON PTY LTD Second Applicant
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AND:
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ALPINE MEDICAL PTY LTD Respondent
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JUDGE:
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KENNY J
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DATE:
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25 AUGUST 2009
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PLACE:
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MELBOURNE
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REASONS FOR JUDGMENT
INTRODUCTION
- The
first applicant, Medrad Inc, is the registered owner of Australian Patent No
2005200597, entitled “Improvements relating
to medical injector
systems”. This is the patent in suit. The earliest priority date claimed
for the patent is 10 July 2000.
The invention is concerned with aspects of a
medical injector system for injecting fluid from a syringe into a patient. An
aspect
of the invention disclosed in the patent relates to the syringes,
including associated hubs and seals, used in the injector system.
- The
second applicant, Imaxeon Pty Ltd, claims to be the exclusive licensee of the
patent in suit.
- The
applicants seek an interlocutory injunction in order to prevent the respondent,
Alpine Medical Pty Ltd, from selling or offering
for sale syringes, including
hubs and seals sold with them, allegedly having features falling within claims
of the patent. In particular,
the applicants seek an interlocutory injunction
against the respondent in respect of the following
syringes:
(a) syringes entitled “High Pressure Syringe”
with product numbers 100104, 100102 and 500102;
(b) syringes the subject of ARTG entry no 158824 that:
(1) include or incorporate any hub for syringes as claimed in claim 1 and/or
claim 4 of the patent; or
(2) include or incorporate any hub and seal combination systems for syringes
as claimed in claim 9 and/or claim 12 of the patent;
and/or
(3) are for use with a medical injector system as claimed in claims 51 and 52
of the patent;
(c) syringes manufactured by Shenzhen Ant Medical Devices Co Ltd, Shenzhen
City, People’s Republic of China that:
(1) include or incorporate either any hubs for syringes as claimed in claim 1
and/or claim 4 of the patent; or
(2) include or incorporate any hub and seal combination systems for syringes
as claimed in claim 9 and/or claim 12 of the patent;
and/or
(3) are for use with a medical injector system as claimed in claims 51 and 52
of the patent.
- In
an amended statement of claim filed 30 July 2009, the applicants allege that
each of these products contain an essential integer
of claims 1, 9, 51 and 52 of
the patent in suit and that, by selling these products or offering them for
sale, the respondent has
infringed claims 1, 9, 51 and 52 of the patent.
- At
the hearing of the application for interlocutory relief, the applicants applied
to amend their statement of claim, in order to
add the further or alternative
allegation that the respondent’s products contain an essential integer of
claims 4 and 12 of
the patent, and that, by selling these products or offering
them for sale, the respondent has infringed claims 4 and 12 of the patent.
The
respondent opposed the amendment, but, for the reasons stated below, I would
grant the applicants the leave they sought. This
application is determined on
this basis.
- In
support of their claim for relief, the applicants rely on two affidavits of
Alwyn William Reynolds sworn on 30 July and 18 August
2009, two affidavits of
Victor Chang Ting Tse sworn on 30 July and 18 August 2009, an affidavit of
Timothy James Hands sworn on
18 August 2009, and an affidavit of Wayne McMaster
also sworn on 18 August 2009.
- The
respondent filed its defence on 19 August 2009, which: (1) denied the alleged
infringements in respect of syringes with product
numbers 100102 and 100104
(i.e, the Stellant substitute syringes) upon the basis that they do not contain
the integers of the claims
as alleged; (2) accepted that syringes with product
number 500102 (i.e, the Klikfit substitute syringe) have the alleged features;
and (3) asserted that claims 1, 9, 51 and 52 of the patent are invalid “as
those claims do not define a patentable invention
for the reason that the
invention, as claimed in claims 1, 9, 51 and 52 of the patent, is obvious having
regard to common general
knowledge at the earliest priority date for each of
those claims”. The respondent indicated in argument that, in so far as
necessary, its challenge to invalidity on the ground of obviousness should be
understood to extend to the invention as claimed in
claims 4 and 12.
- In
opposition to the relief sought, the respondent relied on an affidavit of Susan
Terry Evans sworn on 14 August 2009 and an affidavit
of Frank Papamichalakis
(known also as Frank Pappas) also sworn on 14 August 2009.
BACKGROUND
- In
his 30 July 2009 affidavit, Mr Reynolds, the Managing Director of Imaxeon,
deposed that Imaxeon is a wholly owned subsidiary of
Medrad. Mr Reynolds
described Medrad as “a worldwide, market-leading manufacturer and
distributor of high technology medical
devices”. Mr Reynolds stated that
“Medrad has a worldwide reputation for performance that helps physicians
diagnose
patients more accurately and, ultimately, deliver quality patient
care”. Mr Reynolds noted that Medrad is also the registered
owner of two
Australian trade marks in Australia, both of which are exclusively used in
Australia by Imaxeon. These trade marks
are “KLIKFIT” and
“VISIMAX”.
- Turning
to Imaxeon, Mr Reynolds said that “Imaxeon designs, manufactures, imports,
exports, distributes and supplies contrast
injection systems for computer
tomography (“CT”) and cardiovascular
(“CV”) applications, as well as all associated
consumables”.
- Imaxeon
has been Medrad’s sole distributor in Australia since 2000. According to
Mr Reynolds, the main focus of its business
is CT contrast injection systems and
the sale of consumables for injection systems. Imaxeon’s customers are
typically hospitals
and radiology clinics.
- This
proceeding involves the sale by the respondent of syringes (including their hub
and seal components) for use as part of CT contrast
injector systems supplied by
the applicants for use in CT imaging. Injector systems are used for injecting
contrast dyes intravenously
into patients. Mr Reynolds deposed that CT imaging
frequently involves injecting intravenous contrast dye materials into patients,
in order to enhance the images obtained from a CT scan by highlighting
structures such as blood vessels and soft organs that would
otherwise be
difficult to delineate from their surroundings.
- According
to Mr Reynolds, an injector system consists of:
(a) a programmable
and processor-controlled injector unit that automatically regulates the rate at
which the contrast dye materials
are injected into the patient;
(b) a specifically designed disposable contrast injector syringe that fits
into the injector unit to deliver the contrast dye material
and is automatically
operated by the injector unit according to pre-set parameters; and
(c) tubing that extends from the contrast injector syringe to the intravenous
cannula connected to the patient.
