Amgen 2007 Annual Report Download - page 163

AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
federal court; however, the case was remanded to state court on April 14, 2006. A hearing on Defendants’
motion to dismiss is scheduled for April 20, 2007. A hearing on Defendants’, which includes Amgen and
Immunex together with other pharmaceutical manufacturers, motions to dismiss was held on April 5, 2007
in which Defendants’ motions were denied. In September 2007, Plaintiff filed notice that it will be filing a
motion to dismiss without prejudice those defendants that are also defendants in the Citizens for Consumer
Justice action. The parties are currently engaged in discovery.
County of Oswego v. Abbott Laboratories, Inc., et al. This case was filed against Amgen and Immunex,
along with several other pharmaceutical manufacturers, on May 9, 2006 in the Supreme Court of New York,
Oswego County. On August 21, 2006, Immunex was served with the complaint and on August 24, 2006,
Amgen was served with the complaint. On October 11, 2006, this case was removed to the United States
District Court for the Northern District of New York. Plaintiffs filed a motion to remand on November 6,
2006. On September 1, 2007, the case was remanded to the Supreme Court of New York, Oswego County.
Immunex Governmental Investigations
According to press reports, many pharmaceutical companies are under investigation by the U.S. Department
of Justice, the U.S. Department of Health and Human Services, and/or state agencies related to the pricing of
their products. Immunex received notices from the U.S. Department of Justice requesting the production of
documents in connection with a Civil False Claims Act investigation of the pricing of Immunex’s current and
former products for sale and eventual reimbursement by Medicare or state Medicaid programs. Immunex also re-
ceived similar requests to procure documents from the U.S. Department of Health and Human Services and state
agencies. Several of Immunex’s current and former products are, or were, regularly sold at substantial discounts
from list price. The Company does not know what action, if any, the federal government or any state agency may
take as a result of their investigations.
State Attorney General AMP/AWP Investigations
Amgen and/or Immunex have been advised by the Attorneys General for 14 states of pending investigations
regarding drug pricing practices pertaining to the calculation of AMP and Best Price calculations under the Med-
icaid Drug Rebate Act, as those terms are defined in 42 U.S.C. 1396r-8. These states have requested that Amgen
and Immunex preserve records relating to AMP and best price calculations. Immunex has also been advised that
the Attorney General for the State of Idaho is investigating claims relating to AWP as to numerous companies,
including Immunex. The Company does not know what actions, if any, may be taken as a result of these inves-
tigations.
Johnson & Johnson Matters
Arbitration/Demand for Separate BLA
On November 11, 2003, Ortho Biotech Products, L.P., Ortho Biotech Inc., and Ortho-McNeil Pharmaceut-
ical (each a wholly owned subsidiary of Johnson & Johnson, collectively, “Ortho”) filed a demand for arbitration
against the Company before the American Arbitration Association in Chicago, Illinois. In its demand, Ortho
seeks declaratory relief that, among other things, (i) Ortho has the right under the parties’ Product License
Agreement to apply for its own FDA license to market its brand of recombinant erythropoietin, PROCRIT®,
based on bulk product supplied by the Company, (ii) the Company must cooperate with Ortho to achieve Ortho’s
separate FDA licensure, (iii) pending FDA approval of Ortho’s separate license, the Company must continue to
supply Ortho with Ortho’s commercial requirements of finished erythropoietin products and (iv) pending FDA
approval of Ortho’s separate license, the Company must cooperate with Ortho on erythropoietin development
projects, including Ortho’s proposal for a 120,000 unit per ml formulation.
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