Data protection is based on international obligations to protect undisclosed data necessary to determine the safety and efficacy of a new chemical entity. Section C.08.004.1 of the Food and Drug Regulations provides an "innovative drug" with a period of market exclusivity of eight years, with an additional six months if the drug was the subject of clinical trials designed and conducted for the purpose of increasing the knowledge of the behaviour of the drug in pediatric populations. Further, a manufacturer may not file a submission seeking a notice of compliance ("NOC") on the basis of a direct or indirect comparison between the new drug and an innovative drug prior to the expiry of six years after issuance of the first NOC for the "innovative drug." An "innovative drug" is defined as a drug that contains a medicinal ingredient not previously approved in a drug by the Minister of Health and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.
The present data protection provision came into force on October 5, 2006, and applies to an "innovative drug" that received an NOC on or after June 17, 2006. The Minister of Health maintains a Register of Innovative Drugs that lists drugs that are the subject of data protection.
Two Federal Court decisions have recently issued relating to data protection.
First, in Canadian Generic Pharmaceutical Association v. The Minister, 2011 FC 465, Justice de Montigny dismissed the Canadian Generic Pharmaceutical Asssociation ("CGPA")'s appeal of a Prothonotary's decision (2010 FC 1211) striking its application for judicial review, which had challenged a decision of the Minister of Health to maintain the listing of AVAMYS (containing fluticasone furoate) on the Register of Innovative Drugs. The CGPA sought to argue that because fluticasone furoate is an ester variation of a previously approved medicinal ingredient (fluticasone propionate), AVAMYS was not an "innovative drug." The Minister's position was that fluticasone furoate and fluticasone propionate are both esters of fluticasone; since fluticasone was not "previously approved," fluticasone furaote is not a variation of a previously approved medicinal ingredient. AVAMYS is therefore eligible for data protection.
The CGPA is an industry association that represents most generic drug manufacturers in Canada with respect to regulatory and legal issues affecting its members. The Prothonotary held that the CGPA lacked standing to bring the application and therefore struck the application. Justice de Montigny affirmed, finding that the CGPA is not directly affected by the Minister's decision. Rather, if a member of the CGPA at some time in the future would, if not for data protection, submit a submission for fluticasone furoate, it would have standing to challenge the listing. The Judge also held that the CGPA cannot meet the test for "public interest" standing. The CGPA has appealed (Court File No. A-189-11).
The second decision relates to the interpretation of "innovative drug," and specifically, the meaning of the term "approved" in that definition. In Teva Canada Limited v. Canada (Health), 2011 FC 507, Teva challenged data protection for ELOXATIN (sanofi-aventis's oxaliplatin) on the basis of prior approvals under the Special Access Programme ("SAP") between 1999 and 2005. Teva's argument was that by authorizing those sales, the Minister approved the safety and efficacy of the drug and thus, the Minister erred in law in granting innovative drug status to ELOXATIN. Justice Campbell dismissed Teva's application, finding that the Minister is correct that for a drug to be "approved" as that term is used in the definition of an innovative drug, both a finding that a drug is safe and effective and a market authorization are required. Justice Campbell found that in this case, Teva did not prove that the Minister had made the factual finding that oxaliplatin (ELOXATIN) is safe and effective in connection with the SAP sales. Accordingly, the Court dismissed Teva's challenge. Teva has appealed (Court File No. A-215-11).
Two further cases are of note.
The Court of Appeal will soon consider the meaning of "innovative drug" in the context of prior "approvals" based on applications for a Drug Identification Number ("DIN") and under the Natural Health Products Regulations: EpiCept Corporation v. Canada (Health), Court of Appeal File No. A-397-10. Federal Court decision – 2010 FC 956. As reported in the October 2010 edition of Rx IP Update, the Office of Patented Medicines and Liaison ("OPML") denied data protection for CEPLENE (EpiCept's histamine dihydrochloride). EpiCept sought judicial review of the Minister's decision, and the Federal Court dismissed the application. The Judge reasoned that drugs approved by the DIN process or the process under the Natural Health Products Regulations are not new chemical entities that have not been approved. The Judge proposed a two-step process for the Minister to apply when assessing eligibility for data protection: first, the Minister must consider whether the data concerns a "new chemical entity"; if so, then the Minister must consider whether the data is undisclosed and if other data is necessary to determine safety and effectiveness. In this case, the medicinal ingredient was an old ingredient, and CEPLENE was therefore not a new chemical entity. On this basis, the Judge dismissed EpiCept's application. The CGPA and Canada's Research-Based Pharmaceutical Companies ("Rx&D") have both been granted leave to intervene in EpiCept's appeal. The hearing is scheduled for June 22, 2011.
Finally, Apotex and the CGPA's applications for leave to appeal to the Supreme Court of Canada regarding the Federal Court of Appeal's dismissal of their challenges to the validity of the data protection provisions remain pending: Apotex Inc. v. Minister of Health, et al.; Canadian Generic Pharmaceutical Association v. Attorney General of Canada, et al. (SCC Case Nos. 34084, 34085). Court of Appeal decision – 2010 FCA 334. Federal Court decision – 2009 FC 725. The Supreme Court will likely decide whether it will hear the cases within the next two to three months.
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