LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809 (22 October 2010)

Last Updated: 22 October 2010

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2010] AATA 809

ADMINISTRATIVE APPEALS TRIBUNAL )

) No 2009/5496

GENERAL DIVISION )

Re LTS LOHMANN THERAPIE SYSTEME AG & SCHWARZ PHARMA LTD

Applicant

And COMMISSIONER OF PATENTS

Respondent

DECISION

Tribunal Justice Downes, President

Dr Schafer, Member

Date 22 October 2010

Place Sydney

Decision Decision affirmed.

.............[sgd]................................
Garry Downes
President

CATCHWORDS

PATENTS – Extension of term – meaning of “pharmaceutical substance per se” - transdermal therapeutic system for the treatment of Parkinson’s syndrome – not a pharmaceutical substance per se – extension refused.

RELEVANT ACT/S:

Patents Act 1990 (Cth)

CITATIONS

Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595; [2001] FCA 647

Euro Celtique, S.A. [2007] APO 13

H. Lundbeck A/S v Alphapharm [2009] FCAFC 70

Alphapharm Pty Ltd v H. Lundbeck A/S (2008) 76 IPR 618; [2008] FCA 559

LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12

N. V. Organon [2009] APO 8

Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424; [2003] FCAFC 77

Shi v Migration Agents Registration Authority [2008] HCA 31; (2008) 235 CLR 286

REASONS FOR DECISION

22 October 2010

Justice Downes, President Dr Schafer, Member

1. Certain pharmaceutical patentees can apply for extension of the term of their patent. LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd (LTS) have applied to the Tribunal to review an adverse decision on such an application by the delegate of the Commissioner of Patents. The invention relates to a transdermal therapeutic system for the treatment of Parkinson’s syndrome. The patentees would be entitled to an extension of term if one or more pharmaceutical substances per se are in substance disclosed in the complete specification of the patent and in substance fall within the scope of the claims of the patent.
2. We have decided that the extension was correctly refused because the complete specification does not disclose pharmaceutical substances per se. The components of the invention as disclosed and claimed include an adhesive compound (which carries the active ingredient), a backing layer and a protective layer (which is removed prior to administration of the product).

THE PATENT

3. The invention claimed in the patent is disclosed, in the complete specification, in a passage relied on by the patentee, as follows:

The invention relates to a transdermal therapeutic system for the treatment of Parkinson’s syndrome, comprising a backing layer which is inert to the ingredients of the matrix, a self-adhesive matrix layer containing (-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]-amino]-1-naphthalenol having the below-indicated formula
[formula]
in an effective amount, and a protective layer which is to be removed prior to use.

4. The first claim of the patent is as follows:
   1. A pharmaceutical compound for the treatment of disease adapted to be transdermally administered to a patient in need of said treatment comprising:

a backing layer, which is inert to the (-)-5,6,7,8,-tetrahydro-6-[propyl[2-(2-thienyl)-ethyl]amino]-1-naphthol base and the adhesive compound;
an effective amount of a free base (-)-5,6,7,8,-tetrahydro-6-[propyl[2-(2-thienyl)-ethyl]amino]-1-naphthol and an acrylate or silicone based non-aqueous polymer adhesive compound, wherein the solubility of the (-)-5,6,7,8,-tetrahydro-6-[propyl[2-(2-thienyl)-ethyl]amino]-1-naphthol base is greater than or equal to 5% (per weight); and
a protective layer, which is to be removed prior to administration of the pharmaceutical compound to the patient.

5. Claims 2 to 13 build on the first claim and we need not set them out. Claim 30 is an omnibus claim as follows:
   30. A pharmaceutical compound substantially as hereinbefore described with reference to the Examples.
       

THE LEGISLATION

6. The formula disclosed in the patent describes a drug with the generic name “rotigotine”. The patentee markets its invention as Neupro. This product is included in the Australian Register of Therapeutic Goods (ARTG).
7. Section 70 of the Patents Act 1990 (Cth) provides for the extension of the term of a standard patent where the requirements of the section are satisfied. A number of the requirements are not relevant to this application, but ss 70(2) and (3), and particularly ss (2), are relevant. They provide:

(2) Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
(3) Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.

