In Gilead Sciences Canada Inc. v. Canada
(Minister of Health), 2012 FCA 254, the Federal Court of
Appeal (FCA) dismissed Gilead's appeal of the Minister's
decision not to list Canadian Patent No. 2,512,475 (the '475
Patent) on the patent register. In the Minister's view, the
'475 Patent failed to meet the requirements of the Patented
Medicine (Notice of Compliance) Regulations (PM(NOC)) because
it did not specifically claim all the medicinal ingredients in the
New Drug Submission (NDS).
The '475 Patent specifically claimed two of three medicinal
ingredients, but claimed the third as an unnamed agent selected
from a class, rather than the actual ingredient. In his final
decision, the Minister wrote, "a patent containing claims for
a formulation cannot 'match' the approved formulation [in
the NDS or NOC] unless both formulations explicitly contain all of
the same medicinal ingredients." Classes of ingredients
therefore failed to meet the "matching requirement" due
to a lack of product specificity, and the '475 Patent could not
be listed. This decision was upheld by Justice Mosley of the
Federal Court under paragraph 4(2)(b) of the PM(NOC).
The FCA held that Justice Mosley should have construed the
'475 Patent claims and then interpreted paragraphs 4(2)(a) and
(b) of the PM(NOC) to determine under what paragraph the claims
best fit. The FCA concluded that paragraph 4(2)(a) was the most
appropriate, as the claims were for a new combination of
chemically-stable medicinal ingredients. Citing Purdue Pharma
v. Canada (Attorney General), 2011 FCA 132, the Court noted
that without specific and exact matching between patent claims and
an approved NOC, a patent will not be eligible for listing on the
register due to a lack of product specificity as required by
paragraph 4(2)(a) of the PM(NOC). The Court dismissed Gilead's
appeal. Gilead's leave to appeal to the Supreme Court of Canada
has been dismissed without costs.
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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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