Intellectual Property

When it comes to innovation in the industry, a globally competitive intellectual property environment is crucial.

To this end, we work diligently toward the following goals:

• A Patent Act that provides both protections and incentives similar to other developed nations, one enforced in the context of comparative international norms, such as patent utility.
• Balanced patented medicines regulations that are predictable and equitable for innovators.
• Data Protection Regulations that protect exclusivity to all innovative medicines.
• Patented medicines regulations that provide the Patented Medicine Prices Review Board with a clear and limited mandate, accurately reflecting industry investment in Canada.

Pharmaceutical research innovation help Canadians live longer, and healthier. It’s not all about giant leaps forward; it’s also about continuous, step-by-step research.

Patent Utility

A patent may be obtained for an invention if it is new, non-obvious and “useful” (the so-called “utility” requirement). To meet the utility requirement, an invention must be capable of industrial application, meaning that the invention can be made and/or used in any kind of industry.

Utility is not a Canadian-specific legal requirement. Rather, it is found in patent systems around the world and applies to all patented inventions, pharmaceutical or otherwise. Canadian courts have interpreted the utility requirements of the Patent Act in a way that differs from other countries and which impacts the pharmaceutical industry specifically.

In recent years, a number of patents for pharmaceutical products have been invalidated for “lack of utility,” even though they are clearly useful for treating patients with serious diseases. This has resulted in the early approval of several generic drug products in Canada. This new standard of utility is particularly problematic for pharmaceutical drug patents since most clinical trial studies on drug efficacy are conducted after the patent application is filed.

Courts are applying this new standard of utility retroactively to patents that were drafted and approved long before the change in the courts’ interpretation.

It remains unclear how much evidence is required to meet the Canadian utility standard, since the standard is determined on a case-by-case basis according to what the courts determine the patent has “promised.” This is creating confusion and uncertainty for innovators. Canada’s utility requirement denies protection to inventions that otherwise meet the patentability standards set out in NAFTA and other international treaties. Because pharmaceutical patents have been disproportionately impacted by the Canadian utility standard, this standard inappropriately discriminates against pharmaceutical patents as a field of technology. This patent utility issue is only seen in Canada, and contributes negatively to our country’s ability to attract research and development investment and, in turn, clinical trials.

Comprehensive Economic and Trade Agreement (CETA)

In the fall of 2013, the Government of Canada recognized the role that the innovative pharmaceutical industry plays in Canada’s health, social and economic well-being and took steps to improve intellectual property protection in Canada by finalising the Comprehensive Economic and Trade Agreement (CETA). This historic agreement for Canada is an essential step in strengthening Canada’s position on the international life sciences stage.

The life sciences intellectual property improvements included in CETA are:

• Patent term restoration, which will offer research-based pharmaceutical companies the potential to recover up to two years of time lost on their patent as a result of lengthy regulatory and government approval processes. Canada is the only G7 nation that does not provide any form of patent term restoration.
• The right of appeal, which will allow research-based pharmaceutical companies to more effectively appeal court decisions where a patent is ruled invalid, a process that has been available to challengers but not to patent-owners to date. Innovative Medicines Canada has maintained that regardless of the initial court decision, equal appeal rights for both parties are vital for a fair judicial system.