The Patented Medicine Prices Review Board acted outside its authority in attempting to regulate unpatented medications, the Federal Court of Appeal has ruled. Blacklock's Reporter says Justice David Stratas, in a strongly worded decision, concluded the agency violated the Patent Act in pursuing a pharmaceutical company under the guise of consumer protection.The case, brought by Galderma Canada, a subsidiary of a Swiss pharmaceutical firm, challenged the board’s demand for pricing disclosures related to an acne gel called Differin. The gel’s patent expired in 2009, exempting the company from further reporting to the board. Despite this, the board issued a request in 2016 for continued disclosure, which Galderma refused.“This was understandable,” wrote Stratas in his ruling, stating the Board overstepped its authority. “The Patented Medicine Prices Review Board regulates the pricing of medicines under the market power given by a patent, namely patented medicines. The board does not regulate the pricing of unpatented medicine. After all, it’s right in the board’s name.”Federal lawyers argued that a newly patented version of Differin with a slight formulation change — from 0.1% to 0.3% adapalene, a vitamin derivative — fell under the Board’s jurisdiction.Stratas dismissed the argument, clarifying the board’s mandate does not extend to unpatented drugs.“The board’s work protects consumers of patented medicines,” wrote Stratas. “The prices of patented medicines are lower than they might otherwise be. But focusing on those effects to define the board’s mandate would be to let the tail wag the dog.”The decision emphasized that the board does not have a general mandate for consumer protection or price regulation. “The Constitution, the Patent Act, and jurisprudence under each is clear,” stated the ruling. “Freestanding consumer protection and general price regulation are provincial responsibilities unless justified by an emergency, national concern, or another specific federal power, none of which apply here.”The court ordered the board to pay $20,000 in costs and criticized its overreach. “The board has an important mandate,” wrote. “But the board must temper its dedication and enthusiasm with a firm and unwavering obedience to legality and the rule of law.”
