In a recent decision, the Patented Medicine Prices Review Board (PMPRB) has ruled that it has jurisdiction over products sold in the U.S., but imported into Canada under Health Canada's Special Access Program (SAP).
The recognized benefits of these agreements will provide accelerated access to information and thus make it easier and quicker to protect public health and improve performance and safety.
Under section 83 of the Patent Act, the Board has the power to issue a remedial order where it finds "that a patentee of an invention pertaining to a medicine is selling the medicine in any market in Canada at a price that, in the Board's opinion, is excessive…"
Celgene Corporation argued that the PMPRB does not have jurisdiction over the pricing of its oncology product, Thalomid, on the grounds that:
a- The sales of Thalomid occurred in the U.S. and not in Canada; and
b- Thalomid has only been available under the SAP and has not been commercially marketed pursuant to a Notice of Compliance.
On the first point, the Board found as a fact that under the rules of commercial law, the locus of the sales was the U.S.; the invoices on sales of products delivered to patients in Canada were stamped "F.O.B. New Jersey." Nonetheless, it concluded that it is not restricted by the commercial common law pertaining to the locus of a sale and that its jurisdiction includes:
"… sales of medicines that are regulated by the public laws of Canada, that will be delivered in Canada, to be dispensed in Canada, and where, in particular, the cost of the medicine will be borne by Canadians - patients or taxpayers as the case may be."
On the second argument, the Board found that the sales were made in a "market" in Canada, even if not the commercial market but rather the more limited market available under the SAP, in essence, products supplied directly to patients.
There is a period of 30 days from the date of the decision during which Celgene may file for judicial review.
For more information, please see: http://www.pmprb-cepmb.gc.ca/CMFiles/Board_Order_-_Statutory_Filings_-_Jan_21_0838JOP-1302008-6347.pdf