8. The subject of the patent has been described as a transdermal patch which delivers the D2 receptor agonist rotigotine to the skin surface of subjects wearing the patch. The system permits an accurate dose to be released over time. The product Neupro is marketed in individual tear-apart packages. The product inside is described in the approved product information as follows:

The active ingredient rotigotine is a white to off-white powder. It is freely soluble in organic solvents, soluble in acidic aqueous solutions and practically insoluble in alkaline aqueous solutions.
Neupro is a thin, matrix-type transdermal patch composed of 3 layers:

1. A flexible, tan-coloured backfilm that provides structural support and protection of the drug-loaded adhesive layer.
2. A self-adhesive drug matrix layer. The excipients contained in the self adhesive matrix are povidone, ascorbyl palmitate, d1-alpha tocopherol and sodium metabisulfite. The adhesive matrix consists of a mixture of two proprietary silicone adhesives (BIO-PSA Q7-4301 and BIO-PSA Q7-4201).
3. A clear protective liner which is removed prior to use.
   
9. In use, the self-adhesive drug matrix layer rests against the skin and is covered by the flexible tan-coloured backfilm. The clear protective liner covers the surface to be applied to the skin and is removed prior to use.

PHARMACEUTICAL SUBSTANCE

10. The question we must determine is whether any of the claims in the patent fall within s 70(2)(a). No issue arises as to s 70(2)(b). Section 70(3) is also satisfied, provided that s 70(2)(a) is satisfied. We have set out s 70(3) because it may impact on the construction of s 70(2).
11. Pharmaceutical substance is defined in the dictionary of the Act as follows:

Pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

(a) A chemical interaction, or physico-chemical interaction, with a human physiological system; or
(b) Action on an infectious agent, or on a toxin or other poison, in a human body;

but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.

12. The Act contains no definition of the extended phrase “pharmaceutical substances per se” which appears in s 70(2)(a).
13. There are a number of decisions of the Federal Court and delegates of the Commissioner of Patents relating to the construction of s 70, particularly the phrase “pharmaceutical substances” and the effect of the additional words “per se”. These cases are discussed below. However, conscious of the warning of the High Court of Australia in Shi v Migration Agents Registration Authority [2008] HCA 31; (2008) 235 CLR 286 at 311-312, which we will set out, we think that the appropriate course is to begin by reference to the words of the legislation themselves:

As this Court has so often emphasised in recent years, questions presented by the application of legislation can be answered only by first giving close attention to the relevant provisions. Reference to decided cases or other secondary material must not be permitted to distract attention from the language of the applicable statute or statutes. Expressions used in decided cases to explain the operation of commonly encountered statutory provisions and their application to the facts and circumstances of a particular case may serve only to mask the nature of the task that is presented when those provisions must be applied in another case. That masking effect occurs because attention is focused upon the expression used in the decided cases, not upon the relevant statutory provisions.

14. What s 70(2)(a) requires, before a patent can be extended, is

(1) one or more pharmaceutical substances per se;

(2) in substance disclosed in the complete specification; and

(3) in substance falling within the scope of the claim or claims.

A pharmaceutical substance is:

(1) a substance (including a mixture or compound of substances) for therapeutic use;

(2) whose application involves:

(a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or

(b) action on an infectious agent, or on a toxin or other poison, in a human body.

15. It can be seen that at every level the test is concerned with “substances”. It is not concerned with the manufactured products or goods which are the patentees’ means of exploiting the patent. Section 70(3)(a) imposes a precondition that “goods containing, or consisting of, the substance” must be included in the ARTG, but that only serves to distinguish the goods from the substance. Although in theory the goods may be “the substance”, in most cases, the goods will contain more than “the substance”.
16. We note that the word “substance” is used with two meanings in s 70. Neither is defined in the Act. The definition of “pharmaceutical substance” does not define “substance”. It states qualities which a “substance” must have to be a “pharmaceutical substance”. The word is first used in s 70(2)(a), in the phrase “pharmaceutical substances”, to mean “matter”, to select from the eighth definition in the Oxford English Dictionary Online. When used in the phrase “in substance” it refers to the essential part or the essence of the pharmaceutical substance and requires that to be disclosed and to fall within the scope of the claim. The Oxford English Dictionary Online relevantly gives the following meaning to “in substance”: “In essentials, substantially”.
17. Undoubtedly, rotigotine is a substance, and a pharmaceutical substance at that; but the same cannot so readily be said of the transdermal delivery system containing the adhesive matrix, backing and removable liner. The Patents Act provides that a pharmaceutical substance is limited to “...a substance (including a mixture or compound of substances) for therapeutic use...”. Whilst it is accepted that Neupro is for therapeutic use and its application involves a chemical or physico-chemical interaction with a human physiological system, the issue is whether it falls within the scope of the phrase “a substance (including a mixture or compound of substances)”.
18. This phrase was considered in LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12 (LTS Lohmann). The patent in that case related to a transdermal patch which delivered a known drug, 17-β-estradiol. Claim 1 in the patent was defined in the following terms:

