PMPRB Confirms Jurisdiction Over Generic Manufacturers

Edited by Jane E. Clark and Graham Ragan

The Patented Medicine Prices Review Board (PMPRB) recently released its decision in a proceeding against Sandoz Canada, Inc. (PMPRB-10-D2-SANDOZ). With the Sandoz decision, the PMPRB continues its recent trend of extending the scope of its oversight to cover generic drug manufacturers.

In the Sandoz case, the PMPRB held that it could exercise its jurisdiction over Sandoz - a generic manufacturer affiliated with Novartis Canada and Novartis AG – so as to require Sandoz to report on its sales of patented medicines in Canada. The PMPRB considered a similar issue in the ratio-Salbutamol (PMPRB-08-D3-ratio-Salbutamol) and ratiopharm (PMPRB-08-D3-ratiopharm) decisions last year. In those decisions, the PMPRB concluded that generic manufacturers who sell patented medicines under a licence from the patent-holder fall under the definition of "patentee" found in section 79(1) of the Patent Act (the Act).