11 November 2016Americas

Supreme Court of Canada reserves decision in AstraZeneca v Apotex

The Supreme Court of Canada heard oral arguments in AstraZeneca v Apotex and reserved its decision about patent utility and the ‘promise doctrine’, in a case centring on pharmaceutical company AstraZeneca’s heartburn relief drug Nexium (esomeprazole magnesium).

A reserved decision means a judge has heard a trial but they may not immediately deliver a decision. Instead, the judge will review the evidence and law, and deliver their decision at a later time.

The case centres on Canadian patent number 2139653, which has been owned by AstraZeneca since 2001. The patent covers a compound for a drug used for the treatment of gastric acid and reflux conditions.

Apotex applied to the Minister of Health to obtain a notice of compliance, which would allow it to sell a generic version of the drug.

Following Apotex’s application, AstraZeneca brought a prohibition application against Apotex to stop the drug from entering the market until the patent expired.

AstraZeneca’s prohibition application was dismissed in 2010 after Apotex received its notice of compliance and started selling a generic version of the drug.

AstraZeneca sued Apotex for patent infringement and Apotex counter-claimed that the ‘653 patent was invalid on several grounds.

In 2014, the Federal Court said that the ‘653 patent was invalid because it lacked utility.

Apotex had argued that AstraZeneca “abusively adopted new and contradictory views with respect to two issues", including the promise of the patent relevant to utility.

The court said that “the ‘653 patent, though it was novel and non-obvious, is invalid because it lacks utility.  It promised more than it could provide”.

AstraZeneca appealed against the decision.

In 2015, the Federal Court of Appeal ruled  that AstraZeneca “did not demonstrate legal error” in the Federal Court’s construction of the promise of the relevant claims of the patent.

The court dismissed the appeal with costs.

The latest Supreme Court decision comes after AstraZeneca appealed against the ruling.

According to law firm Smart & Biggar/Fetherstonhaugh, which represented AstraZeneca throughout the proceedings, the Supreme Court heard from both parties, as well as four of the seven interveners.

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