Johnson and Johnson 2014 Annual Report Download - page 70

Janssen Sciences Ireland UC, and Janssen Sciences Ireland UC was substituted for Janssen R&D Ireland as plaintiff in the
above-referenced actions. 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 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 June 2013, ALZA Corporation (ALZA) and Janssen Pharmaceuticals, Inc. (JPI) filed patent infringement lawsuits in the
United States District Court for the District of Delaware against Par Pharmaceuticals, Inc. (Par), Osmotica Kereskedelmies
Szolgaltato Kft (Osmotica), and Norwich Pharmaceuticals, Inc. (Norwich) in response to those parties’ ANDAs seeking
approval to market a generic version of CONCERTA®before the expiration of United States Patent No. 8,163,798 (the
’798 patent). In addition, in September 2013, Par and Osmotica filed counterclaims against ALZA and JPI seeking
declarations of invalidity and noninfringement of the patent-in-suit, and Norwich filed a motion to dismiss. Norwich was
dismissed from the case in October 2013 based on its agreement to be bound by the outcome of the case with
Osmotica. In March 2014, ALZA and JPI amended its complaint against Par and Osmotica to assert infringement of newly
issued United States Patent No. 8,629,179 (the ’179 patent). In June 2014, ALZA, JPI and Osmotica entered into a
settlement of the action, and in September 2014, ALZA, JPI and Par entered into a settlement.
In May 2014, ALZA and 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 the ’798 patent. Mylan filed counterclaims seeking declarations
of invalidity and noninfringement of the patents-in-suit.
In June 2014, ALZA and JPI filed a patent infringement lawsuit in the District of Delaware against Sandoz, Inc. in response
to its ANDA seeking approval to market a generic version of CONCERTA®before the expiration of the ’798 and ’179
patents. Sandoz filed counterclaims seeking declarations of invalidity, unenforceability, and noninfringement of the patents-
in-suit. In December 2014, the parties entered into a settlement agreement and the lawsuit was dismissed.
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.
In each of the above lawsuits, ALZA and/or JPI are seeking an Order enjoining the defendants from marketing their generic
versions of CONCERTA®before the expiration of the ’798 and/or ’179 patents.
NUCYNTA®AND NUCYNTA®ER
In July 2013, Janssen Pharmaceuticals, Inc. (JPI) filed patent infringement lawsuits in the United States District Court for
the District of New Jersey against Actavis Elizabeth LLC, Actavis Inc. and Actavis LLC (collectively, Actavis), as well as
Alkem Laboratories Limited and Ascend Laboratories, LLC (collectively, Alkem). The patent infringement claims against
Actavis and Alkem relate to their respective ANDAs seeking approval to market a generic version of NUCYNTA®ER
before the expiration of United States Reissue Patent No. 39,593 (the ’593 patent), United States Patent No. 7,994,364
(the ’364 patent) and, as to Actavis only, United States Patent No. 8,309,060 (the ‘060 patent). The lawsuit also includes
a patent infringement claim against Alkem in response to its ANDA seeking approval to market a generic version of
NUCYNTA®before the expiration of the ’593 and ’364 patents. In December 2013, JPI filed an additional complaint in the
District Court of New Jersey against Alkem asserting United States Patent No. 8,536,130 related to its ANDA seeking
approval to market a generic version of NUCYNTA®ER. In August 2014, JPI amended the complaint against Alkem to add
additional dosage strengths.
In October 2013, JPI received a Paragraph IV Notice from Sandoz, Inc. (Sandoz) with respect to NUCYNTA®related to
the ’364 patent, and a Paragraph IV Notice from Roxane Laboratories, Inc. (Roxane) with respect to NUCYNTA®related to
the ’364 and ’593 patents. In response to those notices, JPI filed an additional complaint in the United States District
Court for the District of New Jersey against Roxane and Sandoz asserting the ’364 patent against Sandoz and the ’364
and ’593 patents against Roxane. In April 2014, JPI and Sandoz entered into a joint stipulation of dismissal of the case
against Sandoz, based on Sandoz’s agreement not to enter the market prior to the expiration of the asserted patents. In
June 2014, in response to a Paragraph IV Notice from Roxane with respect to NUCYNTA®ER, JPI filed a complaint
asserting the ’364 and ’593 patents against Roxane.
60 •Johnson & Johnson 2014 Annual Report