26/11/2012
The Supreme Court of Canada has unanimously decided that drug giant Pfizer Canada Inc.’s patent on Viagra is invalid, opening the door to less expensive, generic versions of the little blue pill to become available on the Canadian market.
The 7-to-0 decision, announced Thursday, means that generic drug company Teva Canada Limited will be allowed to market its own version of the erectile dysfunction drug onto the Canadian market. And just hours after the decision, Teva Canada posted a notice to its website introducing “a generic alternative to Viagra.”
The top court issued the decision in response to a challenge to Pfizer’s Canadian patent by the generic drug company. Teva Canada had argued in an April hearing that the Viagra patent was invalid because Pfizer did not disclose sufficient information when it applied for it, in violation of the Patent Act.
Specifically, Teva said Pfizer did not sufficiently disclose the exact compound that is effective in treating erectile dysfunction, sildenafil, among a list of 260 quintillion chemical compounds named in the patent, according to court documents.
And the Supreme Court agreed, even though the lower courts had previously ruled in favour of Pfizer, whose patent was set to expire in 2014.
“Pfizer had the information needed to disclose the useful compound and chose not to release it. Even though Pfizer knew that the effective compound was sildenafil at the time it filed the application, it limited its description,” Justice Louis LeBel wrote in the decision.
“If there is no quid – proper disclosure – then there can be no quo – exclusive property rights.”
Pfizer is disappointed with the ruling and expects to face generic competition in Canada shortly, the company said in a statement Thursday.
“Pfizer will continue to vigorously defend against challenges to its intellectual property. Patents provide a vital incentive for biopharmaceutical companies to invest in new and life-saving medicines that benefit millions of patients worldwide,” the company said.
The company is also on the hook for Teva’s court costs.
The ruling is great news for generic drug companies and for consumers, and Canadians are likely to see more generic drugs coming onto the Canadian market as a result, said Eugene Meehan, a partner at Supreme Advocacy LLP in Ottawa, and former executive legal officer at the Supreme Court
But, more broadly, the decision clarifies the disclosure requirements of all patents, he said.
There has been a “certain complacence” amongst patent lawyers that if the disclosure information was sufficient to satisfy the patent office, then that patent was unassailable, Meehan said.
“The Supreme Court of Canada is saying that these patents may not be as rock solid as previously thought,” Meehan said.
“The decision is a legal earthquake in the patent world – it’s like hurricane Sandy blew through the Patent Act.”
While recognizing that there must be a balance between the rights of the innovators and of the public, the court’s central message is that companies and researchers should not be allowed to game the system, said Richard Gold, a patent law expert and professor in the faculty of law at Montreal’s McGill University.
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