“Promises are not the yardstick against which utility is to be measured”

On June 30, 2017 the Supreme Court of Canada (“SCC”) released its highly anticipated decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 which resolves the long debated status of the promise of the patent doctrine (“Promise Doctrine”) in Canada.

AstraZeneca developed and patented an optically pure salt of esomeprazole, a proton pump inhibitor used in the reduction of gastric acid, reflex esophagitis and related maladies and sold it under the brand name NEXIUM. Apotex made and sold a generic version of NEXIUM and was sued by AstraZeneca for infringement of their patent 2,139,653 (“the ‘653 patent”). Apotex counter claimed to have the patent impeached.

The Federal Court found the ‘653 patent was novel and non-obvious and that there was sufficient evidence to soundly predict it would act as a proton pump inhibitor (“PPI”) to reduce acid in the stomach. However, the Federal Court also found that it did not demonstrate or soundly predict a second “promise” made in the description. Therefore, the ‘653 patent was found invalid by the Federal Court for lacking utility under Section 2 of the Patent Act (“Act”) on the basis of the Promise Doctrine.

The Federal Court of Appeal upheld the Federal Courts finding, and the decision was appealed to the SCC.

The SCC has found that the Promise Doctrine is unsound and that it is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Act.

The Court states that any single use that is related to the nature of the subject-matter and demonstrated or soundly predicted by the filing date meets the Section 2 requirement that the subject-matter of a patent be useful.

While only a scintilla of utility is required, a patentee seeking a patent for a machine cannot successfully claim its usefulness comes from acting as a paperweight. The purpose of the utility requirement is “to prevent patenting of fanciful, speculative or inoperable inventions”.

Therefore, the correct approach to determine whether there is sufficient utility under Section 2 is to 1) identify the subject-matter of the invention as claimed in the patent, and 2) determine if the subject-matter is capable of a practical purpose.

As the Federal Court found that the ‘653 patent soundly predicted that NEXIUM would be useful as a PPI to reduce the production of gastric acid, it met the requirements of Section 2.

One note of caution, however, is that the SCC agrees that overpromising is a mischief, but one that is more appropriately dealt with under either Section 27(3) or 53 of the Act.

This post is intended to provide general information concerning developments in the law and is not intended to provide legal advice in respect of any particular situation.