By David Ljunggren
OTTAWA, Nov 8 (Reuters) - Canada's Supreme Court struck down
the patent on global pharmaceuticals giant Pfizer Inc'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 Ltd - 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.
"Pfizer 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.
"As 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.
"Pfizer 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.
Company spokeswoman Christina Antoniou, citing commercial
confidentiality, declined to say how much the Canadian Viagra
market is worth.
Pfizer's Canadian patent - which came into force in 1998 -
was divided into seven parts and covered 260 quintillion
different chemical compounds.
But 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.
"Even 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."
LeBel - 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.
Teva 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 comment.
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 (U.S.) sales, but it'll be minimal," Conover added.
Even 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.
Viagra is Pfizer's sixth-biggest medicine, with annual sales
of about $2 billion. Its sales have been crimped by competition
from Eli Lilly and Co's longer-acting Cialis.
The case is 33951, Teva Canada Ltd against Pfizer Canada Inc
et al.
(Additional reporting by Debra Sherman)
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