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Court quashes NOC for Teva-Exemestane issued from a cross-referenced submission; Teva is required to separately address Pfizer’s patent

On December 19, 2014, Justice Gleason of the Federal Court set aside the Minister of Health’s decision to give Teva Canada a Notice of Compliance (NOC) for exemestane (Pfizer’s AROMASIN): Pfizer Canada Inc v Canada (Attorney General)2014 FC 1243.

The decision considered the question of whether an administrative drug submission, in which a manufacturer is licensed to sell a drug identical to a marketed drug (also referred to as a cross-referenced submission), triggers the requirement to address patents under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”). As we reported previously, in 2012, Health Canada revised its Guidance Document to indicate that, in its view, such submissions will not trigger the requirement to address patents, and an NOC will be issuable after the licensor's drug submission receives its NOC. Justice Gleason held that this interpretation is incorrect.

Pfizer had a patent listed on the Patent Register against AROMASIN. In August of 2013, Pfizer received a Notice of Allegation (NOA) from GMP regarding exemestane. As GMP does not sell products in Canada, Pfizer did not start a prohibition application against GMP. Health Canada then issued an NOC to GMP. Teva filed an administrative drug submission based on a licensing agreement with GMP, identifying AROMASIN as the Canadian Reference Product, and, consistent with the revised Guidance Document, Health Canada issued an NOC to Teva.

Justice Gleason held that the Minister had incorrectly interpreted the Regulations, finding that a company that wishes to enter the market with a generic version of a listed drug will be required to address the relevant patents. In this case, it was clear that Teva sought an NOC “based on the direct comparison of its product to AROMASIN or on an indirect comparison of its drug to AROMASIN by piggy-backing on GMP’s comparison,” and such comparisons engage subsection 5(1) of the Regulations. The Minister thus could not issue Teva an NOC until Teva addressed Pfizer’s listed patent.

Teva and the Minister may appeal, as of right.

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