ThromboGenics NV
[2015] APO 44
•4 August 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
ThromboGenics NV [2015] APO 44
Patent No.:2003300821
Title:Pharmacological vitreolysis
Patentee: ThromboGenics NV
Hearing Officer: P M Spann, Deputy Commissioner of Patents
Decision Date: 4 August 2015
Hearing Date: 12 June 2015; supplementary written submissions completed 17 July 2015
Catchwords: PATENTS – extension of term – method and Swiss claims –whether a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, falls within the scope of the claims – requirements not met – extension application refused.
Representation: Mr B Caine, QC
Mr M Caine, patent attorney, and
Dr S Khosa,
Davies Collison Cave
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent No.:2003300821
Title:Pharmacological vitreolysis
Patentee: ThromboGenics NV
Date of Decision: 4 August 2015
DECISION
The requirements of section 70 is not satisfied and pursuant to subsection 74(3) I refuse to accept the application for an extension of term.
REASONS FOR DECISION
Background
This matter concerns a request for an extension of the term of patent no. 2003300821 in the name of ThromboGenics NV (TG). The date of the patent is 5 December 2003 and accordingly the term of the patent (subject to the payment of renewal fees) will expire on 5 December 2023. An application for extension of the term of the patent under section 70 of the Act was filed on 27 January 2015.
The basis for the request for an extension of term is the inclusion in the Australian Register of Therapeutic Goods (ARTG) of JETREA ocriplasmin. This product was subject to ARTG registration commencing on 9 October 2014 (AUST R 206494) and granted to a licencee of TG, Alcon Laboratories Australia Pty Ltd. It follows from this information and the formula set out in section 77 that, if granted, the extended term of the patent would be 5 years and would expire on 5 December 2028.
Following the filing of the application, a delegate of the Commissioner reported that she considered that:
“Claims 55-58 of the present patent are Swiss claims directed to the use of TPCD, miniplasmin or microplasmin in the manufacture of a medicament for the treatment or prevention of a disorder, or a complication of a disorder, of an eye of a subject. Contrary to the submissions made in the response, these claims are not directed to a medicament or to a process for the preparation of a medicament. These claims have the additional limitation of "for the treatment or prevention of a disorder, or a complication of a disorder, of an eye of a subject". As a consequence of the Swiss-style claim drafting, this intent is not a mere suitability but an essential limitation of the claims. Therefore, a pharmaceutical substance (when produced by a process involving recombinant DNA technology) does not in substance fall within the scope of these claims.
The recent decisions ImmunoGen Inc. [2014] APO 88 and Novartis Vaccines and Diagnosis S.r.l. [2015] APO 2, were directed to processes of producing compositions. Both cases were considered to meet the requirements of S70(2)(b) because the process results in a product, which involved the use of recombinant DNA technology at some point. The processes of the relevant claims end at the production of the products and are not further limited by intent or subsequent use. On the other hand, Swiss claims are purpose-limited process claims. Therefore, the facts of the present case are not superimposable on the case law cited above.
With the recent decisions, claims directed to processes of producing pharmaceutical substances which involve, at any point, the use of recombinant DNA technology were considered equivalent to claims encompassing pharmaceutical substances prepared by such processes.
A purpose-limited process claim, such as a Swiss claim, is necessarily limited to the purpose, such as the treatment of an eye disorder in the present case. The production of a medicament is not the end goal of such a claim and is not equivalent to a claim directed to a substance (when produced by a process that involves the use of recombinant DNA technology).”
The patentee ultimately requested a hearing and provided written and oral submissions to which I will refer as appropriate in my reasons below.
Specification
The specification indicates that the invention relates to methods of treating eye disorders and more particularly methods using a truncated plasmin protein. It is said that plasmin has been suggested as an agent for vitrectomy used to treat eye conditions but that production of suitable plasmin is expensive and, having a high molecular weight, it has a lower diffusion rate to the vitreoretinal interface than smaller molecules. Consequently the invention relies on the use of a composition comprising a truncated plasmin protein comprising a catalytic domain of plasmin (TPCD) which is said to address these limitations. TPCD includes miniplasmin and microplasmin and variants which may be stabilised and/or recombinant.
The description indicates that truncated plasmin protein means any plasmin protein obtained by deleting one or more amino acids of Val79-plasmin (i.e. amino acids 79-791 of human plasminogen), wherein the resulting protein possesses serine protease catalytic activity. The description also mentions the use of modified TPCD and suggests both can be manufactured and prepared for therapeutic use by known methods. It is said that microplasmin can be prepared according to the method disclosed in US patent 4,774,087 and microplasmin and miniplasmin prepared recombinantly by the method disclosed in PCT application WO 02/50290.
While ocriplasmin is not mentioned in the specification, it appears that amino acids 543-791 in the table of variants of microplasmin and SEQ ID NO:4 in figure 2 correspond with the structure of that substance.