Once the injector unit has been programmed, it automatically controls the
piston of the contrast injector, which pushes the hub and
seal within the
syringe barrel to deliver the contrast dye materials for the patient.
- Mr
Reynolds deposed that the software algorithms installed on the computer
processor within the injector unit regulate the rate of
injection of the
contrast material into the patient. The algorithms are designed to take into
account the technical features of the
relevant contrast injector syringe that
are specific to that injector system. Mr Reynolds stated that “the
syringe is an integrated
component of the entire system, the characteristics of
which are important to the accurate and safe operation of the system”.
He
also stated that “[i]t is for this reason that a contrast injector system
uses only the syringes that are specifically
designed for that particular
injector system”.
- According
to Mr Reynolds, the two main contrast injection systems supplied by Imaxeon were
the Imaxeon™ VISIMAX® CT contrast
injector system and the
Medrad™ STELLANT™ CT contrast injector system. Imaxeon and Medrad
only sell single use disposable
syringes for their own systems. Imaxeon
presently prices its STELLANT™ syringes on average at $9 per syringe and
its KLIKFIT
syringes, at $6 each. The VISIMAX® injector system is designed
to use syringes sold by Imaxeon under the “KLIKFIT”
trade mark. The
STELLANT™ injector system is designed to use syringes sold by Imaxeon and
Medrad under the STELLANT™
mark. Both types of syringe include a
transparent cylinder with a hub and seal combination that fits inside the base
of the cylinder.
The syringe, including the hub and seal combination, fits onto
a piston of the injector system.
- Mr
Reynolds stated that, typically, the injector system is supplied to the hospital
or clinic and consumables, including syringes
and tubings, are purchased as
needed on the basis of an agreed unit price. He added that the hospitals and
clinics also engage the
suppliers to service and maintain the injector systems.
Imaxeon considered the revenue obtained in the on-going sale of consumables,
including syringes, in setting the price and terms of supply of the injector
system. Mr Reynolds said that, as the syringes are
disposable, the costs of the
syringes over the life of the injector system will significantly exceed the
initial cost of the injector
system. Mr Reynolds observed that, since Imaxeon
supplies consumables (such as syringes) to its customers on an on-going basis,
Imaxeon is in regular contact with its customers, “keeping it in the
customer’s mind for its future injector system needs”.
- Mr
Reynolds stated that Imaxeon has developed a strong reputation in the disposable
contrast dye syringe market, which is based on
the quality of its products and
after-sale service. Imaxeon holds around 80% of the market for injector systems
and related consumables,
including the syringes, in the CT segment of the
Australian disposable contrast dye syringe market. The respondent is not amongst
its main competitors in this market. Imaxeon’s competitors are typically
other manufacturers of competing injector systems
that require specific single
use syringes manufactured specifically for their own systems.
- Mr
Reynolds stated that, on or about 18 May 2009, Timothy Hands advised him that he
had become aware that the respondent was promoting
syringes for use with the
STELLANT™ injector system. Mr Reynolds later looked at the
respondent’s website, noting, amongst
other things, that one of the
products on the website was entitled “Visimax CT 150ml”. The
website included a statement
about the compatibility of the respondent’s
syringes with Imaxeon’s syringes, stating that “[t]hese are like for
like replacement for popular syringe types”. Mr Reynolds produced a
computer print-out from the respondent’s website
apparently obtained on 27
May 2009 that evidenced these matters.
- In
its defence filed 19 August 2009, the respondent admitted that, since 30 March
2009, it had offered for sale and sold in Australia
syringes with product
numbers 100104 and 100102, which were manufactured by Shenzhen Ant Medical
Devices Co Ltd for use with a medical
injector system, and registered on the
Australian Register of Therapeutic Goods, administered under the Therapeutic
Goods Act 1989 (Cth), under ARTG 158824. These syringes are amongst the
allegedly infringing syringes.
- Mr
Reynolds believed that the respondent’s syringes were being sold at a
price of about $7 – approximately 20% below
the price of comparable
syringes sold by Imaxeon in Australia. Mr Reynolds also noted that some of
Imaxeon’s promotional material
indicated that its syringes were patented.
The affidavit of Mr Hands, a territory manager for Northern New South Wales,
supported
the proposition that the syringes manufactured by Shenzhen Ant are to
be sold at about $2.00 cheaper than the equivalent ones supplied
by Imaxeon.
- Mr
Reynolds deposed that, if the respondent were able to continue to sell the
allegedly infringing syringes, then Imaxeon would be
forced to lower its supply
price in order to be competitive in the market. Mr Reynolds considered that any
such price reduction
would be permanent, and gave his reasons for this opinion.
He added that “[a] price decrease would ... result [in] a significant
overall loss of revenue both immediately and into the future ...”. He
gave further reasons for this view in his affidavit
of 18 August 2009.
- Mr
Reynolds observed that, since the sale of syringes allowed Imaxeon to have
regular contact with its customers, Imaxeon was able
to address any problems
that customers might have with its injector systems. He added that
“[r]egular contact with customers
also allows Imaxeon to understand the
changing needs of its customers and develop improvements and new features for
its products
to address these needs”. Further, Mr Reynolds said that, if
the respondent supplied syringes to its customers and Imaxeon
lost the
opportunity for regular contact, then it also lost the opportunity “to
convince the customer to accept a replacement
injector system from [it] and
continuously develop and maintain its injector systems and associated
products”. Finally, Mr
Reynolds said that he believed that “it is
uncertain whether the Alpine Syringes will work correctly, or to the same
standard
as syringes supplied by Imaxeon, within the injector systems supplied
by Imaxeon”.
- Mr
Tse, a patent attorney, stated that, based on his observations of the pertinent
features of the allegedly infringing products,
it was his opinion that the
Stellant substitute syringe “embodies each and every feature of claims 1,
9, 51 and 52 of the patent
[in suit]”.
- Mr
McMaster’s affidavit was to the effect that searches had failed to
disclose that the respondent had assets sufficient to
meet a compensation claim
and had failed satisfactorily to answer the applicants’ inquiries in this
regard.
- Mr
Pappas, also a patent attorney, gave his opinion that the syringes manufactured
by Shenzhen Ant under product numbers 100102 and
100104 are identical and that
neither 100102 nor 100104 possesses all the features of claims 1, 9, 51 and 52
of the patent. In his
opinion, “[t]he hub of Shenzhen 100102 has an
‘annular engaging portion’, but that engaging portion does
not have or comprise a groove”. Mr Pappas continued that
“feature 108 identified by Mr Tse in photo 7-8 is a ‘ridge’
(or ‘projecting lip’) and not a groove”.
