Friday, June 30, 2017

Empty Promise

The Supreme Court of Canada/La Cour Suprême du Canada ("La Cour Suprême") rarely decides patent cases.  However, when it does, it really decides them.  On June 30, 2017, La Cour Suprême handed down a decision in AstraZeneca Canada v. Apotex.  At issue was the "promise of the patent" doctrine, which the Canadian Federal Court of Appeal, and the Federal Court of Canada below, have long upheld and elaborated.  To satisfy the utility requirement, the disclosure of a patent must, for each claim, either demonstrate or soundly predict utility.  But the utility analysis does not end there;  in addition, the disclosure must also fulfill any specific promise of utility by demonstrating or soundly predicting it.

In the Hinterland Who's Who of patent doctrines, the promise of the patent is something of a Canadian endemic.  In fact, its existence in Canadian patent law has been an irritant in trade relations with the United States, and might have been addressed during any renegotiation of the North American Free Trade Agreement ("NAFTA").  La Cour Suprême has now declared it extinct.  In his Federal Court decision, Judge Rennie declared the promise of the patent "the yardstick against which utility is measured".  By constrast, La Cour Suprême held that Section 2 of the Patent Act/Loi sur les brevets did not contain any such requirement. In relevant part, Section 2 defines "invention" as
any 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...
This doctrine, however, is unsound. It is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act. 
[37] The Promise Doctrine is excessively onerous in two ways: (1) it determines the standard of utility that is required of a patent by reference to the promises expressed in the patent; and (2) where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid.
ultimately, every invention pertains to a single subject-matter, and any single use of that subject-matter that is demonstrated or soundly predicted by the filing date is sufficient to make an invention useful for the purposes of [Section 2].

This judicial decision has implications well beyond the immediate parties in the case.  By relaxing the criteria for meeting the utility requirement, more inventions should be patentable.  Applicants for biopharmaceutical patents, in which demonstrating details of efficacy tends to be more challenging than in other arts, may particularly benefit from the demise of promise doctrine.

The effects of the AstraZeneca Canada v. Apotex may be especially inflammatory to the parties involved in the Eli Lilly and Company v. Canada trade dispute, which largely focused on whether or not promise of the patent doctrine was good Canadian law.  Now that the doctrine has gone up in smoke, it make spark a new fire under Eli Lilly and other patent applicants previously burned by what they view as broken promises.