She regards the case as 'an important one with much at stake for both parties.' She explained, 'The results in this case reinforced the importance of analyzing obviousness from the perspective of a person of ordinary skill in the art. Lisa Barons Pensabene with Fitzpatrick, Cella, Harper & Scinto law firm was lead counsel of this litigation, with extensive experience in patent litigation, particularly in the chemical, biological and pharmaceutical areas. licensee, marketed the above-mentioned drugs. Patent and Trademark Office in April 1997, and Daiichi Sankyo, the U.S. applied for the 599 patent in April 1991 as some scientists of the company had 'come up with a drug that had 10 times the activity of losartan' and 'with a duration long enough to be dosed oncea-day.' The patent was granted by the U.S. Patent Number 5,616,599 (599 patent), claiming olmesartan medoxomil – the active ingredient of Benicar®, Benicar HCT® and Azor®. On the other hand, Mylan could not prove by clear and convincing evidence that the patent was invalid due to obviousness. In 2008, the combined gross sales for the anti-hypertension drugs reached USD 1.3 billion and the huge success comes from the products' intrinsic properties, rather than from any increased marketing effort. The judge further ruled that the products' commercial success also proved the validity of the patent. District Court for the District of New Jersey found no application of those prior arts for the new products on Daiichi's part. already had two patents for ARBs sharing the same chemical backbone of olmesartan medoxomil when Daiichi began its R&D in the domain in 1989. argued that Daiichi's patent was invalid because Benicar® was the seventh angiotensin II receptor blocker (ARB) to seek patent protection since its initial release in 2002. It filed a second suit two years later when finding that Matrix Laboratories had submitted another abbreviated new drug application for another anti-hypertension drug Azor®. Food and Drug Administration (FDA) approval to manufacture and sell the generic versions of Benicar®, a drug used for hypertension treatment which contains the patented ingredient olmesartan medoxomil. in August 2006, as the generic drug maker was attempting to receive U.S. Under Federal Circuit's lead compound test, Mylan argued that the test requires all generic makers to bear the burden of proving that a person of ordinary skill would have chosen the same compound as Daiichi did to arrive at the patented compound.Ī three-judge panel of the Federal Circuit, however, let stand the 2009 decision and deemed the district court's ruling as 'comprehensive and well reasoned'.ĭaiichi first sued Mylan Inc. The petition also noted that the Federal Circuit Court has rejected every obviousness challenge to a patent claiming a new chemical compound. In their petition Mylan and its majority-owned subsidiary Matrix Laboratories claimed that the Federal Circuit Court has applied a rigid lead compound test for determining the obviousness in drug patent cases. On December 8, 2010, Mylan asked the Supreme Court to review the CAFC's injunction. Ltd., a Japanese innovative pharmaceutical company, and Mylan Pharmaceuticals Inc., a U.S. The decision ended the five-year lawsuit between Daiichi Sankyo Co. In September, 2010 the CAFC ruled that Mylan could not market generic version of the anti-hypertension drugs, Benicar®, Benicar HCT® and Azor®, before 2016, when the patent covering the drugs is set to expire. Mylan sought review of the CAFC's decision barring it from producing generic versions of Daiichi's two patented anti-hypertension drugs before 2016. Court of Appeals for the Federal Circuit's (CAFC) decision in Daiichi Sankyo Company, Ltd. Supreme Cour t denied a petition for writ of certiorari seeking review of the U.S.

Azor generic 2016