Manila Times – May 9, 2007

The Philippine International Trading Corp. on Tuesday petitioned the Intellectual Property Office for the cancellation of Pfizer Ltd. (UK) patent for Norvasc, a hypertension maintenance drug.

The agency said it has filed the petition on three grounds: the drug is not new and novel, is obvious and noninventive, and contrary to public order and morality, referring to Pfizer’s Amplodipine besylate, which is an inactive ingredient of Norvasc.

“Amplodipine besylate is merely a variation of the molecule ‘amplodipine,’ combining it with salt ‘besylate’ instead of another salt. [Besylate] was already known and recognized as a pharmaceutically acceptable salt long before Pfizer Ltd.’s patent application,” Teddie Elson Rivera, PITC officer in charge, stressed in a press briefing, PITC imports branded drugs such as Norvasc from authorized dealers in India and Pakistan for as little as P11 per 5 mg. The brand is being sold at major drugstores here for P45 per 5 mg, while its generic version manufactured by Unilab Philippines sells for P17.50.

Rivera revealed that only 3 percent to 4 percent of the population buys generic medicines “unlike in the US and other countries where majority of the population buys generic drugs.”

He added that Pfizer has sent a legal letter to 10 local pharmaceutical companies in connection with the suit it filed against PITC and the Bureau of Food and Drugs for distributing Norvasc (amplo-dipine besylate) allegedly without the authority of the patent owner.

“Once the patent for Amplo-dipine besylate is canceled, those 10 companies are more than prepared to produce the same drug of Norvasc at a much affordable price.”

Rivera said that once PTIC’s petition is granted, the infringement case against the agency at the Makati Regional Trial Court will be trashed. “It would be a double victory,” he said.

In a related development, the US Court of Appeals upheld the petition of Apotex Inc., a Canadian generic drug maker that challenged the patent of Pfizer on amplodipine besylate. The American appellate court stated that indeed there was nothing new on its invention and, thus, does not deserve a patent right.

Norvasc in the Philippines will expire in June this year, while Oxfam, an international nongovernment organization for affordable medicines, said the IPO should act immediately to allow cheaper generic competition even before the patent expires next month. 
--Katrina Mennen A. Valdez