Prosidion Limited v Novo Nordisk (Corrected Version)
[2006] APO 6
•28 February 2006
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 721477 in the name of PROSIDION LIMITED
Title: Use of Dipeptidyl Peptidase IV Effectors for Lowering the Blood Glucose Level in Mammals
Action: Opposition by NOVO NORDISK under Section 104 of the Patents Act 1990
Decision: Issued 28 February 2006 .
Abstract
The claims of the specification as accepted are in the Swiss-style, directed to the use of activity lowering effectors of Dipeptidyl Peptidase (DP IV), or of DP IV-like enzyme activity, for the preparation of a medicament for lowering elevated blood glucose levels. The applicant sought to amend the specification to add claims to a method of lowering elevated blood glucose levels by the administration of a therapeutically effective amount of activity lowering effectors of Dipeptidyl Peptidase (DP IV), or of DP IV-like enzyme activity.
The opponent opposed the allowance of the amendments on the grounds that (i) the claims after amendments would not fall within the scope of the claims before amendment, and (ii) the amended claims would not satisfy the requirements of Section 40 because they would not be succinct.
After considering the European and New Zealand decisions relevant to interpreting Swiss-style claims the delegate concluded that in the Australian jurisdiction they should be construed consistently with accepted international practice i.e. these claims are directed to the manufacture of a medicament wherein the medicament is intended for a specified medical treatment, but do not extend to the method of medical treatment itself.
In relation to the present case, applying the “Distiller’s test” to this construction of the claims as accepted, the subject matter of proposed amended Claims 8 to 14 would not fall within the scope of accepted Claims 1 to 7 at acceptance because the latter do not encompass methods of treatment. Consequently the proposed amendments are not allowable under Section 102(2)(a).
The opposition was successful and costs were awarded against the applicant.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 721477 by PROSIDION LIMITED and Opposition thereto by NOVO NORDISK under Section 104 of the Patents Act 1990
BACKGROUND
15. Patent 721477 was filed in the name of PROBIODRUG GESELLSCHAFT FUR ARZNEIMITTELFORSCHUNG MBH as PCT/DE/00820 under the Patent Cooperation Treaty on 24 April 1997 claiming priority from DE 97/19616486 dated 25 April 1996. The application entered the National Phase in Australia on 30 October 1998 under application number 30233/97 and was advertised accepted on 6 July 2000. A Notice of Opposition under Section 59 was filed on 5 October 2000. The applicant subsequently changed its name to PROBIODRUG AG which was recorded on the application on 21 October 2002.
16. The applicant filed a request to amend the patent under Section 104 on 9 December 2002. The opponent filed comments in relation to this request under Reg. 10.2(7) on 6 March 2003. The applicant responded to these comments on 10 April 2003 and the request was granted on 17 April 2003. The opponent filed a Notice of Opposition in relation to the amendment on 25 June 2003, followed by a Statement of Grounds and Particulars.
17. Ownership of the patent was transferred to PROSIDION LIMITED by assignment on 17 June 2004.
18. The evidentiary stages in respect of the current Section 104 opposition were completed by 29 March 2005.
19. The matter was heard in Melbourne on 12 July 2005. Prosidion Limited was represented by Barry Hess, Counsel for the applicant, instructed by Carolyn Harris, Partner, Kathyrn Harrison, Associate, and Bruce Dowsing, Technical Assistant, all of WaterMark Patent and Trademark Attorneys, Melbourne and Alison Blakey, Patent Counsel and Director of Intellectual Property for the applicant. Novo Nordisk was represented by Ian Horak, Counsel for the opponent and Chris Schlicht of Phillips, Ormonde and Fitzpatrick Patent and Trademark Attorneys, Melbourne.
GROUNDS AND PARTICULARS OF OPPOSITION
20. The grounds specified in the Statement of Grounds and Particulars are :
As a result of the amendments claims 8-14 of the specification would not in substance fall within the scope of the claims of the specification before amendments because they are directed to a method of treatment per se, while the claims prior to amendment (1-7) are limited to a method of preparing a medicament which is suitable for a particular use.
As a result of the amendments the specification would not comply with sub-section 40(2) or (3) of the Patents Act 1990 because, assuming claims 1-7 were held to be directed to a method of treatment per se, the addition of Claims 8-14 would render the claims as a whole unclear and not succinct as they repeat the matter of Claims 1-7.
