This is an informal case summary prepared for the purposes of facilitating exchange during the 2024 WIPO IP Judges Forum.
Session 6
Federal Court of Appeal, Canada [2024]: Pharmascience Inc. v Janssen Inc., 2024 FCA 23
Date of judgment: February 1, 2024
Issuing authority: Federal Court of Appeal, Canada
Level of the issuing authority: Appellate Instance
Type of procedure: Judicial (Administrative)
Subject matter: Patents (Innovations); Enforcement of IP and Related Laws
Appellant: Pharmascience Inc.
Respondents: Janssen Inc. and Janssen Pharmaceutica N.V.
Keywords: Patents, Patent infringement, Patent validity, Obviousness, Permanent injunctions, Pharmaceutical, Medical treatment
Basic facts: This case centers around the dispute between Pharmascience Inc. (the appellant), and Janssen Inc. and Janssen Pharmaceutica N.V. (the respondents). Janssen holds Canadian Patent No. 2,655,335 (the 335 Patent), which covers the drug INVEGA SUSTENNA used for the treatment of schizophrenia and related disorders. The patented method involves a regimen for administering paliperidone palmitate, specifying precise loading doses and maintenance doses for patients.
Pharmascience Inc. sought to market a generic version of Janssen's drug, contending that the claims in Janssen’s patent involved unpatentable methods of medical treatment. The sole validity issue in dispute before the Federal Court was whether the claims constituted unpatentable subject matter. The court found that the claims of the 335 Patent defined a fixed dosage regimen that did not require the exercise of professional skill or judgment by a medical practitioner, thus qualifying as patentable subject matter.
On appeal, Pharmascience Inc. argued that the Federal Court erred in law by:
· Excluding the 335 Patent’s “product” claims from its method of medical treatment analysis; and
· Determining patentability based on a dichotomy between fixed and variable dosing regimens.
Held: The Federal Court of Appeal (FCA) upheld the Federal Court’s earlier decision, dismissing Pharmascience’s appeal.
The court rejected Pharmascience’s argument that the patent constituted an unpatentable method of medical treatment. The court reasoned that the claims did not require the ongoing exercise of medical judgment or skill in their application, as the dosage and treatment regimen were fixed and defined within the patent.
The court also delved into the jurisprudence on the prohibition against patenting methods of medical treatment. The FCA concluded that the key question is whether the use of the invention requires the exercise of skill and judgment. What is prohibited is the need for skill and judgment in deciding how to use the invention, not whether to use it. While it is permissible to consider whether a dosing regimen is fixed or variable, this factor alone cannot determine whether a claim involves an unpatentable method of medical treatment.
Relevant holdings in relation to permanent injunctions: Pharmascience Inc. also contended that the injunction granted by the Federal Court was overly broad, arguing that it covered activities like offering for sale, marketing, importing, and exporting, which it claimed extended beyond the exclusive rights enumerated in Section 42 of the Patent Act.
The FCA rejected this argument, noting that Pharmascience Inc. had failed to raise this issue in its notice of appeal.
Furthermore, the FCA referenced a parallel case involving Apotex (Janssen Inc. v. Apotex Inc., 2023 FCA 253), where it had emphasized that Section 42 defines the patentee's exclusive rights but does not limit the scope of infringement. Infringement includes any action that interferes with the patent holder’s monopoly. The FCA concluded that activities such as distributing and offering for sale clearly constitute infringement, and the primary purpose of the injunction is to prevent future infringement of the exclusive rights. The court found that the reasoning from the Apotex case applied similarly to the present matter.
Pharmascience Inc. would need leave from the Supreme Court of Canada to appeal the FCA’s decision.
Relevant legislation:
· Patented Medicines (Notice of Compliance) Regulations, SOR/93-133