Canada and the European Union (EU) officially signed the Comprehensive Economic and Trade Agreement
(CETA) on October 30, 2016. The following day, Parliament
introduced the first reading of Bill C-30, An Act to implement the
Comprehensive Economic and Trade Agreement between Canada and the
European Union and its Member States and to provide for certain
other measures. CETA's principal goal is to reduce the barriers
of Canada-EU trade; it addresses tariffs, product standards,
professional certification, government procurement and
In order to implement CETA, Canada is required to make changes
to several federal acts, including the Patent Act and
Bill C-30 modifies the definition of geographical indications
(GIs) in the Trade-marks Act. It enables GI protection for
not only wine and spirits, but also agricultural and food products,
such as certain cheeses, oils and meats (e.g. feta). The Registrar
will be responsible for supervising a list of protected GIs, and
will restrict use of certain European GIs to products originating
from the European regions that the GIs are typically associated
with. Consequently, Bill C-30 allows for a GI opposition procedure
for those interested in objecting to the protection of particular
geographical indications. Any person interested may file a
statement of objection within two months after the Minister makes a
statement in respect of a GI published on the CIPO website and the
Registrar enters same on the list.
Furthermore, there will be import/export restrictions for
geographical indications: wines, spirits agricultural and food
products will be banned if they bear the GI and either 1) do not
originate in the territory indicated, or 2) do not conform to the
laws of the territory indicated. Bill C-30 offers owners of
protected GIs the option to file a Request for Assistance with the
Canadian Border Services Agency to help prevent the import of
counterfeit goods through the Intellectual Property Rights
CETA will affect the term of pharmaceutical patent protection,
as well as patent procedural rights. Pharmaceutical companies often
face delays with patents in getting regulatory approval, which lead
to lost patent protection due to the protracted development and
approval process. The Patent Act does not currently
moderate the lost patent protection due to delays; however Bill
C-30 will offer a certificate of supplementary protection. This
certificate provides patent term restoration for a maximum of two
In addition, CETA will provide an innovator right of appeal
under the Patented Medicines (Notice of Compliance)
Regulations (NOC Regulations). The NOC
Regulations link patent protection and regulatory approval for
pharmaceutical products. Linkage proceedings provide innovators
with an avenue to prevent generic drug manufacturers from obtaining
regulatory approval if same would result in patent infringement.
Since CETA requires the effective right of appeal to linkage
proceedings, the NOC Regulations will require
modification, which will be enabled by Bill C-30's amendments
broadening the governor in council's regulation-making
An overhaul to the NOC Regulations proceedings would be
possible with the expansion of regulation-making powers, which
would have a significant impact on pharmaceutical patent
litigation. For example, duplicate litigation, which stems from
summary, non-binding determinations under the current NOC
Regulations might see its last days if the NOC
Regulations permit full actions and final determinations. This
means that innovators will be able to access full appeals like
those in regular patent actions.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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Materials from a recent "refresher training" for examiners at the Canadian Intellectual Property Office (CIPO) highlight inconsistencies between CIPO's examination practices and Supreme Court precedent.
In this recently reported decision, the Court granted Apotex leave to deliver Fresh as Amended Responding Statement of Issues for the reference into AstraZeneca's damages or Apotex's profits, following the Court's decision that the ‘693 Patent is valid and infringed by Apotex.
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