EVIDENCE
21. The evidence in support consists of Statutory Declarations by Michael Horowitz, dated 20 February 2004, accompanied by Exhibit MH-1 and by Edward William Kraegen, dated 24 February 2004, accompanied by Exhibit EWK-1.
22. The evidence in answer consists of Statutory Declarations by Joseph Proietto , dated 18 November 2004, accompanied by Exhibit JP-A, and by William Walter Bachovchin dated 14 December 2004, accompanied by Exhibit WWB-14.
23. The evidence in reply consists of Statutory Declarations by Edward William Kraegen and Michael Horowitz, both dated 21 March 2005.
THE CLAIMS
24. The independent claims of the specification as accepted are in the form of ‘The use of X for the preparation of a medicament for the treatment of condition Y’. This form of ‘use of’ claim is commonly referred to as “Swiss-style” and is exemplified by Claim 1:
The use of activity lowering effectors of Dipeptidyl Peptidase (DP IV), or of DP IV-like enzyme activity, for the preparation of a medicament for lowering elevated blood glucose levels, such as those found in mammals demonstrating clinically inappropriate basal and post-prandial hyperglycaemia.
25. The claims proposed in the amendments are in the form of method of treatment claims exemplified by proposed Claim 8:
A method of lowering elevated blood glucose levels in mammals, such as those found in a mammal demonstrating clinically inappropriate basal and post-prandial hyperglycaemia comprising administering to a mammal in need of such treatment a therapeutically effective amount of an activity lowering effector of Dipeptidyl Peptidase (DP IV) or of DP IV-like enzyme activity.
DECISION
26. The present case is an opposition to the allowance of amendments post acceptance. The right to oppose arises from section 104(4). By virtue of section 104(5), the criteria for determining whether the amendments are allowable are those laid down in section 102.
27. The opponent argued that the proposed amendments are not allowable in the light of Section 102(2)(a)and (b) of the Patents Act 1990 because as a result of their inclusion the specification would not comply with the requirements of Section 40, as set out below:
102 (2) An amendment of a complete specification is not allowable after the specification has been accepted if, as a result of the amendment:
(a) a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b) the specification would not comply with subsection 40(2) or (3).
28. The central issue in the present matter is whether the proposed method of treatment Claims (8 to 14) fall within the scope of the Swiss-style ‘use of’ claims of the application as accepted (1-7).
29. When assessing the allowability of an amendment under section 102(2)(a), the accepted test that has been applied in past Australian judicial decisions is the so-called “Distiller’s Test” which asks whether a proposed new claim would extend the patent monopoly such that it would make something an infringement which was not an infringement prior to amendment (The Distillers Co Ld's Application (1953) 70 RPC 221; W.J. Voit Rubber Corp's Application (1965) AOJP 1752; AMP Incorporated v Commissioner of Patents (1974) AOJP 3224).
30. The question to be decided is therefore whether the inclusion of the proposed method claims into the specification would make anything an infringement that was not an infringement in respect of the use claims in the accepted specification.
31. Both parties filed evidence from expert witnesses who construed the claims based on their experience and understanding of the art. While this evidence may provide some relevant discussion of the meaning of technical terms, the construction of claims is a matter of law to be decided by the court rather than by persons skilled in the art (Flexible Steel Lacing Company v Beltreco Ltd and Another 49 IPR 331).
32. The claims prior to amendment, i.e. as accepted, are drafted in the “Swiss-style”. This form of drafting has been adopted to permit the claiming of a second or subsequent medical use of a known drug in jurisdictions in which methods of medical treatment are excluded. While this type of exclusion applies throughout Europe as a result of specific exclusion under Article 52(4) EPC, and in Great Britain and New Zealand as result of caselaw, there is no corresponding exclusion in the Australian Patents Act 1990.
