Amgen 2015 Annual Report Download - page 121

F-43
On March 19, 2015, the California Northern District Court issued an order dismissing with prejudice Amgen’s state law
claims, and entered judgment in favor of Sandoz Inc. on its cross-motion for partial judgment on the pleadings. The order also
denied Amgen’s motion for a preliminary injunction, as well as Amgen’s motion for partial judgment on the pleadings. On a joint
motion of the parties, on March 25, 2015, the California Northern District Court entered final judgment on the claims and
counterclaims decided by the court’s March 19 order. The remaining patent infringement claim, counterclaim and defenses were
stayed by the court pending appeal. On March 25, 2015, Amgen appealed the judgment in favor of Sandoz Inc. and the denial of
Amgen’s motion for preliminary injunction to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court). On
May 5, 2015, the Federal Circuit Court entered an injunction prohibiting Sandoz Inc. from marketing, selling, offering for sale,
or importing into the United States Sandoz’s FDA-approved Zarxio™ biosimilar product until the Federal Circuit Court resolved
the appeal.
On July 21, 2015, the Federal Circuit Court affirmed the district court’s dismissal of Amgen’s state law claims and directed
the California Northern District Court to enter judgment on Sandoz’s counter-claims consistent with the Federal Circuit’s
interpretation of the BPCIA. The Federal Circuit Court concluded that the only remedies available for a biosimilar applicant’s
failure to provide its BLA by the statutory deadline is to bring a patent infringement claim and seek those patent remedies provided
by the statute. The Federal Circuit Court also concluded that a biosimilar applicant must give 180-day advance notice of first
commercial marketing after the FDA has licensed the biosimilar product. Accordingly, the Federal Circuit Court entered an order
that its previously entered injunction be extended through September 2, 2015, (180 days from Sandoz Inc.’s notice given after
FDA approval) and remanded for the district court to consider the patent infringement claim and counterclaims. Sandoz launched
Zarxio™ in the United States on September 3, 2015.
On August 20, 2015, Amgen and Sandoz each petitioned the Federal Circuit Court requesting rehearing en banc of various
aspects of the Federal Circuit Court opinion on which the other had prevailed. On October 16, 2015, the Federal Circuit Court
denied each of Amgen’s and Sandoz’s petitions for rehearing en banc.
On September 8, 2015, the California Northern District Court granted the parties’ joint motion to lift the stay of the case,
allowing the remaining patent infringement claim, counterclaim and defenses to proceed. Amgen filed a first supplemental and
amended complaint on October 15, 2015, adding to the lawsuit Sandoz’s infringement of U.S. Patent No. 8,940,878, which covers
methods of purifying proteins. A claim construction hearing is scheduled for May 4, 2016.
Apotex Pegfilgrastim/Filgrastim Litigation
On August 6, 2015, Amgen filed a lawsuit in the U.S. District Court for the Southern District of Florida (the Florida Southern
District Court) against Apotex Inc. and Apotex Corp. (collectively Apotex) for infringement of our U.S. Patent Nos. 8,952,138
(the `138 Patent) and 5,824,784 (the `784 Patent) in accordance with the patent provisions of the BPCIA and for a declaration that
Apotex’s pre-licensure notice of commercial marketing is legally ineffective. This lawsuit stems from Apotex’s submission of an
application for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta®. By its complaint, Amgen seeks,
amongst other remedies, an injunction prohibiting Apotex from infringing the `138 and `784 patents and enjoining Apotex from
commencing commercial marketing of any biosimilar pegfilgrastim product until a date that is at least 180 days after Apotex
provides legally effective notice to Amgen. Apotex answered the complaint on October 5, 2015, denying patent infringement,
alleging that the patents are invalid, alleging sham litigation in violation of the Sherman Antitrust Act, seeking a declaration that
the `138 patent is unenforceable for patent misuse and seeking a declaration on the interpretation of the BPCIA commercial notice
provision.
On October 2, 2015, Amgen filed a second lawsuit in the Florida Southern District Court against Apotex for infringement
of the `138 Patent and our U.S. Patent No. 6,162,427 (the `427 Patent) and in accordance with the patent provisions of the BPCIA
and for a declaration that Apotex’s pre-licensure notice of commercial marketing is legally ineffective. This lawsuit stems from
Apotex’s submission of an application for FDA licensure of a filgrastim product as biosimilar to NEUPOGEN®. By its complaint,
Amgen seeks, amongst other remedies, an injunction prohibiting Apotex from infringing the `138 and `427 patents and enjoining
Apotex from commencing commercial marketing of any biosimilar filgrastim product until a date that is at least 180 days after
Apotex provides legally effective notice to Amgen. On November 3, 2015, the Florida Southern District Court consolidated the
two lawsuits into a single case.
On December 9, 2015, the Florida Southern District Court granted Amgen’s motion for preliminary injunction prohibiting
Apotex from commercializing its biosimilar pegfilgrastim product until a date that is at least 180 days after Apotex provides
legally effective commercial notice to Amgen. On December 19, 2015, Apotex appealed this injunction to the Federal Circuit
Court. The patent litigation is proceeding in the Florida Southern District Court during the pendency of the appeal and trial is
scheduled for July 11, 2016.