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Apotex request to re-open validity of esomeprazole patent denied

By Corey McClary & Kristin Wall
April 24, 2018
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The Federal Court dismissed Apotex’s motion to re-open the validity phase of the patent infringement action relating to esomeprazole (AstraZeneca’s NEXIUM®). Apotex had moved to re-open validity to allow the Court to adjudicate the issue of “overpromising” in light of the Supreme Court of Canada’s decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 , which related to the same patent.

As we reported, the only issue before the SCC was utility. The court allowed AstraZeneca’s appeal and struck down the Promise Doctrine as an error of law. After the SCC released its decision, Apotex brought a motion to the SCC to have the issue of “overpromising” remanded to the Federal Court and the issues of anticipation and obviousness remanded to the Federal Court of Appeal (reported here). Apotex’s motion was dismissed by the SCC without reasons.

In this decision, Justice Locke found that the validity of the patent in issue had been finally decided by the SCC, and there were no other validity issues to debate, including any question of “overpromising.” He reasoned that any confusion as to the SCC’s intent concerning the patent’s validity was resolved when Apotex’s motion to the SCC was dismissed. While the SCC decision does refer to the Patent Act treating “the mischief of overpromising in multiple ways,” Justice Locke was unwilling to infer that this meant this patent could be invalid on other grounds without the SCC having expressly said so. As we reported, he followed a similar line of reasoning in his decision to deny Apotex’s section 8 claim relating to esomeprazole.

Justice Locke also granted AstraZeneca’s motion for a declaration that Apotex infringed the patent, and directed that quantification be by way of reference. He left the decision of whether AstraZeneca was entitled to elect an accounting of Apotex’s profits to be decided in the reference.

Apotex has appealed the decision.

Link: AstraZeneca Aktiebolag et al v Apotex Inc, 2018 FC 185

 

Photo of Corey McClary Corey McClary
Read more about Corey McClaryEmail
Photo of Kristin Wall Kristin Wall
Read more about Kristin WallEmail
  • Posted in:
    Food, Drug & Agriculture, Health Care
  • Blog:
    Pharma in Brief
  • Organization:
    Norton Rose Fulbright
  • Article: View Original Source

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