33. At the present time there have been no judicial decisions in Australia that have provided an interpretation of this type of claim. In a recent Patent Office Decision, (Smithkline Beecham plc and Smithkline Beecham Corporation v Lek Pharmaceutical and Chemical Company d.d. 2004 [APO] 10), however, the delegate discussed submissions in relation to the meaning of Swiss-style claims:
‘Ms Howard argued that there has been no determination in Australia of the meaning of "Swiss-style" claims and that European decisions are irrelevant to Australia since methods of treatment are patentable in Australia. However, despite the fact that method claims are patentable in Australia, I see no reason for "Swiss-style" claims to be construed any differently in Australia than they are elsewhere. The same rules of construction apply here as elsewhere but an applicant has a choice about how they may claim their invention. For a new use of a known substance, an applicant may choose to claim their invention in the form of a method claim, a "Swiss-style" claim or both.
Thus, I find that method claims 1 to 5 and 14 are limited to their use in treating bacterial infections in paediatric patients. "Swiss-style" claim 13 is similarly limited. In view of this, I find that the use in treatment of bacterial infections in children is an essential feature of claims 1 to 5, 13 and 14.’
34. Although the delegate in this case concluded that the Swiss style claim in Beecham’s Patent was limited to the therapeutic use in a similar way to the corresponding method per se claims, she did not clarify the meaning of “similarly” in the context of the claim. Furthermore, while the delegate was clearly of the view that Swiss-style claims should be interpreted in a manner consistent with that in other jurisdictions, she did not discuss the nature of these interpretations. Consequently I shall briefly review the law in the Europe, Britain and New Zealand in which jurisdictions some relevant judicial decisions have been handed down.
35. In the European jurisdiction these claims have been construed as being directed to the manufacture of a medicament. The phrase “for the treatment of” is regarded as not limiting the claim to the medical therapy environment but indicating purpose or intention on the part of the manufacturer. (Enlarged Board of Appeal of the EPO stated in Eisa/Second Medical Indication (Decision G05/83), (1985) O.J. E.P.O. 64) Consequently a distinction is drawn between a Swiss-style claim and a claim directed to the “use of a known substance for the treatment of a human or animal body”, the latter being regarded as equivalent to a method of treatment claim and excluded under 52(4) EPC.
36. The Enlarged Board in Eisa (supra) considered that the novelty and inventiveness of Swiss-style claims arise not from the manufacture of the medicament, but from the new medical use. The Enlarged Board reasoned by analogy that just as a product claim could draw novelty from a new medical use, so too a Swiss-style claim for the use of known substances for making known drugs could draw novelty from a new medical use.
“It seems justifiable by analogy to derive the novelty for the process which forms the subject-matter of the type of use claim now being considered from the new therapeutic use of the medicament and this irrespective of the fact whether any pharmaceutical use of the medicament was already known or not. It is to be clearly understood that the application of this special approach to the derivation of novelty can only be applied to claims to the use of substances or compositions intended for use in a method referred to in Article 52(4) EPC.”
37. The Enlarged Board thus interpreted Swiss-style claims to be directed to a method of manufacture of a pharmaceutical where that pharmaceutical must be suitable for the new medical treatment use from which its novelty arises.
38. In the British jurisdiction, the British Full Court of the Patents Court in John Wyeth & Brother Ltd’s Application [1985] RPC 545, while expressing some reservation as to the advisability of allowing the patentability of claims in the Swiss-style, ultimately accepted the same view reached in Eisa as to the source of novelty of Swiss-style claims. It concluded that “having regard to the desirability of achieving conformity, the same approach should be adopted to the novelty of the Swiss type of claim now under consideration under the material provisions of the Act.”
39. In Bristol-Myers Squibb Co, v Baker Norton Pharmaceuticals Inc. [1999] R.P.C. 253, Jacob J, while expressing some reservations about the derivation of novelty in Swiss-style claims and its effect on infringement actions, also accepted that the novelty may rest on disclosure of a newly discovered therapeutic effect even though a method of treatment could not be claimed.
40. Before the British Court of Appeal in Bristol-Myers Squibb Co, v Baker Norton Pharmaceuticals Inc. [2001] R.P.C. 1, Aldous L.J. in reviewing the decisions relating to Swiss-style claims, affirmed the view in Eisa that although the phrase “for treating” in a Swiss-style claim related to mere suitability for the specified second (or subsequent) therapeutic use, the novelty of the claim can still wholly reside in that new therapeutic use. He placed a further restriction on the claim however, by noting that the novelty in a Swiss-style claim must lie, not in the specifics of the method of use but in the new therapeutic purpose for which the substance was used. Consequently, in that case it was found that a claim, while in the form of a Swiss-style claim, was in fact a claim to the method of administration and thus not patentable due to the action of section 4(2) (Article 54(4)):
“The claim is an unsuccessful attempt to monopolise the new method of treatment by drafting it along the lines of the Swiss-type claim. When analysed it is directed step-by-step to the treatment.”
