Johnson and Johnson 2015 Annual Report Download - page 82

In May 2013, Lupin notified Janssen that it filed an ANDA seeking approval to market a new dosage strength of its generic
version of PREZISTA®. In response, Janssen filed a patent infringement lawsuit in the United States District Court for the
District of New Jersey, alleging that Lupin’s new dosage strength would infringe the same patents that Janssen is asserting
against Lupin in the original action. In March 2014, Janssen filed a patent infringement lawsuit against Lupin in the United
States District Court for the District of New Jersey, alleging infringement of United States Patent No 8,518,987 (the ‘987
patent). In January 2015, the Court consolidated these lawsuits (referred to here as the Second Consolidated Action), and
stayed them pending Lupin’s appeal of the Court’s decision in the First Consolidated Action. In April 2015, Lupin filed an
Inter Partes Review in the USPTO seeking to invalidate the ‘987 patent and in October 2015, the USPTO denied Lupin’s
petition. In January 2016, Janssen received a patent notice from Lupin advising that Lupin has amended its ANDA to
reflect a new formulation of darunavir that Lupin alleges does not infringe the relevant Janssen patents, and in February
2016, Janssen filed a lawsuit asserting those patents against Lupin in the United States District Court for the District of
New Jersey. In addition, in January 2016, Lupin filed a motion to stay and deactivate its appeal of the above-referenced
August 2014 decision, and to remand the matter to the District Court where Lupin intends to modify the 2014 District
Court order and injunction to allow Lupin to market its new formulation of darunavir before the expiration of the relevant
patents.
Janssen filed a patent infringement lawsuit against Hetero Drugs, Ltd. Unit III and Hetero USA Inc. in March 2013 in the
United States District Court for the District of New Jersey, alleging infringement of United States Patent Nos. 7,126,015
and 7,595,408. In October 2015, the parties stipulated to a Consent Judgment wherein the Hetero defendants admitted
that the patents-in-suit are valid and would be infringed by the manufacture, importation, use or sale of Hetero’s ANDA
product, and agreed to an injunction with respect to such product during the life of the patents-in-suit. Hetero reserved
the right to develop non-infringing darunavir products and processes.
In August 2014, Janssen filed patent infringement lawsuits against Cipla Ltd. and Cipla USA, Inc. (collectively, Cipla) in the
United States District Courts for the Districts of New Jersey and Delaware in response to Cipla’s ANDA seeking approval
to market a generic version of Janssen’s PREZISTA®product before the expiration of certain of Janssen’s patents relating
to PREZISTA®. Cipla filed counterclaims seeking declarations of noninfringement and invalidity of the patents-in-suit. In
May 2015, Janssen and Cipla entered into a settlement agreement.
In response to its Notice of Allegation seeking approval to market a generic version of PREZISTA®in Canada before the
expiration of Canadian Patent No. 2,485,834, Janssen Inc. and Janssen R&D Ireland filed a Notice of Application against
Mylan Pharmaceuticals ULC in July 2014. In December 2014, Janssen R&D Ireland transferred its PREZISTA®patents to
Janssen Sciences Ireland UC, and Janssen Sciences Ireland UC was substituted for Janssen R&D Ireland as plaintiff in the
above-referenced actions. In February 2016, the parties entered into a confidential settlement and the Notice of
Application has been dismissed.
In January 2015, Janssen Inc. and Janssen Sciences Ireland UC filed a Notice of Application against Teva Canada Limited
in response to its Notice of Allegation seeking approval to market a generic version of PREZISTA®before the expiration of
Canadian Patent No. 2,485,834. In October 2015, the parties entered into a settlement wherein Teva Canada Limited
agreed to withdraw its Notice of Allegation without prejudice to file a new one in the future, and Janssen Inc. and Janssen
Sciences Ireland UC agreed to dismiss their Notice of Application.
In each of the above lawsuits, Janssen sought or is seeking an Order enjoining the defendants from marketing their generic
versions of PREZISTA®before the expiration of the relevant patents.
CONCERTA®
In May 2014, ALZA Corporation (ALZA) and Janssen Pharmaceuticals, Inc. (JPI) filed a patent infringement lawsuit in the
United States District Court for the District of West Virginia against Mylan, Inc. and Mylan Pharmaceuticals, Inc. (Mylan) in
response to its ANDA seeking approval to market a generic version of CONCERTA®before the expiration of United
States Patent No. 8,163,798 (the ‘798 patent). Mylan filed counterclaims seeking declarations of invalidity and non-
infringement of the patents-in-suit. In May 2015, Mylan sought leave to add a counterclaim for invalidity and non-
infringement of U.S. Patent No. 8,629,179 (the ‘179 patent) and the Court denied Mylan’s motion. In July 2015, Mylan
filed a declaratory judgment action in the Eastern District of Pennsylvania seeking a declaration of invalidity and non-
infringement of the ‘179 patent. In October 2015, the parties entered into a confidential settlement of both the West
Virginia and Pennsylvania actions.
In December 2014, Janssen Inc. and ALZA filed a Notice of Application against Actavis Pharma Company (Actavis) in
response to its Notice of Allegation seeking approval to market a generic version of CONCERTA®before the expiration of
Canadian Patent No. 2,264,852 (the ‘852 patent). The hearing is scheduled for September 2016.
70 •Johnson & Johnson 2015 Annual Report