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:
“(a) where the invention is a product–make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or
(b) where the invention is a method or process–use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use” (emphasis added).
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:
20 In the present case, the method of treatment claims are not methods that result in the making of any product. It follows that the reference in paragraph (b) of the definition of exploit to “any act mentioned in paragraph (a) in respect of a product resulting from [use of the method]” cannot apply to any of the method of treatment claims. To the extent that there will be any exploitation of the invention claimed in any of the method of treatment claims, it will be by medical practitioners or patients who perform the claimed method.
27 There are two short points to make in relation to the method of treatment claims. First, there will be no relevant exploitation of the claimed method unless it is performed during the term of the Patent. Secondly, s 117 [which relates to contributory infringement] cannot apply because it is concerned only with acts of supply. Apotex will be restrained from supplying any of the products during the term of the Patent. Hence, even if it were correct to say that by applying for a PBS listing Apotex will have offered to supply the products, this would not amount to an exploitation of any of the method of treatment claims.
28 In relation to the Swiss-style claims, Pfizer submitted that, by applying for a PBS listing, Apotex will be exploiting the claimed invention by offering to sell or otherwise dispose of products that result from the use of a method of manufacture the subject of those claims. I accept that the products that Apotex intends to supply (after patent expiry) result from the use of such a method and that, therefore, para (b) of the definition of exploit is engaged. The question is whether by applying for a PBS listing, Apotex will be offering to sell or otherwise dispose of the products.
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.
Authored by Duncan Longstaff