Healthcare Industry News:  Eli Lilly 

Biopharmaceuticals Generics Oncology Litigation

 News Release - July 28, 2010

US Appeals Court Rules Gemzar(R) Patent Invalid

Affirms the District Court Judgment

Sun Pharma, Though Not a First Filer, Triggered This Successful Patent Challenge


MUMBAI, India--(HSMN NewsFeed)--Sun Pharma today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the U.S. District Court for the Eastern District of Michigan against Eli Lilly and Co. finding certain claims of U.S. Patent No. 5,464,826 (“’826 patent”) invalid. The appeal arose out of a lawsuit that Eli Lilly filed against Sun Pharma in connection with Sun Pharma’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Gemzar®.

In the Michigan lawsuit, Eli Lilly had contented that Sun Pharma’s ANDA infringed certain claims from the ’826 patent and U.S. Patent No. 4,808,614 (“’614 patent”) that describe gemcitabine and its uses, the active ingredient in Gemzar®. Earlier the Michigan District Court had ruled against Eli Lilly stating that the asserted claims of the ’826 patent are invalid for obviousness-type double patenting over U.S. Patent No. 4,808,614 (“’614 patent”). The Appeals Court agreed with the ruling of the District Court, and noted that the Michigan Court had correctly followed the Federal Circuit’s precedent regarding double patenting. The ’826 patent, now ruled invalid, would have expired on November 7, 2012, and would have had pediatric exclusivity through May 7, 2013.

The ’614 patent, not part of the appeal, expired on May 15, 2010, but has pediatric exclusivity through November 15, 2010.

Gemzar® is a registered trademark of Eli Lilly and Co.

About Sun Pharma

Established in 1983, listed since 1994 and headquartered in India, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com.


Source: Sun Pharma

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