Patents
Appeal from Federal Court decision (2019 FC 1355) granting application by respondents pursuant to Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations), s. 6(1) — Decision prohibiting Minister of Health from granting marketing authorization (notice of compliance, or NOC) to appellant for its APO-ABIRATERONE product — APO-ABIRATERONE appellant’s version of respondents’ drug product marketed under name ZYTIGA, listed as Canadian Patent no. 2,661,422 (′422 patent) — Appellant required to address ′422 patent before obtaining NOC for APO-ABIRATERONE — Alleging that ′422 patent invalid for lack of patentable subject matter, obviousness, inutility — Federal Court finding in favour of respondents on all of these issues — Second decision following amendments to Regulations finding ′422 patent invalid for obviousness — Minister issuing NOC for APO-ABIRATERONE — Since decision under appeal merely prohibiting Minister from doing so, present appeal moot — However, appellant noting Court’s decision herein relevant to its right under Regulations, s. 8 to make claim against respondents for losses appellant suffered because of delay in obtaining NOC — Appellant noting correctly that invention obvious if person of ordinary skill in art finding it obvious to try, that being more or less self-evident that what is being tried ought to work merely factor to be considered, not requirement — This point addressed in Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30, 316 A.C.W.S. (3d) 537 —Court noting in Hospira that, whereas being “more or less self-evident to try to obtain the invention” requirement for obviousness to try, being “more or less self-evident that what is being tried ought to work” (per Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265) not requirement but merely factor to be considered — Appellant arguing Federal Court making same error in present case as it did in Hospira regarding obviousness to try test — Whether Federal Court making reviewable error in its obviousness to try analysis — Federal Court not erring — Case herein distinguishable from Hospira — In Hospira, Federal Court treating “more or less self-evident that what is being tried ought to work” as requirement, its consideration of at least one of other factors inadequate — Here, Federal Court considering each of factors relevant to obviousness to try, reaching conclusion based on that consideration — Federal Court can be forgiven for its lack of clarity as to whether “more or less self-evident that it ought to work” should be considered factor in obviousness to try analysis, or requirement — Supreme Court itself giving mixed signals on this point — Court here maintaining view that “more or less self-evident that it ought to work” should be treated as factor in obviousness to try analysis, not as requirement — This appearing to be more consistent with Supreme Court’s intention — Federal Court not erring in its analysis of patentable subject matter, inutility, infringement — Appeal dismissed.
Apotex Inc. v. Janssen Inc. (A-437-19, 2021 FCA 45, Locke J.A., reasons for judgment dated March 4, 2021, 24 pp.)