Janssen’s stranglehold strengthens: Evidence important in indirect infringement

Janssen scored another victory in relation to Canadian Patent No. 2,659,770 in Janssen v Apotex.

Janssen sought to prevent Apotex from selling a generic version of its OPSUMIT product, which contains the medicinal ingredient macitentan, by asserting the 770 Patent. Apotex did not challenge the validity of the 770 Patent, some of whose claims were recently found to be valid in a decision that is now under appeal (discussed previously here).

Janssen alleged that Apotex would infringe claims directed to the administration of a combination of macitentan and a second drug (a PDE5-I) to patients with pulmonary arterial hypertension.

The Court concluded that Apotex would not directly infringe any of the asserted claims because Apotex neither combined macitentan with a PDE5-I nor administered macitentan to patients. With respect to whether Apotex would induce infringement of the 770 Patent, Justice Pallotta applied the three-part test set out in Corlac:

1. there must be infringement by a direct infringer;
2. completion of the direct infringement must be influenced by the inducer to the point that, without the influence, direct infringement would not take place; and
3. the influence must be knowingly exercised by the inducer.

Justice Pallotta noted that the test required the application of factual findings and that each case turns on the totality of the evidence before the court. Justice Pallotta also contrasted inducement jurisprudence in applications under the old PM(NOC) Regulations with jurisprudence in actions under the current Regulations: in the former case the brand could subsequently sue generics for infringement; in the latter case the brand cannot do so.

Direct infringement by physicians

Based on the expert evidence before her, Justice Pallotta held that physicians prescribing Apotex’s product would directly infringe the 770 Patent because they would prescribe macitentan in combination with a PDE5-I.

Influence by Apotex

The Court considered Apotex’s proposed product monograph to determine if it influenced physicians to infringe the 770 Patent. The Apotex PM contained references to a clinical trial that established the safety and efficacy of macitentan alone and when used in combination with a PDE5-I, which the Court held was sufficient to enable physicians to prescribe the combination.

Janssen’s experts opined that physicians would review the Apotex PM before prescribing the generic product; Apotex’s expert disagreed. The Court preferred the evidence of Janssen’s experts because they regularly prescribe treatments for PAH, whereas Apotex’s expert did not, and because the testimony of Apotex’s expert was inconsistent.

Knowing exercise of influence

Justice Pallotta held that Apotex knew or ought to have known that the content of its PM would influence physicians. She reached this conclusion because the Apotex PM was not “scrubbed clean” of references to combination with a PDE5-I and because there was no evidence to establish that Apotex was not in control of the content of its PM.

Justice Pallotta therefore issued a judgment that declared that Apotex’s product would infringe the 770 Patent. The reasons may be found here; the judgment was issued separately and may be found here.