- This
reasoning prompted the applicants to seek the leave mentioned above, to amend
their application and statement of claim a second
time, so as to include
references to claims 4 and 12 of the patent in suit, since both of these claims
referred to a ridge instead
of a groove. I return to this application for leave
below.
- Mr
Pappas also stated that it was his opinion that “the inner surface of the
Shenzhen 100102” could not be described
as “complementary in
shape” to that of the plunger as the claims required. The basis of this
opinion is discussed below.
- If
Mr Pappas’ opinion were accepted, there would be no infringement of
claims 1, 9, 51 or 52 by the Stellant substitute
syringes (products
numbered 100102 and 100104).
- Mr
Pappas also deposed to a number of documented and anecdotal illustrations of the
use of an “annular engaging portion”
and reinforcement by the use of
complementary shapes outside the medical device or injector fields. Both of
these features were
said to pre-date the earliest priority date of the patent in
suit.
- Ms
Evans, a director and secretary of the respondent, stated that the respondent
had received three shipments of syringes (bearing
product numbers 100102, 100104
and 500102) from Shenzhen Ant on 11 March, 7 and 20 April 2009. Ms Evans
deposed that a syringe under
product number 500102 is compatible with
Medrad’s Visimax injector system and a syringe under product numbers
100102 and 100104
is compatible with the Stellant injector system. Ms Evans also
accepted that the respondent made the first sale of the imported syringes
on 30
March 2009. Ms Evans noted that she recalled representatives of Shenzhen Ant
saying that there were no patents that would
cause any issue for the respondent
in selling syringes in Australia.
- As
noted below, Ms Evans disagreed with the proposition that Imaxeon would be
forced to lower the prices of its syringes if the respondent
sold its products
in competition with it.
THE PATENT IN SUIT
- The
field of the invention, as described in the specification, “relates to
medical injector systems for injecting medical fluids
into a patient’s
vascular system”. Under the heading “background of the
invention”, the patent noted that
“[m]edical injectors and syringes
for injecting contrast media into a patient for imaging biological structures
are known in
the art”. The patent illustrated and amplified this
proposition. Amongst other things, the patent noted the need “for
a
simpler front-loading medical injector”. In the course of presenting a
“summary of the invention”, the patentee
stated:
According to a further aspect of the invention, there is provided a hub for a
syringe for use with a medical injector system, comprising
an outer surface
adapted to slidingly engage with a barrel of the syringe, and an inner surface
having a substantially annular engaging
portion adapted to be releasably engaged
by a plunger to permit the hub to be selectively withdrawn along the barrel by
the plunger.
By providing a hub with these features, a number of benefits can be obtained
which relate to the efficiency of use and safety of
the patient to be injected
...
The engaging portion may be of any convenient conformation for example, it may
be a cavity, a groove or a ridge. Where the engaging
portion is a groove, the
groove may define a semi-circular cross-section or the groove may extend at
least partially along the circumference
of the inner surface of the hub.
...
...
According to one preferred embodiment, the inner surface of the hub is
complementary in shape to an outer surface of the plunger.
Preferably the inner
surface of the hub comprises an interior hollow that contacts the plunger. Such
an arrangement allows for
a form fit which has the advantage of providing a
reinforcing effect to the hub. ... Preferably the plunger has a tapered front
end, which is inherently “self centering” as it engages the hub.
...
...
The hub may also be adapted to engage a seal associated with at least a portion
of an outer surface of the hub, or alternatively,
the hub may perform the
function of a seal. ...
As is customary, the patent provided a
detailed and illustrated description of preferred embodiments, to some of which
I was taken
in argument.
- The
claims upon which the applicants rely read as follows:
- A
hub for a syringe for use with a medical injector system, comprising an outer
surface adapted to slidingly engage with a barrel
of the syringe, and an inner
surface having an annular engaging portion comprising a groove adapted to be
releasably engaged by a
plunger to permit the hub to be selectively withdrawn
along the barrel by the plunger wherein the inner surface of the hub is
complementary
in shape to an outer surface of the
plunger.
...
4 A hub according to claim 1 wherein the engaging portion is a ridge.
...
- A
hub and seal combination for a syringe for use with a medical injector system,
the seal comprising an outer surface adapted to slidingly
engage with a barrel
of the syringe and an inner surface adapted to engage the hub, and the hub
comprising an outer surface adapted
to engage the seal and an inner surface
having a substantially annular engaging portion comprising a groove adapted to
be releasably
engaged by a plunger to permit the hub and seal combination to be
selectively withdrawn along the barrel by the plunger wherein the
inner surface
of the hub is complementary in shape to an outer surface of the
plunger.
...
- A
hub and seal combination according to claim 9 wherein the engaging portion is a
ridge.
...
- A
syringe for use with a medical injector system comprising a hub, the hub
comprising an outer surface adapted to slidingly engage
with a barrel of the
syringe, and an inner surface having an annular engaging portion comprising a
groove adapted to be releasably
engaged by a plunger to permit the hub to be
selectively withdrawn along the barrel by the plunger wherein the inner surface
of the
hub is complementary in shape to an outer surface of the plunger.
- A
syringe for use with a medical injector system comprising a hub and seal
combination, the seal comprising an outer surface adapted
to slidingly engage
with a barrel of the syringe and an inner surface adapted to engage the hub, and
the hub comprising an outer
surface adapted to engage the seal and an inner
surface having a substantially annular engaging portion comprising a groove
adapted
to be releasably engaged by a plunger to permit the hub and seal
combination to be selectively withdrawn along the barrel by the
plunger wherein
the inner surface of the hub is complementary in shape to an outer surface of
the plunger.
- Counsel
for the applicants argued that, if Stellant substitute syringes (products
numbered 100102 and 100104) were found to feature
a ridge, instead of a groove,
then the respondent would be found to infringe claims 4 and 12 and properly be
enjoined from selling
the barrel of the syringe alone. Whether this would have
any practical significance is uncertain.
