The Australian Patent Office has issued recent decisions (ThromboGenics NV [2015]APO 44 and AbbVie Biotechnology Ltd [2015] APO 45) finding that an extension of patent term will not be allowed in respect of Swiss-style claims.

Background

Marketing of pharmaceuticals in Australia requires approval by the Therapeutic Goods Administration and inclusion in the Australian Register of Therapeutic Goods (ARTG).  For innovative products, considerable research and testing is required before regulatory approval is obtained and a product can enter the market. Regulatory approval is often not obtained until 10 to 15 years after the initial identification of a new active compound due to the stringent requirements for clinical trials.  As patent applications are typically filed during early phase research or preclinical testing, regulatory approval for a pharmaceutical substance covered by a patent is often not obtained until many years into the 20-year term of the patent.  To compensate for the inability to exploit the invention during this time, in certain circumstances Australian patentees may request an extension of their patent for up to 5 years beyond the standard term (Patents Act s70).

In order for a patent to be eligible for an extension, a pharmaceutical substance per se (s70(2)(a)) or a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology (s70(2)(b)) 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.  Additionally, goods containing, or consisting of, the substance must be included in the ARTG and the period beginning on the date of the patent (usually the filing date) and ending on the first regulatory approval date for the substance must be at least 5 years.

The requirement that the patent relate to a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology was previously thought to preclude the extension of patents only containing second medical use claims (i.e., the new use of a known compound).  As such, method of treatment claims and Swiss style claims (both forms are allowable in Australia) were not thought to confer eligibility for an extension of term.  It was also thought that claims to a method of producing a pharmaceutical substance involving the use of recombinant technology were not sufficient to confer eligibility for an extension of term, and that product-by-process claims were required.

However, recent Patent Office decisions (ImmunoGen Inc. [2014] APO 88 and Novartis Vaccines and Diagnosis S.r.l.  [2015] APO 2), found that claims directed to processes of producing compositions that involve the use of recombinant DNA technology in some way were sufficient to confer eligibility under S70(2)(b).  The Delegates in those decisions concurred that it is not necessary for the claim to explicitly recite recombinant process steps. It is enough that a product made by a process including such steps be “included amongst the things claimed”.  The decisions in these cases made clear that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology (even in a relatively inconsequential way), in substance falls within the scope of a claim directed to the process of producing the pharmaceutical substance, and that product-by process claims are not required to confer eligibility for an extension of term.

In light of the above, ThromboGenics NV and AbbVie Biotechnology Ltd sought to obtain extensions of term for patents containing Swiss-style claims, which are of the general type “Use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use”, on the basis that such claims are directed to a method or process for the manufacture of a medicament (i.e., a pharmaceutical substance).  As such, ThromboGenics NV and AbbVie Biotechnology Ltd contended that the Patent Office’s findings in ImmunoGen Inc and Novartis Vaccines and Diagnosis S.r.l. meant that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of a Swiss-style claim.

The Delegate’s decisions

ThromboGenics NV applied for an extension of term for Patent No 2003300821 which contained Swiss-style claims directed to the use of a composition comprising a truncated plasmin protein comprising a catalytic domain of plasmin (TPCS) for the manufacture of a medicament for treating or preventing a disorder, or a complication of a disorder, of an eye of a subject, wherein the TPCS is made using a recombinant process.

AbbVie Biotechnology Ltd applied for extensions of term for Patent Nos 2012261708, 2013203420, 2013257402.  The ‘708 patent contained Swiss-style claims directed to the use of an isolated human antibody, or an antibody-binding portion thereof, with particular dissociation and neutralisation characteristics, for the manufacture of a medicament for treatment of ulcerative colitis, wherein the antibody or antigen-binding portion thereof is produced by a process that involves the use of recombinant DNA technology.

In his decisions, the Delegate found it necessary to consider the intention of the s70 provisions: “What is clear in s70 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 s70(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”.

 While the Delegate conceded that a Swiss-style claim is to be construed as defining a method or process for the manufacture of the medicament (making reference to the recent Federal Court decision of Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4)[2015] FCA 634), he asserted that the method is further limited and characterised by the specified therapeutic use of the medicament.  In this regard, the Delegate stated “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 [Boehringer lngelheim International v Commissioner of Patents [2000] FCA 1918] 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.

In conclusion, the Delegate stated: “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”.

In both decisions, the Delegate found that a pharmaceutical substance when produced by a recombinant process was disclosed in the specifications, but found that the pharmaceutical substance did not in substance fall within the scope of the claims.  The Delegate found that the requirements of s70 were not satisfied and refused the extension of term applications by ThromboGenics NV and AbbVie Biotechnology Ltd.

The distinction between the recent Swiss claim decisions and the earlier ImmunoGen Inc and Novartis Vaccines and Diagnosis S.r.l decisions is a fine one.  Having found that a product can fall “in substance” within the scope of a process claim, it would appear arguable that a product, when intended for a specific therapeutic use, could fall within the scope of a relevant Swiss style claim. The Delegate appears in the most recent cases to have fallen back on the intention of the legislation and policy behind that, perhaps to close off the flood gates potentially opened in ImmunoGen Inc.

In light of this, and the large amounts of revenue generated by pharmaceutical products towards the end of their patent term (and the value of extending the monopoly), it will be interesting to see whether ThromboGenics NV and/or AbbVie Biotechnology Ltd refer the Patent Office’s extension of term refusal to the Administrative Appeals Tribunal for review (they have until 1 September 2015 to do so).