The Canadian Government has proposed amendments to the PM(NOC)
Regulations ("Regulations"). These changes come in
light of recent decisions of the Federal Court that would not allow
the listing of certain patents on the Patent Register, contrary to
the intent of the Regulations. The preamble to the amendments
states that the "purpose of these amendments is to provide
rules for the interpretation of the eligibility requirements for
listing patents on the patent register in respect of combination
drugs in a manner that is consistent with the purpose of the
PM(NOC) Regulations and the authority under which they are
Patents that are listed on the Patent Register must be addressed
by a company seeking to obtain approval for a generic version of a
medicine, before Health Canada will give them marketing
approval. Contrary to recent decisions of the Federal Court
(e.g. Gilead Sciences Canada Inc. v. Canada (Health),
2012 FCA 254 and Viiv Healthcare Ulc v. Canada (Minister of
2014 FC 328 and
2014 FC 893), the Government is seeking to restore the original
intent of the Regulations by permitting claims to the use of a
medicinal ingredient to be listed on the Patent Register against
products that "may include additional medicinal ingredients,
or additional uses of the medicinal ingredient."
Drug manufacturers who have been affected by these Federal Court
decisions will have a 30 day window to resubmit their patents if a
previous request to add a patent to the register has been denied on
the basis of the Federal Court's interpretation of the
Regulations in Viiv, or if its patent was removed from the register
on the same basis. However, the frozen register rule will
apply. This means a second person filing a submission for an
NOC will not be required to address a patent added to the register
after the filing date of the second person's submission for an
Note that interested persons may make representations concerning
the proposed Regulations within 30 days after the date of
publication of the notice (May 2, 2015).
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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