Federal Court Finds Claims For Fixed Dosage and Fixed Dosing Schedule Not To Be Methods of Medical Treatment

In AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251, Kane J of the Federal Court allowed AbbVie’s appeal from a decision by the Commissioner of Patents (Commissioner) refusing to grant a patent from Canadian Patent Application No 2,385,745 (the 745 Application). The Court directed the Commissioner to allow the claims at issue.

This decision offers further clarification in the area of methods of medical treatment and confirms that certain claims containing specific dosages and/or dosing schedules can be patentable.

Background

The essential elements of the claims at issue are: a preloaded syringe of 40 mg of the drug Humira® (a known human monoclonal anti-TNF? antibody) for the treatment of arthritic disease or an inflammatory bowel disease, administered subcutaneously, for use on an every other week dosing interval of 14 days (ie, bi-weekly). While he determined that the claims at issue were not anticipated or obvious, the Commissioner refused the 745 Application on the basis that the claims were directed to a method of medical treatment. Specifically, the Commissioner interpreted Janssen Inc v Mylan Pharmaceuticals PLC, 2010 FC 1123 (Janssen) as establishing a broad prohibition against any patenting of the “how and when” in the administration of a drug. The Commissioner therefore found that the claims at issue were directed to methods of medical treatment and thus unpatentable.

The above interpretation of the Commissioner is reflected in the Canadian Patent Office’s practice notice PN 2013-04 entitled “Examination Practice Respecting Medical Uses” (previously reported in the E-TIPS® newsletter).

The Federal Court’s Decision

Kane J determined that the issue in this case was solely a question of law: the Commissioner’ interpretation of the scope of the prohibition against methods of medical treatment, and more specifically, “the application of the principles derived from the jurisprudence”. Hence, Kane J applied the standard of correctness when reviewing the Commissioner’s Decision.

Kane J reviewed the jurisprudence against patenting methods of medical treatment which originated from the Supreme Court of Canada decision inTennessee Eastman Co v Commissioner of Patents, [1974] SCR 111 (Tennessee Eastman). She found that the principle established in Tennessee Eastman prohibiting methods of medical treatment had been applied consistently by the Courts to the facts before them.

In particular, Kane J noted three decisions, Merck & Co Inc v Apotex Inc,2005 FC 755 (use of a 70 mg tablet once a week for the treatment of male baldness), Merck & Co Inc v Pharmascience Inc, 2010 FC 510 (use of a 1.0 mg drug daily for the treatment of osteoporosis) , and Bayer Inc v Cobalt Pharmaceuticals Company, 2013 FC 1061 (use of a single dosage of each of two compounds as a contraceptive) contained patentable claims that are analogous to the claims at issue.

Kane J also 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:

[119] Justice Barnes’ comment that physicians “should not be prevented or restricted from applying their best skill and judgment for fear of infringing a patent covering a pure form of medical treatment” does not, in my view, support the Commissioner’s or the respondent’s broader position that a dosage regimen in a claim is contrary to policy. Justice Barnes referred to a patent “covering a pure form of medical treatment (as distinct from a vendible medical or pharmaceutical product)” (at para 53). That remains the issue in every case – to determine if what is claimed, is a form of medical treatment or a vendible product.

[120] The Commissioner and respondent have seized on this passage as the policy or law to be applied and which is also reflected in the new Guidelines, above. However, this must be examined in the context of the claims that Justice Barnes was presented with. The patent claimed a “pure form of medical treatment” – a titration regimen that would require adjustments to the dosage and when to increase it and was already the known approach. The concern expressed by Justice Barnes about the restrictions such a patent would impose does not arise in every claim and is not a new principle. The principle remains the same – where the patent claims a method of treatment or the exercise of professional (in this context, the physician’s) skill and judgment, such that it restricts or interferes with it, it is not patentable.

Kane J accordingly found that the claims at issue were patentable, as there would be no restrictions on the exercise of a physician’s skill or judgment once the drug is prescribed.