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May 17, 2007: Close on the heels of
Brazil and Thailand, Philippines too is seeking to
break the patent monopoly of a blockbuster drug so
that they can avail the anti-hypertension medicine
at affordable costs.
Philippine International Trading Corp. (PITC), a
state-owned company, wants regulators to cancel
the patent held by pharmaceutical giant Pfizer on
one of its largest drug Norvasc.
PITC urged the Intellectual Property Office to
cancel the US-based company's exclusive patents on
amlodipine besylate (the active substance in
Norvasc) so that Filipino pharmaceutical firms can
import or produce cheaper alternatives of the
medicine.
The Philippine patent, granted in June 1990 and
expiring next month, is held by its British unit,
Pfizer Ltd. UK. PITC argued that the patent for
Norvasc was "neither new and novel nor
non-inventive."
A Norvasc tablet costs about one dollar in the
Philippines but only some 10 cents in India, PITC
said on its website. PITC says multinational drug
companies control around 70 percent of the
Philippines' pharmaceutical market.
The world’s top drug maker has been embroiled in a
series of litigations pertaining to Norvasc of
late. Recently, a federal court in North Carolina
upheld Pfizer's patent covering amlodipine
besylate, prohibiting the US subsidiary of Synthon
from launching a generic version of the drug until
September 2007.
The patent covers the besylate salt of amlodipine,
its pharmaceutical composition with a diluent or
carrier, and its tablet formulation consisting of
an anti-hypertensive, antiischemic or
angina-alleviating effective amount of the API.
Before that a federal court jury in Virginia ruled
that Pfizer did not infringe on another patent
owned by Synthon covering a process which Pfizer
has been using for over 15 years for making
amlodipine, and found that patent invalid on
multiple grounds.
Synthon unsuccessfully argued that Pfizer's patent
is invalid because of obviousness and the lack of
adequate written description. The court ruling in
North Carolina is subject to appeal.
Norvasc accounts for $4.71bn (€3.66bn) of Pfizer's
$51.3bn 2005 revenue.
Recently, Brazil decided to issue a compulsory
license for the import or manufacture of generic
versions of another US firm Merck’s efavirenz.
Brazil's health ministry plans to import a generic
version of efavirenz from India, paying about 45
cents per pill, and may also start making its own
copy of the drug after rejecting the New
Jersey-based Merck& Co’s offer to cut its $1.59
per pill price by 30 percent. Brazil wanted to pay
what Merck charges Thailand--$0.65 per pill.
Last year, Thailand had taken a similar decision.
Other countries, including Canada and Italy, have
also used a clause in World Trade Organization
rules to flout drug patents in the name of public
health.
BY OUR PHARMA CORRESPONDENT
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