European Trade Agreement

Canada and the EU have signed a trade agreement, CETA, which has several IP related provisions. Based on the government’s summary and media reports, these include geographic indicators, patent term extensions of up to two years and changes to the PM(NOC) Regulations.

At this time, the text of the agreement does not seem to be released so any analysis or summary is based on the government’s summary documents (available from ActionPlan.gc.ca – PDF). Please let me know of any further changes or of any errors.

Patents – There is significant controversy surrounding changes to the patent regime for pharmaceuticals, and particularly the costs to the health care system. The government’s summary states (at page 34):

With respect to the pharmaceutical sector, CETA will provide extended protection for innovators while ensuring that Canadians continue to have access to the affordable drugs they need. CETA reinforces the Government of Canada’s commitment to attracting and retaining investments that support high-paying jobs in Canada as well as rewarding innovators and ensuring that Canadians are able to reap the fruits of such innovation.

As noted by Michael Geist, the Patented Medicine Prices Review Board issued its annual report yesterday which includes a lengthy analysis of drug prices, R&D expenditures and trends.

Media reports say that the agreement provides for patent term adjustments of up to two years – “CETA will grant an additional two years of patent protection on brand-name drugs that face lengthy reviews.” (Financial Post). The CBC says in its report that “The government is also talking to the provinces and territories about compensation if the provision to extend drug patents by two years increases their costs.”

There are also reports that CETA will require changes to the Patented Medicine (Notice of Compliance) Regulations relating to the “right of appeal”. The Canadian Generic Pharmaceutical Association issued a statement today stating:

CGPA has received written assurances from the Government of Canada that its implementation of the “Right of Appeal” treaty commitment will also address excessive and duplicative litigation by ending the practice of dual litigation. (CGPA – h/t Just Biotech)

Canada’s Research-Based Pharmaceutical Companies (Rx&D) also issued a statement today regarding CETA, which indicated that:

The Right of Appeal 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.”

Geographic Indicators – In addition to the existing geographic indicators for wine and spirits, “CETA will include a wider recognition of EU geographical indications for foodstuffs, such as certain meats and cheeses (e.g., Chabichou du Poitou), that builds upon Canada’s existing regime for geographical indications.” (at page 34)

Copyright and Counterfeits – The government’s summary also mentions copyright and combating counterfeit goods. The summary suggests that the Copyright Modernization Act enacted in 2012 is already consistent with CETA. No specific changes are mentioned with regards to counterfeit goods but Bill C-56, the Combating Counterfeit Products Act, with changes to the Trade-marks Act and the Copyright Act, will likely be re-introduced into parliament.