Innovator Industries Claim Win In Canadian High Court Patent Ruling

The Canadian Supreme Court today upheld a pharmaceutical industry appeal against a tool used in certain cases to overturn patents on products that could be seen as not meriting a patent monopoly. The ruling could effectively block a generic version of a patented drug from being on the market.

In the case, AstraZeneca Canada Inc. v. Apotex Inc., the Court ruled in favor of  innovative drug company AstraZeneca and rejected use of Canada’s controversial “Promise Doctrine” policy to overturn patents, according to the United States Chamber of Commerce Global Intellectual Property Center (GIPC).

According to reports, for instance here, this removes the Promise Doctrine clause as a sticking point in the North American Free Trade Agreement (NAFTA), which is coming under renegotiation.

The ruling states in part:

“AstraZeneca applied for the 2,139,653 patent (“the ‘653 patent”) which claimed the optically pure salts of esomeprazole, a proton pump inhibitor used in the reduction of gastric acid, reflux esophagitis and related maladies. Apotex applied to the federal Minister of Health for a Notice of Compliance, allowing it to sell its generic version of the drug. AstraZeneca’s application to prohibit the Minister from issuing a Notice of Compliance to Apotex was dismissed, allowing Apotex to bring its generic drug to the market. AstraZeneca brought an action against Apotex for patent infringement, and Apotex counter‑claimed to have the ‘653 patent impeached. The Federal Court held that the ‘653 patent was invalid for lack of utility because, applying the promise of the patent doctrine (“Promise Doctrine”), it promised more than it could provide. The Federal Court of Appeal upheld this decision. AstraZeneca appeals, arguing its patent was improperly invalidated on the basis of the Promise Doctrine.

Held: The appeal should be allowed.

The Promise Doctrine is not the correct method of determining whether the utility requirement under s. 2  of the Patent Act  is met.”

“The Promise Doctrine is incongruent with both the words and the scheme of the Patent Act,” the Justices said, going into some detail. “Such a consequence is antagonistic to the bargain on which patent law is based wherein we ask inventors to give fulsome disclosure in exchange for a limited monopoly.”

Corporations that invest heavily in research and development and rely on the patent system for protection of their products hailed the decision.

“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,” Patrick Kilbride, vice president for international IP policy at the Chamber, said in a statement. 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.

Stephen J. Ezell, vice president for global innovation policy at the Information Technology and Innovation Foundation (ITIF), called it a victory for Canada’s innovators, saying in a statement:

“Since 2005, Canadian courts have applied an impractical evidentiary burden not used anywhere else in the world, the so-called Promise Doctrine, which effectively required pharmaceutical innovators to predict at the date of filing—in many cases before research and development (R&D) and clinical trials had even been completed—specifically how useful a patented drug would be in the future. Under the Promise Doctrine, if any one of the initial claims (i.e., “promises”) in the patent application went unrealized, patent applications could be revoked in their entirety. Canada’s discriminatory application of the Promise Doctrine has led to 29 court decisions which invalidated 26 patents on 22 medicines over the past decade, leading pharmaceutical companies to suffer well over $1.1 billion in lost sales.”

 

Image Credits: Supreme Court of Canada