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.

CGPA v. Canada (ongoing)

On November 14, 2006, the Canadian Generic Pharmaceutical Association (CGPA) launched a constitutional 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). The Attorney General of Canada's motion to strike was denied (2007 FC 154 aff'd 2007 FCA 375). For more information see the article “Legal challenges hit data protection law amendments” published February 5, 2007 in Law Times (Vol. 18 No. 5). Ed Hore is representing CGPA.