Federal Court Revisits The Issue Of Medical Uses

In AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251, rendered December 22, 2014, the Federal Court allowed AbbVie's appeal from a refusal of the Commissioner of Patents to grant Canadian Patent Application No. 2,385,745. The refusal was on the basis that the claims at issue cover a method of medical treatment (Decision #1362). The Court held the claims - for use of a known drug, HUMIRA (anti-TNF alpha antibodies) at a specified fixed amount (40 mg) and fixed interval (bi-weekly) - were patentable.

As no facts or claim construction were in dispute, the issue was solely a question of law, namely the Commissioner's determination of "the statutory limits of patentable subject matter... - that is, the nature and extent of the prohibition against methods of medical treatment", and more specifically, the application of principles derived from the jurisprudence.

The prohibition against claims to methods of medical treatment, and the principle that claims to the exercise of professional skill are not inventions and cannot be patented and monopolized, can be traced back to the Supreme Court of Canada's decision in Tennessee Eastman Co v Commissioner of Patents, [1974] SCR 111 ("Tennessee Eastman"). The Court found that the principle in Tennessee Eastman has been applied consistently by the courts to the facts before them.

In particular, the Court noted that in three decisions, Merck & Co Inc v Apotex Inc, 2005 FC 755, Merck & Co Inc v Pharmascience Inc, 2010 FC 510, and Bayer Inc v Cobalt Pharmaceuticals Company, 2013 FC 1061, claims analogous to AbbVie's claims have been found to be patentable.

The Commissioner, however, relied upon Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123 ("Janssen"). In that decision, the judge commented on a "concern in a case like this where the '950 Patent effectively blocks the use of a known compound (galantamine) for an established purpose (treating Alzheimer's disease) using a well-known treatment methodology (titration)".

The Commissioner interpreted Janssen as establishing a broad prohibition against any patenting of the "how and when" in the administration of a drug. This interpretation is reflected in the Canadian Patent Office's practice notice PN 2013-04 issued June 10, 2013, entitled Examination Practice...