Amgen 2007 Annual Report Download - page 167

AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
judgment as a matter of law that Amgen had not satisfied its burden to prove that Roche’s peg-EPO product in-
fringes claim 7 of the ‘349 patent. On October 17, 2007, the Massachusetts District Court granted judgment as a
matter of law that Amgen had not satisfied its burden to prove that Roche’s peg-EPO product infringes claim 9 of
the ‘933 patent. On October 23, 2007, the jury rendered a verdict that ten claims of the ‘933, ‘868 and ‘698 pat-
ents will be infringed by Roche and that all asserted claims of the ‘422, ‘933, ‘868, ‘698 and ‘349 patents are
valid. On the same day, the Massachusetts District Court ruled that Roche did not meet its burden to prove in-
equitable conduct by Amgen during patent prosecution. On October 30, 2007, the Massachusetts District Court
granted Roche’s post-trial motion that Amgen had failed to prove that Roche will infringe claim 12 of the `933
patent under the Doctrine of Equivalents, overturning the jury’s verdict of patent infringement. The Massachu-
setts District Court has yet to rule on certain of Roche’s invalidity defenses of obviousness-type double
patenting, on whether Roche infringes claim 14 of the ‘933 patent or on Amgen’s summary judgment motion re-
lating to Roche’s antitrust allegations. An evidentiary hearing was held on November 15, 2007 and
December 5-7, 2007 which the Massachusetts District Court heard evidence concerning Amgen’s request for a
permanent injunction to prevent Roche from commercializing its peg-EPO product in the United States until ex-
piration of the infringed patents, the latest of which expires in 2013.
On December 26, 2007, Amgen and Roche filed post-trial motions. Further briefing was filed on Jan-
uary 25, 2008. A hearing on these motions is currently set for February 28, 2008. Amgen also has a pending
motion requesting that the Massachusetts District Court enter a permanent injunction to prevent Roche from
commercializing MIRCERA®in the United States during the term of Amgen’s patents which have been found to
be infringed by Roche. Roche in turn has requested the Massachusetts District Court’s authorization to sell
MIRCERA®in the United States under the terms of a proposal that would include a royalty payment to Amgen.
U.S. International Trade Commission
On April 11, 2006, Amgen filed a complaint with the U.S. International Trade Commission (“ITC”) in
Washington D.C. requesting that the ITC institute an investigation of Roche’s importation of peg-EPO into the
United States as Amgen believes that importation of peg-EPO is unlawful because peg-EPO, and the method of
its manufacture, are covered by Amgen’s EPO patents. Amgen asked the ITC to issue a permanent exclusion or-
der that would prohibit importation of peg-EPO into the United States. The ITC instituted an investigation of
Roche’s importation of peg-EPO into the United States.
On July 7, 2006, the Administrative Law Judge (“ALJ”) at the ITC issued a summary determination that
Roche’s importation and use of peg-EPO in the United States to date are subject to a clinical trial exemption to
patent infringement. On July 14, 2006, Amgen filed a petition requesting that the ALJ’s summary determination
be reviewed by the full ITC.
On August 31, 2006, the ITC adopted the ALJ’s summary determination terminating the investigation based
on the clinical trial exemption to patent infringement liability under 35 U.S.C. 271(e)(1). The ITC made no
determination with respect to the merits of Amgen’s claim that Roche’s future importation and sale of peg-EPO
will infringe Amgen’s patents. The decision does not prevent Amgen from re-filing its complaint with the ITC at
a later time.
On October 11, 2006, Amgen filed a petition for review of the ITC’s decision with the United States Court
of Appeals for the Federal Circuit. On January 29, 2007, Amgen timely filed its brief in support of its petition for
review. On August 7, 2007, the Court of Appeals for the Federal Circuit held a hearing on Amgen’s Petition.
Amgen Inc., et al. v. Ariad Pharmaceuticals, Inc.
On April 20, 2006, Amgen, Immunex, Amgen USA Inc., Amgen Manufacturing, Limited and Immunex
Rhode Island Corporation (the “Amgen Entities”) filed a complaint against Ariad Pharmaceuticals, Inc. (“Ariad”)
in the United States District Court for the district of Delaware (the “Delaware District Court”) requesting that the
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