On September 26, 2014, Prime Minister Harper announced that Canada and the European Union
have successfully concluded negotiations on a new trade agreement,
the Comprehensive Economic and Trade Agreement (CETA) that was five
years in the making, and publicly released the consolidated text of the agreement.
CETA is deeper in substance and broader in scope than any other
such agreement in Canadian history, significantly affecting all
economic areas, including the pharmaceutical sector.
additional (sui generis) patent protection for
pharmaceutical products; and
effective rights of appeal for Patented Medicines (Notice of
Compliance) (PM(NOC)) litigants
Article 9.2: Sui Generis Protection for
The sui generis protection for pharmaceuticals provided
for by CETA will allow patent holders to extend patent monopolies
(currently 20 years in Canada) on eligible patents in respect of
products that are subject to regulatory "delay" when
achieving market entry. CETA limits this extra protection to a
period of two to five years, calculated as follows:
Period = Authorization date to market product – Filing
date of patent application – 5 years
Notably, CETA provides discretion to each member nation to
provide further extension to incentivize or reward research in
certain target populations, such as pediatrics.
It appears that Canada intends to cap the sui generis
protection period at two years, allow Canadian-made generic
medicines to be exported during the period of additional protection
and provide extra protection only to pharmaceuticals that are
approved after CETA takes effect in Canada (i.e., there will be no
Article 9 bis: Patent Linkage/Right of Appeal
Another key provision under CETA is the recognition that
litigants under the PM(NOC) Regulations will be
"afforded equivalent and effective rights of appeal." The
current regime handicaps innovators' rights because once a
generic is successful at the trial level, the Minister of Health
immediately issues a notice of compliance to the generic
manufacturer, thereby rendering any appeal moot. A newly
established innovator right of appeal should ensure an
innovator's legal rights are fairly and completely adjudicated
before generic entry into the marketplace is granted. In addition,
there is some speculation that the government is contemplating a
mechanism to limit or eliminate subsequent patent infringement
actions brought by innovators that are unsuccessful in PM(NOC)
In order for CETA to become enforceable in Canada, it must be
ratified and implemented through the passing of specific
implementing legislation to amend Canada's existing laws (e.g.
the Patent Act and the Food and Drug
Regulations). This implementing legislation will specify the
precise terms of sui generis protection and the mechanism
for providing effective rights of appeal to PM(NOC) litigants.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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