• AstraZeneca Canada Inc., AstraZeneca Aktiebolag, AstraZeneca UK Limited v. Apotex Inc., Apotex Pharmachem Inc. (Federal Court of Appeal) (Civil) (By leave) (36654)
  • October 28, 2016 | Authors: Jillian Brenner; Adrian J. Howard; Beverley Moore; Chantal Saunders
  • Law Firm: Borden Ladner Gervais LLP - Ottawa Office
  • On November 8, the Supreme Court is scheduled to hear AstraZeneca's appeal in its application which asks the correct applicable standard for patent utility in Canada and whether a promised utility doctrine properly exists. The following summary was provided by the Supreme Court.

    Intellectual property - Patents - Medicines - Utility - Validity of patent for drug used in treatment of gastric acid conditions challenged in infringement and impeachment action - Whether a promised utility doctrine properly exists - Whether lower courts erred in law in finding that the 653 patent invalid: (i) on the basis of a "promise of the patent" utility doctrine; and/or (ii) by applying an incorrect standard for patent utility.

    The appellants, (collectively, "AstraZeneca") owned the Canadian '653 patent for the compound, esomeprazole, a proton pump inhibitor used in the reduction of gastric acid, reflux esophagitis and related conditions. It was sold under the name Nexium, and was a very successful drug for AstraZeneca. The respondents (collectively, "Apotex") applied to the Minister of Health to obtain a Notice of Compliance which would allow it to sell its generic version of the drug. In response, AstraZeneca brought a prohibition application under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 to prevent Apotex from entering the market until after the expiry of the '653 patent. In 2010, that application was dismissed and Apotex received its Notice of Compliance and commenced sales of its generic esomeprazole. AstraZeneca brought an action against Apotex for patent infringement. Apotex counter-claimed to impeach the '653 patent on several grounds.