Amgen 2009 Annual Report Download - page 165

AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Delaware District Court has entered a scheduling order indicating that the case will be placed in the trial
pool on September 1, 2010.
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 alleging infringement of 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 non-
infringement and patent invalidity.
Teva v. Amgen, the G-CSF Patent Litigation
On November 30, 2009, Teva USA filed a lawsuit in the U.S. District Court for the Eastern District of Penn-
sylvania requesting that Amgen’s U.S. Patent Nos. 5,580,755 and 5,582,823 relating to human G-CSF and
methods for its use, be declared invalid and/or not infringed by Teva’s Filgrastim molecule. Also on No-
vember 30, 2009, Teva 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 counter-
claims seeking a declaration that Amgen’s patents are valid and will be infringed by Teva’s G-CSF product.
Kennedy Institute v. Amgen Inc. and Wyeth
On October 27, 2009, The Mathilda and Terence Kennedy Institute of Rheumatology Trust filed suit in the
Delaware District Court alleging that Amgen and Wyeth have infringed U.S. Patent Number 6,270,766 by the
distribution and sale of ENBREL for the treatment of arthritis by co-administration with methotrexate.
Average Wholesale Price (“AWP”) Litigation
Amgen and Immunex 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 con-
solidated, 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.
These cases have been consolidated into the MDL Proceeding, are being brought by consumer classes and
certain state and local governmental entities. These cases consist of the following:
Citizens for Consumer Justice, et al., v. Abbott Laboratories, Inc., et al.; Teamsters Health & Welfare Fund
of Philadelphia, et al., v. Abbott Laboratories, Inc., et al.; Action Alliance of Senior Citizens of Greater
Philadelphia v. Immunex Corporation; Constance Thompson, et al., v. Abbott Laboratories, Inc., et al.; Ro-
nald Turner, et al., v. Abbott Laboratories, Inc., et al.; Congress of California Seniors v. Abbott
Laboratories, Inc., et al.; County of Suffolk v. Abbott Laboratories, Inc., et al.; County of Westchester v.
Abbott Laboratories, Inc., et al.; County of Rockland v. Abbott Laboratories, Inc., et al.; City of New York v.
Abbott Laboratories, Inc., et al.; County of Nassau v. Abbott Laboratories, Inc., et al; County of Onondaga
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