Late last year in the landmark decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 30, the High Court found that methods of medical treatment of human beings including surgery and the administration of therapeutic drugs can be the subject of patents.
Prior to this decision, the Federal Court had in two relatively recent decisions expressed the view that methods of medical treatment of the human body should be capable of protection by patent. However, these statements were in contrast to a substantial history of case law which excluded methods of medical treatment from being patentable based on a variety of ethical, precedential and public policy reasons.
Sanofi-Aventis was the registered owner of a patent which claimed to protect a method of treating or preventing the skin disorder psoriasis by administering an effective amount of a drug, a compound of which was Leflunomide.
Leflunomide itself was not protected by a patent (as a separate patent in relation to Leflunomide had expired).
Apotex obtained registration of generic versions of Leflunomide on the Australian Register of Therapeutic Goods, with the intention to supply products containing Leflunomide in Australia as treatments for psoriatic arthritis and rheumatoid arthritis.
Sanofi-Aventis alleged that Apotex's proposed supply would infringe Sanofi-Aventis' patent.
The Federal Court at first instance, and the Full Federal Court on appeal, found that Sanofi-Aventis had a valid patent which Apotex had threatened to infringe.
Apotex then appealed to the High Court in relation to the validity of Sanofi-Aventis' patent and whether, if the patent was valid, Apotex had infringed the patent.
The High Court found that, despite the body of case law to the contrary, if the requirements for patentability were met, a method for medical treatment of human beings could be considered a 'manner of manufacture' which would be a patentable invention within the meaning of section 18 of the Patents Act 1990 (Cth).
Chief Justice French commented that "The history of the exclusion of medical treatments from patentability does not disclose a stable, logical or normative foundation and seems to depend on nice distinctions for its maintenance"
The High Court then considered whether Apotex had infringed Sanofi-Aventis' patent. This decision turned on the interpretation of the patent. The High Court found that Sanofi-Aventis' patent would not be infringed unless the purpose, object or aim of administering Leflunomide was to treat the skin disorder psoriasis. This was in contrast to the opposing view that if the actual effect of administering Leflunomide would be to treat psoriasis then Sanofi-Aventis' patent would be infringed.
Because Apotex's product information document gave instructions to restrict the use of Apex's Leflunomide products to the treatment of psoriatic arthritis and rheumatoid arthritis and not the skin disorder psoriasis, the High Court found that Sanofi-Aventis' patent had not been infringed.
Some might see this decision as simply closing an anachronistic loophole, giving force to earlier comments made in recent Federal Court decisions. Others might regard it as an undesirable development of intellectual property rights. Whatever your view, the decision is likely to have a significant effect on the development of new medical procedures.
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