Canada

January 30, 2007. Jillian Clare Cohen and Laura Esmail in the Globe and Mail. Does Canada have the guts to honour its drug pledge to the world's poor?

CPTech Pages on Canada

CPTech PAGE ON BILL C-9: AN ACT TO AMEND THE PATENT ACT AND THE FOOD AND DRUGS ACT. This is the law allowing exports under Paragraph Six of the Doha Declaration.
CPTech's Page on Tamiflu containing information on Biolyse's request that Osteltamivir be added the country's list of pharmaceutical products eligible for compulsory licensing for export.

Extension of Data Exclusivity to 8 Years

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (DATA PROTECTION).
November 14, 2006. Jim Keon for the Canadian Generic Pharmaceutical Association. Generic Drug Makers Launch Legal Challenge to New Federal Data Exclusivity Rules.
October 18, 2006. Canadian Generic Pharmaceutical Association. Amendments to the Patented Medicines Notice of Compliance Regulations and Food and Drug Regulations.

Compulsory Licensing of Pharmaceuticals in Canada

October, 2002. Report by UNCTAD and ICTSD. Non-voluntary Licensing of Patented Inventions: The Canadian Experience.
July 9, 2002. Canandian Court of Appeals. Eli Lilly & Co. v. Novopharm Ltd.
On January 17, 1990, Novopharm applied under s. 39(4) of the Patent Act for a compulsory licence under the patents owned by Eli Lilly. The application was vigorously contested by Eli Lilly, but, it was found that none of the objections constituted a valid reason to refuse the application and the Commissioner of Patents accordingly granted the licence, as he was obliged to do under the Act as it then existed. The licence, which, unless validly terminated by Eli Lilly (a very contentious issue in the instant appeals), is still in force, permits Novopharm to use the patented process to make nizatidine for the preparation or production of medicine, and to import and/or sell medicine made by the process. It also permits Novopharm to make, use, sell and import either or both of the invention for medicine and the invention for the preparation or the production of medicine. The royalty rate to be paid by Novopharm to Eli Lilly Canada on sales of the medicine in final-dosage form is fixed at six percent of the selling price. The Commissioner of Patents, in a decision dated October 21, 1991, found that the licence is not restricted to the forms of medicine listed by Novopharm in its application, as such "would place unnecessary limits on [Novopharm's] operations under the licence".
October, 1993. I. Prakash Sharma. Department of Foreign Affairs and International Trade. Policy Staff Paper No. 93/12. Chapter from Optimal Patent Term and Trade: Some Considerations on the Road Ahead. The Pharmaceutical Industry in Canada.
Frank W. Horner Ltd. v. Hoffmann La-Roche Ltd.
- January 20, 1970. Decision of the Commissioner of Patents
- November 30, 1970. Ruling of the Appeal to Exchequer Court of Canada
- March 1, 1972. Ruling of the Supreme Court of Canada

Efforts Against the Evergreening of Patents

Proposed Amendments to Regulations on the Patenting of Pharmaceuticals
- Government Documents
  - December 13, 2004. Industry Canada press release and backgrounder. Government of Canada Proposes Amendments to Intellectual Property Rules for Pharmaceuticals.
  - December 11, 2004. Canada Gazette. Regulations Amending the Patented Medicines (Notice of Compliance) Regulations; (includes the proposed regulatory changes.
- Statements
  - December 13, 2004. Canadian Generic Pharmaceutical Association. Generic Pharmaceutical Industry Pleased Government Acknowledges Need to Stop Evergreening of Drug Patents.
  - December 12, 2004. National Union of Public and General Employees. NUPGE hails victory in battle to end drug patent abuse.
- News Stories
  - December 15, 2004. Leonard Zehr for the Globe and Mail. Ottawa considers changing patent rules.
  - December 14, 2004. Dennis Bueckert for the Canadian Press. Ottawa changing rules to curb drug patent 'evergreening'.
  - November 15, 2004. Windsor Star. Proposal Will Save Health Cash: MP.
Antitrust Case Brought by the National Union of Public and General Employees
- Statutory Declaration of James Clancy, President, NUPGE.
- June 19, 2003. Canadian Press. Watchdog Eyeing Drug Patent Rules.

Patent Dispute Over Cancer Screening Technology

See CPTech Page on Myriad.

Crackdown on Canadian Pharmacies Exporting to US Customers

May 17, 2004. Shawna Richer for the Globe and Mail. America's new war on drugs targets Canadian pharmacists.
May 23, 2003. Dramatic PhRMA one-page handout. Think Bus Trips To Canada Are Safe? Think Again.
March 21, 2003. GlaxoSmithKline press release. GlaxoSmithKline welcomes Competition Bureau decision.
March 21, 2003. Reuters. Canada Will Not Challenge Glaxo Drug Export Ban.
March 13, 2003. Jake Ulick for CNN. Canada drug crackdown: Buying cheap drugs north of the border may become more difficult.
March 12, 2003. Thomas Burton for the Wall Street Journal. FDA Is Cracking Down On Drugs From Canada: Insurers That Help Americans Import Drugs May Be Held Liable.