THE PARTIES’ SUBMISSIONS ON INJUNCTIVE RELIEF
- Briefly,
the applicants argued that there was a serious question to be tried as to
whether the Stellant substitute syringes infringed
the patent in suit. (As
already noted, the respondent conceded that its Klikfit substitute syringes had
the essential integers of
the applicants’ KLIKFIT syringes.) The
applicants argued that the respondent’s challenge to patent validity
needed “to
be tempered by the proposition that registration of a patent
constitutes prima facie evidence of validity”. Thus, said the
applicants,
unless the case of invalidity was sufficiently strong, the Court should move to
consider the adequacy of damages, the
balance of convenience, and other
discretionary factors. The respondent’s approach to evidence on
invalidity focused, so the
applicants said, on identification of isolated
features of the claims from the prior art:
(i) with full knowledge of the patent and its contents (and therefore
hindsight); (ii) without proper identification of the common
general knowledge;
and (iii) significantly, without proof of relevance to the inquiry under Section
7(3) of the Patents Act. Such an approach does not provide a basis for
qualifying the serious question on infringement.
The applicants submitted that damages would be an inadequate remedy and that
the balance of convenience favoured preservation of the
status quo pending
trial. The applicants cited loss of sales; loss of regular contact with
customers; temporary and permanent reduction
in the price of their Australian
products; and potential loss of reputation. The applicants noted that they had
an established trade,
and that that there was no evidence that the respondent
would be forced out of business or otherwise unable to conduct its business
normally until the trial if an interlocutory injunction were granted. The
applicants noted that the respondent had not provided
any financial or asset
information, notwithstanding requests to do so. The respondent had entered the
market, so the applicants
said, with “its eyes wide open” and there
was insufficient evidence to suggest that it would suffer reputational harm
in
the event of an interlocutory injunction.
- The
respondent argued that there was no serious question to be tried because the
Stellant substitute syringes (products numbered
100102 and 100104) did not have
two essential integers. This argument is explained below. It followed, so the
respondent said,
that none of claims 1, 9, 51 and 52 were infringed. Moreover,
according to the respondent, each of the claims merely defined syringes
or parts
of syringes by reference to broad features that were well known and in use in
syringes in Australia before the earliest
possible priority date. The only ways
in which the defined syringes or parts could differ from the prior art are, so
the respondent
said, with respect to mere specific, constructional features
which, in themselves, were, at that time no more than obvious mechanical
equivalents or design variants for locking components or for providing means of
reinforcement, commonly known in Australia by designers
and engineers alike.
Thus, said the respondent, there was nothing in the claims, either alone or in
combination, which provides an
inventive step to support a patentable invention
in the terms used in the claims.
- The
respondent argued that it had not been shown that the balance of convenience
favoured an interlocutory injunction. Further,
the respondent argued that its
was a growing business and the grant of interlocutory injunctive relief may well
signal to the market
that it is an unreliable supplier.
CONSIDERATION
(a) Approach to the grant of interlocutory
relief
- The
principles governing the grant of interlocutory relief are settled. On
application for an interlocutory injunction, the applicants
must show
that:
(a) there is a serious question to be tried in respect of the
actual or threatened infringement of the patent in suit; and
(b) the balance of convenience favours the grant of an interlocutory
injunction, including that an award of damages would not be an
adequate remedy
for the irreparable harm the applicants would suffer if an interlocutory
injunction were not granted.
In order to demonstrate that there is a serious
question to be tried, the applicants must make out a prima facie case in the
sense
that, if the evidence remains the same, then there is a probability that
at trial they will be found entitled to relief. As Gummow
and Hayne JJ
explained in Australian Broadcasting Corporation v O’Neill [2006] HCA 46; (2006)
227 CLR 57 at 81-82 [65]- [70], “it is sufficient that the plaintiff show a
sufficient likelihood of success to justify in the circumstances the
preservation
of the status quo pending the trial”. Their Honours added at
84 [71], “the governing consideration [is] that the requisite
strength of
the probability of ultimate success depends upon the nature of the rights
asserted and the practical consequences likely
to flow from the interlocutory
order sought”.
- The
respondent’s submission – that, in a patent infringement case such
as this, where the validity of the patent is challenged,
the practice of the
court is to refuse an interlocutory injunction – depended on Beecham
Group Ltd v Bristol Laboratories Pty Ltd [1968] HCA 1; (1968) 118 CLR 618 at 623-624. In
Beecham, Kitto, Taylor, Menzies and Owen JJ referred (at 623) to
“the special considerations which generally arise in a patent action
where
there is a substantial issue to be tried as to the validity of the
patent”. Their Honours (at 623-624) said:
[T]he plaintiff’s prima facie case must be a strong one so far as the
question of validity is concerned, for he asserts a monopoly
and must give more
proof of the right he claims than is afforded by the mere granting of the patent
... The general practice in that
kind of case has long been to refuse an
interlocutory injunction unless either the patent has already been judicially
held to be
valid or it has stood unchallenged for a long period
...
- The
practice to which their Honours referred is no longer the practice of the
courts. This much appears from the authorities to
which counsel for the
applicants referred me, including AB Hassle v Pharmacia (Australia) Pty
Ltd (1995) 33 IPR 63, Genrx Pty Ltd v Sanofi-Aventis [2007] FCA 1485; (2007) 73 IPR
502, and Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498; (2008) 79 IPR 261.
The reason for the change in practice is that the legislative requirements for
grant of a patent are more exacting than they once
were and include provision
for opposition proceedings before the grant.
- In
AB Hassle (33 IPR at 69-70) Ashley J specifically rejected a submission
similar to that made by the respondent in this case and held that,
where the
defendant challenged the validity of the patent, it was for the defendant to
establish a triable question in respect of
validity. If a strong case for
invalidity was provisionally made out, then, as his Honour said, this factor
would be relevant to
the exercise of discretion.
- In
Genrx (73 IPR at 503-504 [2]-[6]), Gyles J again considered the
ongoing significance of Beecham for the grant of interlocutory
injunctions in cases of alleged patent infringement. As his Honour observed,
after American-Cyanamid Co v Ethicon Ltd [1975] UKHL 1; [1975] AC 396, there was a good
deal of discussion about the importance of apparent differences between
American-Cyanamid and Beecham. His Honour continued (at 503 [4]):
The most influential consideration of the issue in relation to patents was that
by Gummow J in Martin Engineering Co v Trison Holdings Pty Ltd (1988) 81
ALR 543; 11 IPR 611. In the course of that judgment his Honour pointed out that
the authorities referred to by the High Court in Beecham Group for not
attributing great significance to the grant of a patent were old cases from
England based upon a different system for grant
than that which had developed in
Australia by that time. The system of examination of patents prior to grant in
Australia was more
stringent than had been the case in England the century
before. The practical effect of this decision was to give greater weight
to the
grant of a patent thereafter than might have been deduced from Beecham
Group.
