The Federal Court of Appeal has clarified that there must be a
"high threshold of consistency" between the content of a
new drug submission and a patent's claims in order for the
patent to be listed on the patent register pursuant to section
4(2)(a) of the
On October 4, 2010, Gilead filed a new drug submission (NDS)
with the Minister for the drug Complera, to be used for the
treatment of HIV infections. As described in the NDS, Complera
contains three medicinal ingredients: (1) tenofovir disoproxil
fumarate (tenofovir); (2) emtricitabine; and (3) rilpivirine.
Health Canada issued an NOC in respect of this NDS which triggered
the listing provisions of the PM(NOC) Regulations.
Gilead submitted eight patents for listing. On October 26, 2010,
the Minister advised Gilead that one of these patents (the '475
Patent) was not eligible for listing on the patent register because
it did not contain a specific claim for all three of the medicinal
ingredients described in the NDS. Rather, the '475 Patent
claimed a combination of tenofovir and emtricitabine with a third
unnamed antiviral agent, selected from various classes of agents
including non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Rilprivirine (the third medicinal ingredient in Complera) is an
Therefore, the patent specifically claimed two of the medicinal
ingredients described in the NDS, along with the class of compounds
to which the third medicinal ingredient belonged.
History of the Dispute
The issue in the appeal was whether the '475 Patent was
eligible for listing on the patent register in respect to
Gilead's NDS. The Minister held that it was not, as the patent
needed to match the approved formulation in the NOC, and it could
not do so unless both "explicitly contain all of the same
medicinal ingredients". This decision was upheld on judicial
review by the Federal Court.
The Decision of the Federal Court of Appeal
The Court of Appeal held that the concept of "product
specificity" was a key feature of the 2006 amendments to the
PM(NOC) Regulations, and that this requires the subject matter of
the patent to reflect the subject matter of the approved drug
submission to qualify for listing on the patent register. The Court
of Appeal referred to its own decision in
Purdue Pharma v. Canada (Attorney General), 2011 FCA 132
(Purdue), which held that "absent precise and specific
matching between the patent claims and the approved NOC, the patent
was not eligible for listing [under section 4(2)(c) of the PM(NOC)
Regulations]". In Gilead, the Court of Appeal applied the
reasoning in Purdue to section 4(2)(a), and held that:
The wording of the PM(NOC) Regulations, as well as their object
and purpose, suggest that the product specificity requirement sets
a high threshold of consistency. Thus, in the case at bar,
"the" medicinal ingredients, i.e. tenofovir,
emtricitabine, and rilpirivine, must be set out in the patent
claims and the NOC for the patent to be eligible on the
The Court of Appeal dismissed Gilead's appeal because not
all of the medicinal ingredients in the submission were explicitly
found in the claims.
As noted above, this decision presents additional challenges for
innovators seeking to protect new innovations by listing patents on
the patent register. Because patent applications and drug
submissions may be filed years apart, it is challenging for
innovators to ensure that their patents meet the specificity
requirements set out by the Court of Appeal.
This decision may also result in increased litigation at the
Federal Court. Typically, a single application is brought in
respect of every patent listed on the patent register for a drug.
This provides for a summary adjudication of validity and
non-infringement allegations, which may settle the patent dispute
relating to the drug (subject to potential section 8 liability).
However, if Gilead results in a new class of patents –
plainly relevant but not listable – such patents may be
appropriate choices for subsequent separate infringement
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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