U.S. Court of Appeals Rules In Lilly's Favor On Alimta Vitamin Regimen Patent

Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Court of Appeals for the Federal Circuit has upheld the district court's decision and ruled in the company's favor regarding validity and infringement of the vitamin regimen patent for Alimta^® (pemetrexed for injection).

In the case of Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et al., the court affirmed the earlier district court's rulings that the vitamin regimen patent is valid and would be infringed by the generic challengers' proposed products. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force. The Alimta compound patent remains in force through January 24, 2017.

In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly's favor regarding infringement of the vitamin regimen patent.

"We are pleased with today's ruling by the Court of Appeals, affirming the earlier district court's decisions, finding the Alimta vitamin regimen patent is valid and would be infringed," said Michael J. Harrington, senior vice president and general counsel for Lilly. "The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection, which has been confirmed in every validity challenge to date. We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. These rights help support the development of the next generation of innovative medicines to treat unmet medical needs."

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.

This release contains forward-looking statements regarding the U.S. 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 expiration of the vitamin regimen patent. 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.