Federal Court Of Appeal Addresses Patentability Of Methods Of Medical Treatment In Canada

• Published date: 04 March 2024
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Gowling WLG
• Author: Mr Alex Gloor and Adam Heckman

Methods of medical treatment are considered to be an exception to patentable subject matter in Canada. However, it is acknowledged that the exception has no explicit statutory basis, and the supporting jurisprudence is both unclear and contradictory. The Court has recently characterized the jurisprudence on point as "inconsistent"¹ and deserving of "deep analysis,"² and 2015 the Federal Court of Appeal (FCA) called for "full consideration" of the status quo by it or the Supreme Court "in a case where the issue is squarely raised on the facts."³

Over time, the exception as it relates to patents claiming the use of a dosage regimen in the treatment of a disease has evolved to distinguish claims covering fixed dosages and intervals (patentable subject matter) from claims covering a range of dosages and intervals (unpatentable subject matter). This distinction has come under scrutiny in recent years.⁴

The recent FCA decision of Pharmascience v Janssen, 2024 FCA 23 [Janssen], addresses many aspects of the method of medical treatment exception to patentability, including: (i) the history of the exception and its statutory basis; (ii) the application of the exception to different claim types; and (iii) the fixed dosage versus range distinction. While Janssen provides a welcome analysis of the exception, significant uncertainty will remain for those seeking to secure and enforce patent rights in Canada.

The decision below and the patent at issue

Janssen is an appeal from a decision relating to a patent containing four claim sets, each with common elements relating to dosage regimens for the administration of the medicine paliperidone palmitate. The Court described the four claim sets as follows:

• Claims 1 to 16 relate to prefilled syringes adapted for administration according to the claimed dosing regimens;
• Claims 17 to 32 relate to a use of a "dosage form" according to the claimed dosing regimens;
• Claims 33 to 48 relate to use of paliperidone as paliperidone palmitate in the manufacture/preparation of a "medicament" adapted for administration according to the claimed dosing regimen; and
• Claims 49 to 63 relate to a "dosage form" adapted for administration according to the claimed dosage regimens.⁵

The Trial Judge distinguished the "use" claims (17-32) from the remaining claims, which were characterized as "product" claims. The product claims were considered vendible products (and thus patentable subject matter) on their face and as such were not the focus of the...