INDIANAPOLIS, October 05,2017 /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).
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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
http://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; +1(317)989-2853 (Media)
Phil
Johnson; johnson_philip_l@lilly.com; +1(317)655-6874 (Investors)
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