The High Court of Australia yesterday issued its long awaited decision in a dispute between Apotex Pty Ltd (Apotex) and Sanofi-Aventis Australia Pty Ltd and related entities (collectively, Sanofi) concerning Sanofi's Australian patent no. 670491 entitled "Pharmaceutical for the treatment of skin disorders" (Patent). In summary:
The majority (French CJ, Crennan, Keifel and Gageler JJ, Hayne J dissenting) held that assuming all other requirements for patentability are met, a method (or process) for medical treatment of the human body can be a "manner of manufacture" and therefore patentable for the purposes of section 18 of the Patents Act 1990 (Cth) (Act).
The Court unanimously held that Apotex did not indirectly infringe the Patent pursuant to section 117 of the Act by supplying Apo-Leflunomide. It was not shown, nor could it be inferred, that Apotex had reason to believe that Apo-Leflunomide would be used in accordance with the patented method, and Apotex's approved product information document did not instruct recipients to use Apo-Leflunomide in accordance with the patented method.
The dispute concerned Leflunomide, a drug used to treat the skin disorder psoriasis. The patent for the substance Leflunomide expired in 2004. The Patent claims a method of using Leflunomide to treat psoriasis.
Apotex registered its generic, Apo-Leflunomide on the ARTG. Apo-Leflunomide was indicated on the Australian Register of Therapeutic Goods (ARTG) for treatment of rheumatoid arthritis and psoriatic arthritis. Importantly, psoriasis and psoriatic arthritis are separate conditions, but most people with psoriatic arthritis will develop psoriasis. The product information for the product expressly excluded use of the product to treat psoriasis.
Sanofi successfully restrained Apotex from supplying products containing Leflunomide in the Federal Court of Australia. Justice Jagot held that supplying Apo-Leflunomide would infringe the patent for the purposes of section 117(2)(c) of the Act, on the basis that using Leflunomide to treat psoriatic arthritis would inevitably treat (or prevent) psoriasis as well, even if Leflunomide was only prescribed for treating psoriatic arthritis.
The Full Federal Court upheld infringement, but on the basis that Apotex had reason to believe that the product would be put to the infringing use because it accepted that rheumatologists do seek, and will seek, to treat both conditions when patients present with psoriatic arthritis and psoriasis concurrently.
High Court Appeal – Manner of manufacture
The majority of the Court held that the Patent was valid.
This was the first time the High Court has considered whether a method of treatment was inherently patentable subject matter, and the majority's decision will have far reaching implications for operators in the pharmaceutical industry.
Importantly, Justices Crennan and Kiefel JJ did draw a distinction between a method of medical treatment which involves a therapeutic use of a pharmaceutical substance, and the activities of doctors or other medical staff when physically treating patients. Such activities or procedures are unlikely to satisfy the test for patentability because they are not capable of being practically applied in commerce or industry, which is a necessary prerequisite for a "manner of manufacture".
High Court Appeal – Indirect infringement
In its application for special leave (heard in December 2012), Apotex also sought leave to appeal the Federal Court's decision regarding whether, its conduct constituted contributory infringement of the Patent pursuant to section 117(1) of the Act.
The Court found that Apotex did not indirectly infringe the Patent by its supply of Apo-Leflunomide. The Court found that Apotex had no reason to believe Apo-Leflunomide would be used to infringe the Patent and nor did it instruct those to whom it supplied the product to do so. This was especially where the entry for Apo-Leflunomide on the ARTG stated that it is a therapeutic good registered for its indicated uses, which specifically excludes use of the method disclosed in the Patent.