Canadian patent law is damaged and that will plague us again

Canadian taxpayers will be grateful that a friendly NAFTA tribunal has recently saved them a $ 500 million cut plus costs. The court’s decision would have attracted much more attention if Canada had lost. As it is, the government can continue to ignore the problems created by some Canadian law called the “doctrine of promise”.

Strattera from $0.99

In patent law, each patent must be “useful” to be issued, if only for a “mere scandalous” utility. A drug patent, for example, should be said to effectively treat some condition, or improve such treatment. But the doctrine of promise takes this much further. If a patent is challenged, the court will read it for “promises” of utility – useful inferences that may be very broad, perhaps, for example, for a greater therapeutic effect. If it is shown that the patent has not fulfilled this extended promise, it is invalid.

Drug maker Eli Lilly had sued Canada over the invalidation of two drug patents, Strattera and Zyprexa, commonly used to treat ADHD and mental illness. Lost. Few Canadians will cry for Big Pharma to deny a payment from their government, but here is what should worry them.

Since the “Promise Doctrine” was introduced in 2005, almost 30 Canadian drug patents have been invalidated. The doctrine of promise has helped Canada to be a bit of a rogue state in the intellectual property community. The Special Report of the Office of the United States Trade Representative of 2016 has Canada on its watch list. The doctrine of promise ranks high among his concerns. This doctrine has undermined billions of dollars in drug sales from the Canadian market.

Eli Lilly patented Strattera in 81 jurisdictions. In Canada alone, the patent was invalidated for lack of “utility”. Most people would find this strange given that enough people find the drug handy that global sales are around US $ 700 million.

In its ruling, the NAFTA court ruled that the promise doctrine did not amount to a large enough or sudden change in Canadian patent law to qualify Eli Lilly for compensation under NAFTA’s investment protection provisions. The court did not even go as far as Eli Lilly’s claim that the promise doctrine offends Canada’s intellectual property obligations under the NAFTA.

The doctrine of promise is a law made by the judge, but even in a common law jurisdiction like ours, the court reasoned, the courts are clearly an arm of the government and their decisions could be open for review. Intellectual property law is the most international of laws; Canadian laws must be consistent with approaches in other countries.

The doctrine of promise will surely emerge in the NAFTA renegotiations that President Donald Trump plans. We’d better have an answer, and the only reasonable one is the end of their excesses. In addition, as Canada seeks to promote an innovation agenda, nothing is more important than strong and clear intellectual property rights.

How to break the doctrine of promise? Perhaps clarifying the Patent Law by amending the legislation. There is no doubt that this would create more interpretive difficulties, but it would solve the current problem.

Alternatively, the case of AstraZeneca v. Apotex will soon be decided by the Supreme Court of Canada. This case provides the court with the opportunity to clarify the doctrine of the promise, and must seize the opportunity. The Supreme Court can correct the errors that the courts, including themselves, have made.

The doctrine of promise seems to have arisen from the doctrine of “sound prediction.” A strong prediction provides a secondary basis for patent holders to meet the requirement for inventions to be useful. The acoustic prediction helps when the utility has not yet been fully demonstrated in fact (for example, “we believe this could cure eruptions”).

How to break the doctrine of promise? Perhaps clarifying the Patent Law by amending the legislation. There is no doubt that this would create more interpretive difficulties, but it would solve the current problem.

Alternatively, the case of AstraZeneca v. Apotex will soon be decided by the Supreme Court of Canada. This case provides the court with the opportunity to clarify the doctrine of the promise, and must seize the opportunity. The Supreme Court can correct the errors that the courts, including themselves, have made.

The doctrine of promise seems to have arisen from the doctrine of “sound prediction.” A strong prediction provides a secondary basis for patent holders to meet the requirement for inventions to be useful. The acoustic prediction helps when the utility has not yet been fully demonstrated in fact (for example, “we believe this could cure eruptions”).

From this sensitive beginning the doctrine of promise arose from reasonable limits. First, it led to the courts seeking patent promises in patents that should not have been conceived as sound prediction; In fact, to potentially base them on any statement in the disclosure of the patent (“it could cure rashes including poison ivy, heat rash and contact dermatitis”). Secondly, it led to the invalidation of patents in which the scope of the promise described had not been fully realized (“Wow, it turns out that poison ivy does not cure”). However, in this example, the patent still meets utility requirements (because it cures rashes other than poison ivy).

The doctrine of promise is very far from the “mere trough” of utility that Canada nominally requires, and other countries actually require it. A permissive doctrine has become his head to invalidate patents instead.

The doctrine of promise has corrupted the Canadian patent law and has irritated international relations. By legislation or judicial intervention, it is time to excise and return to a more sensible understanding of utility.