- Gyles
J rejected a submission to the effect that the decision of the High Court in
Australian Broadcasting Corporation v O’Neill [2006] HCA 46; (2006) 227 CLR 57 had
restored the authority of Beecham in this regard. His Honour noted,
correctly in my view, that the reaffirmation of Beecham by the High Court
in O’Neill concerned the elucidation of what is required for a
prima facie case (or serious question to be tried).
- In
Interpharma, Jessup J stated (79 IPR at 267 [17]) that “[i]n a
patent case, the fact of registration constitutes prima facie evidence of
validity”, noting that it is for the respondent to show that want of
validity is a triable question. His Honour continued
that, in his view, if the
respondent went no further than showing a triable case on validity, “then,
assuming always that the
applicant has shown a triable issue on infringement,
absent questions of validity, the conclusion would remain that the latter had
a
triable question”.
- This
approach is consistent with that of Sundberg J in Sigma Pharmaceuticals
(Australia) Pty Ltd v Wyeth [2009] FCA 595, where his Honour granted an
interlocutory injunction in an alleged case of patent infringement,
notwithstanding that he was satisfied
that there was a prima facie case that the
invention would have been obvious to a person skilled in the relevant art in
light of
the common general knowledge as it existed in Australia before the
priority date. See also Wake Forest University Health Sciences v Smith &
Nephew Pty Ltd [2009] FCA 630 at [36] and [55], where Ryan J held that there
was a serious question to be tried on the issue of novelty, but granted an
interlocutory injunction
on the basis that the applicants had established a
serious question to be tried on infringement.
(b) Serious
question to be tried on infringement
- Each
of claims 1, 9, 51 and 52 of the patent in suit requires each of the following
essential integers, namely a hub having:
(a) an inner surface having
an annular engaging portion comprising a groove adapted to be releasably
engaged by a plunger to permit the hub to be selectively withdrawn along the
barrel by the plunger; and
(b) an inner surface complementary in shape to an outer surface of the
plunger.
- As
previously noted, the respondent has admitted that the Klikfit substitute
syringes have the essential integers of these claims,
as the applicants alleged.
If the respondent fails on its invalidity defence, then the applicants’
case on infringement is
made out in respect of the Klikfit substitutes.
- The
respondent submits, however, that the Stellant substitute syringes do not
contain the integers of the claims as alleged. First,
according to the
respondent, these syringes have no groove adapted to be releasably
engaged by a plunger.
- On
this issue, the applicants relied on the evidence of patent attorney Tse, who
expressed the opinion that the Stellant substitute
syringes had an inner surface
having an annular engaging portion comprising a groove adapted to be
releasably engaged by a plunger to permit the hub to be selectively withdrawn
along the barrel by the plunger. In tables
within his affidavit, Mr Tse observed
that:
The inner surface (which includes the area shown by item 110) of the hub (100)
comprises an annular engaging portion (106) comprising
a groove (112). The
groove (112) is adapted in shape to define a ridge (108) that is releasably
engagable by a plunger of the injector
system to enable the plunger to
selectively withdraw the hub (100) along the barrel (104).
- References
to the item numbers in brackets correspond to the features shown by the numbered
arrows in the photographs that constituted
VCT-1 to Mr Tse’s affidavit.
Photos 5, 6, 7 and 8 are reproduced in Appendix A.
- Mr
Tse added “[t]he plunger has engaging protrusions (116) for engaging a
part of the groove (112) of a syringe” and
that without this feature the
Stellant substitutes would not be compatible with a STELLANT™ medical
injector system.
- In
argument, the applicants submitted that (108) was a ridge and that, when one
drops down the side of that ridge, from (108) to
the flat portion (112), one is
dropping into a groove in the sense of a depression or recess. The pins on the
plunger drop into
the groove so understood. Alternatively, the applicants
submitted that, having regard to Mr Pappas’ affidavit, the engaging
portion comprised a ridge, within claim 4 and claim 12.
- Referring
to a definition of the word “comprising” in the specification, the
respondent argued that the Stellant substitute
syringes have an engaging portion
comprising a ridge, rather than a groove. The respondent relied on patent
attorney Pappas for the
contrary opinion to Mr Tse.
- Mr
Pappas expressed his opinion in this way:
Plainly feature 108 identified by Mr Tse in photos 7-8 is a “ridge”
(or “projecting lip”) and not a groove.
It is this ridge that is
engaged by the plunger by means of pins projecting from the outer surface of the
plunger. When the pins
on the plunger (which are retractable within the body of
the plunger) pass through the smallest diameter of the hub (being the diameter
of the ridge), they extend or can be actuated to extend and, in their extended
state, sit against the ridge. When the plunger is
withdrawn the pins sitting
against the ridge apply a force to the ridge to move the hub in the direction of
the force of the withdrawing
plunger. Whilst the ridge is annular, it is not a
cut or indentation, furrow, track or channel in a surface or any other shape
that
is a groove. Nor is feature (108) a component of a
groove.
Moreover, feature 112 identified by Mr Tse in photos 7-8 is an inner cylindrical
surface. Whilst 112 is cylindrical, there is no
cut or indentation, track or
channel in that surface that in anyway resembles a groove. Nor is feature (112)
a component of [a]
groove.
- As
explained hereafter, because of claim 4, the issue, whether the engaging portion
of the Stellant substitute syringes is a groove
or a ridge, appears to be of
limited practical importance.
- For
this reason, I deal with the submissions on this issue comparatively briefly. In
its ordinary natural meaning, the word “groove”
may signify a
generally narrow channel, hollow, furrow, or rut: see Oxford English
Dictionary and Macquarie Dictionary. The specification for the
patent in suit uses the words “groove or recess” apparently as
indicative of the same feature.
As presently advised, it is reasonably arguable
that the engaging portion is a groove. I accept the applicants’
submission
that, if the engaging portion is the hollow or recess created by and
under the ridge, then the engaging portion may well be said
to comprise a groove
within the meaning of claims 1, 9, 51 and 52.
- If,
however, the engaging portion is, as the respondent said, better described as a
ridge, then the engaging portion will apparently
comprise a ridge within the
meaning of claims 4 and 12.
