The federal government will have to overhaul its regulatory approach and guidelines over patented drug pricing after the Quebec Court of Appeal found a couple of provisions to be unconstitutional and outside the scope of federal jurisdiction over patents, according to a legal expert.
The Appeal Court ruling, expected to have a significant impact on the pharmaceutical industry in Canada, upheld the constitutionality of the legislative framework of the Patented Medicines Prices Review Board(PMPRB) and it current regulations. In a unanimous decision, the Appeal found that controlling abusive pricing of medicines resulting from a monopoly conferred by a patent has a logical, real and direct connection with federal jurisdiction over patents and does not constitutionally encroach on provincial jurisdiction.
Seven pharmaceutical companies, along with a string of intellectual property organizations and patients’ groups acting as interveners, that challenged the constitutionality of new regulations intended to lower patented drug prices were rebuffed after Quebec Superior Court found that the price control of patented drugs falls within the scope of the federal government’s powers over patents.
The long-awaited decision will likely have a substantial impact on the pharmaceutical industry in Canada, will compel Ottawa to overhaul its regulatory approach and guidelines over patented drug pricing, and may even broaden the federal government’s reach to regulate other intellectual property, according to legal experts.
The Federal Court has plainly and forcefully struck down the approach used by the Canadian Intellectual Property Office (CIPO) to patent claims in a decision widely expected by the patent bar to have far-reaching implications, particularly for computer-implemented inventions.
An international agreement signed by Canada and 16 other countries is widely expected to simplify and speed up the patent prosecution process while yielding significant cost savings to patent applicants at a time when intellectual property has become the backbone of innovative companies.