Appeals Court Affirms Patent Infringement Rulings Against Roche's peg-EPO Product
September 15 2009 - 4:53PM
PR Newswire (US)
THOUSAND OAKS, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced that the Court of Appeals for the
Federal Circuit affirmed the Massachusetts District Court's
decision that Roche's peg-EPO product, Mircera, infringes four
Amgen patents ('868, '698, '933 and '422) relating to recombinant
erythropoietin (EPO) and processes for making it. Regarding a fifth
patent ('349), the Federal Circuit reversed the holding of
non-infringement by the District Court and remanded that issue for
a new trial allowing Amgen to show that Roche's product infringes
that patent as well. The Federal Circuit also affirmed the validity
of Amgen's patents except for a single issue of obviousness-type
double patenting which only impacts Amgen's later expiring patents
('933, '422 and '349). The Federal Circuit remanded this issue to
the District Court for further analysis. "We are pleased with
today's decision," said David Scott, Amgen's senior vice president
and general counsel. "The successful enforcement of intellectual
property rights enables Amgen to continue to invest in truly
innovative new medicines." Today's decision affirms the
infringement and validity on all grounds for Amgen's process
patents ('868 and '698), affirms the infringement on Amgen's
product patents ('933 and '422), affirms all but one validity issue
which will be further reviewed by the district court on the '933,
'422 and '349 patents, and allows Amgen a new trial to show
infringement of the '349 patent. The Federal Circuit left
undisturbed the permanent injunction that prohibits Roche from
selling its pegylated EPO product, Mircera in the United States.
Scott added, "Biotechnology innovation is complex, expensive and
extremely risky. Companies and investors need appropriate
intellectual property protection to justify the risk and to realize
an appropriate return on investment." About Amgen Amgen discovers,
develops, manufactures and delivers innovative human therapeutics.
A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and
effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, and other serious illnesses.
With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our
vital medicines, visit http://www.amgen.com/. CONTACT: Amgen,
Thousand Oaks David Polk, 805-447-4613 (media) John Shutter,
805-447-1060 (investors) (Logo:
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO
http://photoarchive.ap.org/ DATASOURCE: Amgen CONTACT: media, David
Polk, +1-805-447-4613, or investors, John Shutter, +1-805-447-1060,
both of Amgen, Thousand Oaks Web Site: http://www.amgen.com/
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