- The
respondent argued that, even if the engaging portion were a ridge, it would not
follow that the Stellant substitute syringes
infringed the patent in suit by
falling within claim 4. The respondent contended that to so conclude involved a
misconstruction
of claim 4. The respondent submitted that claim 4 required a
hub according to claim 1, such that the engaging portion is a ridge
and that did
not obviate the necessity for a groove. On the respondent’s construction,
“an inner surface having an annular
engaging portion comprising a
groove” was to be read as “an inner surface having an annular ridge
comprising a groove”.
- At
this stage, I would be inclined to reject the respondent’s construction.
As the applicants submitted, I would construe
claim 4 so as relevantly to read,
“an inner surface having an annular engaging portion comprising a
ridge”. Hence, I
am inclined to the view that little may in practice turn
on whether the engaging portion is said to be a groove or a ridge.
- Secondly,
the respondent submitted that the inner surface of the hub of the Stellant
substitute syringes is not complementary in shape to an outer surface of
the plunger. The respondent relied on an asserted lack of conformity with this
integer. The respondent noted
that the plunger was cylindrical with a thruster
conical tip whilst the inner hub of the Stellant substitute syringe was complex
in shape (because of its interior ribs) and flaring outwards. The respondent
argued that the applicants’ case disregarded
the conical tip at the end of
the syringe and the complexity brought about by the ribs and the flaring.
- In
this respect too, the applicants relied on the opinion of Mr Tse. In his first
affidavit, Mr Tse gave the opinion that “[t]he
inner surface (which
includes the area shown by item 110) of the hub (100) is complementary in shape
to an outer surface (118) of
the plunger of a STELLANT™ medical injector
system, which has a substantially round cross-section”. Mr Tse added that
the Stellant substitute syringes and each of the applicants’ Stellant
syringes “have this feature and work in the same
way”. That is,
the hub was designed to fit over the plunger by adopting a shape conformable to
the plunger.
- In
his affidavit, Mr Pappas expressed the contrary view. Mr Pappas’
reasoning is as follows:
In the specification at page 10 of the Patent ... lines 19-24, an embodiment is
described that explains what is meant by “complementary
in shape”
when the plunger engages the hub. An advantage of this feature is a form fit
which provides a reinforcing effect
to a thin walled hub. The presence of a
thin walled hub is said to contribute to economies of manufacture: see lines
15-18 on the
same page. This arrangement is also described between page 35 line
29 to page 36 line 4 of the Patent (pages 65 to 66) of the Tse
affidavit).
The plunger of the STELLANT medical injector system is illustrated in exhibit
VCT-5 at pages 141 to 143 of the Tse affidavit. It
can be seen that that part
of the plunger which engages the hub of the syringe comprises a shaft that is of
substantially uniform
cylindrical shape (I leave aside the engaging pins
indicated by the numeral 116), with a frusto-conical tip or dome on which there
is a projecting pin.
By way of contrast, the inner surface of the Shenzhen 100102 (a) has no area or
portion that corresponds to the frusto-conical tip
and projecting pin of the
STELLANT plunger (the rubber seal itself forms a “dome” and simply
sits on the hub where it
is directly engaged by the tip of the plunger that
passes through the hub); and (b) is of a complex shape that is generally flared
(because of differing diameters) with numerous reinforcing ribs. When the
plunger of a STELLANT medical injector system is engaged
with the hub of the
Shenzhen 100102, in no way can the inner surface of the hub be
“complementary in shape” to that of
the plunger or any part of the
plunger.
With respect to the differing diameters, the smallest (narrowest) diameter of
the hub of the Shenzhen 100102 is at the annular engaging
ridge. The plunger
must pass through that portion of the hub so that the pins on the plunger can
engage with the ridge. The inner
cylindrical surface of the hub of the Shenzhen
100102, being the feature identified by numeral 112 as indicated in photos 7-8
of
exhibit VCT-1 on page 18 of the Tse affidavit, has a diameter grater than the
diameter where the plunger passes through the annular
engaging ridge. This
arrangement is in fact the opposite to that shown in Fig 6 of the Patent ... in
the sense that, in Fig 6, the
diameter of the inner surface of the hub is
substantially constant until it narrows in the region of the
frusto-conical tip. On the other hand, in the Shenzhen 100102, the diameter of
the inner surface of the hub
in fact widens in the region beyond the
engaging portion provided by the ridge. If in fact the plunger was
complementary in shape to the inner surface
of the Shenzhen 100102, that part of
the plunger that was complementary in shape to that region of the hub beyond the
ridge (towards
the tip of the seal) would not be able to pass through the
diameter of the annular engaging ridge. It would be impossible for it
to do so.
Similarly, in the region of the Shenzhen 100102 before the annular engaging
ridge, the diameter of the inner surface of
the hub is in fact wider than
the diameter of the annular engaging ridge.
Because the inner surface of the Shenzhen 100102 hub is not complementary in
shape to an outer surface of the plunger in the STELLANT
medical injector, there
is no form fit between the plunger and the hub so as to provide a reinforcing
effect on the hub. ...
- In
Mr Pappas’ opinion, Mr Tse was wrong to regard the inner surface of the
hub as “complementary in shape” to an
outer surface of the plunger
simply because the plunger has a “substantially round
cross-section”. Mr Pappas argued
that:
The claim, by definition, expressly requires “the inner surface of the
hub” to be complementary in shape with an outer
surface of the plunger.
This means that the whole inner surface of the hub must be
“complementary in shape” to an outer surface of the plunger, except
for where the groove/annular
engaging portion is.
- The
applicants argued that Mr Pappas’ reasoning was erroneous because Mr
Pappas sought to construe claim 1 by reference to
a preferred embodiment, which
gave a form fit. The applicants noted that the notion of “form fit”
was not part of claim
1 but was part of claim 5. There is some substance to
this objection.
- The
whole of the specification, including the preferred embodiments, may assist in
the construction of the claims. The preferred
embodiment of the invention is,
in this instance, a statement of the preferable method of construction of the
article (or, in other
instances, best method of performing the invention), but
it is the claim that actually defines the invention the subject of the patent.
As presently advised, the respondent’s argument on form fit apparently
seeks to limit the monopoly as fixed by the words of
claim 1 by adding a gloss
drawn from the statement of a preferred embodiment in the specification. There
would appear to be no good
reason to do this, especially having regard to claim
5.
