Promise Doctrine Archives

The issue of disclosure requirements with respect to sound prediction was addressed squarely by the Supreme Court in AstraZeneca Canada Inc. v. Apotex Inc., where the Court held that the so-called Promise Doctrine was not good law, in that it conflated the requirement for utility with the requirements for the specification.

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August 9, 2021

Photograph of an auto-injector needle with a drop of liquid at the tip of the needle.

August 9, 2021

Federal Court of Appeal Reaffirms Overbreadth as Grounds for Invalidity

2021 FCA 154: The FCA held that overbreadth is not an “improper re-emergence of the promise doctrine”. Overbreadth is supported by bargain theory and s. 27 of the Act.

December 4, 2018

The ONSC Dismisses Apotex’s Attempt to Revive the Promise Doctrine Under the Guise of Fraud

2018 ONSC 5199 – ONSC rejects Apotex’s attempt to recast Promise Doctrine under s. 53 fraud allegations.

December 12, 2017

Federal Court shoots down an attempted revival of the promise doctrine

2017 FC 774 - The FC granted Pfizer's order pursuant to Section 6 of the PM(NOC) Regulations, prohibiting the Minister of Health from issuing a NOC to Apotex, with respect to a Canadian patent The FC found, on a balance of probabilities, that Apotex’s allegations of obviousness, inutility, non-infringement, overpromising, anticipation and double patenting were not justified.

June 30, 2017

Canada’s Supreme Court Abolishes Controversial “Promise Doctrine”

2017 SCC 36 - The Supreme Court of Canada struck down the “promise doctrine” of Canadian patent law in favour of merely requiring a single use related to the nature of the subject-matter of the invention having a scintilla of utility.

June 27, 2017

ICSID Tribunal dismisses Eli Lilly’s NAFTA claim against Canada

Case No. UNCT/14/2 - An ICSID Tribunal dismissed Eli Lilly’s claim against Canada, which was brought in relation to two Canadian patents owned by Eli Lilly that had been invalidated for failing to provide the utility they promised.

October 3, 2016

Careful Patent Drafting Saves Novartis’s EXJADE Patent Despite Two Distinct Promises

2016 FCA 230 - The FCA found that the EXJADE patent was drafted so as to make an important distinction between the utilities of the Formula I and Formula II compounds, and thereby held the Formula II claims to a lesser promise, and dismissed Teva’s allegations of inutility.

April 5, 2016

Strike Two: Second Prohibition Application Regarding Mylan’s Proposed Tadalafil Tablets Denied

2015 FC 125 - The existing patent was invalid on the grounds of lack of utility for having made a promise of utility that could not be demonstrated nor soundly predicted, was anticipated by a previous patent of the applicant that claimed an overlapping dosage range, and was also therefore made obvious by the same previous patent.

March 28, 2016

Utility For A Pharmaceutical Patent Must Relate To How It Is Used, Not Simply to Its Properties

PAB 1384 - If a pharmaceutical patent is construed to make a promise, then that promise must relate to how the invention will ultimately be used – not simply to the properties of the pharmaceutical itself.

September 16, 2015

FC Finds Novartis Patent Promises a Mechanism of Action, not a Treatment

Novartis Pharmaceuticals Canada Inc v Teva Canada Limited, 2015 FC 770 - Novartis was able to uphold its patent against allegations of invalidity from Teva, but not without the Federal Court making a number of razor thin distinctions between what the patent promised and what it did not.

September 9, 2015

The Word “will” can Indicate a Patent Promise, not an Expectation

AstraZeneca Canada Inc v Apotex Inc, 2015 FCA 158 - The FCA acknowledged that the word “will” often refers to an expectation or goal rather than a promise, but still held that the FC did not err in finding that a promise was made when reading the patent as a whole from the eyes of a skilled reader.

March 3, 2015

Physical Stability Experiments did not Adequately Demonstrate or Soundly Predict Utility for Overbroad Eye Drop Patent

Alcon Canada Inc v Cobalt Pharmaceuticals Company, 2014 FC 149 - The Court examined in detail a number of experiments disclosed in the patent that were said to establish the claimed utility, but the experiments did not demonstrate or soundly predict utility for the broad ranges of molecular weight and chemical concentration claimed.

November 21, 2014

FCA Dismisses Apotex Appeal to have the Promise Doctrine Extended

Apotex Inc v Pfizer Canada Inc, 2014 FCA 250 - The Court rejected Apotex’s sweeping argument that any given promise in the patent must be construed as overarching to all of the patent’s claims.

July 29, 2013

FCA Upholds the Plavix Patent, Reverses Lower Court’s “Promise of Patent” and “Obvious to Try” Analyses

Sanofi-Aventis v. Apotex Inc. – 2013 FCA 186 Per Pelletier J.A. (Noel J.A. concurring): Apotex attempted to market a generic version of clopidogrel bisulfate (clopidogrel), sold […]