Transdermal therapeutic system containing the active substance 17-β-estradiol and optionally further active substances, with a laminated structure comprising a backing layer which is substantially impermeable to moisture and impermeable to active substance, one or more matrix layers and, where non-adhesive matrix layers are present, an adhesive layer, characterised in that the concentration of the dissolved estradiol in all matrix layers and, where an adhesive layer is present, in the adhesive layer, lies between its saturation concentration in dry condition and its saturation concentration in moist condition, whereby the term "dry condition" is understood to mean that the base material is in equilibrium with a gas phase with less than 10% relative humidity, and the term "moist condition" is understood to mean that the base material is in equilibrium with a gas phase with more than 90% relative humidity.

19. In LTS Lohmann, the Hearing Officer concluded that the phrase “including a mixture or compound of substances” makes it clear that the term “substance” is not limited to single chemical entities, but extends to mixtures and compounds of chemical entities. He further stated, at [16], that the “definition of a “pharmaceutical substance” is necessarily limited to chemical entities per se, compounds of chemical entities, and mixtures of chemical entities.” We agree with this proposition. In addition, specifically referring to 17-β-estradiol in a transdermal patch, the Hearing Officer concluded, at [17]:

if a claim to an alleged pharmaceutical substance includes features specifying the spatial configuration of the entities in the substance, it is not a claim to a pharmaceutical substance per se but a claim to an arrangement of substances characterised by that spatial configuration.

20. The patent for Euro Celtique, S.A. [2007] APO 13 (Euro Celtique) also concerned a transdermal delivery system. In that case, the relevant claims for the purposes of s 70 were directed to “[a] pharmaceutical formulation for treating pain”. Claim 22, which was representative of the relevant claims, stated:

A pharmaceutical formulation for treating pain in a human patient comprising a pharmaceutically effective amount of buprenorphine in a transdermal delivery system containing buprenorphine as the active ingredient together with instructions for applying said transdermal delivery system onto the skin of a human patient to provide a substantially first order plasma level increase of buprenorphine over a first three-day dosing interval, such that a mean plasma concentration from about 20 pg/ml to about 1052 pg/ml is attained, about 72 hours after application of said transdermal delivery system; and maintaining said transdermal delivery system on the skin of a human patient for at least an additional two-day dosing interval, such that a mean relative release rate from about 0.3 μg/hr to about 9 μg/hr is maintained over said at least two-day additional dosing interval and a human patient experiences analgesia throughout the at least two-day additional dosing interval.

21. The patentee in Euro Celtique sought to distinguish LTS Lohmann, as follows (at [21]):

Specifically, the claims of the patent do not include features specifying spatial configuration of the entities in the substance, they simply define any formulation which meets particular pharmacokinetic parameters, those parameters being dependent on the claim being assessed. Such a formulation could be any transdermal formulation meeting those parameters including a buprenorphine gel or cream - both of which are topically applied. See page 18 lines 17-21 of the patent where it is stated that ‘Any type of transdermal delivery system may be used provided the desired pharmacokinetic and pharmacodynamic responses are attained over at least 3 days...Preferable transdermal delivery systems include eg., transdermal patches, transdermal plasters, transdermal discs, iontophoretic transdermal devices and the like.’
In conclusion, the claims do not define an arrangement of entities or a layered arrangement and therefore can be distinguished from the claims in the LTS Lohmann decision as not being claims to substances qualified by a spatial arrangement.

22. The Delegate in Euro Celtique was satisfied that the relevant claims in the patent were distinguishable from LTS Lohmann because the claims in LTS Lohmann were clearly characterised by features of spatial configuration, whereas the claims in Euro Celtique did not define an arrangement of substances characterised by configuration, other than the existence of a pharmaceutically effective amount of buprenorphine “in a transdermal delivery system”.
23. The patentee in Euro Celtique argued that the pharmaceutical formulation claimed was exactly analogous to the preparation of a mixture of entities in tablet form, except that the mixture of entities was formulated into a transdermal delivery system. The patentee also argued that the product, Norspan, was a transdermal dosage form which was equivalent to a controlled-release dosage form but was absorbed through the skin rather than the gastro mucosa. In this regard, the patentee argued that Norspan should not be distinguished from such other pharmaceutical substances.
24. The delegate’s position, however, was that unlike a simple tablet which merely consists of a mixture of chemical entities in tablet form, a “transdermal delivery system”, by its very nature, suggests the presence of a backing layer or patch upon which the mixture of chemical entities is applied. In his view, the term “tablet” merely represented the intrinsic form or shape in which the mixture of chemical entities existed, whereas the phrase “transdermal delivery system” related to a separate physical integer unrelated to the mixture of chemical entities.
25. On this basis, it was held that the claim in the Euro Celtique case was to a method of treatment and the patent term extension was therefore refused.

