Patentability of Biologics in Canada: Beyond Patentable Subject Matter

Abstract

Gowling Lafleur Henderson LLP 160 Elgin Street, Suite 2600, Ottawa, Canada *Author for correspondence: E-mail: john.norman@gowlings.com As in Europe and the USA, issues related to the patent protection of biologics are of current interest in Canada. However, unlike in the USA and in many European countries, Canadian courts have yet to deal with the patentability of biologics beyond the question of which biologics are patentable subject-matter [1,2]. Nevertheless, the paucity of Canadian case law on Canadian biologics patents does not mean that other issues regarding the patentability of biologics have not created any difficulty for applicants or the Canadian Patent Office. In fact, over one third of the 34 decisions of the Patent Appeal Board that have been reported in the Canadian Patent Reporter since 2007 have involved patent applications related to biologics. The majority of these decisions have dealt with the issues of sufficiency and utility. Furthermore, it is only a matter of time before allegations of invalidity are raised as defenses in biologics patent infringement actions or in proceedings under the Patented Medicines (Notice of Compliance) Regulations where the drug at issue is a biologic [3]. Of greatest interest to foreign and Canadian practitioners alike may be the issue of utility, which has recently developed features that are unique to Canada and which may be unfamiliar to those from other jurisdictions. The intention of this article is to briefly explore the requirement that an invention be useful, as applied to biologic inventions, in order to anticipate some of the issues that we may expect to see in future Canadian court proceedings involving biologics patents.