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Rejection of doctrine may encourage exaggerated claims

Focus on: Intellectual Property Law
|Written By Michael McKiernan
Rejection of doctrine may encourage exaggerated claims
Patrick Kierans says it can take years for a full appreciation of a particular drug’s usefulness in human subjects to emerge.

The Supreme Court of Canada’s rejection of the promise doctrine incentivizes patent applicants to exaggerate claims about their invention’s capabilities, according to an intellectual property professor. 

Jeremy de Beer, a professor at the University of Ottawa’s faculty of law, appeared before the nation’s top court in the case of AstraZeneca Canada Inc. v. Apotex Inc., which ended with a 9-0 judgment dismissing the controversial doctrine as “unsound.”

“This decision is going to make it easier for applicants to apply for patents on speculative inventions, because there’s an incentive now to use more hyperbole and exaggeration when disclosing an invention,” says de Beer, who acted on behalf of the Centre for Intellectual Property Policy.

Of the seven groups granted leave to intervene before the Supreme Court, only the CIPP and the Canadian Generic Pharmaceutical Association argued in favour of maintaining the promise doctrine.

Rather than emerging via laws passed in Parliament, the doctrine was recognized in a series of Federal Court judgments, and it involved viewing patent applications as a whole to identify whether they “promised” certain utilities. Failing to deliver on those promises could then result in the patent being declared invalid for failing to meet the utility requirement found in s. 2 of the federal Patent Act.   

But in his June 30 decision on behalf of the court, Supreme Court Justice Malcolm Rowe wrote that this interpretation of utility was at odds with “both the words and the scheme” of the act.

“The Promise Doctrine is excessively onerous in two ways: (1) it determines the standard of utility that is required of a patent by reference to the promises expressed in the patent; and (2) where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid,” Rowe added.

Patent examiners will have a harder job as a result of the decision, says de Beer.

“The more exaggeration and hyperbole we see, the more difficult it will be for them to figure out what exactly is being claimed, and what is mere puffery,” he says. “There were some problems with the doctrine for pharmaceutical companies, but in the longer term, it forced them to be forthright, honest and accurate.

“Without being held to the accuracy of their disclosure, it makes it possible for applicants to take a more shotgun approach. If it turns out they were wrong, it’s no longer such a big deal,” de Beer adds. 

Patrick Kierans, global co-head of the life sciences and health-care practice group at Norton Rose Canada LLP, also appeared before the Supreme Court, acting for intervenors Innovative Medicines Canada and BIOTECanada. He says he got the sense during oral arguments that the judges of the court wanted to take some sort of action on the promise doctrine.

“We’re very happy that it’s gone,” says Kierans, a senior partner in the firm’s Toronto office. “The industry is happy, and the holders of patents are happy, particularly in the pharmaceutical industry, because it had more impact there than anywhere else.”

A number of patent applicants in the pharmaceutical field have fallen foul of the promise doctrine in recent years, and Canada’s “heightened utility requirements” were cited by the United States Trade Representative when it decided to place the country on its IP Watch List back in 2013.

Canada’s unique stance on utility also attracted action from Eli Lilly under the North American Free Trade Agreement, with the drugmaker complaining about the rejection of one of its patents for a formulation that was recognized in other jurisdictions.  

Jean-Charles Grégoire, a lawyer with the Ottawa office of international intellectual property firm Marks & Clerk, says the Supreme Court’s decision is particularly timely, coinciding as it does with the renegotiation of NAFTA following the election of Donald Trump as U.S. president. 

“It helps Canada align with its obligations under the agreement,” Grégoire says. “It’s also a great help for patentees, because it rejects a doctrine that was severe and unworkable.”

Kierans sees the roots of the promise doctrine in the Supreme Court’s landmark 2002 judgment in Apotex Inc. v. Wellcome Foundation, which involved a challenge to the validity of an AIDS-fighting drug. 

While Canadian courts traditionally required inventions to demonstrate just a “scintilla of utility” in order to be patentable, Kierans says the top court departed from that principle and from the approach of most industrialized nations by holding that patentees must demonstrate or predict the utility of their invention at the time of filing. 

He says the higher standard is particularly unrealistic for pharmaceutical companies, where it can take years for a full appreciation of a particular drug’s usefulness in human subjects to emerge.  

In the most recent Supreme Court case, the patent application concerned a drug developed by AstraZeneca to help patients with gastric acid problems. Following a challenge to is validity by generic manufacturer Apotex, a trial judge at the Federal Court ruled that AstraZeneca’s invention had fulfilled its promise as a proton pump inhibitor that reduces acid in the stomach.

However, the judge went on to find that the patent was still invalid under the promise doctrine because it had failed to deliver on a second promise to provide less variation in patient response thanks to its improved metabolic properties.

The Federal Court of Appeal upheld that decision, but it was overruled by the Supreme Court, which found that the promise doctrine is not the right approach for determining “whether a patent has sufficient utility.”

“The Promise Doctrine risks, as was the case here, for an otherwise useful invention to be deprived of patent protection because not every promised use was sufficiently demonstrated or soundly predicted by the filing date,” wrote Rowe in his decision for the unanimous court.

Describing overpromising as a “mischief,” Rowe said interpretation of the utility requirement was not the way to deal with it, pointing to other sections of the act where patents can be invalidated for wilfully misleading claims or inadequate disclosure. 

The judge then went on to lay out the proper way to determine a patent’s utility: The first step is to identify the subject matter of the invention claimed by the patent. Secondly, the judge should ask whether the subject matter is capable of a practical purpose. 

“The Actdoes not prescribe the degree or quantum of usefulness required, or that every potential use be realized — a scintilla of utility will do. A single use related to the nature of the subject-matter is sufficient, and the utility must be established by either demonstration or sound prediction as of the filing date,” Rowe added.

But de Beer says if Canada’s approach to utility was regarded by its trading partners as too strict when the promise doctrine applied, then the pendulum has swung too far the other way with this decision. 

“It’s very difficult to imagine any invention being found to lack utility the way the court has described it. For all intents and purposes, it means that there is no meaningful or effective utility criteria in Canada; anything will do,” he says.

“In the U.S., you need to have a specific, substantial and credible utility. In the context of NAFTA, we’re in a situation now where it may actually be Canada who has to raise its utility standard to put ourselves back in line with the U.S.”         

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