Changes may be on the horizon for Canada’s legal and regulatory regime for patents and pharmaceuticals. Included in the Trans-Pacific Partnership Agreement (TPP), concluded Oct. 5, 2015 are negotiated outcomes for the protection and enforcement of intellectual property (IP) rights that may change the legal and regulatory landscape for the pharmaceutical industry.
The text of the TPP agreement has not yet been released, however, the Department of Foreign Affairs recently published two documents of interest to pharmaceutical industry stakeholders: (1) a technical summary of the IP outcomes chapter of the TPP1, and (2) the anticipated benefits for Canada’s life sciences industry2.
Below is a brief overview of the TPP outcomes3 and the implications they raise for the pharmaceutical industry.
Canada has stated that, under the TPP, pharmaceutical industry stakeholders can expect that consistent rules will apply across the entire TPP market, owing to “a strong regional standard” for protection and enforcement of IP rights that includes patent and pharmaceutical IP4.
Under the TPP, patent protection will be ensured for inventions in all fields of technology. However whether the patentability criteria for pharmaceuticals will change is unknown as, according to the Government, Canada’s current regime of patentability and exclusion are in line with the TPP5.
Pharmaceutical IP Protection
Patent Term Restoration: Canada has stated that the TPP will give it the flexibility to implement patent term restoration using a sui generis mechanism and to retain a two year cap on additional patent protection to be accorded where regulatory approval is delayed. According to Canada, this is consistent with the outcomes negotiated under theComprehensive Economic Trade Agreement (CETA).
Early Working Exception: The exception that allows market entry of generic pharmaceuticals soon after patent expiration will remain available under the TPP regulatory review exception. While this exception is said to reflect Canada’s existing regime, no details are yet available as to any changes that can be expected.
Patent Linkage: Canada has indicated that its existing linkage regime is TPP compliant.
Clinical Trial Data: Canada has indicated that the protections for clinical trial data reflect Canada’s existing regimes, systems, and laws.
Pharmaceutical industry stakeholders may benefit from greater certainty regarding the enforceability of their IP rights under the TPP. The IP enforcement measures include comprehensive remedies and civil procedures that will enable right holders to seek redress where their rights have been violated across the TPP region.8
Issues for Pharmaceutical Industry Stakeholders
The TPP appears to mirror the changes negotiated in CETA under which pharmaceutical patent holders may benefit from the introduction of the patent term restoration provision.9
However, the Canadian government has not yet disclosed how it will address any TPP provisions on other topics, including additional data protection for biologics and whether additional changes are expected to the early working exception framework beyond what was negotiated in CETA.10
The TPP does not yet have the force of law. Before coming into force, the agreement will have to be ratified by each country. In Canada, it is expected that the TPP agreement will be tabled during the next session of Parliament.11