On April 26, 2008, the government of Canada published for
comment proposed amendments to the Patented Medicines
(Notice of Compliance) Regulations, commonly referred to
as the "PM(NOC) Regulations." These regulations
create the regulatory framework for pharmaceutical patents to
be listed on Health Canada's Patent Register.
Most recently, the regulatory framework underwent amendment
in October 2006, implementing significant changes to patent
listing eligibility requirements regarding patent lists
submitted after June 17, 2006. Patents included on earlier
filed patent lists (referred to as "grandfathered
patents") were to be subject to the listing requirements
applicable before June 17, 2006. In making the decision to
grandfather these patents, the government noted the potential
unfairness of subjecting listed patents to new eligibility
requirements, as well as the possibility of market disruption
and investment uncertainty.
Despite the Canadian government's intent regarding
grandfathered patents, a decision of the Supreme Court of
Canada released shortly after June 17, 2006, brought about a
re-interpretation of the pre-June 17, 2006 listing requirements
by the Federal Court of Appeal,1 bringing them into
line with the amended requirements. According to this decision,
there must be relevance between the invention claimed in the
patent to be listed and the regulatory submission for which the
patent list is submitted. Prior jurisprudence stood for the
proposition that patents are listed generally against a drug,
rather than against the specific drug submission for which the
patent list is submitted.
Citing concerns about widespread delisting of or refusal to
list grandfathered patents and the consequential sudden and
unexpected loss of market exclusivity for a drug, the proposed
amendments are designed to address the impact of these recent
According to the proposed amendments, the Minister of Health
would be prohibited from deleting from the Patent Register
patents included on patent lists submitted before June 17,
2006, subject to certain common-sense exceptions (i.e., if a
patent has expired or been declared invalid; if the drug in
respect of which a patent is listed is no longer marketed; or
if a patent has been found ineligible for listing under section
6(5)(a) of the PM(NOC) Regulations).
The proposed amendments would also revise section 6(5)(a) to
prevent a generic pharmaceutical manufacturer from seeking to
have a prohibition application brought by an innovative
manufacturer dismissed solely on the ground that a
grandfathered patent does not meet the listing requirements in
effect before June 17, 2006. The Minister of Health would also
be prohibited from refusing to add to the Patent Register a
patent on a patent list submitted before June 17, 2006 solely
because the patent is not relevant to the supplement to a new
drug submission (SNDS) in relation to which it was
According to the transitional provisions, it will be
possible to "undo" any actions taken by the Minister
of Health in relation to grandfathered patents as a result of
the above-noted decision of the Federal Court of Appeal. Thus,
an innovative drug manufacturer would be able to request
relisting of a patent that was deleted from the Patent Register
solely because it was not relevant to the SNDS in relation to
which it was submitted for listing. Similarly, an innovative
manufacturer would be able to request that a grandfathered
patent be added to the Patent Register if listing was refused
because it lacked relevance to the SNDS in relation to which it
was submitted for listing. The addition of a patent to the
Register as a result of these transitional provisions would not
operate as an impediment to a generic drug manufacturer that
has already filed a submission for a notice of compliance. Nor
would the proposed amendments to section 6(5) apply to a
summary dismissal motion brought under that section before
April 26, 2008.
Stakeholders have been invited to submit comments on the
proposed amendments before May 11, 2008. This
relatively short comment period has been justified on the
ground that the proposed amendments reaffirm the intended
effect of one of the 2006 amendments, thereby obviating the
need for a longer consultation period.
1. Ratiopharm Inc.v.Wyeth and
Wyeth Canada, 2007 FCA 264.
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