The Full Court of the Federal Court has decided that Swiss type (second medical use) claims cannot form the basis for a patent term extension (PTE) in Australia (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129). A copy of the decision can be accessed here.

The decision confirms the previously established practice of IP Australia and reverses a decision of the Administrative Appeals Tribunal (AAT). That AAT decision had opened up the possibility of obtaining PTEs on the basis of claims characterised by therapeutic use of pharmaceutical substances produced by a process that involved the use of recombinant DNA technology (Re AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682).

Background

Delay in market entry caused by the process of obtaining marketing authorisation for new pharmaceuticals reduces an innovator’s effective patent term. Many countries, including Australia, grant patent term extensions (PTEs) and supplementary protection certificates (SPCs) aiming to provide an effective patent term approximately in line with that available to products or services in other fields of technology.

The applications for PTE under consideration concerned the blockbuster pharmaceutical HUMIRA® (adalimumab). HUMIRA® is an anti-TNF monoclonal human antibody that has been hugely successful in treating rheumatoid arthritis and psoriatic arthritis, amongst other indications, and consequently successful for its developer AbbVie. Given the impressive revenue derived from HUMIRA®, even small increases in the PTE term could be commercially valuable.

PTEs are available in Australia for patents relating to pharmaceutical substances provided that the patent discloses and claims:

(a) a pharmaceutical substance per se; or

(b) a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.

PTEs extend to all claims of the patent within the scope of which the pharmaceutical substance having marketing authorisation falls. In other words, PTE protection is not restricted to the specific pharmaceutical substance that obtained marketing authorisation. Therefore, if the claims cover more than one pharmaceutical substance, all will have their protection extended by the PTE (unlike European SPCs and United States PTEs).

PTEs are, however, restricted to pharmaceutical substances for human therapy. It is an exception to infringement during the PTE to use a pharmaceutical substance covered by the claims for anything other than human therapy.

The proceedings

The Deputy Commissioner of Patents initially held that Swiss type claims are characterised by a therapeutic use. Consequently, it was held that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, did not in substance fall within the scope of the Swiss type claims as required by s 70(2)(b) of the Patents Act 1990 (AbbVie Biotechnology Ltd [2015] APO 45). On that basis, the Deputy Commissioner of Patents refused the applications for PTE.

The patentee sought review of the Deputy Commissioner’s decision before the AAT. In a surprising decision, the AAT overturned the Deputy Commissioner’s decision in part. The AAT held that PTEs were eligible to be based on Swiss type claims when the pharmaceutical substance is produced by a process involving the use of recombinant DNA technology. However, the AAT confirmed that the first marketing authorisation date cannot be the date of any indication listed on the marketing authorisation; instead, the date must be the date of the original marketing authorisation for the pharmaceutical substance.

The Commissioner of Patents appealed the AAT decision and the Full Court of the Federal Court has affirmed the Deputy Commissioner’s original decision insofar as the applications for PTE did not comply with s 70(2)(b) of the Patents Act 1990 as Swiss type claims are appropriately characterised as a “method or process”, not as a “product” (at [15]).

The Full Court found (at [60]) that “it is the pharmaceutical substance that must be the subject matter of the claim or claims, not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance.” And that (at 61]) “the claims in suit are in the form of Swiss type claims necessarily means that the pharmaceutical substance in question (adalimumab) does not “in substance fall within the scope of the claim or claims” of the specifications in suit, within the meaning of s 70(2)(b).”

As the Commissioner of Patents has prevailed, this is likely to be the final word on this issue unless another patentee seeks to challenge a refusal of an application for a PTE on the basis of Swiss type claim(s). AbbVie filed a submitting notice in the appeal to the Full Court choosing not to contest the relief sought by the Commissioner. Therefore, it is unlikely that AbbVie will apply to the High Court of Australia seeking special leave to appeal.

Although this decision closes the door on the possibility of expanded scope for PTEs in Australia based on Swiss type claims, the term “involves the use of recombinant DNA technology” has been interpreted liberally by the Commissioner of Patents. In an earlier decision (ImmunoGen, Inc. [2014] APO 88), the Deputy Commissioner held that the recombinant DNA technology need not be explicitly recited in a claim, and it may be enough to recite in the claim the name of a recombinantly produced pharmaceutical substance, such as, for example, adalimumab.