- The
word “complementary” is not apparently a technical term. The word
“complement” can signify “[s]omething
which, when added,
completes or makes up a whole; each of two parts which mutually complete each
other, or supply each other's deficiencies”:
see Oxford English
Dictionary. If understood as broadly as this, it may well be that
“complementary in shape” includes a feature wherein the inner
shape
of one component follows the general shape of an outer surface of another
component that is in close proximity, such as the
Stellant substitute hub and
plunger. As presently advised, I do not consider that “complementary in
shape” requires
that the inner surface of the hub must entirely conform to
the whole outer surface of the plunger.
- Having
said this, however, I would not discount Mr Pappas’ observations entirely.
It may be that more is required to make the
inner surface of the hub
complementary in shape to an outer surface of the plunger than merely
having a common round cross-section that enables the hub of the Stellant
substitute
syringe to fit over the plunger as it presently does. Whilst the
construction of a claim is essentially a matter for the court,
expert evidence
is admissible on the meaning of technical terms and generally to put the
court in the same position as a skilled addressee. Doubtless the parties will
present evidence of the latter
kind at the trial, which may assist on this
aspect of the case.
- As
things presently, however, there is a serious question as to whether the
respondent’s Stellant substitute syringes infringe
the applicants’
Stellant syringes because the requirement for complementary surfaces in claims
1, 9, 51 and 52 is a feature
of the Stellant substitute syringe. That is, this
requirement may very well be found to involve no more than a round cross-section
that enables the hub of the syringe to encircle the body of the plunger as it
does in the Stellant substitute.
- I
have reached this conclusion that there is indeed a serious question to be tried
as to whether there has been an infringement of
the kind alleged by the
applicants and not admitted by the respondent, especially having regard to the
photos in Appendix A and to
exhibits A1 and R1. The respondent accepts that,
but for the issue of validity, the Klikfit substitute syringe would infringe the
patent in suit.
(c) Triable case on invalidity
- The
respondent has challenged the validity of the patent in suit on the ground of
obviousness. Mr Pappas stated that he had seen
“many publications and
patent documents in the medical connector field and fluid connection fields ...
which predate the earliest
possible priority date for the Patent ... and which
utilise movable engaging members, releasably or permanently engaging with
annular
grooves and recesses in other members both ‘complementary’
and ‘non-complementary’ in shape” and sought
to illustrate his
point by reference to numerous patents. He augmented this evidence by reference
to arrangements in other fields,
especially engineering. Mr Pappas also gave
evidence directed to showing that reinforcement by the use of complementary
shapes,
especially in relation to the design and manufacture of plastic items,
was well-known.
- The
respondent argued that Mr Pappas’ evidence showed that to use an annular
engaging portion as a means of locking or connecting
two complementary members
was to specify a well-known and obvious design technique. The respondent also
observed that Mr Pappas
referred to the fact that using complementary shapes as
reinforcement was a well-known technique. The respondent relied on the fact
that
Mr Pappas was an engineer, and, so it said, therefore a person skilled in the
art. In this context too, the respondent relied
on the evidence of Ms Evans as
a practising radiographer.
- As
Mr Tse noted, the documents to which Mr Pappas referred did not relate to
medical injector systems, and did not appear to describe
“any mechanism
that enables two different parts to releasably engage with each other so that
one part can selectively withdraw
the other part from a container (such as a
syringe)”.
- In
argument, the applicants submitted that there was no evidence that any of the
inventions disclosed in the documents to which Mr
Pappas referred was part of
the common general knowledge of a person skilled in the art at the relevant
date. Thus, so the applicants
submitted, there was no evidentiary basis for s
7(2) of the Patents Act 1990 (Cth). The respondent disclaimed any
reliance on s 7(3) of that Act.
- As
things presently stand, I do not consider that the respondent has made out a
prima facie case that the invention would have been
obvious to a person skilled
in the relevant art in light of the common general knowledge as it existed in
Australia before the priority
date. This is because there is insufficient
evidence that the invention disclosed in the patent in suit would have been
obvious
to a person skilled in the art in the light of common general knowledge
as it existed in the patent area before the priority date.
Mr Pappas’
evidence amounted to no more than general assertions about common arrangements
in different fields of endeavour
with different problems to confront. It is by
no means clear that he should be regarded as a person skilled in the art simply
because
he has engineering qualifications. The respondent has not produced any
document identifying a similar use of technology in the prior
art to that found
in the patent in suit. Ms Evans’ evidence was not that of a person
skilled in the art and was of a generalised
kind. For these reasons, her
evidence was of very limited utility.
(d) Adequacy of damages, balance of convenience and other
discretionary factors
- Further,
I am persuaded that the inadequacy of damages and the balance of convenience
favour the grant of an interlocutory injunction.
- First,
the respondent has not been engaged in selling the impugned syringes for very
long and the quantities involved are comparatively
slight. Against this, the
applicants have been in the business of selling syringes and medical injector
systems for many years.
They have a considerable business interest at stake.
- It
may be as Ms Evans deposed, that, if the respondent were enjoined as the
applicants seek, then this would adversely reflect on
the respondent’s
reputation for reliability as a supplier. It seems probable, however, that the
respondent’s representatives
will be able to offer suitable explanations
to its relatively new customers. The respondent has not said that it would
suffer any
other kind of harm to its business.
- Secondly,
damages would not be an adequate remedy for the harm that the applicants are
likely to suffer.
- There
is no evidence that the respondent has assets available to satisfy an award of
damages in the applicants’ favour. The
respondent, which was incorporated
about two years ago, has paid-up capital of $2 and searches have revealed no
significant assets.
The respondent has stated that it is prepared to deposit
into a separate bank account the gross profits it has received, and receives,
from the sales of products numbered 100102, 100104 and 500102, pending the final
determination of the proceeding, but this does not
provide the needed assurance
that the respondent could meet a significant award of damages. As previously
noted, the respondent
is a relatively new entrant into the market and is
apparently still in the process of building its business. There is no dispute
about the applicants’ capacity to pay damages pursuant to the usual
undertaking to do so.
- Further,
Mr Reynolds’ evidence is that, if the respondent is permitted to sell the
syringes in issue, there will be what Gyles
J called “interference with
... trade patterns”: see Genrx at 506 [15] and Interpharma
at 280 [71]. That is:
- If
the respondent is permitted to continue supplying its syringes at a price that
is approximately 20% less than Imaxeon’s price,
then Imaxeon would
probably be compelled to lower the price for its equivalent syringes or lose its
customer base.
- There
is a real risk that if it held to its higher price, this would damage its
reputation and have ramifications when a customer
came to purchase or upgrade
their injector system.