41. The British Court of Appeal thus generally accepted the view expressed in Eisa (supra), however concluded that under certain circumstances, a claim taking the Swiss form could be, in fact, a disguised claim to a method of medical treatment.
42. A similar construction has been adopted in the New Zealand jurisdiction by the Court of Appeal in Pharmaceutical Management Agency Ltd. v Commissioner of Patents (Pharmac) (2000) NZCA 330. It commented that “The Swiss-form of claim has been devised to avoid claiming the method of treatment but to secure protection for the use of the known compound or composition in the preparation of a medicament for the new medical use…It is said that by constructing the claims so as to refer to the purpose for which the medicament is made, the Applicant is able to invoke the novelty of the new use without claiming a method of treatment.”
43. The court considered that this situation was no different to that which applied in respect of the claiming of a product in a particular pharmaceutical form wherein the novelty lies not in the form per se but in the use to which the form predisposes the product so formulated:
“The discovery of a pharmaceutical use for a known compound is claimable. A purpose-limited product claim can be directed to the pharmaceutical composition containing the compound or to the compound in a pharmaceutically pure form. The novelty is considered to lie in the fact that there has not previously been a pharmaceutical composition or a compound in pharmaceutically pure form, though the true inventive step is in the discovery of the new use. To claim the compound or the composition in terms qualifying it as “pharmaceutical” is, in effect, to claim by reference to the purpose for which the compound or composition is to be used and rests on the inventiveness of the use. When claimed in this form it could be said that the novelty equally lies in the intended use.”
44. The Court of Appeal then adopted the same reasoning to the “Use of” construction as applied by the Enlarged Board in Eisa (supra) to conclude that a claim to the method of manufacture of a pharmaceutical composition could be considered novel by reference to the intended use to which the product of the manufacture is intended to be put.
45. The court also noted that, in the light of relevant (pre 1977) English cases and the recent New Zealand and Australian cases, the exclusion of medical treatment claims cannot be said to be on the basis that they are not an invention. Rather such exclusion “is on policy (moral) grounds. The purpose of the exclusion is to ensure that medical practitioners are not subject to restraint when treating patients.” The court concluded that
“As already indicated, the law and practice on patentability in New Zealand is little different from that provided for in the EPC. Claims to methods of medical treatment are precluded. New methods of treatment of the human body now are recognised as inventions and may be claimed except in areas of diagnosis and therapy. Product claims for inventions arising from the discovery of a first pharmaceutical use for known substances are allowed.”
46. Several things arise from considering these authorities:
(i)there is general agreement in the European, British and New Zealand jurisdictions as to the construction of claims drafted in the Swiss style;
(ii)in these jurisdictions Swiss-style claims are construed as being directed to the manufacture of a ‘good’ i.e. they are not regarded as extending to a method of treatment;
(iii)reference to therapeutic use in a Swiss style claim is not determinative of the claim’s scope, but is regarded as limiting on that scope for the purposes of assessing novelty;
(iv)this construction is limited to claims directed to inventions involving the medical use of a substance i.e. a claim having the same form as a Swiss-style claim but not directed to medical use is not construed as a Swiss-style claim;
(v)the adoption of this interpretation would appear to be driven by the need to provide a facility to protect second medical use in the face of legislative restrictions or public policy considerations.
38. In these jurisdictions Swiss-style claims are thus interpreted as formulaic claims pertaining to a medical use which are given a specific construction unique to this form and invoked only where the form is adopted in the context of a medical use.
39. The practical effect of this construction is that a Swiss-style claim is regarded as being directed to the manufacture of the medicament with the intention of a specified medical use without the claim extending to that use. It is therefore limited to the preparation and sale of a product for the purpose of carrying out a specific medical treatment.
40. In the Australian context this construction merely provides an explicit statement of the rights inherent in the contributory infringement provisions of Section 117. It therefore may be argued that this construction is consistent with existing provisions and provides a tangible and distinct right to which the Australian legislation already makes reference.
