|CPTech Pages on Canada|
|Extension of Data Exclusivity to 8 Years|
|Compulsory Licensing of Pharmaceuticals in Canada|
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".
|Efforts Against the Evergreening of Patents|
|Patent Dispute Over Cancer Screening Technology|
|Crackdown on Canadian Pharmacies Exporting to US Customers|
|WTO Dispute Settlement Cases|
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.
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|
|PhRMA Submissions on Canada|
|Canadian Drug Industry|