July 19, 2017

Pangaea Express - The End of the Promise Doctrine

by Marla Weingarten, Consultant

On June 30, 2017, the Promise Doctrine was struck down by the Supreme Court of Canada. For years, Innovative Pharma companies have been challenging the “excessively onerous” nature of this doctrine in proving the utility of the drug to uphold patent protection.

In this most recent case, The Supreme Court ruled in favour of AstraZeneca in their appeal against Apotex regarding the patent of Nexium. The original trial judge had previously ruled the patent to be invalid for lack of utility as AstraZeneca had not demonstrated or soundly predicted the promise of the drug when the patent was filed. AstraZeneca had appealed this decision but the Federal Court of Appeal dismissed the plea. AstraZeneca then appealed to the Supreme Court arguing that the Promise Doctrine is unsound.

Even though Eli Lilly had recently challenged this doctrine under NAFTA and lost their case, this Court’s decision will now remove one potential stumbling block in the upcoming NAFTA negotiations.

The U.S. Chamber of Commerce’s Global Intellectual Property Center (GIPC) released the following statement: “The Doctrine’s extremely restrictive approach has created harmful instability and uncertainty for medical innovators by making it difficult to obtain or defend a life science patent in Canada. Today, the Supreme Court has begun to restore much-needed clarity and confidence that biopharmaceutical innovators will be afforded equal protections under the law. This ruling sends an important signal that Canada is open for the business of innovation."

For more information, please contact Marla Weingarten, Consultant, The Pangaea Group

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