INDIANAPOLIS,
Oct. 5, 2017 /PRNewswire/
-- Eli Lilly and Company (NYSE: LLY) today announced that the
Patent Trial and Appeal Board of the U.S. Patent and Trademark
Office (PTO) has ruled in the company's favor regarding
patentability of the vitamin regimen for Alimta®
(pemetrexed for injection).
In the inter partes review (IPR) proceedings initiated by
Neptune Generics, LLC and Sandoz Inc., the U.S. PTO found that the
claims of the vitamin regimen patent are valid. 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.
"We are pleased with today's ruling by the U.S. PTO
finding the claims of the Alimta vitamin regimen patent are valid,"
said Michael J. Harrington, senior
vice president and general counsel for Lilly. "This
ruling largely confirms the earlier decision of the district court
which was affirmed on appeal by a unanimous court."
Harrington continued, "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."
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. The U.S. Court of Appeals for the Federal
Circuit confirmed these rulings in a unanimous decision in
January 2017, finding the patent is
valid and would be infringed by the generic challengers' proposed
products.
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.
C-LLY
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.
Alimta® (pemetrexed, Lilly)
Refer to:
|
Lauren Zierke;
lauren_zierke@lilly.com; (317)
989-2853 (Media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; (317)
655-6874 (Investors)
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/us-patent-and-trademark-office-rules-in-lillys-favor-on-alimta-vitamin-regimen-patent-300532094.html
SOURCE Eli Lilly and Company