Links + Resources

Canada's Biologics Portal

Gowling Lafleur Henderson LLP is pleased to provide a one-stop portal to information on the regulation of biologics, including subsequent entry biologics. Access presentations, legislation and guideline updates from Canada, the U.S., Europe and other international jurisdictions involved in regulating SEBs, as well as learn how Gowlings can help your company remain competitive in today's market.   Click here.
 

National Agricultural Biotechnology Council (NABC) - Road Forward gives an excellent example of different uses of bioproducts and industrial biotechnology. The document discusses the movement from a petroleum based economy to a more sustainable one relying on bioproducts in the context of new crops and bio-sources for value-added markets, and national benefits improving security, economy and environmental sustainability.

Published in the August 2009 monthly reporter newsletter to our members:

EXPERT OPINION

Court Upholds Data Exclusivity Rules for Pharmaceutical Manufacturers

By: Adrienne Blanchard , Partner, Gowlings Lafleur Henderson LLP

The Federal Court, in a decision released on July 17, 2009, has upheld Canada's Food and Drug Regulations as they relate to the protection of data that is submitted by innovators for the purpose of obtaining regulatory approval (the Data Protection Regulations).

Currently, the Data Protection Regulations, implemented on October 5, 2006, provide a period of 8 years of protection from the date of an innovator's first Notice of Compliance for an "innovative drug", and the possibility of a further 6 month period if studies are conducted in the pediatric population. During the period of protection, no competing manufacturer can compare its product to the innovative product in order to obtain approval. Effectively, this protects the underlying clinical trial and other data submitted by innovators from being relied upon by competitors seeking their own approvals. The system was implemented to bring Canada into compliance with its obligations to protect this information, as required by the North American Free Trade Agreement (NAFTA) and the World Trade Organization's Agreement on Trade-related Aspects of Intellectual Property (TRIPS).

Read the full text of this article in the latest edition of Pharmacapsules
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