[Ip-health] Canada: Supreme Court ruling invalidating Pfizer patent on Viagra
relliott at aidslaw.ca
Thu Nov 8 15:12:02 PST 2012
As outlined in the article below, the Supreme Court of Canada issued a judgment today invaliding Pfizer's patent on Viagra on the basis that there had been inadequate disclosure in the patent claim. Full judgment in Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, is available at: http://scc.lexum.org/decisia-scc-csc/scc-csc/scc-csc/en/item/12679/index.do.
Pfizer girds for generic competition
as top court tosses Viagra patent
By Laura Stone | Nov 8, 2012 11:17 am
The Supreme Court of Canada has stripped pharmaceutical giant Pfizer Canada Inc. of its patent for Viagra, paving the way for generic versions of the erectile dysfunction drug and clarifying the law around patent protection.
While the ruling applies specifically to Pfizer, experts believe it sends a strong message to other pharmaceutical companies who may try to skirt the patent system by muddying what's actually in the invented product.
"What the court is saying more generally...is that we don't want people playing games with the patent system," said Richard Gold, a McGill University law professor and founding director of the Centre for Intellectual Property Policy.
"You can't start playing games and trying to hide what your invention is. More generally I think it's a message about, 'We're going to start watching you.'"
In a major victory for generic drug manufacturer Teva Canada Ltd., the high court ruled that Pfizer did not sufficiently disclose what makes the little blue pill work to help erectile dysfunction - meaning it is no longer protected under the Patent Act.
"I conclude that Patent '446 does not meet the disclosure requirements set out in the Act," Justice Louis LeBel wrote in the decision.
"I would therefore allow the appeal on the basis of insufficient disclosure."
The act stipulates that inventors must disclose specifically what's in a product in order to warrant the 20-year patent protection and a monopoly on the field. When the patent is up, anyone can recreate the product.
The decision opens up the possibility of other generic manufacturers creating the popular sex-boosting drug, subject to health regulations. Health Canada confirmed Thursday a Notice of Compliance (NOC) was issued to Novopharm, a subsidiary of Teva, for a generic version of Viagra - meaning it can start making the drug.
In a statement posted on the company website, Teva president and CEO Barry Fishman said he expects Teva's generic version of Viagra to be significantly cheaper.
"Through such litigation, generics have generated cumulative savings for Canadians of more than $20 (billion) compared to awaiting patent expiry," said Fishman.
"There's no doubt that legal challenges to brand drug patents result in a spillover benefit to patients, drug plans sponsors, and the health care system as a whole. Teva Canada will continue to lobby the Canadian government for policies and regulations that encourage its future investment in litigation to provide cost-effective generic products that save Canadians money."
Gold said the decision will clarify for lower courts the rules for patent protection and may impose more discipline on patent agents.
In the 7-0 decision, LeBel wrote that Pfizer obscured the true invention, by failing to state in clear terms what the invention was.
"Pfizer gained a benefit from the Act - exclusive monopoly rights - while withholding disclosure in spite of its disclosure obligations under the Act," he wrote.
"As a matter of policy and sound statutory interpretation, patentees cannot 'game' the system in this way."
In a statement, Pfizer said it was disappointed with the ruling and expects "to face generic competition in Canada shortly."
"Pfizer will continue to vigorously defend against challenges to its intellectual property," it said. "Patents provide a vital incentive for biopharmaceutical companies to invest in new and life-saving medicines that benefit millions of patients worldwide." A spokeswoman said the company does not release financial information about specific product sales in Canada.
In its original patent application in 1994, Pfizer included seven claims for Viagra. It included formulas for a massive number of compounds - 260 quintillion - down to two specific compounds, one of which was sildenafil, the chemical compound which makes up Viagra.
But in the patent application, Pfizer never specified which compound worked. It was granted a patent in 1998.
While Pfizer had argued that each claim in a patent application should be considered independently, the Supreme Court said Section 58 of the Patent Act in fact does not allow a court to consider each claim independently from another. Therefore, Pfizer did not sufficiently disclose what is in Viagra to warrant a patent.
Even though two of the claims in the patent application focused on specific compounds, Pfizer did not reveal which one made up Viagra.
"Further testing would have been required to determine which of those two compounds were actually effective in treated ED," wrote LeBel.
Teva began court proceedings in 2007. The Supreme Court overturned lower court rulings from the Federal Court and Federal Court of Appeal that had declared Pfizer's patent valid. The Federal Court suggested Teva had started the legal challenge too late, and the Court of Appeal said an individual claim was enough to warrant a patent.
Teresa Scassa, a law professor at the University of Ottawa who specializes in intellectual property, said she's not surprised by the ruling because the Supreme Court has been taking a firm line over the past few years in its intellectual property decisions.
She said the decision reflects the court's attempt to balance inventors' right and public interest.
"I think it's an evolving trend in their jurisprudence, which respects intellectual property rights and maintains their importance but also gives much more attention to the public interest and the interests of users than courts used to in the past," she said.
Pfizer's patent was set to expire in 2014. The company was also ordered to pay Teva's legal fees, as is standard.
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