In a landmark ruling in the case of Apotex Pty Ltd (“Apotex”) v. Sanofi-Aventis Australia Pty Ltd (“Sanofi”), the High Court of Australia has confirmed that methods of medical treatment are patentable in Australia. The High Court also decided that the generics manufacturer, Apotex, did not infringe Sanofi’s second medical use Patent, on the basis of the “skinny labelling” used by Apotex for their generic product.
Pharmaceutical companies with patents covering commercially successful pharmaceutical products often seek to obtain extended patent protection by claiming second medical uses for the compound in question. This can create uncertainty for companies looking to supply generic versions once the basic patent for the product has expired. In particular, Generics may be reluctant to risk an allegation of contributory infringement by a Patentee in possession of a second medical use Patent by bringing their generic product to market.
There is the possibility in some countries for Generics to adopt the counter-strategy of explicitly excluding the patented second medical use from the product information supplied with the generic product, so-called “skinny labelling”. However, the issue of whether or not skinny labelling will stand up to an allegation of contributory infringement is one that multiple national jurisdictions are yet to tackle. Until recently this included Australia. However, the Judgement issued by the High Court of Australia in the case of Apotex v Sanofi, issued on 4 December 2013, has now shed more light on the situation in this territory (Case S1/2013 – High Court of Australia).
The case centres on Leflunomide, a drug approved to treat psoriatic arthritis and rheumatoid arthritis. The basic Patent covering this drug has expired, but Sanofi is the registered owner of a further Patent (“the Patent”) claiming a method of preventing or treating psoriasis by administering Leflunomide, which is in force. Sanofi sued Apotex, who supply generic Leflunomide for treatment of psoriatic arthritis and rheumatoid arthritis, on the basis that the supplied Leflunomide could also be used to prevent or treat psoriasis. Apotex counter-claimed for revocation of the Patent on multiple grounds, one of which was that methods of medical treatment are unpatentable in Australia, as is the case in Europe.
The High Court of Australia dismissed Apotex’s counter-claim and ruled that methods of medical treatment are patentable in Australia. Thus, the Patent could not be revoked. However, the Court also ruled by majority that Apotex did not infringe the Patent. This conclusion was reached with emphasis on Apotex’s approved product information document which included the following statement: “…Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease”. It was held that this statement demonstrated that Apotex’s generic version of Leflunomide “…is a therapeutic good registered for its indicated uses, which specifically excludes use of the patented method identified in claim 1 [of the Patent]…[thus]… it was not shown, nor could it be inferred, that Apotex had reason to believe that the unpatented pharmaceutical substance, which it proposes to supply, would be used by recipients in accordance with the patented method, contrary to the indications in Apotex’s approved product information document.”
Whilst this Decision addresses the complex situation of contributory infringement of a second medical use claim in Australia, and arguably leads to more certainty concerning the issue of skinny labelling in the Australian market, it is still likely that each case will turn on its own facts. The issue of contributory infringement of second medical use claims granted by the European Patent Office is yet to be tackled and it is difficult to know whether courts in Europe will adopt the same view i.e. that “skinny labelling” demonstrates that the generic manufacturer has no reason to believe that the supplied product will be administered for the patented second medical use. Only time will tell.