On Nov. 26, 2014, Industry Canada announced an important
proposed change to the eligibility requirements for listing a
patent against a drug in Canada under the Patented Medicines
(Notice of Compliance) Regulations (the
"Regulations"). The proposed change is a direct
response to recent Federal Court cases refusing to list patents
against fixed dose combination drugs.
While the proposed amendments have not been issued, Industry
Canada's Notice states that the Regulations "will
be amended to address the exclusion of certain pharmaceutical
patents from Health Canada's Patent Register following recent
Federal Court and Federal Court of Appeal decisions relating to
patents claiming single medicinal ingredients found in combination
drugs." The decisions are believed to be Viiv v Teva,
2014 FC 893 and Gilead v Canada, 2012 FCA 254, each of
which held that the listing requirements under the
Regulations require a patent to claim the specific
combination of medicinal ingredients in a combination drug.
In Viiv, two combination drugs were at issue: KIVEXA
(abacavir sulphate & lamivudine) and TRIZIVIR (abacavir
sulphate, lamivudine, & zidovudine). Claim 32 of Canadian
Patent No. 2,289,753 (the "753 Patent") claimed abacavir
hemisulfate and another medicinal ingredient selected from a
defined group. The specification stated that lamivudine was a
member of that defined group. But since there were no
claims to the exact combinations of medicinal
ingredients in KIVEXA and TRIZIVIR, the 753 Patent was held to be
not listable against either drug.
Moreover, Claim 2 of Viiv's 753 Patent claims abacavir
hemisulfate alone. Notwithstanding Health Canada's policy
allowing the listing of patents claiming single medicinal
ingredients against combination drugs the Court refused to list the
753 Patent. The Minister, in fact, appeared as a party at the
hearing supporting Viiv's argument. The Viiv decision
has been appealed to the Federal Court of Appeal.
In Gilead, the drug in issue was COMPLERA (tenofovir,
emtricitabine, & rilpivirine). Canadian Patent No. 2,512,475
(the "475 Patent") included claims to tenofovir,
emtricitabine, and a third antiviral agent selected from, inter
alia, a non-nucleoside reverse transcriptase inhibitors
("NNRTI"). Although rilpivirine is a NNRTI, the relevant
claims did not explicitly refer to rilpivirine and therefore the
Federal Court of Appeal held that the 475 Patent was not listable
Industry Canada's Notice states, "the
proposed amendments would confirm established Health Canada
practices in relation to the policy intent of the NOC Regulations
and clarify the listing requirements as they relate to single
medicinal ingredients found in combination drugs."
Health Canada's relevant Guidance Document
states, "a patent claiming, as a compound, a single
medicinal ingredient will be eligible for listing with respect to a
drug that contains the said medicinal ingredient in combination
with other medicinal ingredients." As such, it would appear
that Industry Canada's proposed amendment will bring about a
welcome change for pharmaceutical innovators.
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