WTO Dispute Settlement Cases

February 28, 2001 Arbitration on Under Article 21.3[c] of the Understanding on Rules and Procedures Governing the Settlement of Disputes
September 18, 2000. Report of the appelate Body
May 5, 2000, WTO Panel Report,WT/DS170/R-Canada-Patent protection of Pharmaceuticals, Complaint by the United States (Part 1), (Part 2)
March 17, 2000, WTO Panel Report, WT/DS114/R-Canada-Patent Protection of Pharmaceutical Products Complaint by the European Communities and their Member States
November 12, 1998, DGI press release, European Union launches WTO panel against Canada protection. This and the following items concern the Canadian practice of permiting companies to manufacture and store or export pharmaceuticals prior to expiration of patent in Canada. Canada does not permit a generic drug to be sold in Canada until after the patent expires.
November 12, 1998, the Canadian Drug Manufacturers Association (CDMA), press release, Generic Drug Industry confident European Union's attempt to delay entry of generic drugs to market will fail .
December 2, 1998. A WTO Dispute:
European Communities - Patent Protection for Pharmaceutical and Agricultural Products, complaint by Canada (WT/DS153/1). This dispute, dated 2 December 1998, is in respect of the protection of inventions in the area of pharmaceutical and agricultural chemical products under the relevant provisions of EC legislation, particularly Council Regulation (EEC) No. 1768/92 and European Parliament and Council Regulation (EC) No. 1610/96, in relation to EC obligations under the TRIPS Agreement. Canada contends that under the above Regulations, a patent term extension scheme, which is limited to pharmaceutical and agricultural chemical products, has been implemented. Canada alleges that Regulations (EEC) No. 1768/92 and (EC) No. 1610/96 are inconsistent with the EC's obligations not to discriminate on the basis of field of technology, as provided by Article 27.1 of the TRIPS Agreement, because these Regulations only apply to pharmaceutical and agricultural products.
December 19, 1997, at the WTO:
Canada - Patent Protection of Pharmaceutical Products, complaint by the European Communities (WT/DS114/1). This request, dated 19 December 1997, is in respect of the alleged lack of protection of inventions by Canada in the area of pharmaceuticals under the relevant provisions of the Canadian implementing legislation (in particular the Patent Act). The EC contends that Canada's legislation is not compatible with its obligations under the TRIPS Agreement, because it does not provide for the full protection of patented pharmaceutical inventions for the entire duration of the term of protection envisaged by Articles 27.1, 28 and 33 of the TRIPS Agreement. On 11 November 1998 the EC requested the establishment of a panel.

Canadian Government Documents

Articles and Briefs

June 30, 2004. Aidan Hollis, University of Calgary. How Cheap Are Canada's Drugs Really?
March 15, 2004. Kevin Libin for the Toronto Star. Patently Absurd.
March 27, 2003. Leonard Zehr for the Globe and Mail. Canada lags in pharma R&D: report.
June 10, 2003. Glen McGregor for the Ottowa Citizen. Bureaucrats misleading on patent drugs, MPs say.
February 23, 2003. The Toronto Star. Drug patent laws fair, health minster says.
January 24, 2003. Letter to the editor of Forbes from the Canadian Generic Pharmaceuticals Association. CGPA Responds to "Cheap Drugs Myth" Article.
January 21, 2003. Toronto Star. Glaxo backs off threat to Internet sellers.
January 21, 2003. Julie Appleby for the USA Today. Glaxo wants to keep cheap drugs out of USA.
January 16, 2003. Op-ed by Ira Carnahan in Forbes Magazine. The Cheap Drugs Myth. Also see the response to the ip-health email list from Joel Lexchin.
October 22, 2002. Joel Baglole for the Wall Street Journal. Canadians Express Concerns About Drug Imports by U.S.
October 19, 2002. Glen McGregor for the Ottowa Citizen. Generic drug group vows to save us $1B.
September 25, 2002. Canada's Research-Based Pharmaceutical Companies. Canada's Innovative Pharmaceutical Industry: A New Deal for Canadians. Also see the following News Stories:
- September 25, 2002. Ian Jack for the Financial Post. Drug firms want federal help to fend off generics: Promise to double R&D.
- September 25, 2002. Simon Tuck for the Globe and Mail. Drug industry offers to boost R&D spending.
May 14, 2002. Ontario College of Pharmacies press release. Charges Laid Against the Canadian Drug Store Inc. for Operating an Illegal Internet Pharmacy.
September 7, 2001. William Langbein for Reuters Health. Web Company Offers Drugs in U.S. at Canadian Prices.
January 20, 2002. Glen McGregor form the Ottowa Citizen. Take two patents ... and call me next year: The never-ending war to redraw Canada's arcane drug patent laws.
August 29, 2001. Tom Blackwell for the National Post. Consumers pay price as red tape delays drugs.
November 1996, Joel Lexchin, M.D., BILL C-91 coming up for review: Drug firms wallowing in profits -- but they want more, from The CCPA Monitor. See also: Lexchin J. Pharmaceuticals, patents and politics: Canada and Bill C-22. International Journal of Health Services 1993;23:147-60, and Lexchin J. After compulsory licensing: coming issues in Canadian pharmaceutical policy and politics. Health Policy 1997;40:69-80.
May 3, 1996, Ed Hore, Brief of the Canadian Drug Manufacturers Association with respect to the size, shape and colour of generic drugs (Draft)

PhRMA Submissions on Canada

February 18, 2000, 301 Submission to USTR
December 3, 1999, 2000 NTE Submission to USTR
February 16, 1999, 301 Submission to USTR
December 4, 1998, 1999 NTE Submission to USTR

Canadian Drug Industry

Canadian Drug Manufacturers Association (CDMA) This group represents the Canadian generics industry.
Canada's Research Based Pharmaceutical Companies

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