The Office of the US Trade Representative (USTR) recently released the 2017 Special 301 Report. The Report identifies trade barriers to US companies and products due to the intellectual property laws, such as copyright, patents and trademarks, in other countries.
As in 2016, Canada remains on the Watch List. Specifically, the Report states that “U.S. innovators face challenges including restrictive patentability criteria, that undermine opportunities for export growth in countries such as Argentina, Canada, India, and Indonesia”, emphasis added.
The Report further states that “In addition, the United States continues to have serious concerns about the lack of clarity in, and the impact of, utility requirements for patents imposed by Canadian courts. In these cases, courts have invalidated valuable patents held by U.S. pharmaceutical companies on utility grounds by interpreting the “promise” of the patent and finding that insufficient information has been provided in the application to substantiate that promise. These decisions, which have affected products that have been in the market and benefiting patients for years, have led to uncertainty for patent holders and applicants, including with respect to how to effectively meet this standard. This unpredictability also undermines incentives for investments in the pharmaceutical sector. The United States understands that the Supreme Court of Canada has the opportunity to clarify this doctrine in the near future. The United States urges Canada to engage meaningfully with affected stakeholders and the United States on patent utility issues”, emphasis added.
The Supreme Court of Canada’s (SSC) case AstraZeneca Canada Inc., et al. v. Apotext Inc. et al. (esomeprazole) is likely the “opportunity” the Report is referring to. Already a closely monitored case in the IP community in Canada, the significance of the SCC’s ruling appears to have been ratcheted up another level as Canada’s trade with the Trump administration may well be affected by the SCC’s decision.