Apotex v Sanofi
The Full Court (Keane CJ, Bennett and Yates JJ) has unanimously dismissed Apotex’ appeal from Jagot J findings that it had infringed Sanofi-Aventis’ patents and copyright. Bennett and Yates JJ delivered a joint opinion, Keane CJ his Honour’s own reasoned opinion.
Sanofi’s patent had just one claim:
A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of pharmaceutical composition containing as an active ingredient a compound of formula I or II … [i.e., leflunomide]
Manner of manufacture
Keane CJ recorded at  that Apotex did not press orally its argument that methods of medical treatment are not patentable in Australia. Both judgments, however, explicitly refused to re-open the question following Rescare and Bristol-Myers Squibb in light of long standing practice and Parliament’s lmitation of the exclusion from patentability in s 18(2) to humans and the biological processes for their generation.
Keane CJ, Bennett and Yates JJ would also have granted leave to Apotex to argue on appeal that “methods of medical treatment for a “second or later medical use” not limited by the purpose of the treatment are not patentable inventions.”
Whatever the merits of that ground “(a matter on which we express no view)”, however, Bennett and Yates JJ considered at  it could not succeed in this case as there was no disclosure on the face of the specification to found the Microcell argument as interpreted in Bristol-Myers Squibb. Keane CJ at  considered the ground as argued failed because, properly construed, the claim did not extend to any use of leflunomide that inevitably had some incidental beneficial effect on psoriasis.
The Court unanimously rejected Sanofi’s argument that the claim covered any administration of leflunomide which happened to (or also to) result in the treatment of psoriasis. In this context, their Honours were concerned about giving Sanofi a “monopoly” wider than its disclosure or the consideration for the grant of the patent.
This didn’t help Apotex, however.
First, Apotex’ product was approved for, and its product literature stated it was indicated for the treatment of active rheumatoid arthritis and active psoriatic arthritis. The product literature also stated “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.”
Use of leflunomide to treat rheumatoid arthritis itself would not infringe. However, those treating psoriatic arthritis knew that the patient would also have psoriasis or, if not treated, would develop psoriasis. Thus, the Full Court agreed with Jagot J that the plain meaning to those skilled in the art of the statement “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease” was an instruction to use Apo-Leflunomide for the treatment of psoriasis in conjunction with the treatment or prevention of psoiratic arthritis.
Secondly, use for the purpose of treating, or preventing, psoriasis in conjunction with psoriatic arthritis would be an infringing use. Their Honours were not overwhelmed by the supposed terrors of determining the purpose for which leflunomide was prescribed, bearing in mind that it was a prescription drug. Bennett and Yates JJ saw this at  is simply a question of characterising the impugned conduct. Keane CJ questioned at  to  whether the proposition from Merrell Dow that infringement did not depend on the infringer’s state of mind was in fact “absolute” and noted that, in circumstances where a prescription only drug was being prescribed by medical practitioners, the purpose of administration should be reasonably ascertainable.
Accordingly, Apotex infringed on the basis of (at least) s 117(2)(c).
May be the subject of a later post.
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2)  FCAFC 102