In the Matter of Sandoz Canada Inc.

The Patented Medicine Prices Review Board (the “Board”) commenced this proceeding against Sandoz by Notice of Application, seeking to require Sandoz to provide the information set out in the Patent Act (the “Act”) and the Patented Medicines Regulations, namely the average prices of various medicines sold by Sandoz.

Sandoz is a wholly owned subsidiary of Novartis Canada Inc., which is a wholly owned subsidiary of Novartis AG. The Panel determined that Sandoz is a patentee as defined in section 79(1) of the Act, although Sandoz does not own any patents, because Sandoz is entitled to the benefit of the patents in issue that are owned by Novartis. This is because, although there is no express licence or distribution agreement between Novartis and Sandoz, Novartis instructs Sandoz to enter the market to sell a particular medicine thereby granting an implied licence.

The Panel then determined that Sandoz was the patentee of patents that pertain to medicines sold by Sandoz. The Panel set out the test to determine whether a patent pertains to a medicine, which includes a patent that has not been used or is not being used because this patent prevents others from exploiting the invention.

The Panel rejected Sandoz’ argument that the regulation of prices of generic pharmaceutical products is unconstitutional.