PHARMACEUTICAL SUBSTANCE PER SE

26. The leading decision which considered the term “per se” in the phrase “pharmaceutical substance per se” is Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595; [2001] FCA 647 (Boehringer). In that case, the patent claims were for a container comprising an aerosol or spray composition for nasal administration. The composition contained a certain “pharmaceutical substance” as its active ingredient. The primary Judge, Heerey J, held that s 70(2)(a) was not satisfied because the pharmaceutical substance itself (per se) was not disclosed in the complete specification and did not fall within the scope of a claim of the patent specification. Examining the legislative history behind ss 70–79, his Honour’s conclusion was that patents for new and inventive processes or new and inventive modes of treatment of old or known products are not the subject of s 70; only patents for new and inventive products are. Accordingly, the expression per se showed that an extension of term is to be available only where the claim is for a pharmaceutical substance as such, not a substance forming part of a new delivery method or process.
27. The Full Court in Boehringer agreed (at [37]). Their Honours noted (at [39]) that the Second Reading Speech relating to the Intellectual Property Laws Amendment Bill 1997 (Cth) (which inserted the relevant sections into the Act) referred to the “development of a new drug” and of the research and testing required before a “product” could enter the market. In addition, their Honours noted (at [40]) that the Bill’s Explanatory Memorandum stated that a “pharmaceutical substance per se” is usually restricted to “new and inventive substances”. They considered that the expression “fall within the scope of the claim or claims of that specification” in s 70(2)(a) means that they must be “included amongst the things claimed ” (at [42]).
28. Thus, in Boehringer, the Court distinguished between a pharmaceutical substance that is the subject of a product claim (which they held to be within s 70(2)(a)) and a substance that forms part of a method or process claim (which they held not to be within s 70(2)(a)).
29. Similarly, in Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424; [2003] FCAFC 77, all of the claims were method claims, not product claims. The Commissioner’s delegate refused an application for an extension of term. The Full Court agreed with the decision of the Commissioner’s delegate in finding that a substance that is mentioned in the context of a method claim does not satisfy the requirement in s 70(2)(a) that the substance per se fall within the scope of a claim (at [23] – [24] per Wilcox and Cooper JJ, [28] per Allsop J).
30. Counsel for the Applicant sought to rely on the decision in N. V. Organon [2009] APO 8 (Organon), a decision of the Australian Patent Office, to support the proposition in the present case that the product Neupro was a pharmaceutical substance per se for the purposes of s 70(2)(a). In this regard, it is relevant to set out the abstract in the Organon decision:

The patent relates to a drug delivery system adapted to the slow release of particular steroidal mixtures such as for the purpose of contraception or hormone replacement therapy. A key aspect of the invention is that the steroidal mixture is contained in a thermoplastic polymer core over which is laid a permeable thermoplastic skin.

The patentee applied for an extension of term of the patent based on the inclusion of NUVARING® on the Australian Register of Therapeutic Goods. If allowed and, subject to any opposition that might be filed, granted, the effect of the extension would be that the maximum term of the patent would expire on 27 June 2021 rather than 8 April 2018.

Considered whether the product NUVARING as claimed in the patent was a pharmaceutical substance within the meaning of the Act and more particularly whether it was a substance (including a mixture or compound of substances) for therapeutic use as provided in the definition given in Schedule 1.

Found that the definition of a pharmaceutical substance encompasses a compound with a controlled spatial configuration if, as a whole, it can still be considered a “pharmaceutical substance”, but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure is excluded. It may be difficult to determine whether a particular feature of a product is correctly considered part of a “substance” rather than a separate physical integer but in the present case the steroidal components are mixed with and necessarily diffuse through the thermoplastic materials in the core and skin regions and as such the product as a whole exhibits a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.

