PITC files landmark patent case against Norvasc

BY REAGAN D. TAN, BusinessWorld Reporter State-owned Philippine International Trade Corp. (PITC) has filed what it claimed was a "landmark" case at the Intellectual Property Office of the Philippines (IP Philippines) to nullify the patent of Norvasc, Pfizer (United Kingdom) Ltd.’s anti-hypertension drug. The patent of Norvasc — which carries the generic name amlodipine besylate — in the country will expire on June 13. But PITC and government lawyers said that they will pursue the case since it will "make sure that companies cannot claim patents on products that are not a product of an invention." "Bottom line is to set a precedent in terms of unlawful and abusive practices of pharmaceuticals that fool people because of [having] a patent," Government Corporate Lawyer Alberto C. Agra said. The case sought to declare that one of the active ingredients in Norvasc — besylate salt — is not patentable because it is 1) not a new invention; 2) scientifically obvious that the ingredient will lead to such a therapeutic effect; and 3) contrary to public order. "As early as 1977, or long before its application, the salt besylate was already recognized by the US Food and Drug Agency," a PITC statement outlining its petition read. "By seeking to patent a product that is neither new nor inventive, Pfizer Ltd., in effect, would like to unconsciously and unreasonably indefinitely extend — if not perpetually — its exclusive rights over [the] product." Mr. Agra said the case stemmed from the decision of the United States Court of Appeals for Federal Circuit last March 22 to nullify the patent for amlodipine besylate. The US Court upheld the petition of Apotex, Inc., a Canadian generic drug maker, challenging the patent of Pfizer on the ingredient. "We believe we have a strong case," Mr. Agra said. State lawyer, Reginald Jeremy Wan said Norvasc’s Philippine patent was based on its US patent and that the US court’s decision strengthened PITC’s case. Mr. Wan said winning the case would lower the price of the anti-hypertension drug or its generic counterparts. Pfizer Philippines declined to comment at this time, saying the company had yet to receive a copy of the petition. Its legal counsel Ramon S. Esguerra was not available as of press time. Meanwhile, the Pharmaceutical Healthcare Association of the Philippines (PHAP), which represents major drug firms in the country, also declined to comment on the development. Surprise move For its part, the Philippine Chamber of the Pharmaceutical Industry, Inc. Director William P. Fabroa said the government’s move was a "surprise." The association represents organization of pharmaceutical manufacturers and distributors. He also downplayed a possible favorable action on the petition from the IP Philippines. "A petition like that cannot actually change the law. It is surprising. I don’t think IPO can do anything about that," he told BusinessWorld. "The effect is nothing at this point. The industry won’t release a patented product. There is no way we can do it since there is no available raw materials to produce. The industry will wait for the patent to expire," he added. In a separate interview, Xeno Pharmaceuticals Philippines, Inc. Chairman Amado Tadena said it was better for the government to have taken the legislative tack by passing a law that would help local medicine manufacturers bring down the costs of drugs. "I don’t know what they are trying to do. I don’t think it is possible to void a patent. That would be a violation of intellectual property rights," he said. "The best is to wait for the patent to expire next month and file for generic equivalents after the patent expiration. It is just one month to wait and not violate the law is much better for the industry," he added. Parallel importation Senate Bill 2139 by Sen. Manuel A. Roxas II pushes for parallel importation of drugs through amending the Intellectual Property Code of the Philippines. Under a parallel importation scheme, variants of the same drug sold cheaper in other countries where its patent has expired may be imported. The bill is pending at the House of Representatives. Norvasc generates P1 billion in sales annually for Pfizer. Pfizer Philippines sued PITC last year after the government company purchased samples of Norvasc from India under a parallel importation scheme before the expiration of Pfizer’s local patent for the drug locally. The PITC claims that Norvasc purchased abroad would cost the equivalent of P10 as opposed to the P45 drug sold in the country by Pfizer Philippines. PITC Vice-President Teddie E. Rivera told reporters that the government firm was also considering lawsuits against other Pfizer drugs such as cholesterol drug Lipitur (generic name Atorvastatin). "We have a technical working group with the IP Philippines to see which drugs are going to expire soon," he said. IP Philippines Director-General Adrian S. Cristobal, Jr., said in a text message that he has ordered the IP Philippines’ Bureau of Legal Affairs to "proceed with dispatch on this petition." Mr. Agra said the government was hopeful that the IP Philippines would act on the matter before the expiration of Norvasc on June 13. — with Ruby Anne M. Rubio/BusinessWorld