Claim 1 of the specification is as follows:
1. A method of treating or preventing a disorder, or a complication of a disorder, of an eye of a subject comprising contacting a vitreous and/or an aqueous humor with an effective amount of a composition comprising a truncated plasmin protein comprising a catalytic domain of plasmin (TPCD).
Claims 2-54 are also directed to methods for treating or preventing eye conditions. By contrast claims 55-58 are of the Swiss type:
55. Use of a TPCD in the manufacture of a medicament for the treatment or prevention of a disorder, or a complication of a disorder, of an eye of a subject.
56. Use according to claim 55 wherein the TPCD is made using a recombinant process.
57. Use of a miniplasmin or microplasmin in the manufacture of a medicament for the treatment or prevention of a disorder, or a complication of a disorder, of an eye of a subject.
58. Use according to claim 57 wherein the miniplasmin or microplasmin is made using a recombinant process.
10. Remaining claims 59-73 are dependent on the proceeding method and/or use claims mentioned above.
Law
11. Part 3 of Chapter 6 of the Patents Act provides a statutory framework for the extension of the term of standard patents relating to pharmaceutical substances. Section 70 relevantly provides:
“(1)The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(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.
(4)The term of the patent must not have been previously extended under this Part.
(5)For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is:
(a) if no pre-TGA marketing approval was given in relation to the substance—the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b) if pre-TGA marketing approval was given in relation to the substance—the date of the first approval.
(6)For the purposes of this section, pre-TGA marketing approval, in relation to a pharmaceutical substance, is an approval (however described) by a Minister, or a Secretary of a Department, to:
(a) market the substance, or a product containing the substance, in Australia; or
(b) import into Australia, for general marketing, the substance or a product containing the substance.”
12. The expression "pharmaceutical substance" is defined in Schedule 1 of the Act. It is:
“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.”
13. The term "therapeutic use" is also defined in Schedule 1. It means:
“use for the purpose of:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process in persons; or
(c) testing the susceptibility of persons to a disease or ailment.”
Consideration
14. The key issue in this matter is whether one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology in substance falls within the scope of the claim or claims of the specification. The examiner did not think this was the case finding that, being limited by a method of treatment, the claims were not equivalent to a claim directed to a substance when produced by a process that involves the use of recombinant DNA technology.
15. The Explanatory Memorandum to the Intellectual Property Laws Amendment Bill 1997 states:
“9. The extension of term provisions will be available for patents that include claims to pharmaceutical substances per se (provided the other criteria are met). These claims to pharmaceutical substances per se would usually be restricted to new and inventive substances. Patents that claim pharmaceutical substances when produced by a particular process (product by process claims) will not be eligible unless the process involves the use of recombinant DNA technology. Claims which limit the use of a known substance to a particular environment, for example claims to pharmaceutical substances when used in a new and inventive method of treatment, are not considered to be claims to the pharmaceutical substance per se.
10. An extension of term will not be available for claims to new processes of making pharmaceutical substances or new methods of using pharmaceutical substances where the substances themselves are already known”
16. Cases arising for judicial consideration have all primarily concerned the application of subsection 70(2)(a) rather than (2)(b). However the Full Federal Court (in Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647) has referred with approval to Justice Heerey’s analysis of the legislative scheme at first instance in Boehringer lngelheim International v Commissioner of Patents [2000] FCA 1918 (Boehringer 1):
“[12] By the Patents (World Trade Organization Amendments) Act 1994 (Cth) Div 2 of Pt 3 of Ch 6 of the 1990 Act, containing the extension provisions in ss 70 to 79, was repealed. Section 70 and related sections in their present form were introduced by the Intellectual Property Laws Amendment Act 1998 (Cth). For the first time, provision was made for the extension of not just of a “pharmaceutical patent”, but a “pharmaceutical patent per se”.
[13] The 1990 Act in its present form manifests a policy which draws a distinction between, on the one hand, a pharmaceutical substance that is the subject of a patent claim and, on the other hand, a pharmaceutical substance that forms part of a method or process claim. The specific exception to the latter (an exception which proves the rule) is the provision for recombinant DNA technology in s 70(2)(b).
[14] Broadly speaking, a claim in relation to a pharmaceutical substance can be made in three ways
(i) a new and inventive product alone;
(ii) an old or known product prepared by a new and inventive process;
(iii) an old or known product used in a new and inventive mode of treatment.[15] What is clear in s 70 is that only the first type of claim to a pharmaceutical product is to be subject to extension rights. So far as a new process is concerned, it is only when the new process answers the particular description in s 70(2)(b) (recombinant DNA process) that it can be the subject of an extension. As counsel for the Commissioner submitted, the policy to be deduced in the light of the legislative history is that Parliament has decided that what is intended to be fostered is primary research and development in inventive substances, not the way they are made or the way they are used, with the sole (and important) exception of recombinant DNA techniques, this being an area particularly worthy of assistance for research and development.”