- If
Imaxeon is compelled to lower the price for its syringes, the price reduction
would probably be permanent (even if Imaxeon succeeded
at trial) and result in a
significant overall loss of revenue which would be very difficult to quantify.
- Any
price increase would compromise Imaxeon’s reputation and goodwill and the
chances of securing new customers in a market
where prices are either stable or
declining.
- By
regularly supplying their customers with replacement syringes, Imaxeon retains
regular contact with the applicants’ customers.
This confers various
advantages, including that Imaxeon is foremost in the customer’s mind when
the time arrives to replace
an injector system.
- Imaxeon
would likely suffer a loss of reputation if there were defects in the
respondent’s syringes because the defects would
affect the operation of
the injector system. (I note that, in argument, the applicants did not invite
the court to give this consideration
a great deal of weight since there was no
evidence of defects in the respondent’s syringes.)
- The
respondent noted that the applicants had presented little detailed evidence on
pricing and the effects of competition. The respondent
noted that Mr
Reynolds’ affidavit established that, in any event, the major suppliers of
injector systems compete against one
another on the cost of the injector systems
and consumables and that the prices for the applicants’ syringes broadly
reflect
the pricing for other CT contrast injector systems. It followed, so the
respondent said, that price competition was a feature of
the market and that the
applicants were already competing with the respondent, which was supplying
syringes to competing systems.
The respondent noted that the applicants had not
yet lowered their prices as a result of the respondent’s entry into the
market.
Further, the respondent challenged Mr Reynolds’ evidence that any
price reduction would be permanent and, in this regard,
referred to Ms
Evans’ evidence that this had not been her experience in the business of
Jacobs Medical Australia Pty Ltd.
The respondent observed that, in elaborating
on the harm likely to befall their business, the applicants had engaged in a
degree
of speculation.
- I
accept that evidence about the nature of the competition in the medical injector
systems and associated consumables market and
the effect of new entrants might
well be complex. Obtaining complete evidence of this kind would be expensive
and probably unjustified
for this application. It is undisputed that the
applicants occupy a large proportion of the present market, and derive a large
proportion
of their revenue from the sales of consumables for the contrast
injector systems, particularly KLIKFIT syringes and STELLANT™
syringes for
the VISIMAX® CT and the STELLANT™ CT contrast injector systems
respectively.
- Although
the respondent disputed the propositions advanced by Mr Reynolds, ultimately,
the respondent fails to take its case beyond
the level of mere disagreement.
The evidence of Ms Evans was very limited in that it concerned her experience in
a different and
not necessarily comparable business. None of the
respondent’s evidence seriously undermined the assessment made by Mr
Reynolds
as Imaxeon’s managing director and a person with apparently
considerable experience in the relevant market. As things presently
stand, the
respondent has not demonstrated that Mr Reynolds’ assessment of the effect
of the respondent’s sales of the
impugned syringes is significantly wrong
in any material respect.
- The
effect on Imaxeon strongly argues in favour of preservation of the status quo
until the issues in dispute can be determined at
trial, the date for which is
already fixed. The effect on the respondent provides no strongly countervailing
consideration. Further,
it is apparent that at least some of the harm that
would be done to Imaxeon if an interlocutory injunction were not granted would
not readily be met, if met at all, by an award of damages.
- The
applicants submitted that the respondent got itself into this situation with its
eyes wide open. As noted above, Ms Evans’
evidence was that
representatives of Shenzhen Ant had said that there were no patents that would
cause any issue for the respondent
in selling syringes in Australia. The
applicants argued that the respondent ought to have checked the position for
itself. That
is, the respondent has offered for sale or sold the syringes in
the knowledge that they were the subject of a patent, or in circumstances
where
the respondent should have known of the patent. A consideration of this kind
has been weighed in the balance of convenience
from time to time: see
Beecham 118 CLR at 626; Tidy Tea Ltd v Unilever Australia Ltd
(1995) 32 IPR 405 at 415; Pharmacia Italia SpA v Interpharma Pty Ltd
(2005) 67 IPR 397 at 408 [52]; Interpharma 79 IPR at 282 [77]; and
Sigma Pharmaceuticals [2009] FCA 595 at [61]- [62]. There would indeed
appear to be some force in the applicants’ criticism of the
respondent’s conduct in this regard.
The evidence on this point is
slight, however, and I would not therefore be inclined to give this factor much
weight in determining
the outcome of the applicants’ interlocutory
injunction application.
(e) Leave to amend the statement of
claim and application
- The
final question raised on this application for interlocutory relief is whether
the application should be determined by reference
to the amendments that the
applicants stated they wished to make to their previously amended statement of
claim and amended application.
In view of the way the respondent sought to
answer the applicants, it would be contrived and artificial not to consider the
present
application for an interlocutory injunction on the basis of the
applicants’ further proposed amendments.
- The
respondent submitted that, had it known that the applicants would rely on claims
4 and 12, it would have presented evidence:
(1) on the infringement question to
the effect that the ridge on the hub of the Stellant substitute syringe does not
contain a groove;
and (2) on the validity question, that the use of a ridge as
an engaging portion was common general knowledge.
- For
the reasons already given, I doubt that evidence on either of these matters
would affect the conclusion that I have reached.
First, as I have said, I am
disinclined at this stage at least to accept the construction of claim 4 that
the respondent urges.
Secondly, had Mr Pappas and Ms Evans given further
evidence as to the use of a ridge as an engaging portion, their evidence would
still have suffered from the deficiencies to which I have already
referred.
(f) Disposition
- For
the reasons stated, I would grant the interlocutory injunction sought by the
applicants. I would fix the trial of the matter
for 10.15 am on 22 February
2010, with an estimate of 4 days. I would direct that, on or before 4 pm
on 27 August 2009:
(a) the applicants file and serve minutes of
order in conformity with these reasons; and
(b) the parties file and serve short submissions on costs.
I certify that the preceding eighty-nine (89)
numbered paragraphs are a true copy of the Reasons for Judgment herein of the
Honourable
Justice Kenny.
|
Associate:
Dated: 25 August 2009
Counsel for the
Applicants:
|
Mr A J Ryan SC with Mr I P Horak
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Solicitor for the Applicants:
|
Mallesons Stephen Jaques
|
|
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Counsel for the Respondent:
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Mr D M Yates SC
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Solicitor for the Respondent:
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Hazan Hollander
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URL: http://www.austlii.edu.au/au/cases/cth/FCA/2009/949.html