INDIANAPOLIS, June 25, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that the Court of Appeal has
ruled that the Alimta® (pemetrexed disodium) vitamin regimen patent
would be indirectly infringed by a generic competitor that had
stated its intent to market certain alternative salt forms of
pemetrexed in the United Kingdom
prior to the UK patent's expiration in June
2021.
Specifically, the Court of Appeal held that commercialization of
these alternative salt forms in the products as proposed would
constitute indirect infringement by supplying an essential means
for putting the patented invention into effect. The decision came
in the case of Actavis v. Eli Lilly and Company.
The Court of Appeal also held there was no difference between
the law in the UK and that in France, Italy
and Spain as it relates to
indirect infringement, and so reversed the High Court's decision
granting declarations of noninfringement over the Alimta vitamin
regimen patents in those countries.
Actavis may seek permission to appeal the decision to the UK
Supreme Court. In addition, Actavis has stated it may ask the High
Court to decide whether a different proposed product would infringe
the patent. The Court of Appeal has ruled that the High Court will
need to decide whether it will hear this new claim. If the High
Court decides to hear Actavis' case on the different proposed
product, Lilly will defend the case vigorously.
In Europe, the compound patents
for Alimta remain in force and are expected to provide exclusivity
through December 2015. This decision
increases the likelihood that the vitamin regimen patents for
Alimta will provide exclusivity in the UK, France, Italy
and Spain through June 2021.
"We are pleased with the UK Court of Appeal's ruling that
confirms the Alimta vitamin regimen patent would be infringed by
the entry of these generic pemetrexed products in the United Kingdom prior to June 2021. We are also pleased the ruling has
cancelled the declarations of noninfringement with respect to
France, Italy and Spain," said Michael
J. Harrington, senior vice president and general counsel for
Lilly.
Harrington continued, "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."
In a separate appeal earlier this year, the Dusseldorf Court of Appeal ruled the Alimta
vitamin regimen patent would not be infringed by a generic
competitor that has stated intent to market pemetrexed dipotassium
in Germany after the compound
patent expiration in December 2015.
Lilly has asked for permission to appeal this ruling.
Lilly's vitamin regimen patents were 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.
C-LLY
This release contains forward-looking statements regarding the
UK and German 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.
Alimta® (pemetrexed, Lilly)
Refer to:
Lauren Zierke;
lauren_zierke@lilly.com; +1 317-277-6524 (U.S. Media)
Louisa Stevenson;
ukpublicaffairs@lilly.com; +44 1256 775374 (U.K. Media)
Phil Johnson;
johnson_philip_l@lilly.com; +1 317-655-6874 (Investors)
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SOURCE Eli Lilly and Company