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 Inc2005 FC 755Merck & Co Inc v Pharmascience Inc2010 FC 510, and Bayer Inc v Cobalt Pharmaceuticals Company2013 FC 1061, claims analogous to AbbVie’s claims have been found to be patentable.

The Commissioner, however, relied upon Janssen Inc v Mylan Pharmaceuticals ULC2010 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 Respecting Medical Uses.

The Court concluded that the Commissioner erred in interpreting Janssen as a change in the law rather than an application of the prevailing jurisprudence to the particular claims and the evidence. Noting that in Janssen the claims involved a dosage range with several variables, and a known approach (a titration regimen) requiring a physician to monitor the patient and make adjustments, and thus covered a “pure form of medical treatment”, the Court found that the comments in Janssen arose from the specific facts in that case and do not support the Commissioner’s broader position that a dosage regimen in a claim is contrary to policy.  

The Court accordingly found the claims at issue to be patentable. There was no evidence to suggest that the bi-weekly dosage is not fixed and precise and that further skill and judgment would be expected to be exercised. Unlike Janssen, it does not seek to claim a known approach (titration). It does not restrict the physician’s skill and judgment to determine if the claimed use is appropriate for the patient: the physician decides to prescribe it as is or not at all.

This decision offers further clarification in the area of dosage claims and methods of medical treatment. The Commissioner may yet appeal as of right.