Shire's Vyvanse Patent Valid And Infringed – Federal Court Raises Key Patent Law Issues

Introduction

In Apotex Inc. v. Shire LLC, 2018 FC 637 ("Vyvanse"), Justice Fothergill of the Federal Court dismissed Apotex's action to impeach Shire's patent covering its drug Vyvanse. Vyvanse contains the active ingredient lisdexamfetamine, a prodrug of the central nervous system stimulant dextroamphetamine, used to tread attention deficit hyperactivity disorder. When Vyvanse is administered to a patient, the prodrug, which is inactive, converts over an extended period of time to dextroamphetamine, the active form of the drug. Peak levels in the body are substantially reduced. Because of this, Vyvanse is less prone to abuse (for instance by crushing and snorting, or dissolving and injecting) and oral overdose compared to other stimulant drugs. Shire's patent claimed the prodrug itself, compositions containing the prodrug, as well as uses for the prodrug.

Apotex additionally sent Shire a notice of allegation ("NOA") under the former Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations"). In response, Shire commenced an application to prohibit the Minister of Health from granting Apotex a notice of compliance ("NOC"). The parties generally agreed that the result of the impeachment action should govern the prohibition application. Since Apotex's impeachment action was dismissed, the prohibition application was granted, and the Minister of Health was prohibited from issuing Apotex a NOC.

In response to Apotex's action to impeach, Shire commenced a counterclaim for infringement, which was dismissed. The court held that all of Apotex's copycat version of Vyvanse had been manufactured for regulatory and experimental uses, which are exempted from infringement under subsections 55.2(1) and (6) of the Patent Act.

This blog summarizes a few interesting portions of the Federal Court's decision.

Effect of Foreign Judgments in Canadian Litigation

Shire argued decisions from the US and Europe upholding the validity of Shire's patents should be considered instructive.1 The Court rejected Shire's argument, holding that it was to "decide the legal issues raised...in accordance with the factual record and Canada's own laws."2

This holding is consistent with a number of cases from the Federal Court including a recent decision by Justice Phelan, SNF Inc. v. Ciba Specialty Chemicals Water Treatments Limited, 2015 FC 997 ("SNF FC"), who faced an argument that an Australian decision upholding a patent should be influential. Justice Phelan held that, "[a]s persuasive as judgments from the Australian Federal Court may be, the decision here turns on the facts and law applicable here."3 It now seems clear that the Federal Court will not consider foreign decisions on the validity or infringement of corresponding foreign patents.4

Selection Patent Criteria and Invalidity

Shire and Apotex also disputed whether the patent at issue was a selection patent. The court cited the Supreme Court's...