Amgen 2010 Annual Report Download - page 162

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Teva v. Amgen, the ’603 Patent Litigation
On May 20, 2009, Teva Ltd. filed a lawsuit against Amgen in the U.S. District Court for the Eastern District of
Pennsylvania (the “Pennsylvania District Court”) alleging infringement of Teva’s U.S. Patent No. 7,449,603 by its
manufacture, importation, use, sale and/or offer for sale of Sensipar»(cinacalcet hydrochloride). Amgen filed an
answer and counterclaims of noninfringement and patent invalidity. Pretrial discovery is ongoing.
Teva v. Amgen, the G-CSF Patent Litigation
On November 30, 2009, Teva USA filed a lawsuit in the Pennsylvania District Court requesting that Amgen’s
U.S. Patent Nos. 5,580,755 and 5,582,823 (the “’755 patent” and the “’823 patent”, respectively) relating to human
G-CSF and methods for its use, be declared invalid and/or not infringed by Teva USA’s G-CSF product, a filgrastim
molecule. Also on November 30, 2009, Teva Ltd. announced that it had filed a biologics license application with the
FDA seeking approval to market its G-CSF product in the United States. On January 15, 2010, Amgen filed an
answer and brought counterclaims against Teva USA and Teva Ltd. seeking a declaration that Amgen’s patents are
valid and will be infringed by Teva’s G-CSF product. On May 4, 2010, Teva withdrew its non-infringement
affirmative defense and Teva USA withdrew its non-infringement counterclaim. On September 10, 2010, the
Pennsylvania District Court issued its claim construction ruling. On September 24, 2010, Amgen moved for
summary judgment of infringement of certain claims of the ’755 patent and the ’823 patent, and on September 29,
2010, Teva USA sought leave to amend its pleadings to re-allege non-infringement of the patents-in-suit. The Court
denied both motions on November 19, 2010. Teva announced on September 30, 2010 that it received a complete
response letter from the FDA for its G-CSF product Neutroval
TM
, indicating that the FDA wanted further
information but that Teva believed that no further pre-marketing clinical trials would be necessary. Discovery
is ongoing and no trial date has yet been set.
Simonian v. Amgen Inc.
On March 9, 2010, Thomas A. Simonian filed a lawsuit in the U.S. District Court for the Northern District of
Illinois alleging that Amgen violated a false marking statute by marking product packaging or product inserts of its
NEUPOGEN»product with U.S. Patent Nos. 4,810,643 and 4,999,291, now both expired. After a three month stay,
plaintiff’s amendment of its complaint, and denial of Amgen’s motion to dismiss, Amgen filed an answer to the
complaint on December 7, 2010 denying the allegation that Amgen violated the false marking statute. Pretrial
proceedings are ongoing.
Average Wholesale Price (“AWP”) Litigation
Amgen and its wholly-owned subsidiary Immunex Inc. are named as defendants, either separately or together,
in numerous civil actions broadly alleging that they, together with many other pharmaceutical manufacturers,
reported prices for certain products in a manner that allegedly inflated reimbursement under Medicare and/or
Medicaid programs and commercial insurance plans, including co-payments paid to providers who prescribe and
administer the products. The complaints generally assert varying claims under the Medicare and Medicaid statutes,
as well as state law claims for deceptive trade practices, common law fraud and various related state law claims. The
complaints seek an undetermined amount of damages, as well as other relief, including declaratory and injunctive
relief.
The AWP litigation was commenced against Amgen and Immunex on December 19, 2001 with the filing of
Citizens for Consumer Justice, et al. v. Abbott Laboratories, Inc., et al. Additional cases have been filed since that
time. Most of these actions, as discussed below, have been consolidated, or are in the process of being consolidated,
in a federal Multi-District Litigation proceeding (the “MDL Proceeding”), captioned In Re: Pharmaceutical
Industry Average Wholesale Price Litigation MDL No. 1456 and pending in the Massachusetts District Court.
F-40
AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)