41. It is noteworthy that the application of a unique interpretation to a claim of a specific form is not without precedent in construction of claims in Australia. This is the approach taken in construing omnibus claims which adopt a variety of recognisable standard ‘forms’ that are subject to specific interpretations.
42. Furthermore, for reasons of certainty amongst the public and the not unreasonable expectation that claims will be subject to similar interpretations in different jurisdictions, it is well established that where legally possible, it is desirable for authorities in different jurisdictions to adopt the same interpretations of forms of claims.
43. Given the specific nature of the Swiss claim, the use of the claim form in many countries, and the lack of any jurisprudence in Australia, I consider that it is appropriate to construe Swiss-style claims consistently with their construction in other jurisdictions. That is, Swiss-style claims are directed to the manufacture of a medicament wherein the medicament is intended for a specified medical treatment, but do not extend to the method of medical treatment itself. The novelty of these claims, however, resides in the medical treatment for which the medicament is manufactured.
44. Consequently I consider that the claims as accepted are directed to a method of preparing a medicament from activity lowering effectors of Dipeptidyl Peptidase (DP IV), or of DP IV-like enzyme activity, where the purpose of the medicament is for it to be used in a method of treatment for lowering elevated blood glucose levels, such as those found in mammals demonstrating clinically inappropriate basal and post-prandial hyperglycaemia using a substance prepared, to lower elevated blood glucose levels, and wherein the substance is at least suitable for that treatment. These claims do not encompass the medical treatment itself.
45. The applicant argued, however, that even if this construction is adopted the accepted Swiss-style claims will be infringed by a method of treatment due to the definition of “exploit” provided in Schedule 1 to the Act. When read in conjunction with Section 13, this provides that a patentee has the exclusive rights to a claimed process, the product of that process and the subsequent use of that product. The applicant concluded that, as a result of this provision, the scope of the accepted claims would include a method of treatment using the medicament, even if they were construed as limited to methods of preparing that medicament.
46. When the definition of “exploit” is applied to a claim to a method of treatment of a mammal, as in the claims as proposed to be amended, the claim is infringed not only by that method of treatment, but also by the product of that method, i.e. the treated mammal, and any subsequent use of the product. If the mammal to be treated was a cow, for example, the amended claim would be infringed by a cow so treated, and by its subsequent use, such as in a method for the production of beef or milk. Neither of these, however, would infringe a claim to the method of preparing the medicament. That is, a treated mammal and its subsequent use would not infringe the accepted Swiss-style claims. Consequently I do not accept the applicant’s argument.
47. The claims as proposed to be amended consist of the claims as accepted with the addition of Claims 8 to 14 directed to a method of lowering elevated glucose levels comprising administering to a mammal in need of such treatment a therapeutically effective amount of an activity lowering effector of Dipeptidyl Peptidase (DP IV) or of DP IV-like enzyme activity. Thus a method of treatment would be an infringement of proposed Claims 8 to 14 but would not be an infringement of the claims as accepted.
48. Consequently, applying the “Distiller’s test” (supra), I consider that the subject matter of proposed Claims 8 to 14 would not fall within the scope of Claims 1 to 7 at acceptance and the proposed amendments are not allowable under Section 102(2)(a).
49. The opponent also argued that if the claims at acceptance were held to encompass the method of medical treatment to which the amended claims were directed, the amendments should not be allowed under the provisions of S 102(2)(b) on the basis that they render the claims as whole not clear and succinct, because new Claims 8 to 14 would repeat the matter claimed in Claims 1 to 7. Clearly I have concluded that the claims as proposed to be amended would be of different scope to the claims at acceptance. Consequently the opposition has not succeeded on this ground.
CONCLUSION
50. I find that the proposed method of treatment claims do not fall within the scope of the original Swiss-style claims to the preparation of a medicament. As a consequence, the proposed amendments are not allowable under Section 102(2)(a). I therefore refuse the request for leave to amend the specification dated 9 December 2004.
COSTS
51. It is normal practice for costs to follow the event. I see no reason to depart from this principle. I award costs against the applicant.
Leigh Tristram
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Watermark, Melbourne
Patent attorneys for the opponent : Phillips, Ormonde & Fitzpatrick, Melbourne
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