In this precedent setting case, the Supreme Court of Canada delivered an important and highly anticipated decision, rejecting the “promise doctrine” and upholding AstraZeneca’s NEXIUM patent (esomeprazole) as useful. The unanimous decision also served to clarify the requirement for patent “utility” in Canada representing an important victory for life science innovators seeking protection for pharmaceutical patents in Canada.
The so-called “promise doctrine” developed by the Federal Courts in recent years had become the yardstick against which utility is measured. This had become a highly contentious issue as it resulted in the invalidity of numerous pharmaceutical patents as not “useful”. The Supreme Court fully rejected the doctrine as “incongruent with both the words and the scheme of the Patent Act”.
The Supreme Court’s total rejection of the promise doctrine is clear: “The Promise Doctrine is not the correct method of determining whether the utility requirement under s. 2 of the Patent Act is met”; “it is not good law” and is “unsound”.
Update: On October 23, 2017, the SCC dismissed Apotex’s motion to amend the SCC’s judgment. Apotex had asked that the case be remanded to the Federal Court to determine if “overpromising” renders the 653 patent invalid on the basis of insufficient disclosure, overbreadth and willful misleading. The SCC also denied Apotex ‘s request that other grounds of patent validity, rejected by the trial judge be remanded for determination by the Federal Court of Appeal. Following the SCC decisions, the Federal Court determined that the validity of AstraZeneca’s NEXIUM patent had been finally determined and Apotex infringed the patent. Apotex’s concurrent claim for damages for being delayed in marketing its esomeprazole magnesium product (a generic version of AstraZeneca’s NEXIUM) was also dismissed by the Federal Court. The Federal Court found that, if hypothetically Apotex was not delayed, it would have entered the market with an infringing product, as it did in the real world. In this hypothetical world, Apotex’s liability for patent infringement fully offset its loss from being kept off the market.