Canada’s Supreme Court rejects ‘promise doctrine’

The Supreme Court of Canada has handed down a  ruling rejecting the ‘promise doctrine’.

In its decision in AstraZeneca Canada v Apotex on Friday, June 30, it upheld the validity of a patent owned by AstraZeneca.

The promise doctrine requires the demonstration or evidence of a patent’s utility—if the utility falls short of fulfilling the ‘promise’ contained in the patent, it will be invalidated, even if it is useful for purposes other than those promised.

But the Supreme Court said in its decision that the promise doctrine is not the correct method of determining whether the utility requirement under the Patent Act is met.

The case arose when AstraZeneca applied for the 2,130,653 patent, which claimed esomeprazole in Nexium, used to treat symptoms of gastroesophageal reflux disease.

Apotex then applied to the federal minister of health for a Notice of Compliance to sell a generic version.

Following this, AstraZeneca filed an application to prohibit the minister from issuing a Notice of Compliance to Apotex, but it was dismissed. This resulted with Apotex being granted permission to bring its generic drug to the market.

AstraZeneca then sued Apotex for patent infringement, which Apotex counterclaimed by questioning the validity of the ‘653 patent.

The Federal Court held that the ‘653 patent was invalid for lack of utility because, applying the doctrine, it promised more than it could provide. The Federal Court of Appeal upheld this decision.

AstraZeneca appealed, arguing that its patent was improperly invalidated on the basis of the doctrine.

The Supreme Court said the promise doctrine is “not good law” and is “unsound”.

Patrick Kilbride, vice president of international intellectual property policy of the US Chamber of Commerce, said in a  statement: “We welcome today’s ruling that upholds AstraZeneca’s patent rights and rebuffs Canada’s so-called ‘promise doctrine’.”

He added: “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.”

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