The Federal Court has recently issued a decision that highlights the importance of including Swiss-style claims in Australian pharmaceutical patents.
As reported previously, the Federal Court (Nicholas J) confirmed in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3)  FCA 94 that offers made during the term of a patent to supply infringing products after the patent has expired will infringe the patent. However, the Court also found an application lodged during the term of a patent to list an infringing product on the Pharmaceutical Benefits Scheme (PBS) will not infringe the patent if the date of listing occurs after the expiry date of the patent as it "would fall short of offering to sell or otherwise dispose of the products".
An interesting aspect of the Court's decision relates to the types of second medical use claims that are infringed by an offer made during the term of a patent to supply an infringing product after the term of the patent has expired.
In Australia, second medical use claims (i.e., new uses of a known pharmaceutical) are acceptable in the method of treatment format (A method of treating disease X comprising administering compound Y) or the Swiss-style format (Use of compound X for the manufacture of a medicament for the treatment of disease Y). While not allowable in many jurisdictions (including Europe, Canada, Japan and China), method of treatment claims have been deemed patentable in Australia by the High Court (Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50 – see discussion here). Swiss-style claims are construed in Australia as defining a method or process for the manufacture of a medicament (Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4)  FCA 634) and have been found to confer eligibility for a patent term extension if the medicament contains a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology in some way ( AbbVie Biotechnology Ltd Commissioner of Patents  AATA 682 – see discussion here).
Importantly, in the present decision, Nicholas J distinguished between the scope of method of treatment claims and Swiss-style claims. In the context of the excerpt from the decision below, it is important to note that, under the Patents Act 1990, a patent confers on the patentee the exclusive rights, during the term of the patent, to "exploit" the invention. As defined in the Act, "exploit" includes:
Given that, to find infringement, exploitation of the invention has to take place during the term of the patent, Nicholas J stated the following regarding potential infringement of method of treatment claims and Swiss-style claims by an offer made during the term of a patent to supply an infringing product after the term of the patent has expired:
It is clear from the above, that an offer made during the term of the patent to supply an infringing product after the term of the patent has expired will infringe a Swiss-style claim, but not a method of treatment claim.
The Court's decision confirms that method of treatment claims and Swiss-style claims are directed to different infringing acts and highlights the importance of including both claim types in Australian pharmaceutical patents.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
|Shelston IP ranked one of Australia's leading Intellectual Property firms in 2015.|