SCC Rejects Promise Doctrine In Seminal Pharmaceutical Patent Case

The Supreme Court of Canada's (the "Court" or the "SCC") recent judgment in AstraZeneca Canada Inc. v Apotex Inc., (2017 SCC 36, "AstraZeneca v Apotex") released on June 30, 2017, constitutes an important paradigm shift in Canadian patent law. As described in greater detail below, the SCC has rejected the "promise of the patent" doctrine (the "Promise Doctrine"), a doctrine which has been a unique and fundamental principle in Canadian patent law, used to determine if the subject matter claimed in a patent is useful, as required by section 2 of the Patent Act.

This decision appears to be a victory for those seeking patent protection in Canada, arguably lowering the standard to be met for utility and providing some guidance to patentees and their agents with respect to information that should and should not be included in the specification. However, it should be noted that disclosure requirements in Canada remain unchanged with respect to soundly predicting utility of claimed subject matter and clients and foreign counsel should continue to be made aware of these requirements.

The Background Facts

The patent at issue, applied for by AstraZeneca in 1994 (the "Patent"), claimed the optically pure salts of the (-) enantiomer of omeprazole, esomeprazole (the "drug"). Following their success in gaining market access for the drug through Canada's patented medicines regulatory process, Apotex began selling the generic version of the drug, leading AstraZeneca to bring an action against Apotex for patent infringement, and Apotex to bring a counter-claim against AstraZeneca to have the Patent declared invalid.

Judicial History

The key issue in question in AstraZeneca v Apotex was whether the Patent was invalid for lack of utility. Both the Federal Court and the Federal Court of Appeal relied on the Promise Doctrine in their analyses to find that the Patent held by AstraZeneca was invalid.

What is the Promise Doctrine?

Under section 2 of the Patent Act (the "Act"), an invention is defined as a "new and useful art, process, machine, manufacture or composition of matter or any new and useful improvement in any art, process, machine, manufacture or composition of matter", with usefulness being a condition precedent to patentability. The Promise Doctrine is a principle that has been developed and relied on in Canadian Federal courts over the past decade or so to determine whether an invention is "useful", and holds that "if a patentee's patent application...