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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 Philippines follows suit, the PITC can now legally import Norvasc at only one-eighth its usual price. Filipino generic drug makers also would be able to produce it locally.

Norvasc manufacturer Pfizer Inc. expectedly will resist the PITC plea for patent annulment. But it already lost its US license when a three-man panel ruled that Norvasc’s active ingredient, amlodipine besylate salt, was not the result of discovery but of predictable experiment, with the result obvious and not novel. The magistrates also found the patent unenforceable due to Pfizer’s alleged inequitable conduct before the US Patent and Trademark Office.

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 US district courts earlier disallowed three drug makers from producing amlodipine besylate on grounds of patent infringement. One of the three was a generic maker that used an alternative besylate salt version.

Granted in 1989, Norvasc’s US patent would have run till Sept. 27, 2007. But the US appeals court ruling now allows Pfizer competitors to produce it and openly fight for market shares. In the Philippines, Norvasc’s patent is set to expire on June 17, 2007, but the PITC earlier had complained that Pfizer was working to extend it.

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 Philippines. Roxas says the same Norvasc formulation retails in India for only P5.77. The PITC should be allowed to legally import from India, he adds, “to benefit 7.76 million hypertensive Filipinos.”

“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 India and Pakistan. With an import outlay in 2000 of only P50 million, however, the PITC hardly made a dent in its aim of influencing pharmaceutical firms to cut prices.

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 India for testing on efficacy in local laboratories. Pfizer promptly sued him for copyright infringement.

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 Philippines,” Roxas says. “Hypertension is the fifth leading cause of morbidity.”

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 US appellate court’s basis for canceling drug patents. The revisions passed the Senate but stalled at the House of Reps.

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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