Amgen 2007 Annual Report Download - page 164

AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On July 12, 2006, a hearing was held on the motions for summary judgment submitted by Amgen and Ortho
before the arbitration panel. Both parties’ respective motions were denied. From September 11-15, 2006, a final
arbitration hearing was held before the arbitration panel in Chicago, Illinois. Closing arguments were held before
the panel on November 29, 2006.
Ortho Biotech Antitrust Litigation
On October 11, 2005, Ortho Biotech Products, L.P. (“Ortho Biotech”) filed suit in the United States District
Court for the District of New Jersey (the “New Jersey District Court”) against Amgen alleging violations of §§ 1
& 2 of the Sherman Act, §15 U.S.C. Sections 1 and 2. The complaint sought a preliminary injunction to enjoin
Amgen from offering discounts to oncology clinics on its G-CSF products (NEUPOGEN®and Neulasta®) and
Aranesp®if customers purchased certain amounts of both types of products. Ortho Biotech also seeks a perma-
nent injunction against such discounts, as well as damages it has allegedly sustained by virtue of Amgen’s
contracting program.
The parties engaged in extensive discovery, for the purpose of Ortho Biotech’s motion for a preliminary in-
junction, from October 2005 through June 2006. From June 12-15, 2006, a hearing was held on Ortho Biotech’s
motion for preliminary injunction in Trenton, New Jersey before the New Jersey District Court. The parties filed
findings of fact and conclusions of law, along with the evidentiary record, in addition to providing post-hearing
briefs and oral closing arguments once the evidentiary hearing concluded.
On November 22, 2006, the New Jersey District Court ruled that Ortho Biotech had not demonstrated irrep-
arable harm to justify the granting of a preliminary injunction and therefore, denied Ortho Biotech’s motion. On
October 18, 2007, the New Jersey District Court revised its previously-entered discovery Order and entered a
new Order extending the date of discovery deadlines and summary judgment deadlines to second and third quar-
ters of 2008. No trial date has been set.
Ortho Biotech Spillover Arbitration
On October 25, 2007, Ortho Biotech filed an arbitration demand with the American Arbitration Association,
pursuant to a prior arbitral order and the parties’ product license agreement, in an attempt to reform the estab-
lished methodology which accounts for U.S. Epoetin alfa sales into the other party’s contractual market segment,
or spillover sales. Ortho alleges that introduction of Aranesp®affected a “fundamental change” in the U.S. ESA
market and correspondingly rendered the previously-established spillover methodology inaccurate and un-
reliable. Under its demand, Ortho seeks a new order reforming the spillover methodology and, assuming that a
new methodology is approved, retroactive application of the methodology back to the introduction of Aranesp®.
The Company disputes these allegations.
Roche Matters
Amgen Inc. v. F. Hoffmann-La Roche Ltd., et al.
On November 8, 2005, Amgen filed a lawsuit in the Massachusetts District Court in Boston, Massachusetts
against F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffmann-La Roche, Inc. (collectively,
“Roche”) seeking a declaration by the Court that defendants’ importation, use, sale or offer to sell peg-EPO in-
fringes Amgen’s patents. Amgen alleged infringement of six of its U.S. Patents that claim erythropoietin
products (“EPO”), pharmaceutical compositions, and processes for making erythropoietin, specifically U.S. Pat-
ent Nos. 5,756,349; 5,621,080; 5,618,698; 5,955,422; 5,547,933 and 5,441,868. Amgen is seeking a permanent
injunction preventing the defendants from making, importing, using, offering for sale or selling recombinant hu-
man EPO, including pegylated EPO, in the United States. On March 9, 2006, Ortho Biotech filed a motion to
intervene as a plaintiff in the lawsuit.
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