Eli Lilly Canada Inc v Attorney General of Canada et
al, 2014 FC 152
On February 17, 2014, the Federal Court dismissed an application
by Eli Lilly for judicial review of the Minister of Health's
refusal to list Lilly's Canadian Patent No. 2,379,329 in
respect of its drug product, TRIFEXIS®. The Federal Court
held that it was bound by the decision of the Federal Court of
Appeal in Gilead Sciences Canada Inc v Canada (Ministry of
Health), 2012 FCA 254, with respect to the product specificity
requirements prescribed by paragraph 4(2)(b) of the
Patented Medicines (Notice of Compliance)
The underlying decision indicated that the '329 Patent
claimed a formulation comprising only one medicinal ingredient,
spinosad, rather than claims for a formulation that contained the
two medicinal ingredients present in TRIFEXIS® (spinosad and
The Federal Court held that the Minister erred in construing the
claims of the patent, and that, properly construed, the claims of
the '329 Patent include both spinosad and milbemycin
oxime. Yet despite this conclusion, the Court felt bound by
Gilead and concluded that the general family of
milbemycins in the patent's definition of oral formulation is
not specific enough to conclude that the claims match the
formulation contained in TRIFEXIS®.
This decision is significant because it exemplifies the
inconsistencies in the law for listing patents and, in particular,
the product specificity requirements. The product specificity
requirements were initially introduced to restrict listing of
patents to those where the subject matter of the patent is linked
with the content of the approved drug product. In other
words, patents can only be listed where the claimed invention is
incorporated into the approved drug product from which generic drug
manufacturers can derive a benefit. This decision, by
following Gilead, seems to disregard the invention
claimed, endorsing a word-search test that requires a perfect match
between words found in the patent and words describing the content
of the approved drug product.
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