On April 11, 2017, in Bristol-Myers Squibb Canada Co v Teva Canada Limited (2017 FCA 76), the Federal Court of Appeal (FCA) clarified the test for assessing obviousness subsequent to the Supreme Court of Canada’s 2008 seminal decision on this test in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 (Plavix 1).  In Plavix 1, the SCC elaborated on how to construe the “inventive concept of the claim” and adopted the “obvious to try” test, which, it noted, might be appropriate in areas, such as pharmaceutical industry, where advances are often won by experimentation.

In the lower court’s decision, the Federal Court (FC) dismissed BMS’ prohibition application relating to atazanavir (BMS’ REYATAZ) and Canadian Patent No. 2,317,736 (736 Patent) directed to atazanavir bisulfate salt. The FC found that Teva’s allegation of obviousness of the 736 Patent was justified, noting that the inventive concept “includes the salt’s anhydrous crystalline solid form and its solid-state physical stability” and that the claims were obvious, although the skilled person could not predict the anhydrous solid form or the physical stability of the claimed salt.  BMS appealed, alleging that the FC erred in its application of the “obvious to try” test, particularly given its finding that some of the properties of the claimed salt were not predictable before it was made or tested.

The FCA dismissed BMS’ appeal.  Regarding the issue of inventive concept, the FCA noted that the “inventive concept” has been referred to as “the solution taught by the patent”, “what is claimed” or “the invention” in the jurisprudence and that how the inventive concept is defined will make a finding of obviousness more or less likely. In this case, the FCA found that the FC erred in its identification of the inventive concept; particularly, it appeared to have erred by adopting an inventive concept which focused on the properties of the claimed salt.   The FCA found that the “inventive concept” was not materially different from “the solution taught by the patent”, namely, the claimed salt.  The FCA then found that had the FC correctly defined the inventive concept, it would not have been necessary to consider “obvious to try”, as there was no difference between the state of the art and the inventive concept.

The FC had also clarified that the obviousness test should be expansive and flexible and stated that there was no hard and fast rule for assessing obviousness.  It noted that the obviousness analysis essentially asks whether the distance between the state of the art and the “inventive concept” can be “bridged” by the skilled person using only the common general knowledge as of the relevant date.  Regarding “obvious to try”, the FCA cautioned that this is not required for every case and if it applies, the test does not need to “follow in the furrow of the preceding application”.

Summary By: Junyi Chen

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