March 21, 2007
For Immediate Release
Apotex Invalidates Norvasc® Patent
Company to Launch In Near Future
Weston,
FL (March 21, 2007) — Apotex Corp. announced today the
Federal Circuit Court of Appeals in the
case of Pfizer, Inc. v. Apotex, Inc. reversed a trial court's ruling and
found that Pfizer's U.S. Patent 4,879,303
(the ‘303 patent) covering the Pfizer product Norvasc® was invalid. The
‘303 patent covers amlodipine
besylate the active ingredient in Norvasc® as well as tablets made from
amlodipine besylate. Because the
limiting patent expires in two days, no company will have exclusivity
over the product. Apotex expects to
launch the product in the very near future.
The Federal Circuit found that Apotex had proven that the ‘303 patent was
invalid because it was obvious. In
other words, the patent should never had been issued because someone skilled in
the art would have known to
make amlodipine besylate from materials, called prior art, that were publicly
available. The Federal Circuit
cited as some of the prior art an earlier Pfizer patent that taught amlodipine
maleate as well as amlodipine with
other pharmaceutically acceptable salts. The earlier Pfizer patent did not
specifically mention besylate but the
Court found that it was sufficient that besylate salt was discussed in other
pieces of prior art.
By finding the Pfizer ‘303 patent invalid and not infringed by Apotex's ANDA,
the Court is allowing Apotex to
obtain final approval for its generic amlodipine besylate product. By finding
Pfizer'303 patent invalid the Court
also causes Pfizer to loose the additional six months of pediatric exclusivity
that they had obtained.
"Our pursuit of this case after losing at the District Court level was rooted
in Apotex's belief that the right thing
to do for consumers and customers is to never, ever stop fighting to bring
generics to market at the earliest
possible time," said Apotex CEO Barry Sherman. “There was no guarantee when we
appealed the case that we
would be able to enter the market if we won. The odds, in fact, were against us
achieving that outcome. But we
believed we have an obligation to consumers to keep fighting, and are extremely
pleased that our victory in the
courts will bring significant savings in short order to the US health care
system."
"It goes without saying that we will continue to press on all fronts for
changes in the US legislative and
regulatory framework that will better serve consumers . The commitment to the
consumer that guided our
actions in this case will continue to guide our efforts in Washington, DC, for
instance, to work with
policymakers to put an end to anti-competitive patents settlements that delay
consumer access to affordable,
quality generic medicines," Sherman added.
"Today's decision also has implications for the outcome of the clopidogrel
case as some of the same legal
principles are at stake in that trial. As today's ruling underscores, consumers
can be sure we will do everything
in our power to prevail in that case as well," Sherman added.
The Apotex Group manufactures more than 200 different high-quality generic
pharmaceuticals, used by
millions of patients worldwide. Its product line includes oral solids, liquids,
injectables, nasal sprays,
opthalmics, and inhalation solutions.
Norvasc® is a registered trademark of Pfizer, Inc.
Apotex
Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned
manufacturer of prescription drugs. Through its sales and marketing
headquarters in Weston, Florida and operations center in Indianapolis,
Apotex Corp. is committed to providing safe and affordable generic
medicines. Products manufactured and marketed by the Apotex Group are sold
in 115 countries around the world. For more information visit
www.apotexcorp.com.
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