CGPA v. Canada, 2009 FC 725

As published in the Law Times, On November 14, 2006, the Canadian Generic Pharmaceutical Association (CGPA) launched a legal challenge to the October 2006 amendments to the Food and Drug Regulations passed by the federal government. The amendments call for eight years of data protection after a “brand” drug manufacturer receives a Notice of Compliance (NOC) during which no generic drug company can receive an NOC for the same drug. The new amendments also restrict a generic company’s ability to file a new drug submission comparing its drug to a brand drug until six years has passed since the issuance of the brand’s NOC. Under the previous legislation, the term of data protection was five years and there was no ban on filing drug submissions during that time. CGPA argues the legislation is ultra vires because the statute under which the regulations are passed only authorizes regulations “deemed necessary” for the implementation of Canada’s international obligations under NAFTA and TRIPS. CGPA argues the Federal Court of Appeal explicitly stated that Canada was in compliance with its treaty obligations under the existing rules. CGPA also argues the regulations are ultra vires the federal government since protection of intellectual property is exclusively provincial jurisdiction under s. 92(13) of the Constitution Act (Property and Civil Rights in the Province). On July 17, 2009, Justice Mandamin of the Federal Court dismissed CGPA's application. CGPA is appealing the decision. Ed Hore is representing CGPA.

Abbott v. Sandoz, 2008 FC 1359

Justice Hughes dismissed Abbott's application under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing Sandoz a Notice of Compliance for its clarithromycin product until after the expiry of Canadian Patent No. 2,386,527 (the "527 Patent"). At issue was claim 5 which Justice Hughes construed as "the use of clarithromycin, at least some of which is Form I, for the treatment of bacterial infections in a host mammal." Justice Hughes found that Sandoz's allegation of anticipation was justified because claim 5 was disclosed and enabled by U.S. Patent 4,990,602 (the "602 Patent"). Finding that the 602 Patent disclosed the recrystallization of clarithromycin to Form I, Justice Hughes held that it was not material that the crystal form in the 602 Patent was not disclosed as "Form I" since that is simply a name of convenience given later. On enablement, Justice Hughes found that the 602 Patent described clarithromycin, its use, and how to make it in Form I. Justice Hughes also found that Sandoz's allegation of obviousness was justified because the molecule, its use and its crystal form were all disclosed in the prior art. Justice Hughes rejected Abbotts' argument that a person skilled in the art would not know that Form I was sufficiently soluble so as to provide therapeutic use and found that solubility would be in the mind of any person skilled in the art and there was no evidence to suggest that testing for solubility would be anything other than routine. Sandoz was represented by Ed Hore, Kevin Zive, and Jonathan Mesiano-Crookston.

Apotex v. Sanofi-Synthelabo, 2008 SCC 61

The Supreme Court of Canada dismissed Apotex's appeal from an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of its clopidogrel bisulfate drug. The issue whether the patent claiming the enantiomer (clopidogrel), which had better efficacy over the racemate, was invalid in light of the earlier genus patent claiming the racemate. The Supreme Court found that although the claims of the earlier genus patent included the two enantiomers, the patent did not teach a person skilled in the art how to produce the enantiomer or that one of the enantiomers was more effective than the other. The Supreme Court then went on to redefine anticipation as requiring both disclosure and enablement, and found that the genus patent did not disclose the advantages of clopidogrel and did not enable a person skilled in the art to perform the invention taught by the later patent without "undue burden". Turning to obviousness, the Court referred to recent U.S. and U.K. jurisprudence and noted that an "obvious to try" approach may be warranted in certain cases, including this one. The Court discussed certain factors that courts should consider in determining when an invention is obvious to try, including whether there is a motive to experiment, the amount of effort required to get the invention to work, and whether it is self-evident that what is being tried ought to work. For selection patents, it should be more or less self-evident what to select and what to omit. The Court found on the facts of this case that it was not self-evident that clopidogrel had special advantages over the other compounds disclosed in the genus patent, and thus the allegation of obviousness must fail. Ed Hore represented the intervener Canadian Generic Pharmaceutical Association.

Biovail v. Rhoxalpharma, 2006 FC 784

Biovail commenced a notice of application seeking to prohibit the Minister of Health from issuing a Notice of Compliance (“NOC”) to Sandoz for its bupropion hydrochloride sustained release formulation. Biovail claimed the Sandoz formulation infringed patent nos. 2,142,320 (the “‘320 Patent”) and 2,168,364 (the “‘364 Patent”) listed against WELLBUTRIN SR. In reasons released June 21, 2006, Justice O’Reilly dismissed the application on the basis that Sandoz did not infringe either patent. He found that Sandoz did not infringe the ‘320 Patent because hydroxypropyl methylcellulose was an essential element of the patent and was not present in the Sandoz formulation. He also found Sandoz did not infringe the ‘364 Patent because Sandoz’s tablet did not use any of four stabilizing agents claimed in the patent. He rejected Biovail’s argument that the Sandoz product used hydrochloric acid (“HCl”) as a stabilizer and in any event found HCl to be outside the claims of the ‘364 Patent. Sandoz was represented by Ed Hore and Kevin Zive.

AstraZeneca v. Apotex, 2006 SCC 49

In unanimous reasons released November 3, 2006, the Supreme Court of Canada overturned the Federal Court of Appeal, and restored the lower court’s decision that the Minister of Health was correct to issue a Notice of Compliance to Apotex for its omeprazole magnesium capsules. The issue turned on the correct interpretation of the words “another drug” in subsection 5(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”). That provision says that a generic must address patents when it "compares ...or makes reference to, another drug...and that other drug has been marketed in Canada." AstraZeneca had listed new patents for its omeprazole capsules (LOSEC) after it had pulled its capsules off the market. AstraZeneca claimed Apotex was required to address these newly listed patents because the words “another drug” included a drug that was once marketed in Canada but no longer is. Apotex claimed “another drug” referred to the drug as it was when it was marketed in Canada, which was when the comparison was made, and excludes patents listed afterwards. The Supreme Court of Canada agreed with Apotex’s interpretation, noting that as the intent of the Regulations was to offset the benefit derived by generic drug manufacturers from the “early working exception” (s. 55.2 of the Patent Act), it would be unfair to require them to address patents which they could not have benefited from. Ed Hore and Kevin Zive represented the intervener, Canadian Generic Pharmaceutical Association.