A strong intellectual property regime is essential to the success of Canada’s biotechnology industry. BIOTECanada works to ensure adequate IP protection for Canadian innovators.
BIOTECanada Granted Leave to Intervene Merck Frosst Canada Ltd vs. The Minister of Health
BIOTECanada has been granted leave to intervene in the case of Merck Frosst Canada Ltd vs. The Minister of Health. The case involves the release, under an Access to Information request, of confidential business information contained within a regulatory file held by Health Canada. Given the importance of confidential trade secret information to the developers of biotechnology applications across health, agricultural and industrial biotechnology sectors, BIOTECanada sought leave intervene in this case before the Supreme Court on behalf of our diverse membership and in support of a predictable, science-based regulatory system for biotechnology products.
Read our brief prepared by Gowling Lafleur Henderson LLP
Read our intervener factum prepared by Gowling Lafleur Henderson LLP
Read the expert opinion by Peter Wilcox from Torys to learn what this means for Canada, and the world.
Ownership and Use of Intellectual Property and Proprietary Data Related to Agricultural Biotechnology Products
As agricultural biotechnology matures and moves into a second generation of products, innovator companies may discontinue or replace some original products. As a result, "follow-on" versions of first generation products may be submitted for approval by third parties.
The development of follow-on agricultural biotechnology products has implications for the approval process, stewardship responsibilities and related issues in Canada. Since agricultural biotechnology products must be approved prior to commercialization using safety data submitted by the applying company, the data used for regulatory decisions has value as intellectual property (IP) and the rights of the innovator company to the ownership of the data or IP must be respected.
The issues surrounding data ownership are the same irrespective of the patent status of any particular product. In order for the discussion around follow-on agricultural products to progress, BIOTECanada urges that ownership of data packages submitted by innovator companies as a condition of regulatory approval be definitively established. Data protection and use, and the type of data packages acceptable for approval are additional items that require consideration.
Intellectual Property Law and the Pharmaceutical Industry: An analysis of the Canadian Framework Dr. Lybecker