German Supreme Court Grants Lilly Appeal in Alimta® Vitamin Regimen Patent Lawsuit

Alimta Case Returned to Court of Appeal for New Ruling

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Jun 14, 2016, 06:15 ET

INDIANAPOLIS, June 14, 2016 /PRNewswire/ -- The German Federal Supreme Court has granted the appeal by Eli Lilly and Company (NYSE: LLY) in the case of Eli Lilly and Company v. Actavis, vacating the prior decision denying infringement. The German Supreme Court returned the case to the Court of Appeal (Dusseldorf) for further proceedings. The case concerns whether Lilly's vitamin regimen patent for Alimta^® (pemetrexed disodium) would be infringed by a generic competitor that had stated an intention to market a dipotassium salt form of pemetrexed in Germany.

"We are pleased with the ruling by the German Federal Supreme Court granting our appeal regarding infringement of Alimta's vitamin regimen patent in Germany," said Michael J. Harrington, senior vice president and general counsel for Lilly. "This ruling supports our continuing belief that Alimta's vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June 2021."

Harrington also stated, "We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs."

The separate infringement proceeding and validity challenge with Hexal AG will continue unaffected by this ruling. The preliminary injunction against Hexal was confirmed by the German Court in late May 2016 and will stay in force pending any further appeal by Hexal and the outcome of the cases on the merits. The separate infringement proceedings with ratiopharm GmbH should continue, taking this ruling into account.

In major European countries, the compound protection for Alimta expired in December 2015. The patent protection for the Alimta vitamin regimen will expire in June 2021.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. C-LLY

This release contains forward-looking statements regarding Germany Alimta 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. Also, the company cannot predict whether generic pemetrexed will be marketed prior to the resolution of this litigation. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements except as required by law.

Refer to:  Lauren Zierke; [email protected]; +1 317-277-6524 (U.S. media)
               Katrin Blank; [email protected]; +49 6172 273-2738 (German media)
               Phil Johnson; [email protected]; +1 317-655-6874 (Investors)

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SOURCE Eli Lilly and Company