A recent Federal Court of Appeal (FCA) decision, Bristol-Myers Squibb Canada Co. v Teva Canada Limited, has provided welcome clarification of the FCA’s understanding of the “inventive concept” of the claims and the “claims as construed”. The decision related to the validity of a patent claim directed to a specific crystalline form of a pharmaceutically acceptable salt having increased bioavailability over the free base and increased solid-state stability
The meaning of the “inventive concept” of a claim and of the “claim as construed”, and how to determine their subject matter, has been an issue of much contention and many opinions in Canada. This issue especially gained relevance when the Supreme Court of Canada stated in 2008 that in a case of a chemical formula ─ where the inventive concept of the claims is not readily discernible from the claims themselves it must be acceptable to read the specification in the patent to determine the inventive concept of the claims.
For example, the validity of Sanofi-Aventis’ Plavix patent CA1336777 had been repeatedly considered by Canadian courts in the past with, in part, different results. In 2013 the Federal Court of Appeal reaffirmed the validity of the Plavix Patent in line with the above mentioned 2008 Supreme Court of Canada decision after the patent was found invalid by a 2011 Federal Court decision for failure to meet a promise identified by the court in the patent’s description. However, the 2013 FCA decision also affirmed – inconsistent with the 2008 Supreme Court of Canada decision – the presence of the “Promise of a Patent” doctrine in Canada.
Now, in 2017 the FCA referred to the 2008 Supreme Court decision as Plavix 1 and the 2013 Federal Court of Appeal decision as Plavix 2 and held that “inventive concept” is typically synonymous with “the solution taught by the patent” which is often synonymous with “what is claimed in the patent” or “the invention”. Further, the Court held that one should be wary of seeing things in Plavix 2 that have no foundation in Plavix 1 and that the governing authority remains Plavix 1, the 2008 Supreme Court of Canada decision. In other words, the FCA now indicates without making any use of the word “promise” that the “Promise of a Patent” doctrine is not the solution and has no place in Canada.
The approach expressed by the FCA is entirely consistent with the Supreme Court of Canada decision of June 30 2017 which concludes that the Promise Doctrine is not the correct method of determining whether the utility requirement under section 2 of the Patent Act is met.