Johnson and Johnson 2012 Annual Report Download - page 66

and Teva filed counterclaims alleging non-infringement and invalidity. In May 2011, ALZA and JPI filed a second lawsuit
against Teva in response to Teva’s filing of a second major amendment to its ANDA seeking approval to market additional
dosage strengths of its generic CONCERTA®product before the expiration of ALZA and JPI’s patent relating to
CONCERTA®. In each of the above cases, ALZA and JPI sought an Order enjoining the defendants from marketing its
generic version of CONCERTA®prior to the expiration of ALZA and JPI’s CONCERTA®patent. In September 2012, a
settlement agreement was entered into with Impax and Teva pursuant to which those parties were granted a license under
the patent-in-suit to market their generic version of CONCERTA®starting July 14, 2013 (or earlier under certain
circumstances), if and when they obtain FDA approval.
ORTHO TRI-CYCLEN®LO
A number of generic companies have filed ANDAs seeking approval to market generic versions of ORTHO TRI-CYCLEN®
LO. In February 2012, JPI and Watson Laboratories, Inc. and Watson Pharmaceuticals, Inc. (collectively, Watson) entered
into a settlement agreement. Pursuant to the settlement agreement, the parties entered into a supply agreement whereby
JPI will supply to Watson a combinational oral contraceptive containing certain specified compounds from December 31,
2015 (or earlier under certain circumstances) through the expiration of the ‘815 patent on December 6, 2019. In addition,
in the event Watson does not wish to exercise its rights under the supply agreement, JPI has granted Watson a license to
market Watson’s ANDA product from December 31, 2015 (or earlier under certain circumstances) through December 6,
2019.
In January 2010, OMJPI (now JPI) filed a patent infringement lawsuit against Lupin Ltd. and Lupin Pharmaceuticals, Inc.
(collectively, Lupin) in the United States District Court for the District of New Jersey in response to Lupin’s ANDA seeking
approval to market a generic version of ORTHO TRI-CYCLEN®LO prior to the expiration of JPI’s patent relating to
ORTHO TRI-CYCLEN®LO (the OTCLO patent). Lupin filed a counterclaim alleging invalidity of the patent. Trial
concluded in June 2012, and in September 2012, the Court issued a decision in favor of JPI. In particular, the Court
ordered that the effective date of the approval of Lupin’s ANDA (which had previously been approved) be not earlier than
the expiration of the OTCLO patent. Lupin has appealed the decision to the Court of Appeals for the Federal Circuit. Oral
argument was heard in February 2013, and the Court’s decision is pending.
In November 2010, OMJPI (now JPI) filed a patent infringement lawsuit against Mylan Inc. and Mylan Pharmaceuticals, Inc.
(collectively, Mylan), and Famy Care, Ltd. (Famy Care) in the United States District Court for the District of New Jersey in
response to Famy Care’s ANDA seeking approval to market a generic version of ORTHO TRI-CYCLEN®LO prior to the
expiration of the OTCLO patent. Mylan and Famy Care filed counterclaims alleging invalidity of the patent. In November
2012, JPI and Mylan entered into a settlement agreement pursuant to which Mylan was granted a license under the
OTCLO patent to market its generic version of ORTHO TRI-CYCLEN®LO starting December 31, 2015 (or earlier under
certain circumstances), if and when they obtain FDA approval.
In October 2011, JPI filed a patent infringement lawsuit against Sun Pharma Global FZE and Sun Pharmaceutical
Industries (collectively, Sun) in the United States District Court for the District of New Jersey in response to Sun’s ANDA
seeking approval to market a generic version of ORTHO TRI-CYCLEN®LO prior to the expiration of the OTCLO patent.
In May 2012, JPI filed a patent infringement lawsuit against Haupt Pharma, Inc., Ranbaxy Laboratories Limited and
Ranbaxy Inc. (collectively, Haupt) in the United States District Court for the District of New Jersey in response to Haupt’s
ANDA seeking approval to market a generic version of ORTHO TRI-CYCLEN®LO prior to the expiration of the OTCLO
patent. In December 2012, JPI and Haupt entered into a settlement agreement pursuant to which Haupt was granted a
license under the OTCLO patent to market its generic version of ORTHO TRI-CYCLEN®LO starting December 31, 2015
(or earlier under certain circumstances), if and when they obtain FDA approval.
In August 2012, JPI filed a patent infringement lawsuit against Glenmark Generics Ltd. and Glenmark Generics Inc., USA
(collectively, Glenmark) in the United States District Court for the District of New Jersey in response to Glenmark’s ANDA
seeking approval to market a generic version of ORTHO TRI-CYCLEN®LO prior to the expiration of the OTCLO patent.
In November 2012, a settlement agreement was entered into with Glenmark pursuant to which Glenmark was granted a
license under the OTCLO patent to market its generic version of ORTHO TRI-CYCLEN®LO starting December 31, 2015
(or earlier under certain circumstances), if and when they obtain FDA approval.
In each of the above cases, JPI sought or is seeking an Order enjoining the defendants from marketing their generic
versions of ORTHO TRI-CYLCEN®LO before the expiration of the OTCLO patent.
58 •Johnson & Johnson 2012 Annual Report