The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: market exclusivity

Canada’s Data Protection Regulations Upheld Against Court Challenge

Scale_of_justiceJPEGLast Friday* the Federal Court of Canada upheld the constitutional validity of Canada’s Data Protection Regulations, dismissing the applications of the Canadian Generic Pharmaceutical Association and Apotex Inc.

Canada’s data protection regime provides innovative drugs with:

  • a six-year data exclusivity period;
  • an eight-year market exclusivity period; and
  • an additional six-month period of market exclusivity in some cases for pediatric applications.

The Data Protection Regulations were enacted in 2006 to bring Canada into compliance with its TRIPS and NAFTA obligations.  Here’s today’s press release from Rx&D.

*The decision has not yet been posted. The citation will be 2009 FC 725.

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