Patented Medicines Regulations

5 (1) For the purposes of subsection 88(1) of the Act, information concerning the identity of any licensee in Canada of the rights holder and the revenues and research and development expenditures of the rights holder shall indicate

• (a) the name and address of the rights holder and their address for correspondence in Canada;

• (b) the name and address of all licensees in Canada of the rights holder;

• (c) the total gross revenues from all sales in Canada during the year by the rights holder of medicine for human and veterinary use and the total revenues received from all licensees from the sale in Canada of medicine for human and veterinary use; and

• (d) a summary of all expenditures made during the year by the rights holder towards the cost of research and development relating to medicine for human or veterinary use carried out in Canada by or on behalf of the rights holder, including

  • (i) a description of the type of research and development and the name of the person or entity that carried out the research and development,

  • (ii) the expenditures of the rights holder or the person or entity that carried out the research and development, in respect of each type of research and development, and

  • (iii) the name of the province in which the research and development was carried out and the expenditures in that province by the rights holder or the person or entity.

(2) The information referred to in subsection (1) shall be provided for each calendar year and shall be submitted within 60 days after the end of each calendar year.

(3) The total gross revenues referred to in paragraph (1)(c) shall comprise revenues from sales of medicine

• (a) for which a drug identification number has been issued under the Food and Drug Regulations or which has been approved for sale to qualified investigators under those Regulations;

• (b) that is used in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or the symptoms thereof or in the modification of organic functions in humans or animals; and

• (c) the sale of which is promoted by any means to physicians, dentists, veterinarians, hospitals, drug retailers or wholesalers or manufacturers of ethical pharmaceutical products.

(4) For the purposes of paragraph (1)(d), the rights holder shall specify

• (a) the total capital expenditures on buildings and the annual depreciation of the buildings which depreciation shall be calculated at an annual rate of four per cent for a maximum of 25 years;

• (b) the total capital expenditures on equipment; and

• (c) the source and amount of the funds for expenditures made by the rights holder towards the cost of research and development.