Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has suffered a legal defeat in Europe. The German Court of Appeal has ruled that the vitamin regimen patent for the cancer treatment Alimta would not be infringed by a generic competitor looking to market an alternative form of the drug.

March 6, 2015

News Release

Indianapolis, Ind. — The German Court of Appeal has ruled that Eli Lilly and Company's (NYSE: LLY) vitamin regimen patent for Alimta (pemetrexed disodium) would not be infringed by a generic competitor that intends to market a dipotassium salt form of pemetrexed in Germany once the compound patent expires in December 2015.

The German Court ruled in favor of the generic competitor in the case of Eli Lilly and Company v. Actavis. This decision vacated the prior decision of the Regional Court of Dusseldorf in April 2014.

The compound patent for Alimta in Germany remains in force and is expected to provide exclusivity through December 2015.

“We strongly disagree with the ruling by the German Court of Appeal regarding Alimta's vitamin regimen patent,” said Michael J. Harrington, senior vice president and general counsel for Lilly.

Harrington continued, “Although Alimta's compound patent remains in force and is expected to provide exclusivity in Germany through December 2015, we continue to believe 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. We will seek permission to appeal this ruling to the German Supreme Court.”

In April 2014, the English High Court ruled that the vitamin regimen patents for Alimta would not be infringed by a generic competitor that has stated intent to market certain alternative salt forms of pemetrexed in United Kingdom, Italy, France and Spain. The appeal of this decision remains pending and is scheduled for hearing starting March 9, 2015.

Lilly's vitamin regimen patent was upheld in a prior ruling by the Opposition Division of the European Patent Office. An appeal is pending before the Technical Board of Appeal of the European Patent Office.

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 http://newsroom.lilly.com/social-channels.

Source: Eli Lilly and Co.

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