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Lilly Evista patents upheld

Eli Lilly has won a court victory that the company said will keep osteoporosis drug Evista protected from generic competition in the US until 2014

Eli Lilly has won a court victory that the company said will keep its blockbuster osteoporosis drug Evista (raloxifene) protected from generic competition in the US marketplace until March 2014.

In the ruling, the US Court of Appeals for the Federal Circuit upheld a 2009 decision by the US District Court for the Southern District of Indiana that the company's method-of-use patents for the drug are valid on all accounts, including the doctrines of obviousness, enablement, and inequitable conduct.

The patents had been challenged by Teva Pharmaceuticals, which has won tentative approval from the US Food and Drug Administration (FDA) for generic Evista but cannot launch the product until Lilly's patents expire or are deemed invalid.

Although the overall decision was a victory for Lilly, the appeals court also affirmed the district court's ruling that held Evista's particle-size patents invalid. Lilly said it would "review its legal options" regarding that part of the ruling.

Evista, which is used in the prevention of osteoporosis in postmenopausal women, brings in about $700m a year for Lilly. The drug is also cleared for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

2nd September 2010

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