17. It will be apparent that the scheme does not require an assessment of what in the claims is new and inventive but rather, on the assumption that the patent is valid (and therefore the invention claimed is new and inventive), focuses on the nature of the invention claimed to achieve its policy objectives. So, for example, the requirement in subsection 70(2)(a) that a pharmaceutical substance per se falls within the scope of the claims means that under that subsection extensions are only available for new and inventive substances.
18. A particular feature of the present case is that what are involved are claims either to a method of treatment or to ‘Swiss’ type claims. Swiss claims were discussed in some detail by Justice Yates in the recent decision in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634. While not resolving all questions as to the validity of that form of claiming in Australia, his Honour at [100]-[121] did reach a conclusion on the construction of Swiss claims that appears apposite to the present matter.
19. Essentially, a claim of the general type “the use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use” is to be construed as defining a method or process for the manufacture of the medicament. However that method is further limited and characterised by the specified therapeutic use of the medicament. In this way, where permitted in other jurisdictions, they are considered to allow a form of patent protection for secondary medical uses while avoiding statutory prohibitions on methods of medical treatment.
20. Consequently, while technically a claim to a process of manufacturing a medicament, I consider a Swiss claim to be quite distinct from a product by process claim as discussed by Justice Heerey in Boehringer 1 and which in my view is clearly the focus of the s70(2)(b) exception. Swiss claims are generally not directed to “substances when produced by a particular process” and neither the product nor the process of its manufacture is required to be, and usually is not, new and inventive. Rather novelty is derived solely from the new use. Granting an extension of term on this basis is difficult to reconcile with what is said in the Explanatory Memorandum and in Boehringer 1 on the reasonable assumption that the exception in s70(2)(b) exists to encourage the development of new processes of manufacture involving recombinant technology.
21. Similarly it is apparent from Explanatory Memorandum and Boehringer 1 that the present extension scheme is not intended to support the development of new uses of known substances however made. Neither can any policy be inferred that new therapeutic uses involving substances produced by known recombinant techniques are to be favoured over other new uses of known pharmaceutical substances. Again, the granting of an extension on the basis of claims intended to extend patent protection to a second medical use appears to be in tension with the object of the legislation.
22. Subsection 70(2)(b) requires that one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology in substance fall within the scope of the claim or claims of that specification. It is submitted that under the previous extension scheme a pharmaceutical a substance was found in Astra Lakemedel v Commissioner of Patents [1995] FCA 1091 to substantially fall within the scope of claims defining or limited by a therapeutic use and that, by extension, a claim directed to the manufacture of a medicament intended for a particular therapeutic purpose includes within its scope the medicament. It is to be understood that the former scheme (either under the 1952 Act or as remade under the 1990 Act) required only that a pharmaceutical substance be in substance disclosed and in substance fall within the scope of the claims. Conversely, as indicated above, the current scheme limits extensions to pharmaceutical substances per se with the explicit exemption for substances when produced by processes involving recombinant technology.
23. The patentee’s submissions essentially require subsection 70(2)(b) to be taken in isolation. The legislation must however be considered as a whole in light of its underlying purpose or objective. Therefore, in my view, the reference in subsection 70(2)(b) to a substance when produced by a process involving recombinant technology means that product as such, not characterised by its therapeutic use, mode of delivery or features other than its process of production. Consequently a substance when produced by a process that involves the use of recombinant DNA technology will not fall within the scope of a claim that is characterised by a therapeutic use in the same way as a pharmaceutical substance per se does not fall within the scope of such claims. Otherwise extensions of term will be granted that are clearly inconsistent with the purpose of the Act. In particular it seems clear that patents covering new therapeutic uses of old substances produced by old processes should not be extended even if they involve recombinant DNA technology.
24. For these reasons, while I am prepared to accept in the present case that the substance ocriplasmin when produced by a recombinant process is disclosed in the specification, I do not consider that ocriplasmin when produced by a process that involves the use of recombinant DNA technology in substance falls within the scope of the claims. I do not find that the specification of recombinant process (eg claim 56) or other features of the process of production (eg claims 66-67) fundamentally change the nature of what is claimed, that is, a method or process limited to a particular therapeutic use. On this basis my conclusions in ImmunoGen, Inc. [2014] APO 88 are of no assistance to the patentee. What was involved there was a process for producing trastuzumub not characterised by its therapeutic use.
25. To the extent that the patentee might argue that its ability to benefit from the invention has been impacted by regulatory delay the answer is quite straight forward. If entitled, and subject to the other requirements of the Act including for a claimed invention to be novel and involve an inventive step, it could have obtained a patent claiming ocriplasmin per se or a process of producing ocriplasmin that may have been extendable under the provisions of section 70. It however it did not, either as a matter of choice or because ocriplasmin and its method of production are known or obvious. Instead it obtained a patent for the invention of using TPCD to treat or prevent eye conditions. This is clearly not intended to be extendable under the current pharmaceutical extension of term scheme.
Conclusion
26. The requirements of section 70 are not satisfied and pursuant to subsection 74(3) I refuse to accept the application for an extension of term.
P M Spann
Deputy Commissioner of Patents
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