31. Organon advanced the proposition that the product NUVARING was a pharmaceutical substance, notwithstanding the fact that etonogestrel and ethinyloestradiol, the active ingredients in the product which were responsible for the therapeutic effect, were not "new and inventive substances" (cf Boehringer). The delegate's reasoning was that the diffusion of the active ingredients through the thermoplastic materials in the core and skin regions conferred a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.
32. However, this decision is inconsistent with judicial reasoning, which indicates that it is the active ingredient(s) in a product, rather than the product as a whole, which is considered the pharmaceutical substance for the purposes of s 70(2)(a). The case of H Lundbeck A/S v Alphapharm [2009] FCAFC 70 (Lundbeck) involved an extension of the term of the patent for escitalopram, or (+)-citalopram, the active ingredient in Lundbeck's product Lexapro. Lundbeck had previously obtained registration of the drug Cipramil, which contained citalopram, a racemic mixture of (+)-citalopram and (-)-citalopram. Although the basis of the proceedings concerned an analysis of whether Cipramil "contained" (+)-citalopram for the purposes of s 70(3) (the first inclusion in the ARTG), there was also some consideration of the term "pharmaceutical substance per se" in s 70(2).
33. At first instance, Alphapharm Pty Ltd v H. Lundbeck A/S (2008) 76 IPR 618; [2008] FCA 559 at 125-127, Lindgren J stated:

The expression “pharmaceutical substance” is defined in Schedule 1 to the Act to mean, relevantly:

a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

(a) a chemical interaction, or physio-chemical interaction with a human physiological system; ...

The expression “therapeutic use” is defined in Schedule 1 to mean, relevantly:

(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; ...

Clearly, both citalopram and (+)-citalopram are pharmaceutical substances.

...

and at 131:

The racemate, citalopram, is the pharmaceutical substance per se disclosed in the specification of the Australian Citalopram Patent, whereas the (+)-enantiomer of that racemate is the pharmaceutical substance per se disclosed in the specification of the [Escitalopram] Patent, in each case for the purpose of s 70(2)(a).

34. The Full Court agreed. Bennett J (with whom Middleton J agreed) stated at 70:

There is no dispute that the pharmaceutical substance for the purposes of s 70(2)(a) is (+)-citalopram.

...

And at 73:

....the pharmaceutical substance per se is the molecule, the (+)-enantiomer. The racemic mixture is a solution that contains both (+) and
(-) enantiomers in equal proportions. That (+)-enantiomer molecule per se fulfils the requirements of s 70(2). It is the molecule that 'works' as a pharmaceutical substance alone, or together with other substances, in goods listed on the ARTG.

35. According to the decision in Lundbeck, it is the active ingredient in a product which is the pharmaceutical substance for the purposes of s 70(2), and that substance per se must be within the scope of the claims in a patent for a patent term extension to be granted. This is consistent with the reasoning in Boehringer, which held that a patent term extension is only available for a "new and inventive substance" and not for a known substance which form part of a new method of delivery or process.
36. We do not agree with the decision in Organon. In our view, the proper characterisation of the claims in the patent in that case is, consistent with judicial reasoning, to a new method of delivery of known active ingredients. We do not, therefore, consider that this case should be distinguishable from LTS Lohmann, despite the opposing decisions in both cases.

THE PRESENT CASE

37. The decision dated 21 August 2009 of the Deputy Commissioner of Patents in the present case states, (at [7]-[8]):

During prosecution of the extension the examiner advised LTS that the application did not satisfy the requirements of s 70(2)(a) of the Patents Act 1990, because the claimed “transdermal therapeutic system” comprising 3 layers included a separate physical integer unrelated to the mixture of chemical entities and as a result were not directed to a “pharmaceutical substance per se” within the meaning of the Act.
The examiner reported that proposed amendments filed by LTS on 20 January 2009 were contrary to ss 102(1) and 102(2)(a), since inter alia they introduced new claims in which the phrase “transdermal therapeutic system” was substituted with “pharmaceutical preparation for the treatment of disease” or “dosage form for the treatment of disease”. On 19 March 2009, LTS proposed further amendments in which the “dosage form” claims were deleted and the claims reciting a “pharmaceutical preparation” were amended to a “pharmaceutical compound”. LTS submitted... that the pharmaceutical compound as claimed comprised the polymer matrix and rotigotine. The backing and protective layers were separate and subsidiary physical integers that “in no way contribute to the working of the therapeutic substance of the pharmaceutical compound”. While the examiner reported that the claims as proposed to be amended were not directed to a pharmaceutical substance per se, the amendments were allowed on 14 August 2009 and will be advertised on 1 October 2009.
Despite these amendments to the specification and further submissions by LTS, on 18 May 2009 the examiner maintained in a fourth report that the subject matter of the claims does not qualify as a “pharmaceutical substance per se” under the Act, because it relates to a device having three distinct layers, rather than the pharmaceutical substance by itself.

