Ottawa - Canada's Supreme Court struck down the patent on global
pharmaceuticals giant Pfizer's Viagra erectile dysfunction drug on
Thursday and opened the door to generic competition.
The court backed an appeal by
Israeli-based Teva Pharmaceutical Industries - the world's largest
generic drug maker - which argued Pfizer had been too vague when filing
its patent, which runs out in 2014 in Canada.
In a unanimous 7-0 verdict, the court said Pfizer had not provided enough details to identify the active ingredient in Viagra.
gained a benefit from the [patent] act - exclusive monopoly rights -
while withholding disclosure in spite of its disclosure obligations
under the act," Justice Louis LeBel wrote on behalf of the court.
a matter of policy and sound interpretation, patentees cannot be
allowed to 'game' the system in this way ... [the patent] is invalid."
In the past, Pfizer has successfully defended patent lawsuits from Teva in the United States, Spain, Norway and New Zealand.
expects to face generic competition in Canada shortly. The company...
is disappointed with the court's ruling," the firm said in a statement
e-mailed to Reuters.
spokesperson Christina Antoniou, citing commercial confidentiality,
declined to say how much the Canadian Viagra market is worth.
Canadian patent - which came into force in 1998 - was divided into
seven parts and covered 260 quintillion different chemical compounds.
only one of the compounds - sildenafil - was active and the court said
the patent had not provided enough information to allow another company
to produce Viagra.
"Pfizer had the information needed to disclose the useful compound and chose not to release it," the ruling said.
though Pfizer knew that the effective compound was sildenafil at the
time it filed the application... it chose a method of drafting that
failed clearly to set out what the invention was."
- who said "wilful intent to mislead has not been alleged or proven in
this case" - noted that Pfizer's submission to the Supreme Court had
offered no explanation for withholding the information.
took the case to the Supreme Court after two lower courts in Canada
ruled against it. No one at the firm was immediately available for
Damien Conover, an
analyst at Morningstar, said he expects the Canadian ruling to have
minimal impact on Viagra sales in the United States, even though people
are more likely to buy "lifestyle" drugs such as Viagra as generics than
they are to buy generic life-saving drugs.
"But I think it'll be a minor impact. I can't say how much it will hurt [US] sales, but it'll be minimal," Conover added.
Teva isn't expected to gain much, said Kevin Kedra, an analyst at
Gabelli & Co. "I don't think this is something that will move the
needle for either company," he said.
is Pfizer's sixth-biggest medicine, with annual sales of about $2bn. Its sales have been crimped by competition from Eli Lilly and
Company longer-acting Cialis.