كندا

This is an informal case summary prepared for the purposes of facilitating exchange during the 2025 WIPO IP Judges Forum.

Session 2: Pharmaceutical Patents

Federal Court of Appeal, Canada [2024]: Pharmascience Inc. v Janssen Inc. et al., 2024 FCA 23

Date of judgment: February 1, 2024

Issuing authority: Federal Court of Appeal

Level of the issuing authority: Appellate Instance

Type of procedure: Judicial (Civil)

Subject matter: Patents (Inventions)

Plaintiff: Janssen Inc. and Janssen Pharmaceutica N.V.

Defendant: Pharmascience Inc.

Keywords: Pharmaceutical patents, patent infringement

Basic facts: The trial involved two patent infringement actions related to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, in respect of Canadian Patent No. 2,655,355 (the “355 Patent”).

The Plaintiffs sought a declaration that the Defendant would infringe the 335 Patent if it were to make, use or sell its generic version of the Plaintiffs’ patented medicine called INVEGA SUSTENNA.

INVEGA SUSTENNA involved a suspension of paliperidone palmitate for the treatment of schizophrenia and related disorders. The 335 Patent teaches a regimen to achieve an optimum plasma concentration-time profile. It teaches the first loading dose administered in the deltoid muscle on day 1, a second loading dose administered in the deltoid muscle on day 8, and then monthly maintenance doses thereafter administered either in the deltoid or gluteal muscle. For non-renally impaired patients, the first and second loading doses are 150 and 100 mg equivalent (mg-eq.), respectively, and the monthly maintenance doses are 75 mg-eq., respectively, and the monthly maintenance doses are 50 mg-eq. each.

At trial, it was found that the 335 Patent was valid, and the defenses of obviousness and non-patentable subject matter (a method of medical treatment which has been held not to be patentable in Canada) failed.

The only issue on appeal to the Federal Court of Appeal was whether the trial court erred in finding that the claims of the 355 Patent were valid and did not comprise unpatentable subject matter as methods of medical treatment. As a starting point, both the trial Court and Court of Appeal took the position that it is well settled that claims to a vendible product are not prohibited as methods of medical treatment. The focus needed to be on whether professional skill and judgment are required to practice the claimed invention, specifically here, in relation to particular dosages and specific administration schedules. The Federal Court of Appeal (“FCA”) stated at paragraph 37:

[37]   To summarize, whether or not a patent claim to a dosing regimen relates to a method of medical treatment cannot be based exclusively on whether its dosing and schedule is fixed or not. The proper inquiry remains whether use of the invention (i.e., how to use it, not whether to use it) requires the exercise of skill and judgment, and the burden remains on the party challenging the patent. It is difficult to provide more detailed guidance than this for parties involved in future litigation and courts faced with allegations of invalidity of patent claims due to unpatentable subject matter, namely methods of medical treatment. Such allegations will generally turn on the particulars of the case and the evidence on the record.

The FCA upheld the trial decision. The Supreme Court of Canada (“SCC”) granted leave and will hear the parties’ arguments in October 2025.

The questions for the SCC boil down to two main issues:

·         Are methods of medical treatment patentable in Canada?; and

·         What constitutes a method of medical treatment or what test should guide its determination?

The history of methods of medical treatment being unpatentable in Canada have a genesis from the 1974 Supreme Court of Canada decision in Tennessee Eastman v Commissioner of Patents, [1974] SCR 111.

The appeal is scheduled to be heard on October 9, 2025. Five intervening parties will also present to the SCC.

Held: The FCA upheld the trial decision that 335 Patent was valid, and the defenses of obviousness and non-patentable subject matter (a method of medical treatment which has been held not to be patentable in Canada) failed. The SCC granted leave and will hear the parties’ arguments in October 2025.

Relevant holdings in relation to Session 2: medical treatment not patentable (subject to SCC’s decision in subsequent proceedings)

Relevant legislation: subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations