In Apotex v Janssen (2024 FCA 9) and Pharmascience v Janssen (2024 FCA 10), the Federal Court of Appeal held that Apotex and Pharmascience would induce patent infringement by recommending that their respective generic products be sold and used according to the dosing regimen claimed in Janssen’s 335 Patent.
In Canada, there is a three-part judicial test for determining whether the sale of any product, including a generic drug product, will “induce infringement” of patent claims. This test requires the patentee to establish that:
- there was direct infringement by a third party;
- the defendant influenced the third party to the point that the infringing act would not have occurred without the influence; and
- the defendant knew that its influence would bring about the infringing act.
This test has been the subject of considerable jurisprudence over the last twenty years, including several recent cases in which the Federal Court has relied on statements made in generic drug manufacturers’ product monographs as the factual basis for finding induced infringement.
The patent at issue in the present case (“335 Patent”) claimed a dosing regimen for treating schizophrenia that required patients to receive:
i. A first loading dose of 150 milligrams equivalent [mg-eq.] of paliperidone palmitate administered into the deltoid muscle on Day 1 of treatment;
ii. A second loading dose of 100 mg-eq. of paliperidone palmitate administered into the deltoid on Day 8 ± 2 days; and
iii. Maintenance doses of 75 mg-eq. of paliperidone palmitate administered into the deltoid or gluteal muscle monthly ± 7 days after the second injection.
Janssen alleged that Apotex and Pharmascience would induce infringement of the 335 Patent by recommending in their respective product monographs that their generic paliperidone palmitate products should be administered to patients according to the claimed dosing regimen.
At trial, the Federal Court had held that Apotex would induce infringement by recommending in its product monograph that physicians administer its paliperidone palmitate product to patients according to the dosing regimen claimed in the 335 Patent. The Federal Court held that these statements would influence physicians and patients to use the claimed dosage regimen, and that without this influence, direct infringement would not take place. The fact that some physicians would exercise skill and judgment in selecting an appropriate dosing regimen was not a defence.
On appeal, 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 a physician to prescribe the dosing regimen claimed in the 335 Patent. 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 the 335 Patent 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 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.
Apotex and Pharmascience each have 60 days from the dates of the respective judgments to file an application for leave to appeal to the Supreme Court.