On June 27, 2024, the Supreme Court of Canada dismissed the applications for leave to appeal in Apotex Inc. v. Janssen Inc. et al., 2024 FCA 9 and Pharmascience Inc. v. Janssen Inc. et al., 2024 FCA 10, both Federal Court of Appeal decisions pertaining to inducing infringement of a patented dosing regimen. We published an earlier blog, Generic Manufacturers Induce Patent Infringement by Recommending Use of a Patented Dosing Regimen in their Product Monographs – Markwell Clarizio LLP (markwelllaw.com) on both Federal Court of Appeal decisions but below are the key highlights of those decisions.
Apotex Inc. v. Janssen Inc. 2024 FCA 9
On appeal of the Federal Court decision regarding induced infringement of a patented dosing regimen, Apotex made two main arguments: (1) the second step of the inducement test requires evidence of “but for” causation; and (2) any influence that Apotex’s product monograph has on physicians would not meet the threshold required at the second step of the inducement test.
Apotex’s second argument was based on the fact that its product monograph would essentially be a copy of the product monograph for Janssen’s INVEGA SUSTENNA product and the assertion that physicians would not change their prescribing practices upon the market entry of Apotex’s generic product.
The Court of Appeal did not object to Apotex’s characterization of the threshold at the second step as requiring “but for” causation, but found it to be the same as the “would not have occurred without” and “sine qua non” characterizations provided in earlier jurisprudence. Thus, Apotex’s re-characterization of the second step was of no moment.
The Court of Appeal disagreed with Apotex’s second argument and held that the Federal Court did not err in finding (based on expert testimony) that patients may receive the claimed dosing regimen as a result of prescribing physicians referring to Apotex’s product monograph. The Federal Court had also found that parts of Apotex’s product monograph would influence physicians to prescribe the claimed dosing regimen. The Court of Appeal concluded that there was sufficient evidence for the lower court to find that the threshold of the second step of the inducement test was met.
The Court of Appeal also clarified that the second step of the test did not require that physicians must change their prescribing practices as a result of Apotex’s market entry. Even if physicians did not change their prescribing practices, there would be direct infringement of some of the patent’s claims if the drug products were obtained from Apotex and used according to Janssen’s claimed dosing regimen. There was evidence to conclude that this infringement would occur as a result of Apotex’s product monograph being available for consultation.
Pharmascience v. Janssen Inc. 2024 FCA 10
Pharmascience argued at trial that it could not be liable for patent infringement because it did not intend to sell an essential component of the patented dosing regimen , i.e., a 75 mg unit dose. As such, physicians and patients wishing to use this dose as a maintenance therapy would have to obtain the product from Janssen – and that any such sale and acquisition would necessarily exhaust Janssen’s rights in the patented combination and/or confer an implied license to use the claimed dosing regimen. The Federal Court rejected these arguments.
On appeal, Pharmascience argued that the Federal Court erred in its review of the jurisprudence on implied licenses. However, after reviewing the relevant case law, the Court of Appeal concluded that the purchase of Janssen’s 75 mg drug product in a single dose did not include an implied license to use that dose in combination with doses obtained from other sources, such as Pharmascience, in the claimed dosing regimen. In other words, the implied license to use the single 75 mg dose did not extend to a license to use the claimed dosing regimen since the 75 mg dose was only one component of the overall combination. However, the Court of Appeal did recognize that there may be an exception if the evidence shows that, at the time of sale of the single component, the patentee intended the sold component to be used as part of the broader patented combination.
Having found that Janssen’s sales of 75 mg doses do not grant an implied license over the entire claimed dosing regimen, the Court of Appeal concluded that the Federal Court was correct in its finding of direct infringement in the first step of the induced infringement test.