AstraZeneca has filed a lawsuit against Dr. Reddy’s Laboratories Ltd., claiming the proposed generic version of blockbuster heartburn drug Nexium by the generic player infringes three AstraZeneca patents.
In a complaint filed Thursday in the U.S. District Court for the District of New Jersey, AstraZeneca alleged that the Indian generic maker’s ANDA to the USFDA for 20 mg and 40 mg delayed release esomeprazole magnesium caplets infringes its Nexium patents.
According to AstraZeneca’s complaint, Dr. Reddy’s ANDA seeks to market its esomeprazole magnesium products before the expiration of AstraZeneca’s patents, U.S. Patent Numbers. 5,714,504; 6,875,872 and 6,369,085, thus infringing the patents.
AstraZeneca claims that Dr. Reddy’s is required to submit to the FDA specific reasons why its generic product will not infringe AstraZeneca's patents. Dr. Reddy’s has failed to meet this requirement, the complaint said.
In December, AstraZeneca asked Dr. Reddy’s to supply more information and samples of its generic product so that the drug maker could determine whether the proposed product would infringe its patents.
“DRL refused to agree to timely provide AstraZeneca sufficient access to all of the requested documents, information and samples and instead offered to produce only selected portions of DRL’s ANDA Number 78-279 and certain finished product samples,” the complaint said.
AstraZeneca filed the suit in part “to employ the judicial process and the aid of discovery” to determine whether Dr. Reddy's proposed generic esomeprazole magnesium will infringe its three patents, according to the complaint.
AstraZeneca is seeking a permanent injunction barring Dr. Reddy’s from marketing an infringing product, court costs and attorneys’ fees.
In November 2005, the company asserted the three patents and others against a slew of generic makers, including Ranbaxy Pharmaceuticals Inc., Ivax Corp. and Teva Pharmaceuticals Industries Ltd. That case is still pending the New Jersey District Court.
AstraZeneca also faced challenges to Nexium from competitors in Europe. But in November, the European Patent Office reportedly ruled that a patent covering Nexium was still valid in its amended form despite challenges from four generic competitors.
In December 2006, the EPO said it had revoked the substance-of-matter patent, which was not set to expire until 2014, following an appeal from Ratiopharm.
Nexium is a slightly revised form of Prilosec, another AstraZeneca blockbuster heartburn drug. It is also one of the world’s top-selling drugs, with global sales of $2.62 billion in the first half of 2007.
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