Johnson and Johnson 2015 Annual Report Download - page 83

Download and view the complete annual report

Please find page 83 of the 2015 Johnson and Johnson annual report below. You can navigate through the pages in the report by either clicking on the pages listed below, or by using the keyword search tool below to find specific information within the annual report.

Page out of 112

  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
  • 13
  • 14
  • 15
  • 16
  • 17
  • 18
  • 19
  • 20
  • 21
  • 22
  • 23
  • 24
  • 25
  • 26
  • 27
  • 28
  • 29
  • 30
  • 31
  • 32
  • 33
  • 34
  • 35
  • 36
  • 37
  • 38
  • 39
  • 40
  • 41
  • 42
  • 43
  • 44
  • 45
  • 46
  • 47
  • 48
  • 49
  • 50
  • 51
  • 52
  • 53
  • 54
  • 55
  • 56
  • 57
  • 58
  • 59
  • 60
  • 61
  • 62
  • 63
  • 64
  • 65
  • 66
  • 67
  • 68
  • 69
  • 70
  • 71
  • 72
  • 73
  • 74
  • 75
  • 76
  • 77
  • 78
  • 79
  • 80
  • 81
  • 82
  • 83
  • 84
  • 85
  • 86
  • 87
  • 88
  • 89
  • 90
  • 91
  • 92
  • 93
  • 94
  • 95
  • 96
  • 97
  • 98
  • 99
  • 100
  • 101
  • 102
  • 103
  • 104
  • 105
  • 106
  • 107
  • 108
  • 109
  • 110
  • 111
  • 112

In February 2015, Janssen Inc. and ALZA filed a Notice of Application against Apotex Inc. (Apotex) in response to its
Notice of Allegation seeking approval to market a generic version of CONCERTA®before the expiration of the ‘852
patent. In August 2015, Janssen Inc. and ALZA voluntarily dismissed the Notice of Application.
In each of the above lawsuits, ALZA and/or JPI sought or are seeking an Order enjoining the defendants from marketing
their generic versions of CONCERTA®before the expiration of the relevant patents.
ZYTIGA®
In June and July 2015, Janssen Biotech, Inc. (JBI) received notices of paragraph IV certification from several companies
advising of their respective ANDAs seeking approval for a generic version of ZYTIGA®before the expiration of one or
more patents relating to ZYTIGA®. In July 2015, JBI, Janssen Oncology, Inc. and Janssen Research & Development, LLC
(collectively, Janssen) and BTG International Ltd. (BTG) filed a patent infringement lawsuit in the United States District
Court for the District of New Jersey against several generic ANDA applicants (and certain of their affiliates and/or
suppliers) in response to their respective ANDAs seeking approval to market a generic version of ZYTIGA®before the
expiration of United States Patent Nos. 5,604,213 (the ‘213 patent) (expiring December 2016) and/or 8,822,438 (the
‘438 patent) (expiring August 2027). The generic companies include Actavis Laboratories, FL, Inc. (Actavis); Amneal
Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York, LLC (collectively, Amneal); Apotex Inc. and Apotex Corp.
(collectively, Apotex); Citron Pharma LLC (Citron); Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
(collectively, Dr. Reddy’s); Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively, Mylan); Par Pharmaceuticals, Inc. and
Par Pharmaceutical Companies, Inc. (collectively, Par); Sun Pharmaceutical Industries Ltd. and Sun Pharmaceuticals
Industries, Inc. (collectively, Sun); Teva Pharmaceuticals USA, Inc. (Teva); Wockhardt Bio A.G.; Wockhardt USA LLC and
Wockhardt Ltd. (collectively, Wockhardt); West-Ward Pharmaceutical Corp. (West-Ward); and Hikma Pharmaceuticals,
LLC (Hikma). The Court entered a stay of the New Jersey lawsuit against each of Par and Citron, as each agreed to be
bound by the decision against the other defendants in the New Jersey action. In February 2016, the New Jersey Court set
a trial date of October 2017.
In August 2015, Janssen and BTG filed an additional jurisdictional protective lawsuit against the Mylan defendants in the
United States District Court for the Northern District of West Virginia. In October 2015, Mylan filed a motion to dismiss
the New Jersey lawsuit for lack of personal jurisdiction and improper venue. In February 2016, the West Virginia Court
stayed the West Virginia case pending a decision on Mylan’s motion to dismiss in the New Jersey lawsuit, but set a
conditional trial date of February 2018. The Court will dismiss the West Virginia lawsuit if Mylan’s motion to dismiss in
New Jersey is denied.
In August 2015, JBI received a notice of paragraph IV certification from Hetero USA Inc., the U.S. Regulatory Agent for
Hetero Labs Limited Unit-V, a division of Hetero Labs Limited (collectively, Hetero) advising of Hetero’s ANDA seeking
approval for a generic version of ZYTIGA®before expiration of the ‘438 patent. In September 2015, Janssen and BTG
filed an amended complaint in the New Jersey lawsuit to allege infringement of the ‘438 patent by Hetero.
The filing of the above-referenced lawsuits triggered a stay until October 2018 during which the FDA will not grant final
approval of the generics’ ANDAs unless there is an earlier district court decision finding the patents-in-suit invalid or not
infringed.
In December 2015, Amerigen Pharmaceuticals Limited filed a petition for an Inter Partes Review in the USPTO seeking to
invalidate the ‘438 patent.
In each of the above lawsuits, Janssen is seeking an Order enjoining the defendants from marketing their generic versions
of ZYTIGA®before the expiration of the relevant patents.
COMPLERA®
In August and September 2015, Janssen Pharmaceutica NV and Janssen Sciences Ireland UC (collectively, Janssen) and
Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) filed patent infringement lawsuits in the United
States District Court for the District of Delaware and West Virginia against Mylan, Inc. and Mylan Pharmaceuticals, Inc.
(collectively, Mylan) in response to their ANDA seeking approval to market a generic version of COMPLERA®before the
expiration of United States Patent Nos. 8,841,310; 7,125,879; and 8,101,629. In September 2015, Mylan filed an Answer
in the West Virginia action that included counterclaims seeking declarations of invalidity and non-infringement of the
patents-in-suit as well as United States Patent No. 8,080,551. In September 2015, Mylan filed a motion to dismiss the
Delaware lawsuit for lack of personal jurisdiction. In January 2016, Janssen and Gilead filed a first amended complaint in
the New Jersey Action adding claims for patent infringement with respect to United States Patent Nos. 7,399,856 and
Johnson & Johnson 2015 Annual Report •71