Update Nov Dec 2013 - (Page 33)

Enforcement one of the few to consider data protection eligibility in Canada. Celgene Inc. v. The Minister of Health30 considered whether previously approved drugs (i.e., old drugs) with new uses-such as thalidomide- could be considered "innovative drugs", and therefore qualify for data protection. Now, even in circumstances where a drug manufacturer has expended considerable resources and effort to develop a significant and new use for a previously approved product, a drug like thalidomide is precluded from being "innovative" in Canada. The Minister of Health v. Celgene Inc. Conclusion Once THALOMID was granted market approval, Celgene applied to list the drug on the Register of Innovative Drugs. The Minister of Health denied this request on the basis that thalidomide had been "previously approved" in two other drugs. On judicial review, the Federal Court overturned the Minister's decision finding that the prior thalidomide approvals were irrelevant given that the drugs had been removed from the market.31 The Federal Court of Appeal reversed this decision. Thalidomide's previous marketing approvals rendered it "previously approved" and ineligible for data protection market exclusivity, regardless of being removed from the market for issues of safety. Though Celgene submitted that the word "currently" should be read into the definition of "innovative drug", the court rejected the argument. The Federal Court of Appeal warned that an interpretation favouring currently approved medicinal ingredients would create a slippery slope where drugs could be treated differently depending on whether or not their approvals had been withdrawn. In a dissenting opinion, Justice Nadon disagreed with the majority, finding that a market removal in the circumstances should nullify a previous approval, thus entitling THALOMID to data protection. The Minister of Health and Federal Court of Appeal have narrowly interpreted the meaning of "innovative drug". FDLI The 1960s thalidomide tragedy highlighted the need for reform of Canada's drug approval process. It prompted a modernization of the Food and Drugs Act and underlying regulations which have shaped today's drug regulation standards in Canada. Five decades later, these legislative reforms remain present in Health Canada's current legislation and practices. Thalidomide has continued to impact the federal regulation of drugs, specifically with regards to the jurisdiction of the PMPRB over drug pricing and the scope of data protection available to manufacturers developing new uses for known drugs. Since its entry into the Canadian market, thalidomide has had the unintended effect of forcing legal and regulatory change for new drugs in Canada. CANADA 3, 387-449, 438 [hereinafter Pugsley]. 7. Pugsley, 438. 8. An Act to Amend the Food and Drugs Act, 11 Elizabeth II, ss 1 - 3. 9. An Act to Amend the Food and Drugs Act. 10. Food and Drug Regulations, C.R.C., c. 870 [hereinafter FDR]. 11. Pugsley, 438 12. Pugsley, 439. 13. FRD, s. C.08.002(2)(h). 14. FDR, s. C.08.005.1(1). 15. Pugsley, 438. 16. Pugsley, 436. 17. Pugsley, 436. 18. Pugsley, 436. 19. Patent Act, R.S.C. 1985, c. P-4 [hereinafter Patent Act]. 20. Patent Act, s. 80(1)(b). 21. Patent Act, s. 83(1). 22. Patented Medicine Prices Review Board (PMPRB), Mandate and Jurisdiction, available at http://www. pmprb-cepmb.gc.ca/english/View. asp?x=1434 (last visited Aug. 1, 2013). 23. FDR, ss. C.08.010 and C.08.011. 24. FDR, ss. C.08.002 and C.08.004. 25. Health Canada, Guidance Document for Industry and Practitioners: Special Access Programme for Drugs, available at http://www.hc-sc.gc.ca/dhpmps/alt_formats/hpfb-dgpsa/pdf/acces/ sapg3_pasg3-eng.pdf (last visited Sept. 10, 2013) [hereinafter SAP Guidance]. 26. 1. 2. 3. 4. 5. 6. The authors would like to thank Kimberly Grange, Student at Law, for her assistance with this article. Health Canada, Brief History of Drug Regulation in Canada, available at http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/info-renseign/ hist-eng.php (last visited Sept. 10, 2013). Health Canada, THALOMID authorization for sale, available at http://www. hc-sc.gc.ca/dhp-mps/prodpharma/ activit/fs-fi/thalidomide_fs_fd-eng.php (last visited Sept. 10, 2013) [hereinafter THALOMID]. THALOMID. THALOMID Product Monograph (November 1, 2011), Celgene Inc. L.I. Pugsley, The administration and development of federal statutes on foods and drugs in Canada, 23 MEDICAL SERVICES JOURNAL SAP Guidance. 27. Celgene PMPRB at paras 30 - 33. 28. Celgene PMPRB at para 32. 29. Celgene PMPRB at para 29. 30. Celgene Inc. v. The Minister of Health, 2013 FCA 43. 31. Celgene Inc. v. The Minister of Health, 2012 FC 154. The Federal Court held that THALOMID was eligible for data protection, as Celgene conducted new studies and obtained significant confidential data for a new use of the medicine. Moreover, the Court held that the prior thalidomide approvals should not have been granted, as those products were withdrawn from the market. However, Montigny J. stated the case was an "exceptional one" that would have "limited impact in the foreseeable future" since thalidomide had a "tragic and chequered [rare] history" (para 47). November/December 2013 Update 33 http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1434 http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1434 http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1434 http://www.hc-sc.cg.ca/dhpmps/alt_formats/hpfb-dgpas/pdf/acces/sapg3_pasg3-eng.pdf http://www.hc-sc.cg.ca/dhpmps/alt_formats/hpfb-dgpas/pdf/acces/sapg3_pasg3-eng.pdf http://www.hc-sc.cg.ca/dhpmps/alt_formats/hpfb-dgpas/pdf/acces/sapg3_pasg3-eng.pdf http://c http://c http://c http://www.hc-sc.gc.ca-dhp-mps/prodpharma/activit/fs-fi/thalidomide_fs_fd-eng.php http://www.hc-sc.gc.ca-dhp-mps/prodpharma/activit/fs-fi/thalidomide_fs_fd-eng.php http://www.hc-sc.gc.ca-dhp-mps/prodpharma/activit/fs-fi/thalidomide_fs_fd-eng.php

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013