With the decision of the Full Court of the Federal Court of Australia in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 (“AbbVie”), it is unequivocal that patents directed to Swiss-style claims are not eligible for an extension of term, regardless of whether the pharmaceutical substance is a product of recombinant DNA technology.

This decision is of particular note as it is the first instance that construction of s 70(2)(b) of the Patents Act 1990 has been considered by the Court. Broadly, under the legislative scheme, an extension of patent term is only available in respect of a pharmaceutical substance per se that in substance falls within the scope of a claim of a patent, with the exception of pharmaceutical substances produced by a process involving the use of recombinant DNA technology. Under s 70(2)(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 a claim of that specification to be eligible for a patent term extension.

In 2014, Abbvie Biotechnology Ltd applied under s 70(2)(b) to extend the term of AU2012261708, AU2013203420 and AU2013257402, each of which claims the use of adalimumab (a monoclonal antibody) in the manufacture of a medicament for the treatment of ulcerative colitis, Crohn’s disease, and rheumatoid spondylitis, respectively. Adalimumab for the treatment of rheumatoid arthritis was first included in the Australian Register of Therapeutic Goods on 10 December 2003. The application was denied by the Deputy Commissioner of Patents (as a delegate of the Commissioner) based on the following rationale:

“… while notionally directed to a method or process of manufacturing a medicament, the claims are characterised by a therapeutic use. Consequently, on the basis of my reasons in ThromboGenics I do not find that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of the claims. I must therefore refuse the application for an extension of term.” (AbbVie Biotechnology Ltd [2015] APO 45 at paragraph 13)

On appeal to the Administrative Appeals Tribunal (Re AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682), it was held that s 70(2) does not indicate that Swiss-style claims are to be excluded from eligibility for extension, and in particular “the fact that such patent is characterised by its specified therapeutic use as a medicament does not, on its face, suggest that there is a legislative barrier to eligibility for extension of the patent” (paragraph 62).

Unsurprisingly, the Commissioner of Patents appealed the Tribunal decision. The FCAFC set aside the Tribunal’s decision in this regard. As a threshold matter, the Court held that Swiss-style claims are not directed to pharmaceutical substances, but rather are method claims. Consequently, Swiss-style claims are of different scope to the claims considered by s 70(2) (AbbVie at paragraph 58).

In relation to the claims under consideration, the Court held that the Swiss-style claims are not directed to adalimumab produced by recombinant DNA technology but, rather, are directed to methods in which adalimumab is used to produce a medicament, wherein the medicament has a specific (and further) therapeutic use.

To enliven s 70(2)(b), not only should the pharmaceutical substance be produced by a process involving recombinant DNA technology but must also, in substance, fall within the scope of a claim of the specification. Or put another way, the pharmaceutical substance must be the subject matter of a claim, “not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance” (AbbVie at paragraph 60).