Federal Court of Appeal Dismisses Appeal Relating to Patent Validity Concerning Apixaban

On August 4, 2022, the Federal Court of Appeal of Canada (FCA) issued its decision in Pharmascience Inc. v Bristol-Myers Squibb Canada Co., 2022 FCA 142, finding that the Federal Court (FC) did not err in holding that the patents at issue are valid.

The proceeding relates to four actions under the Patented Medicines (Notice of Compliance) Regulations involving Patent Nos 2,461,202 (‘202 Patent) and 2,791,171 (‘171 Patent). Both patents of the Respondent, Bristol-Myers Squibb (BMS), concern apixaban, a Factor Xa inhibitor and anticoagulant for treating thrombosis (marketed by BMS as ELIQUIS). Apixaban is also part of a large genus of compounds disclosed in the earlier BMS Patent No. 2,349,330 (‘330 Patent).

The Appellant, Pharmascience Inc. (PMS), appealed on numerous grounds the trial decision concluding that BMS’ patents are valid (2021 FC 1). PMS claimed that the ‘202 Patent was not a selection patent, that there was insufficient disclosure, and that the ‘202 Patent was obvious. In considering the ‘171 Patent, PMS claimed that it was obvious, ambiguous and overbroad.

With regards to the ‘202 Patent, PMS asserted that the FC: (i) did not make a clear finding as to whether the ‘202 Patent was a selection patent; (ii) erroneously found that the ‘202 Patent disclosed a special advantage; and (iii) erred in finding that the ‘202 Patent disclosed an invention. The FCA first found that the FC stated the requirements for a selection patent and that such requirements were met. The FCA affirmed the FC’s conclusion that the ‘202 Patent disclosed a special advantage over the compounds described in the prior ‘330 Patent, and that it provided the public with a novel and useful product. Further, the FCA stated there was no need for the ‘202 Patent to provide an explicit comparison between apixaban and any other compound falling in the scope of the ‘330 Patent.

Next, the FCA found that the FC correctly identified the inventive concept, that is, the selection of apixaban from among other compounds falling within the scope of the ‘330 Patent. Further, there was no reviewable error in the FC’s lack of discussing each step of the obviousness analysis separately.

With respect to insufficient disclosure, the FCA disagreed with PMS’s argument that assessing insufficiency should be based on the date of publication of the patent application. The FCA found that the insufficiency assessment ought to be based on the issued patent itself and that “there is no doubt that it is the issued claims that are relevant to that determination, not the claims that were pending before the Patent Office at the claim date”.

On the issue of the validity of the ‘171 Patent, the FCA held that the FC was correct in finding the ‘171 Patent to be non-obvious. Additionally, PMS argued that the FC erred in defining the “obvious to try” analysis. The FCA disagreed, and found that the FC did not misquote the legal test and properly considered other relevant factors in the “obvious to try” assessment, although did not separately identify each of them. The FCA also rejected PMS’s arguments around ambiguity and overbreadth of the ‘171 Patent.

The FCA dismissed PMS’s appeal, with costs.

Summary By: Sharan Johal