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SCC Re-examines the NOC Regulations in AstraZeneca Canada Inc. v. Canada (Minister of Health)


February 6, 2007

The Supreme Court of Canada released its much-anticipated decision in AstraZeneca Canada Inc. v. Canada (Minister of Health) (AstraZeneca). The unanimous decision, written by Mr. Justice Binnie, overturned the decision of the Federal Court of Appeal, reinstating Apotex’s Notice of Compliance (NOC) for the generic version of LOSEC 20® (omeprazole).

In 1989, AstraZeneca Canada Inc. (AstraZeneca) obtained a NOC for its omeprazole capsules, marketed in Canada as LOSEC 20. In 1993, Apotex filed an ANDS for a generic version of omeprazole. Apotex compared its drug to AstraZeneca’s LOSEC 20. In 1996, AstraZeneca removed LOSEC 20 from the market following the development and approval of omeprazole magnesium tablets, marketed in Canada as NEXIUM®.

Notwithstanding that LOSEC 20 was no longer on the market, AstraZeneca filed an ANDS for it for a new use, and in 2002-03 added two new patents to the Patent Register against LOSEC 20.

In 2004, the Minister determined that Apotex did not have to address AstraZeneca’s newly listed patents and issued a NOC to Apotex allowing it to manufacture and sell its generic version of LOSEC 20. AstraZeneca moved to quash the NOC. The motions judge upheld the Minister’s decision. The Federal Court of Appeal (Noel and Malone JJ.A; Sharlow, J.A. dissenting) reversed this decision and quashed the NOC. That decision was stayed pending the Supreme Court’s judgment.

McCarthy Tétrault Notes:

The Supreme Court’s decision focuses primarily on the interpretation of section 5(1) of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). The issue was whether Apotex should be required to address new patents related to LOSEC 20 in any of its formulations (including formulations never brought to market) or, more narrowly, the version of LOSEC 20 based on the 1989 NOC which Apotex copied.

Justice Binnie held that the grant of the regulation-making power conferred in section 55.2 of the Patent Act is expressly limited to preventing patent infringement by those who take advantage of the ‘early working exception.’ Justice Binnie reasoned that because both of the patents in issue were filed after Apotex’s ANDS, "it is difficult to see in principle why in respect of those patents Apotex should be subject to the NOC Regulations regime, with a consequent further delay of two years, and perhaps longer."

Justice Binnie observed that the NOC Regulations contemplate that a generic must address only those patents listed against the drug to which it compares for the purpose of establishing bioequivalence. As a result, he held that Apotex was only required to address patents listed against submissions relevant to the 1989 version of LOSEC 20.

The facts upon which this decision is based are quite unique (Justice Binnie quoted the trial judge’s remarks that this situation is ‘novel’) and as a result, it can be argued that the decision should not be extended more broadly to other situations. Moreover, the concerns raised by the Court in this decision are largely addressed by the recently enacted amendments to the NOC Regulations which require a more ‘patent-specific’ analysis and ‘freeze’ the Register in terms of generics addressing patents added after the filing of the ANDS.

That said, generic drug manufacturers will undoubtedly attempt to use this decision to limit the number of patents they are required to address when seeking to obtain a NOC for a copy-cat version of an innovator’s drug, whether under the old or new NOC Regulations.

This decision has implications for Regulatory Affairs (DIN notifications and the like), Marketing and Sales strategy (implementing product changes) and, obviously, for patent filing and prosecution. If you have any questions regarding this decision and its potential implication to your patent portfolio and drug submissions, please contact us.