Patent Appeal Board Allows Dosage Regimen Claims ' No Physician Skill Needed

• Published date: 26 January 2021
• Law Firm: Bereskin & Parr LLP
• Author: Ms Patricia Folkins and Shuo Xing

In the recent Commissioner's Decision Re Amgen Research (Munich) GmbH (2021 CACP 2), the Patent Appeal Board allowed medical use claims reciting a dosage range in Amgen's Canadian Patent Application 2,633,594 (the 594 application).

It is well known that in Canada, while methods of medical treatment are not patentable subject matter, medical use claims are considered patentable. Nevertheless, there have been several Federal Court decisions¹ where a claim directed to the exercise of professional skill or judgment, for instance a claim containing a dosage range, was held to be not patentable.² Consequently, CIPO issued the 2015 Revised Examination Practice Notice (PN 2015-01), which specified that where an essential element of a medical use claim prevents, interferes with or requires the professional skill of a physician, the claim is considered to encompass a method of medical treatment and is not patentable subject matter under s.2 of the Patent Act.

The claims in questions in the 594 application are directed to an antibody for use in the treatment of B cell non-Hodgkin lymphoma or B cell leukemia, wherein the antibody is for administration for at least 1 week in a daily dose of 10 μg to 80 μg...