May 11, 2022

Supreme Court clears production of cheaper generic Viagra

OTTAWA – The Canadian market for generic erectile dysfunction drugs was opened for business on Thursday after the Supreme Court of Canada struck down the Viagra patent held by pharmaceutical giant Pfizer.

Hours after Teva Canada, the Canadian pharmaceutical company, won its High Court appeal, it posted a notice of its own generic version on its website – the first commercial challenge to Pfizer’s 14-year monopoly on Viagra .

The Supreme Court, in a unanimous 7-0 decision, overturned Pfizer’s patent on Viagra, saying it was trying to “play” with the Canadian system. The High Court sided with Teva Canada’s challenge to the patent’s legitimacy, paving the way for cheaper generic versions.

The move has big implications for erectile dysfunction drug users and the pharmaceutical industry, as it allows companies to create generic versions that are generally cheaper for consumers.

Teva Canada did not immediately comment, but its website had a notice titled “Introducing Novo-Sildenafil”, a product it described as “a generic alternative to Viagra”.

The notice contained few other details except to say that the company’s products are available by prescription and that patients and customers are encouraged to discuss their options with healthcare professionals.

“Canadian consumers will save money on this product. There will likely be other generics involved soon enough,” said Richard Gold, intellectual property expert at McGill University in Montreal.

The move erases Pfizer’s market dominance with Viagra. His patent was due to expire in 2014.

Pfizer said it was disappointed with the decision.

“Pfizer expects to face generic competition in Canada shortly,” the company said in a statement issued by its New York office. “Pfizer will continue to vigorously defend itself against challenges to its intellectual property.

The case also has broad commercial implications for patent law.

The Patent Act grants a company a 16-year monopoly on a product if it can prove that it is a new invention. In return, the company must publicly show in its app how it created its product, so that others can copy it later.

“Pfizer has taken advantage of the law – exclusive monopoly rights – while denying disclosure despite its disclosure obligations under the law,” Judge Louis LeBel wrote on behalf of the tribunal.

“In terms of policy and sound statutory interpretation, patentees cannot be allowed to ‘play’ the system in this way. This is, in my opinion, the key issue in this appeal.

“Pfizer had the information necessary to disclose the useful compound and chose not to disclose it.”

That case revolved around whether Pfizer deliberately thwarted Teva’s ability to copy the drug’s key chemical compound.

Teva disputed the validity of Pfizer’s patent, saying it did not meet the disclosure requirements of the law.

In its original patent application, Pfizer listed an impressive number of chemical compounds, but did not specify which one actually worked – sildenafil.

Pfizer obtained the patent in 1998 after filing an application four years earlier. It was first challenged by the generic drug maker in 2007.

Teva initially challenged Pfizer’s patent in Federal Court and Federal Court of Appeal, but lost on both levels.

The decision sends a strong message to future patent applicants that the system’s “game” will no longer work, Gold said.

“This is particularly important in the pharmaceutical industry where manufacturers of branded products and generics play games, waste court resources, and invest money in litigation rather than actual research.”

Gold has said in recent years that several large companies have closed their research and development branches in the Canadian pharmaceutical industry.

“It’s a good day for Canadian patent law, for Canadian courts and for Canadians,” he said. “With this clear signal, the Court has put the emphasis of the patent system back on innovation and away from the game and strategy that only hurt Canadians.”

In its statement, Pfizer said the patent process spurs innovation.

“Patents are a vital incentive for biopharmaceutical companies to invest in new life-saving drugs that benefit millions of patients around the world. At Pfizer, we apply science and our global resources to improve health and wellness at every stage of life.


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