One of the world’s pharmaceutical giants, Pfizer, owns a patent for the anti-cholesterol drug “Atorvastatin Calcium” under Warner Lambert, which is valid and is in force until September 2012 in the Philippines. Pfizer marketed this drug under the brand Lipitor.
The largest Philippine drug-maker, United Laboratories Inc. (Unilab), started selling in 2009 the generic version of the anti-cholesterol drug “Atorvastatin Calcium” under the brand Avamax. Subsequently, Pfizer filed an infringement case against Unilab for selling Avamax and the case is still pending before the Intellectual Property Office of the Philippines.
While the patent infringement case is still pending, Pfizer also filed a court injunction to temporarily stop Unilab from selling Avamax. Pfizer also demanded retail drugstores to stop selling the generic drug. Pfizer warned the drugstores that they would be contributing to the infringement of valid and existing patent and exclusive distribution rights, causing grave and irreparable damage and injury to them. Pfizer further demanded the drugstores to inform them in writing of their compliance with the foregoing request to stop selling the generic drug and indicate their willingness to execute an undertaking whereby they will forever desist promoting, advertising, distributing or selling the generic drug.
According to the resolution written by Senator Mar Roxas, Pfizer’s tactics of trying to prevent retail drugstores from selling the generic version of “Atorvastatin Calcium” is a possible unfair trade practice that is in restraint of trade and promotes unfair competition, to the damage and prejudice of Filipino consumers. The Senate Committee on Trade and Commerce is yet to conduct an inquiry, in aid of legislation, to investigate and look into the possible unfair trade practices committed by Pfizer Inc. and other multinational pharmaceutical companies.
Unilab, on the other hand, filed a patent invalidation case against the Lipitor patent on the grounds that it is a “frivolous invention”. Unilab claims that an invention is not considered new when it uses an existing compound and the only difference is form. Unilab alleges that Lipitor is crystalline and Pfizer’s witnesses admitted that the expired patent covered crystalline. This case is still pending before the Intellectual Property Office of the Philippines.
In February 2009, Makati Regional Trial Court denied Pfizer’s request for an injunction to stop Unilab from selling its generic version of “Atorvastatin Calcium”. The court took note of Pfizer witnesses’ admissions that the disputed patent was similar to one that had already expired. According to Unilab, the court’s refusal to grant a temporary injunction indicates that the infringement case filed by Pfizer is weak. Quoting Jose Ochave, Unilab Vice President, “The court denied the petition. This decision will carry over to the main case”. On the other hand, Neena Moorjani, spokesperson for Pfizer, said “A court’s denial of Pfizer’s application for preliminary injunction is by no means a final judgment by the court on the validity of Pfizer’s claim nor does it make any judgment on the validity of our patent”. Pfizer remains confident that its patents continued to be valid and would ask the court to reconsider the ruling. Pfizer said that “research-based pharmaceutical companies like Pfizer commit billions of dollars to discover breakthrough, life-saving medicines to address the world’s most feared diseases. Companies like ours vigorously protect and uphold intellectual property because doing so allows us to continue to find more cures for more people and contribute to saving lives”. Pfizer further exclaimed that it just wants its patents to be respected until expiry.
Despite the ongoing infringement case, Unilab aims to start the sale of the generic versions of Pfizer’s antibiotic Zithromax and Pfizer’s Lyrica, which is used to control epileptic seizures.
Unilab also plans to challenge more Pfizer patents including Pfizer’s patent on a drug to manage epilepsy. Unilab said that Pfizer has a patent just on the method of use. According to Republic Act No. 9502 also known as the Cheaper Medicines Law, “In the case of drugs and medicines, there is no inventive step if the invention results from the mere discovery of a new form or 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 any new property or new use for a known substance, or the mere use of a known process unless such known process results in new product that employs at least one new reactant”.
The battle between Pfizer and Unilab has just started. The question of who will win remains to be uncovered — Is it the pharmaceutical giant, who claims that its product is being infringed? Or is it the local drug-maker, who markets the product at a more reasonable price for the consumers’ welfare? The answer is yet to unfold.