Amgen 2010 Annual Report Download - page 161

Diagnostics GmbH, and Hoffmann-La Roche Inc. (collectively, “Roche”) as respondents in the investigation. 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 had been subject to a clinical trial exemption to patent
infringement under 35 U.S.C. 271(e)(1). On August 31, 2006, the ITC adopted the ALJ’s summary determination
terminating the investigation.
On October 11, 2006, Amgen filed a petition for review of the ITC’s decision with the U.S. Court of Appeals
for the Federal Circuit (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 Federal Circuit Court remanded the case back to the ITC for further proceedings to determine if patent
infringement had occurred and to provide a remedy, if appropriate.
Amgen had previously filed a separate lawsuit in November 2006 in the United States District Court for the
District of Massachusetts (the “Massachusetts District Court”) against F. Hoffmann-La Roche Ltd., Roche
Diagnostics GmbH and Hoffmann-La Roche Inc. (collectively, “Roche Defendants”) seeking a declaration by
the Massachusetts District Court that the importation, use, sale or offer to sell peg-EPO infringes Amgen’s EPO
patents, specifically U.S. Patent Nos. 5,547,933; 5,621,080; 5,955,422; 5,756,349; 5,618,698 and 5,441,868. After a
jury trial and an appeal, on December 22, 2009, the Massachusetts District Court entered final judgment and a
permanent injunction against the Roche Defendants prohibiting the Roche Defendants from infringing the five
Amgen patents-in-suit. The judgment was accompanied by the Roche Defendants’ admission that the 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 did not include any financial payments between the parties. Thereafter, in the ITC
matter 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 they were not opposing Amgen’s motion. The ITC has not yet
issued a decision on Amgen’s motion.
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 U.S. District Court for the District
of Delaware (the “Delaware District Court”) for infringement of four patents — U.S. Patent Nos. 6,001,068 (the
“’068 Patent”); 6,031,003 (the “’003 Patent”); 6,313,146 (the “’146 Patent”) and 6,211,244 (the “’244 Patent”). 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.
Trial in this action commenced on November 30, 2010 on Teva’s and Barr’s invalidity and inequitable conduct
defenses. Prior to commencement of trial and based on agreement between the parties, the Delaware District Court
entered an order that Teva and Barr infringe the ’068, ’003 and ’244 patents and dismissed all claims relating to
the ’146 patent. The Delaware District Court issued its Memorandum Decision and Order on January 7, 2011
rejecting Teva’s and Barr’s defenses, finding the ’068, ’003 and ’244 patents valid, enforceable and infringed, and
enjoining Teva and Barr from the commercial manufacture, use, import or sale of their generic version of cinacalcet
hydrochloride until the last of the three patents expires. On February 4, 2011, Teva and Barr filed a notice of appeal
of the Delaware District Court’s Memorandum Decision and Order.
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AMGEN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)