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
For pharmaceuticals, the TPP contains provisions on four areas
that the Department of Foreign Affairs explains as
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 the Comprehensive Economic Trade
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
Canada has indicated that its existing linkage regime is TPP
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
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
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
3. This overview of outcomes is based on the Technical
Summary of Negotiated Outcomes: Intellectual Property Chapter and
Opening markets for industrial goods and consumer products
documents published on the Department of Foreign Affairs website on
Oct. 1 and 5 and cited herein.
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