Johnson and Johnson 2014 Annual Report Download - page 69

applicable patents. In the event the subsidiaries are not successful in these actions, or the statutory 30-month stays of the
ANDAs expire before the United States District Court rulings are obtained, the third-party companies involved will have the
ability, upon approval of the FDA, to introduce generic versions of the products at issue to the market, resulting in the
potential for substantial market share and revenue losses for those products, and which may result in a non-cash
impairment charge in any associated intangible asset.
PREZISTA®
A number of generic companies have filed ANDAs seeking approval to market generic versions of PREZISTA®.In
November 2010, Tibotec, Inc. (now Tibotec, LLC) and Tibotec Pharmaceuticals (now Janssen R&D Ireland) (collectively,
Tibotec) filed a patent infringement lawsuit against Lupin, Ltd., Lupin Pharmaceuticals, Inc. (collectively, Lupin), Mylan, Inc.
and Mylan Pharmaceuticals, Inc. (collectively, Mylan) in the United States District Court for the District of New Jersey in
response to Lupin’s and Mylan’s respective ANDAs seeking approval to market generic versions of Tibotec’s PREZISTA®
product before the expiration of Tibotec’s patent relating to PREZISTA®. Lupin and Mylan each filed counterclaims
alleging non-infringement and invalidity. In July 2011, Tibotec filed another patent infringement lawsuit against Lupin in the
United States District Court for the District of New Jersey in response to Lupin’s supplement to its ANDA to add new
dosage strengths for its proposed product. In August 2011, Tibotec and G.D. Searle & Company (G.D. Searle) filed a
patent infringement lawsuit against Lupin and Mylan in response to their notice letters advising that their ANDAs are
seeking approval to market generic versions of Tibotec’s PREZISTA®product before the expiration of two additional
patents relating to PREZISTA®that Tibotec exclusively licenses from G.D. Searle. In September 2011, the Court
consolidated the above lawsuits (referred to here as the First Consolidated Action).
The approved New Drug Application for PREZISTA®was transferred from Tibotec, Inc. to Janssen Products, LP in
December 2011. In 2012 and 2013, Janssen Products, LP and Janssen R&D Ireland (collectively, Janssen) added several
patents that they own or exclusively license from G.D. Searle to the First Consolidated Action against Mylan and Lupin. In
June 2013, Janssen and G.D. Searle dismissed their claims relating to the patents owned by G.D. Searle against Lupin
and Mylan, based on those parties’ agreement not to seek FDA approval of their respective ANDAs until the November
2017 expiration of the G.D. Searle patents. After a trial regarding the remaining patents in the First Consolidated Action,
the Court issued a decision in August 2014 in favor of Janssen, holding that the asserted patents are valid and would be
infringed by Lupin’s and Mylan’s marketing of their proposed products. Lupin filed an appeal.
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. 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.
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. Discovery in this case is ongoing and a trial date is set for October 2015.
Janssen and G.D. Searle also filed patent infringement lawsuits against Teva Pharmaceuticals USA, Inc. and Teva
Pharmaceuticals, Ltd. (collectively, Teva) in the United States District Court for the District of New Jersey in response to
Teva’s ANDA seeking approval to market a generic version of PREZISTA®before the expiration of certain patents relating
to PREZISTA®that Janssen either owns or exclusively licenses from G.D. Searle. In March 2014, the parties entered into a
settlement agreement and the lawsuits against Teva were dismissed.
In July 2014, Janssen filed a patent infringement lawsuit against Mylan in the United States District Court for the District of
New Jersey, alleging infringement of United States Patent No. 8,153,829. Discovery in the case in ongoing.
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.
Discovery is ongoing.
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
Johnson & Johnson 2014 Annual Report •59