L.R. Imperial (LRI) Inc., a division of Unilab, launched recently the prescription drug Versant™-XR, a generic version of the anti-hypertensive Felodipine drug aimed at benefiting over 12.6 million Filipinos afflicted with hypertension. But the drug’s introduction was met with a court case filed by AstraZeneca, which stands to lose its monopoly over the local sales of Felodipine (Plendil™).
Claiming patent infringement, AstraZeneca filed a temporary restraining order (TRO) on April 14 to prevent Unilab from manufacturing and selling Versant™-XR. The TRO was lifted two days later by Judge Raul de Leon of Branch 258 of the Parañaque Regional Trial Court.
LRI has denied infringement upon AstraZeneca’s patents, saying they utilized an entirely different process to manufacture Versant™-XR. The process that LRI employs has even been patented in the United States.
Moreover, LRI contends that AstraZeneca’s applying for and securing a TRO 24 hours prior to Versant™-XR’s launch was clearly meant to block legitimate competition and is an unlawful abuse of the patent system. AstraZeneca did not file a similar suit against two other pharmaceutical companies – New Smart Formulae and Croma Medic – which have marketed their own version of Felodipine even before LRI introduced Versant™-XR.
Unilab stressed that Versant™-XR is part of its pharmacoeconomics-based campaign to reduce the prices of essential and lifesaving drugs. Cheaper by 50 percent than AstraZeneca’s Plendil™ ER, Versant™ can save a patient as much as P6,800 per year, a significant amount because hypertension management requires lifetime medication. AstraZeneca’s Plendil™ sells for P37.50 a tablet versus Unilab’s Versant™ at P18.90 at leading drugstores in Metro Manila.
Filing lawsuits to prevent the entry of generics seems to be a global strategy of AstraZeneca, as demonstrated by 71 lawsuits it has filed against generic companies around the world for introducing their own versions of the blockbuster drug Prilosec.
AstraZeneca’s TRO filing against Versant™-XR is contrary to government efforts to reduce the prices of medicines.
Calling AstraZeneca’s complaint "clearly malicious, baseless and anti-competitive," LRI seeks to hold the multinational accountable in a countersuit for actual, moral and exemplary damages.
Bioequivalent studies have proven Versant™-XR to have the same safety and efficacy profile as AstraZeneca’s. A bioequivalent study is an internationally and scientifically accepted method of comparing two drugs to determine whether they have the same therapeutic effect.
LRI further asserts that as a consequence of AstraZeneca’s accusations of patent infringement, "Unilab and LRI’s goodwill and reputation have been gravely besmirched, damaged and prejudiced." Unilab is the Philippines’ leading pharmaceutical and healthcare company, and has established a strong presence in Southeast Asia.
"As a Filipino-owned company, Unilab believes that Filipinos deserve only the best pharmaceutical products priced within the reach of majority of Filipinos," the countersuit stated.
Unilab president Carlos Ejercito said: "We are undeterred by AstraZeneca’s lawsuit. Unilab will continue to launch new products at reduced prices to benefit Filipinos."