Apotex attempted to sell a generic version of AstraZeneca’s heartburn drug, Nexium, to which AstraZeneca responded with a patent infringement lawsuit.
Canada’s Federal Court of Appeals held that AstraZeneca’s patent for the drug was “invalid for lack of utility because, applying the promise of the patent doctrine, it promised more than it could provide”.
The dispute then went to the Supreme Court, which ruled that the promise doctrine is “not the correct method of determining whether the utility requirement under Section 2 of the Canadian Patent Act is met”.
“The promise doctrine is incongruent with both the words and the scheme of the Patent Act.”
The US Chamber of Commerce’s Global Intellectual Property Center (GIPC) welcomed the decision, with vice president of international intellectual property policy, Patrick Kilbride, describing the “restrictive approach” of the doctrine as “making it difficult to obtain or defend a life sciences patents 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,” he said. “This ruling sends an important signal that Canada is open for the business of innovation.”
According to the GIPC, since the creation of the promise doctrine in 2005, 26 patents that covered 22 innovative medicines have been overturned.
Earlier this year, Eli Lilly lost its North American Free Trade Agreement (NAFTA) dispute with Canada over the doctrine.
Eli Lilly claimed that the doctrine contravened Canada’s NAFTA obligations, but a panel said it didn’t amount to a denial of justice warranting investor-state arbitration.
At the time, Kilbride said the doctrine “dramatically undermines legal certainty for medical innovators in Canada”.