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Nearly eight million Filipinos have hypertension. Stressfully high medicine prices worsen their ailment. But relief is probably in sight. The state-owned Philippine International Trading Corp. is seeking to void the local patent of the hot-selling hypertension drug Norvasc. And it has strong legal basis for it.
The petition, pending at the Intellectual Property Office, is supported by Sen. Mar Roxas. It is similar to the cancellation last March of Norvasc’s US patent by the Court of Appeals for the Federal Circuit. If the
Norvasc manufacturer Pfizer Inc. expectedly will resist the PITC plea for patent annulment. But it already lost its
Taking the cue, the PITC in April asked the IPO to drop Norvasc’s local patent as well because the drug was not new, novel or inventive but instead “contrary to public order and morality.”
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Amlodipine is a member of a class of compounds referred to as dihydropyridines. Three
Granted in 1989, Norvasc’s
Norvasc, Pfizer’s No. 2 best-selling drug, has been posting annual sales of $2 billion since 2003. Last year the US Food and Drug Administration approved Pfizer’s combination therapy Caduet, which blends Norvasc and the cholesterol-lowering Lipitor, the No. 1 seller. Analysts suggest that Pfizer hopes to convert its Norvasc patients to Caduet before the patent protection expires.
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Norvasc sells for P41.41 per 5-mg tablet in the
“Hypertensive patients cannot afford to miss their expensive maintenance drugs even for a day,” Roxas says. “With the cancellation of the patent over Norvasc, they will benefit from reduced prices.”
During his term as Secretary of Trade and Industry, Roxas had initiated parallel importations of cheaper branded drugs from
PITC’s drug import budget grew six-fold under then-chairman, now Bulacan governor, Roberto Pagdanganan. The drug firms began to react — by lobbying against the parallel import program. At one time Pagdanganan bought seven tablets of Norvasc from
Pagdanganan also has helped strengthen Filipino drug makers, particularly those that produce generics. Without Norvasc’s patent, the local makers may produce their own amlodipine besylate.
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Roxas derives his figures on hypertensive patients from the health department. The 7.76 million sufferers comprise almost one-fifth of the adult population.
“Diseases of the heart and of the vascular system remain the two top causes of death in the
From records of the National Statistics Coordinating Board, 342,284 Filipinos died of ailments related to hypertension in 2004, or a morbidity rate of 428 per 100,000-population. Heart diseases caused 70,138 deaths, and of the vascular system, 49,519 in 2002.
Roxas is pushing amendments to the Intellectual Property Code, akin to the
One of Roxas’ amendments is a new provision that specifies: “There is no inventive step if the invention results from mere discovery of a new form or a new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of a new use for a known substance or a known process unless such process results in a new product that employs at least one new reactant.”
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