Amgen 2009 Annual Report Download - page 164

AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
infringement dispute to an end. The judgment was accompanied by the Roche Defendant’s admission that the five
Amgen patents involved in the lawsuit are valid, enforceable and infringed by the Roche Defendant’s peg-EPO
product, and by Amgen allowing Roche to begin selling peg-EPO in the United States in mid-2014 under terms of
a limited license agreement. The settlement terms do not include any financial payments between the parties.
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 August 31, 2006, the ITC adopted the
ALJ’s summary determination terminating the investigation based on the clinical trial exemption to patent in-
fringement liability under 35 U.S.C. 271(e)(1).
On October 11, 2006, Amgen filed a petition for review of the ITC’s decision with the Federal Circuit
Court. On March 19, 2008, the Federal Circuit Court reversed the ITC’s dismissal of the investigation on
jurisdictional grounds. In response to Roche’s request for rehearing, on April 30, 2009, the Federal Circuit Court
vacated the ITC’s dismissal of the ITC investigation for non-infringement. The Court remanded the case back to
the ITC for further proceedings to determine if patent infringement had occurred and to provide a remedy, if ap-
propriate. After the settlement of the dispute between the parties in December 2009, Amgen filed a motion for
summary determination of violation with a request for entry of a limited exclusion order. The Roche respondents
notified the ITC that it was not opposing Amgen’s motion. No decision has been issued on Amgen’s motion.
Human Genome Sciences Litigations
On November 30, 2007, Human Genome Sciences (“HGS”) filed an action under 35 U.S.C. §146 against
Amgen in the Delaware District Court to review a Decision on Motions entered on July 26, 2007 and the Final
Judgment entered November 20, 2007 by the Board of Patent Appeals and Interferences in Interference
No. 105,240. On May 9, 2008, the Delaware District Court granted Amgen’s Motion to Dismiss and HGS filed
an appeal to the Federal Circuit Court. Thereafter, HGS withdrew its appeal and on October 14, 2009, the Federal
Circuit Court entered an order on HGS’ motion to dismiss HGS’ appeal.
On October 21, 2009, the Delaware District Court entered orders on stipulated motions dismissing with prej-
udice HGS’ actions under 35 U.S.C. § 146 which had been filed by HGS after it had received unfavorable final
judgments from the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences on each of
Interference No. 105,380 and Interference No. 105,381.
Teva Matters
Sensipar®Abbreviated New Drug Application (“ANDA”) Litigation
On July 25, 2008, Amgen, NPS Pharmaceuticals (“NPS”) and Brigham and Women’s Hospital (“BWH”),
filed a lawsuit against Teva Pharmaceuticals USA, Inc. (“Teva USA”), Teva Pharmaceutical Industries Ltd.
(“Teva Ltd.”, and together with Teva USA, “Teva”) and Barr Laboratories, Inc. (“Barr”) in the Delaware District
Court for infringement of four patents — U.S. Patent Nos. 6,001,068; 6,031,003; 6,313,146 and 6,211,244. The
lawsuit is based on ANDAs filed by Teva and Barr which seek approval to market generic versions of Sensipar®
(cinacalcet hydrochloride). Amgen’s filing of the lawsuit stays any U.S. Food and Drug Administration (“FDA”)
approval of the Teva or Barr ANDA until September 2011, unless there is an earlier decision by the Delaware
District Court adverse to Amgen.
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