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In Gilead Sciences Canada, Inc. v. Minister (Health),
2012 FC 2, Gilead filed an application for judicial review of the
Minister of Health's decision that Canadian patent no.
2,512,475 (the "475 Patent") was not eligible for listing
on the Patent Register against its new drug submission
("NDS") for COMPLERA. COMPLERA contains
tenofovir, emtricitabine and the non-nucleoside
reverse transcriptase inhibitor ("NNRTI")
rilpivirine.
The 475 Patent includes a claim for a formulation comprising
tenofovir, emtricitabine, and an NNRTI, and a claim for a
combination of such ingredients. The claims do not recite
rilpivirine, specifically. The patent also claims a combination of
two medicinal ingredients, tenofovir and emtricitabine.
The Minister held the patent was ineligible for listing because
it does not contain a claim for the medicinal ingredients
tenofovir, emtricitabine and
rilpivirine. A claim to NNRTIs as a class, without
specifying rilpivirine, was deemed insufficient for listing under
s. 4(2) of the Patented Medicines (Notice of Compliance)
Regulations (the "PM(NOC) Regulations")
The essence of the dispute was whether the 475 Patent should be
considered for eligibility under para. 4(2)(a) or (b) of the
PM(NOC) Regulations. Gilead argued that the patent
contains claims for the combination of the medicinal ingredients
that are the subject of the NDS, and therefore should be eligible
for listing under para. 4(2)(a). The Minister argued that the
relevant claims must be considered for eligibility under para.
4(2)(b) as "formulations," rather than as
"combinations (compounds)." The distinction was crucial,
because under para. 4(2)(a) claims to two medicinal ingredients
(e.g., tenofovir and emtricitabine) are listable against a product
that contains these two medicinal ingredients even when accompanied
by other additional medicinal ingredients. But, under para. 4(2)(b)
the "product specificity requirement" mandates that the
claims identify each medicinal ingredient in the formulation.
Relying on Bayer v. Canada (2009 FC 1171, aff'd
2010 FCA 161) the Federal Court stated that a "compound"
patent contains a claim for the approved medicinal ingredient,
whereas a "formulation" patent does not contain a claim
for the medicinal ingredient itself, but rather for the approved
mixture of medicinal and non-medicinal ingredients that are
actually administered to the patient. The Court held that the 475
Patent was a formulation patent; therefore eligibility for listing
was to be considered pursuant to para. 4(2)(b) of the PM(NOC)
Regulations.
According to the Court, the product specificity requirement of
para. 4(2)(b) had not been met. All of the ingredients in the NDS
have to be found in the formulation in the claim. A reference to
the class of NNRTIs, in the claim, coupled with the fact that the
475 Patent did not point specifically to rilpivirine as the NNRTI,
did not satisfy the specificity requirement for listing. Since the
claimed formulation and the approved formulation did not match
precisely, the Court held that the requirement of product
specificity is not met and that the Minister's decision that
the patent was not eligible for listing was reasonable. Gilead has
appealed.
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