Declaring an attempt at negotiating a voluntary licence under Canada's Access to Medicines Regime

The pharmaceutical company must complete and submit to the Commissioner of Patents a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act. The form sets out the information that must appear in the declaration, including that the company

• unsuccessfully sought a voluntary licence from the patent holder or holders at least 30 days prior to the date of the application; and
• provided the patent holder or holders with information that is substantially the same as in its application.

An attempt to negotiate a voluntary licence is required to comply with Article 31(b) of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).