On March 23, 2023, the Federal Court of Appeal of Canada (FCA) issued its decision in Teva Canada Limited v. Janssen Inc., 2023 FCA 68, in which it dismissed Teva Canada Limited’s (Teva’s) appeal and allowed a cross-appeal by Janssen Inc. and Janssen Pharmaceutica N.V. (collectively, Janssen), finding that Teva would induce infringement of Canadian Patent No. 2,655,335 (the 335 Patent) by bringing its paliperidone palmitate product to market.
Janssen’s 355 Patent describes dosing regiments for injectable paliperidone palmitate formulations to be used in the treatment of schizophrenia and related disorders. The Federal Court (FC) found that (i) the 355 Patent was valid and not obvious; (ii) Teva’s paliperidone palmitate product would infringe certain claims of the 355 Patent; and (iii) Teva would not induce infringement of any claims of the 355 Patent. Teva appealed the decision on the grounds that the FC erred in findings (i) and (ii), while Janssen, in its cross-appeal, submitted that the FC erred in finding (iii).
The FCA determined that there was no basis for interfering with the FC’s findings in relation to obviousness or direct infringement, but it agreed with Janssen that the FC made a reviewable error in deciding on whether Teva induced infringement of the 355 Patent. In examining this issue, the FCA recited the test for inducing infringement, which requires the plaintiff to prove that:
The FCA found that the FC erred in its analysis of the second element of the test. The FC reasoned that despite Teva’s product monograph (PM) covering information claimed in the 355 Patent, Teva would not influence infringement as the dosing regiment would “…ultimately be made by physicians based on various factors beyond what was set out in the Teva PM.” However, the FCA stated that a physician’s use of their own skill and judgement does not apply in this case and for “…a generic drug, inclusion as one of the recommended uses within the PM for the drug of the alleged infringing use, among others, has been found to be sufficient to constitute the requisite encouragement to satisfy the second prong of the test…” This led the FCA to conclude that the second step of the test was met and, after determining that Teva must have been aware of the contents and recommendations of its PM, confirmed that the final element was satisfied too.
Based on its findings, the FCA dismissed Teva’s appeal and granted Janssen’s cross-appeal, declaring that the making, constructing, using or selling of Teva’s paliperidone palmitate product in accordance with the matter at hand would induce infringement of the 335 Patent.
Summary By: Imtiaz Karamat
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