U.S. District Court Upholds Validity of Lilly's Evista Patents Through 2014

INDIANAPOLIS, Sept. 23 /PRNewswire-FirstCall/ -- The U.S. District Court for the Southern District of Indiana today upheld Eli Lilly and Company's (NYSE:LLY) method-of-use patents on Evista (raloxifene HCl tablets). In the case of Eli Lilly and Company v. Teva Pharmaceuticals Industries Ltd., the court ruled in favor of Lilly on all accounts for these method-of-use patents, including the patent doctrines of obviousness, enablement, and inequitable conduct. These patents provide protection for Evista through March of 2014.

"We are pleased with the court's rulings on Evista's method-of-use patents. We have always been very confident that these patents are valid and enforceable and today's court ruling sends a clear message on the strength of those patents," said Robert A. Armitage, senior vice president and general counsel for Lilly. "Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the physicians and patients we serve, as these rights help support the development of the next generation of innovative medicines to treat unmet medical needs."

In addition, the Court held Lilly's Evista particle-size patents invalid. The company is reviewing this aspect of the ruling to determine whether or not to appeal.

Evista is a breakthrough medicine indicated for the treatment and prevention of osteoporosis in postmenopausal women; and the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

Important Safety Information about EVISTA (raloxifene HCl tablets)

Here are a few things you should know about EVISTA: EVISTA is not right for everyone. You should only take prescription EVISTA if you are past menopause. Before taking EVISTA, talk to your doctor about all your medical conditions.

You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs or eyes, as it may increase the risk of blood clots. Stop taking EVISTA and call your doctor if you have leg pain or warmth, swelling of the legs, hands or feet, chest pain, shortness of breath or a sudden vision change, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a long time, talk to your doctor about ways to reduce the risk of blood clots.

EVISTA does not increase the risk of a heart attack or stroke in women who have had or are at risk for a heart attack; however; EVISTA increases the likelihood of dying from stroke in these women, should one occur. Before taking EVISTA tell your doctor if you have had a stroke, a mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe you have other risk factors for stroke or a heart attack.

If you are pregnant, nursing or may become pregnant, do not take EVISTA, as it may cause fetal harm. Women with liver or kidney disease should use EVISTA with caution. EVISTA should not be taken with estrogens in the form of pills, patches or injections.

Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. C-LLY

This release contains forward-looking statements regarding the U.S. Evista patent litigation. These statements are based on management's current expectations but actual results may differ materially. There can be no assurance that the company will prevail in any appeal. Other risk factors that may affect the company results can be found in company's Form 10-Q dated July 2009 and Form 10-K dated February 2009.

Evista (raloxifene, Lilly)

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

Photo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO

Source: Eli Lilly and Company

CONTACT: Mark Taylor, +1-317-276-5795, or Angela Sekston,
+1-317-276-5046, both of Eli Lilly and Company

Posted: September 2009


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