Janssen Inc. v. Apotex Inc., 2019 FC 1355 (Abiraterone*)

Justice Phelan - 2019-10-29

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This is an application brought under subsection 55.2(4) of the Patent Act and subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, as they appeared on September 20, 2017, to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex. The Regulations prior to amendment in 2017 apply because the Respondent, Apotex, served its NOA on the Applicant, Janssen, on September 19, 2017, two days before the new Regulations came into force on September 21, 2017. ... The Asserted Claims claim the use of therapeutically effective amounts of AA and of PN in combination to treat prostate cancer. This raises the question of whether the 422 Patent claims a combination of AA and PN that has an effect beyond the known effects of its component parts. ... I have concluded that the prior art had not established the existence of any side effects from AA, but the POS would be wary of potential effects given the slight cortisol responses observed in the short-term response in O’Donnell 2004. Given this uncertainty about the side effects of AA, it would not be obvious to combine AA with a glucocorticoid merely to prevent the possibility of yet-to-be observed side effects. ... Therefore, by directing physicians to prescribe APO-ABIRATERONE and PN in combination for the treatment of mCRPC, Apotex will be inducing them to infringe the 422 Patent.

Decision relates to:


Canadian Intellectual Property