Importantly, any confusion and worry caused by the SCC's
original judgment as to whether patents can be suddenly voided by
the Federal Court under the scheme of the PM(NOC)
Regulations is now over.
Pfizer's story highlights an important distinction that all
patentees of pharmaceutical products need to be aware of.
PM(NOC) Regulations vs. Patent Act
The scope and purpose of applications brought under the
PM(NOC) Regulations differ from patent actions brought
under the Patent Act. So do the remedies available
Applications brought under the PM(NOC) Regulations are
intended to be summary in nature (decided within two years), and
confined to administrative purposes. The Court's scope in
adjudicating patent infringement and invalidity is limited to
determining whether the allegations made are "justified"
or not. Where a "second person" (typically a generic
manufacturer) has addressed all relevant patents pertaining to a
specific drug, and the Court finds its allegations justified, the
Minister of Health is free to issue the requested Notice of
Compliance (subject to regulatory approval issues), paving way for
generic product entry into the Canadian marketplace.
In contrast, patent actions brought under the Patent
Act involve full-blown trials, with parties entitled to a full
ambit of procedural rights including discovery, and viva
voce evidence (i.e. live trial witnesses). In this context,
the Court is free to impeach a patent (i.e. declare invalid and
void), or make a declaration as to infringement.
The VIAGRA® Saga Continues
Unfortunately for Pfizer, the effect of the SCC's amendment
does not serve to "un-void" their '446 patent.
This is because a patent impeachment action brought by Apotex
Inc. (another generic) on the VIAGRA® patent
was concurrently proceeding while the Supreme Court was hearing
Teva's appeal under the PM(NOC) Regulations.
On November 20, 2012, the Honourable Justice Zinn granted
Apotex's motion for summary judgment declaring the '446
Patent void in light of the SCC's judgment: see Apotex Inc v Pfizer Ireland Pharmaceuticals, 2012
FC 1339. The Court specifically considered the possibility
of Pfizer's success on the amendment motion before the SCC, but
found nonetheless that the Supreme Court's ruling on
insufficiency was a legal determination that was binding on the
Pfizer's appeal of Justice Zinn's decision is slated to
be heard by the Federal Court of Appeal later this year. In the
mean-time, the VIAGRA® patent remains void and
unenforceable in Canada.
On 8 September 2016 (C-160/15), the CJEU ruled that the posting of a hyperlink to copyright-protected works located on another website does not constitute copyright infringement when the link poster does not seek financial gain.
The chapter on the UK summarises the IP court and litigation system in the UK, recent developments in relation to IP law and practice, the forms and availability of IP protection and trends and outlook in the IP sphere.
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