Johnson and Johnson 2015 Annual Report Download - page 84

7,563,922. In addition, in the New Jersey Action, the Court dismissed Mylan’s motion to dismiss and set a trial date of
February 2018, and in the West Virginia Action, the Court set a trial date of December 2017. In February 2016, Mylan
renewed its motion to dismiss for lack of jurisdiction.
In each of the above lawsuits, Janssen is seeking an Order enjoining the defendants from marketing their generic versions
of COMPLERA®before the expiration of the relevant patents.
XARELTO®
A number of generic companies have filed ANDAs seeking approval to market generic versions of XARELTO®. In October
2015, Janssen Pharmaceuticals, Inc. (JPI) and Bayer Pharma AG and Bayer Intellectual Property GmbH (collectively,
Bayer) filed a patent infringement lawsuit against Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc., Breckenridge
Pharmaceutical, Inc., Micro Labs USA Inc., Micro Labs Ltd., Mylan Pharmaceuticals Inc., Mylan Inc., Prinston
Pharmaceutical, Inc., Sigmapharm Laboratories, LLC, Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. in the
United States District Court for the District of Delaware in response to those parties’ respective ANDAs seeking approval
to market generic versions of XARELTO®before the expiration of Bayer’s United States Patent Nos. 7,157,456,
7,585,860 and 7,592,339 relating to XARELTO®. JPI is the exclusive licensee of the asserted patents. JPI is seeking an
Order enjoining the defendants from marketing their generic versions of XARELTO®before the expiration of the relevant
patents. In November 2015, Mylan moved to dismiss the action. In December 2015, JPI, Bayer, and Mylan stipulated and
agreed to dismiss the claims against Mylan Inc. and suspend further briefing and argument on Mylan’s motion to dismiss
pending appeals relating to personal jurisdiction over Mylan Pharmaceuticals Inc. in the District of Delaware.
In January 2016, JPI and Bayer received a paragraph IV notice from Invagen Pharmaceuticals Inc. (Invagen) advising that it
is seeking FDA approval for a generic XARELTO®product before expiration of the relevant patents. In February 2016, JPI
and Bayer filed a patent infringement action against Invagen asserting the same XARELTO®patents asserted in the
original case, and the Invagen case has been consolidated with the original case. The Court set a trial date of March
2018.
Government Proceedings
Like other companies in the pharmaceutical and medical devices industries, Johnson & Johnson and certain of its
subsidiaries are subject to extensive regulation by national, state and local government agencies in the United States and
other countries in which they operate. As a result, interaction with government agencies is ongoing. The most significant
litigation brought by, and investigations conducted by, government agencies are listed below. It is possible that criminal
charges and substantial fines and/or civil penalties or damages could result from government investigations or litigation.
Average Wholesale Price (AWP) Litigation
Johnson & Johnson and several of its pharmaceutical subsidiaries (the J&J AWP Defendants), along with numerous other
pharmaceutical companies, are defendants in a series of lawsuits in state and federal courts involving allegations that the
pricing and marketing of certain pharmaceutical products amounted to fraudulent and otherwise actionable conduct
because, among other things, the companies allegedly reported an inflated Average Wholesale Price (AWP) for the drugs
at issue. Payors alleged that they used those AWPs in calculating provider reimbursement levels. Many of these cases,
both federal actions and state actions removed to federal court, were consolidated for pre-trial purposes in a Multi-District
Litigation (MDL) in the United States District Court for the District of Massachusetts.
The plaintiffs in these cases included three classes of private persons or entities that paid for any portion of the purchase
of the drugs at issue based on AWP, and state government entities that made Medicaid payments for the drugs at issue
based on AWP. In June 2007, after a trial on the merits, the MDL Court dismissed the claims of two of the plaintiff classes
against the J&J AWP Defendants. In March 2011, the Court dismissed the claims of the third class against the J&J AWP
Defendants without prejudice.
AWP cases brought by various Attorneys General have proceeded to trial against other manufacturers. Several state
cases against certain subsidiaries of Johnson & Johnson have been settled, including the case in Alaska, which settled in
April 2014, and cases are still pending in Illinois, New Jersey, Wisconsin and Utah. The cases in Illinois, New Jersey and
Wisconsin have not yet proceeded to trial. In Utah, the claims brought by the Attorney General were dismissed by the
Court in 2013, but the State may appeal the dismissal after the conclusion of similar pending matters against other
defendants. The AWP case against the J&J AWP Defendants brought by the Attorney General of the Commonwealth of
Pennsylvania was tried in Commonwealth Court in 2010. The Court found in the Commonwealth’s favor with regard to
certain of its claims under the Pennsylvania Unfair Trade Practices and Consumer Protection Law (“UTPL”), entered an
72 •Johnson & Johnson 2015 Annual Report