Recent Developments On Patent-Eligibility Of Medical Use Claims In Canada

Last December, the Federal Court of Canada overturned a decision of the Commissioner of Patents to refuse a patent claiming a fixed dosage regimen for the drug Humira® (Adalimunab) used in rheumatoid arthritis. The Court's decision1 is found here: 2014 FC1251.

This Court decision was an appeal of Decision No. 1362 of the Commissioner of Patents ("the Commissioner"), refusing to grant Canadian Patent Application No. 2,385,745 ("the '745 application") to AbbVie Biotechnology Ltd. ("AbbVie") on the grounds that the claims at issue encompass an unpatentable method of medical treatment.

The claims at issue, relating to the use of Humira® as a treatment using a fixed dosage (40 mg) on a fixed (bi-weekly) schedule, were deemed to be patentable by the Federal Court.

Patent Appeal Board (PAB) Proceedings - Commissioner's Decision

Before the PAB, AbbVie argued that because the claims defined a fixed dose and a fixed dosing schedule, they avoided the exercise of skill or judgment of a medical professional, and thus related to patentable subject matter. However, the PAB interpreted the case law, notably the decision of Janssen Inc. v Mylan Pharmaceuticals ULC2 (Janssen), as having established the rule "that the mere presence of these two features [i.e., a fixed dosage and fixed dosing schedule] in a claim is not always sufficient to avoid the method of medical treatment prohibition", and asserted that the claims at issue, by placing restrictions on "how and when" the drug is to be administered, would interfere with the ability of physicians to exercise their judgment in the administration of Humira® when generic versions of this drug become available. The PAB thus concluded that the claims encompassed an unpatentable method of medical treatment. The Commissioner adopted the PAB's recommendation, and issued a decision confirming the refusal to grant the '745 application.

Federal Court Decision

AbbVie was successful upon appeal of the Commissioner's Decision to the Federal Court of Canada, Trial Division. Justice Kane of the Federal Court acknowledged that the prohibitions against claims to methods of medical treatment and to claims relating to the exercise of professional skill have been consistently applied by Canadian Courts. However, Justice Kane remarked that such decisions are based on the specific facts of each case. Justice Kane referred to three decisions, Merck & Co Inc v Apotex Inc.3, Merck & Co. Inc. v Pharmascience Inc.4, and Bayer Inc. v...