Amgen 2015 Annual Report Download - page 122

F-44
Hospira Epoetin Alfa Litigation
On September 18, 2015, Amgen filed a lawsuit in the Delaware District Court against Hospira, Inc. (Hospira), a subsidiary
of Pfizer, for infringement of our U.S. Patent Nos. 5,856,298 (the `298 Patent) and 5,756,349 (the `349 Patent) in accordance with
the patent provisions of the BPCIA and for a declaration that Hospira has failed to comply with certain requirements of the BPCIA.
This lawsuit stems from the submission by Hospira under the BPCIA of an application for FDA licensure of an epoetin product
as biosimilar to Amgen’s EPOGEN®. Amgen seeks a declaration that the BPCIA requires that Hospira provide Amgen with notice
of commercial marketing 180 days before it first begins commercial marketing of any biosimilar epoetin product and that this
notice can only be given after the FDA has licensed Hospira’s biosimilar product. By its complaint, Amgen seeks, amongst other
remedies, an injunction prohibiting Hospira from using or selling infringing cells and/or product manufactured during the `298 or
the `349 patent terms and enjoining Hospira from commencing commercial marketing of any biosimilar epoetin product until a
date that is at least 180 days after Hospira provides legally effective notice to Amgen.
On November 12, 2015, Hospira filed a motion to dismiss the one count of Amgen’s complaint which seeks a declaration
that Hospira has failed to comply with the notice requirements of the BPCIA. A hearing on the motion to dismiss has been set for
February 16, 2016.
Onyx Litigation
Between August 28, 2013 and September 16, 2013, nine plaintiffs filed purported class action lawsuits against Onyx, its
directors, Amgen and Arena Acquisition Company (Arena), and unnamed “John Doe” defendants in connection with Amgen’s
acquisition of Onyx. Seven of those purported class actions were brought in the Superior Court of the State of California for the
County of San Mateo (the San Mateo County Superior Court), captioned Lawrence I. Silverstein and Phil Rosen v. Onyx
Pharmaceuticals, Inc., et al. (August 28, 2013) (“Silverstein”), Laura Robinson v. Onyx Pharmaceuticals, Inc., et al. (originally
filed in the Superior Court for the County of San Francisco on August 28, 2013, and re-filed in the San Mateo County Superior
Court on August 29, 2013) (“Robinson”), John Solak v. Onyx Pharmaceuticals, Inc., et al. (August 30, 2013) ("John Solak"),
Louisiana Municipal Police Employees’ Retirement System and Hubert Chow v. Onyx Pharmaceuticals, Inc., et al. (September 3,
2013) (“Louisiana Municipal”), Laurine Jonopulos v. Onyx Pharmaceuticals, Inc., et al. (September 4, 2013) (“Jonopulos”),
Clifford G. Martin v. Onyx Pharmaceuticals, Inc., et al. (September 9, 2013) (“Martin”) and Merrill L. Magowan v. Onyx
Pharmaceuticals, Inc. et al. (September 9, 2013) (“Magowan”). The eighth and ninth purported class actions were brought in the
Court of Chancery of the State of Delaware, captioned Mark D. Smilow, IRA v. Onyx Pharmaceuticals Inc., et al. (August 29,
2013) ("Smilow") and William L. Fitzpatric v. Onyx Pharmaceuticals, Inc., et al. (September 16, 2013) (“Fitzpatric”). On September
5, 2013, the plaintiff in the John Solak case dismissed his case. On September 10, 2013, the plaintiff in the Smilow case dismissed
his case. On September 10, 2013, plaintiffs in the Silverstein and Louisiana Municipal cases filed an amended complaint alleging
substantially the same claims and seeking substantially the same relief as in their individual purported class action lawsuits. Each
of the lawsuits alleges that the Onyx director defendants breached their fiduciary duties to Onyx shareholders, and that the other
defendants aided and abetted such breaches, by seeking to sell Onyx through an allegedly unfair process and for an unfair price
and on unfair terms. The Magowan and Fitzpatric complaints and the amended complaint filed in the Silverstein and Louisiana
Municipal cases also alleged that the individual defendants breached their fiduciary duties with respect to the contents of the tender
offer solicitation material. Each of the lawsuits sought, among other things, rescission of the merger agreement and attorneys’ fees
and costs, and certain of the lawsuits sought other relief. The Silverstein, Robinson, Louisiana Municipal and Jonopulos cases
were designated as “complex” and assigned to the Honorable Marie S. Weiner of the San Mateo County Superior Court, who
subsequently entered an order consolidating the Silverstein, Robinson, Louisiana Municipal, Jonopulos, Martin and Magowan
cases (the Consolidated Cases). On October 31, 2013, the plaintiffs in the Consolidated Cases filed a consolidated class action
complaint seeking certification of a class and alleging breach of fiduciary duties of loyalty and good faith against the Onyx directors
and aiding and abetting breach of fiduciary duties against Onyx. The complaint sought certification of a class of all Onyx
shareholders, damages (including pre- and post-judgment interest), attorneys’ fees and expenses plus other relief. The plaintiffs
in the Consolidated Cases simultaneously filed a notice of dismissal without prejudice of Amgen and Arena. On January 9, 2014,
the court sustained a demurrer without leave to amend as to Onyx. The plaintiff in the Fitzpatric case dismissed his case on August
22, 2014. On January 30, 2015, the court granted class certification and appointed Mr. Rosen as class representative in the
Consolidated Cases. A hearing on defendants’ summary judgment motion has been set for February 24, 2016, and the trial date
has been set for April 28, 2016.
Federal Securities Litigation - In re Amgen Inc. Securities Litigation
The six federal class action stockholder complaints filed against Amgen, Kevin W. Sharer, Richard D. Nanula, Dennis M.
Fenton, Roger M. Perlmutter, Brian M. McNamee, George J. Morrow, Edward V. Fritzky, Gilbert S. Omenn and Franklin P.
Johnson, Jr., (the Federal Defendants) in the U.S. District Court for the Central District of California (the California Central District