A Full Bench of the Federal Court of Australia has overturned an earlier decision of the Administrative Appeals Tribunal (AATA) and ruled that Swiss-style claims relating to pharmaceutical substances produced using recombinant DNA technology are not eligible for patent term extension.
The decision in Commissioner of Patents v AbbVie Biotechnology Ltd relates to three Patents Nos 2012261708, 2013203420 and 2013257402. These three patents all claim the use of a pharmaceutical substance called adalimumab in the manufacture of a medicament for the treatment of a different medical condition (ulcerative colitis, Crohn’s disease and rheumatoid spondylitis, respectively). Adalimumab is produced by recombinant DNA technology and is sold under the brand name HUMIRATM.
Claims of the format of “use of substance X in the manufacture of a medicament of treatment of condition Y” are generally known as Swiss type claims and are a way of claiming a second medical use of pharmaceutical substance X.
For most pharmaceuticals, a patent term extension is available only if a relevant claim of a patent covers the pharmaceutical substance per se. In other words, a new use of a known pharmaceutical substance protected by a patent claim is generally not extendible beyond the standard 20 year term. Under s 70(2)(b), an extension is also available where a claim or claims of a patent disclose a pharmaceutical substance ‘when produced by a process that involves the use of recombinant DNA technology’. In their prior decision, the AATA reasoned that s 70(2) does not indicate that Swiss type claims are to be excluded from eligibility for extension and concluded that “eligibility for extension of a patent would be applied to product claims and to process claims but only where such claims were made in respect of a substance produced by a process of recombinant DNA technology.”
The Commissioner appealed the AATA decision and this has provided the first occasion on which the construction of s 70(2)(b) of the Patents Act has been considered by the Federal Court. Interestingly, AbbVie declined to participate in the proceedings and so there was no contradictor to the Commissioner’s case.
In considering the appeal, the Full Court focused on the meaning of pharmaceutical substance within the context of both s 70(2)(a) and s 70(2)(b). They were clear that the provisions of s 70(2) are concerned with inventions that are products, not inventions that are methods or processes, and also not additional or other matter concerning or involving the use of pharmaceutical substances. The Court referred also to the specific acknowledgement in the Explanatory Memorandum that claims to pharmaceutical substances when used in new and inventive methods of treatment are not intended to be part of the extension of term regime.
The Court went on to state that Swiss type claims are not claims to pharmaceutical substances at all, but rather method or process claims which are fundamentally different to the scope of the claims addressed by s 70(2).
The Court also found that the claims in suit were not directed to adalimumab produced by recombinant DNA technology. The Court held that, firstly, the claims in suit are to a method or process in which adalimumab is used to produce a medicament, and secondly, they are directed to a medicament containing adalimumab that is to be used for specific therapeutic purposes. The Court concluded that the claims in suit were of an entirely different scope to those addressed in s 70(2)(b), reasoning that the fact that “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”.
This decision underlines the fact that second medical use claims, whether Swiss-style or method of treatment, are not eligible for patent term extension in Australia because they are process claims rather than product claims and therefore do not fulfil the requirements of s 70(2).