Johnson and Johnson 2015 Annual Report Download - page 81

If any of the REMICADE®related patents discussed above is found to be invalid, any such patent could not be relied upon
to prevent the introduction of biosimilar versions of REMICADE®. Biosimilar versions of REMICADE®have been
introduced in certain markets outside the United States, resulting in a reduction in sales of REMICADE®in those markets.
The timing of the possible introduction of a biosimilar version of REMICADE®in the United States is subject to
enforcement of patent rights, approval by the FDA and compliance with the 180-day notice provisions of the BPCIA. In
February 2016, the Arthritis Advisory Committee of the FDA recommended approval of Celltrion’s investigational biosimilar
version of REMICADE®by a vote of 21-3 across all eligible indications in the United States. There is a risk that a
competitor could launch a biosimilar version of REMICADE®following FDA approval (subject to compliance with the 180-
day notice provisions of the BPCIA), even though one or more valid patents are in place. Introduction to the U.S. market of
a biosimilar version of REMICADE®will result in a reduction in U.S. sales of REMICADE®.
Litigation Against Filers of Abbreviated New Drug Applications (ANDAs)
The following summarizes lawsuits pending against generic companies that have filed Abbreviated New Drug Applications
(ANDAs) with the FDA, or undertaken similar regulatory processes outside of the United States, seeking to market generic
forms of products sold by various subsidiaries of Johnson & Johnson prior to expiration of the applicable patents covering
those products. These ANDAs typically include allegations of non-infringement, invalidity and unenforceability of the
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. In addition, from time to time, subsidiaries may settle these actions
and such settlements can involve the introduction of generic versions of the products at issue to the market prior to the
expiration of the relevant patents.
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. Mylan and Lupin filed an appeal.
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. In November 2015, Janssen and Mylan entered
into a confidential settlement. Pursuant to the settlement agreement, the parties are in the process of seeking a dismissal
of this action. In addition, the appeal of the August 2014 decision as it relates to Mylan has been dismissed and remanded
to the District Court where the parties are seeking a modification of the Court’s 2014 order in accordance with the
settlement agreement.
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