38. Counsel for the Applicant sought to distinguish the present case from the decision in Euro Celtique in the following way:

MR McCORMACK: So [Euro Celtique] was a case involving a transdermal delivery system comprising a particular drug on the register. Now, that was not allowed, this is a decision in 2007. It’s distinguishable on its facts - - -
DR SCHAFER: How is it distinguishable?
MR McCORMACK: Transdermal delivery system and its words in the claim.
DR SCHAFER: And?
MR McCORMACK: And ours is not, ours is a pharmaceutical compound which is delivered no differently than the Organon case, by a means of delivery which happens to be transdermal patch. So that’s the point of distinction and we would respectfully suggest it’s a [clear] one. It’s not a distinction without a difference, it’s one that identifies the line that needs to be considered as a matter of fact applying these principles on the construction of the Act. So at 26 the point made as to analysis of the various cases and focusing on the transdermal delivery system was mentioned.
DR SCHAFER: So are you saying [then] that with the Euro Celtique case, the reason you’re distinguishing the two cases is simply in the manner in which the claims were specified in the patent specification? Because on their face they’re both two delivery systems - - -
MR McCORMACK: Yes.
DR SCHAFER: Similar delivery systems, each containing an active ingredient that’s delivered by means of a transdermal patch. But you’re distinguishing that case simply because the claim as read in the patent specification is different in the two?
MR McCORMACK: Yes. It’s what’s claimed, it’s the invention. You start at the claim and you’ll see what it’s claimed. I mean, if this patent was to claim a transdermal delivery system which is able to be used for rotigotine of a freeform base, that would be a different matter.

39. In essence, counsel for the Applicant argued that the relevant claims in the present case to a “pharmaceutical compound” are distinguishable from the Euro Celtique case, in which the claim was to a “transdermal delivery system”. It is relevant, however, that the original claims in the patent in the present case were to a “transdermal therapeutic system”, but the Applicant subsequently amended the claims in the patent specification and substituted the phrase “transdermal therapeutic system” with “pharmaceutical compound”. Notably, despite these amendments to the specification and further submissions on 18 May 2009, the examiner maintained that the subject matter of the claims did not qualify as a pharmaceutical substance per se under the Act because it related to “a device having three distinct layers rather than a pharmaceutical substance by itself”.
40. Amending the words in the claims does not overcome the fact that the patent, in substance, relates to a “transdermal therapeutic system”. Indeed, despite the amendments to the claims, the very first sentence in the patent specification still reads:

The invention relates to a transdermal therapeutic system for the treatment of Parkinson's syndrome.

41. Although the determination of what is protected by a patent must be found strictly within the claims, it does not follow that the substitution of one phrase for another in a claim will change the proper characterisation of the invention. In the present case the substituted phrase does not change the substance of what is claimed, which is the "pharmaceutical compound....adapted to be transdermally administered”, the description of the adaptation taking up the bulk of the claim. It would be a surprising consequence if the result of this application should change simply because changes were made to the wording of the claims in the patent. We do not think that it does.
42. We agree with the delegate’s decision that the patent does not claim a pharmaceutical substance per se. It relates to a new transdermal therapeutic system for the administration of rotigotine which was, at the time of filing, a known active ingredient. In this regard, as stated in the Explanatory Memorandum, a new method of using pharmaceutical substances, where the substances themselves are known, is excluded from the patent term extension provisions.
43. For the reasons stated above, the decision under review will be affirmed.

I certify that the forty-three (43) preceding paragraphs are a true copy of the reasons for the decision herein of Justice Downes, President and Dr Schafer, Member.

Signed: ..................................[sgd]..........................................

Alison Connor, Associate

Date/s of Hearing: 5-6 August 2010

Date of Decision: 22 October 2010

Solicitor for the Applicant: Benjamin McInnes Lawyers

Counsel for the Applicant: Mr R McCormack

Solicitor for the Respondent: Australian Government Solicitor

Counsel for the Respondent: Ms J Gleeson