Johnson and Johnson 2010 Annual Report Download - page 69

NOTES TO CONSOLIDATED FINANCIAL ST A TEMENTS67
In October 2008, the Company’s subsidiary Ortho-McNeil-
Janssen Pharmaceuticals, Inc. (OMJPI) filed suit in Federal District
Court in New Jersey against Watson Laboratories, Inc. (Watson) in
response to Watson’s ANDA regarding ORTHO TRI-CYCLEN® LO.
In June 2009, OMJPI filed suit in Federal District Court in New
Jersey against Sandoz Laboratories, Inc. (Sandoz) in response to
Sandoz’s ANDA regarding ORTHO TRI-CYCLEN® LO. The Sandoz
and Watson cases have been consolidated. In September 2010,
OMJPI entered into a settlement agreement with Sandoz.
In January 2010, the Company’s subsidiary OMJPI filed suit in
Federal District Court in New Jersey against Lupin Ltd. and Lupin
Pharmaceuticals, Inc. (collectively Lupin) in response to Lupin’s
ANDA regarding ORTHO TRI-CYCLEN® LO. The Lupin case has been
consolidated with the Watson case (discussed above). In November
2010, the Company’s subsidiary OMJPI filed suit in Federal District
Court in New Jersey against Mylan Inc. and Mylan Pharmaceuticals,
Inc. (collectively Mylan), and Famy Care, Ltd., in response to Famy
Care’s ANDA regarding ORTHO TRI-CYCLEN® LO.
In the action by McNEIL-PPC, Inc. (McNeil-PPC) and ALZA Cor-
poration (ALZA) against Andrx Corporation (Andrx) with respect to
its ANDA challenge to the CONCERTA® patents, a five-day non-jury
trial was held in the Federal District Court in Delaware in December
2007. In March 2009, the court ruled that one CONCERTA® patent
would not be infringed by Andrx’s proposed generic product and that
the patent was invalid because it was not enabled. The court dis-
missed without prejudice Andrx’s declaratory judgment suit on a sec-
ond patent for lack of jurisdiction. McNeil-PPC and ALZA filed an
appeal in May 2009. The appeals court heard argument on February
3, 2010. On April 26, 2010, the court of appeals affirmed the judg-
ment of the district court that the patent is invalid because it is not
enabled. The court did not reach the issue of infringement.
In January 2010, ALZA and OMJPI filed suit in Federal District
Court in Delaware against Kremers-Urban, LLC and KUDCO Ireland,
Ltd. (KUDCO) in response to KUDCO’s ANDA challenge regarding
CONCERTA® tablets. In its notice letter, KUDCO contends that two
ALZA patents for CONCERTA® are invalid and not infringed by a
KUDCO generic. One patent has since been dropped from the case.
In November 2010, ALZA and OMJPI filed suit in Federal
District Court in Delaware against Impax Laboratories, Inc., Teva
Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.
in response to notice from Impax that it made a major amendment
to its ANDA with respect to its 56 mg dose generic version of
CONCERTA®. In its notice letter describing its major amendment,
Impax contends that a CONCERTA® patent is invalid and not
infringed by its proposed generic version.
In the action against Lupin Pharmaceuticals, Inc. (Lupin)
regarding its ANDA concerning LEVAQUIN®, Lupin contended that
the U.S. Patent and Trademark Office improperly granted a patent
term extension to the patent that Ortho-McNeil, Inc. (now Ortho-
McNeil-Janssen Pharmaceuticals, Inc. (OMJPI)) licenses from
Daiichi Pharmaceuticals, Inc. (Daiichi). Lupin alleged that the active
ingredient in LEVAQUIN® was the subject of prior marketing, and
therefore was not eligible for the patent term extension. Lupin con-
ceded validity and that its product would violate the patent if mar-
keted prior to the expiration of the original patent term. Summary
judgment against Lupin was granted in May 2009 and Lupin
appealed. Oral argument was held in September 2009. In May
2010, the Court of Appeals affirmed the judgment of the trial court
in favor of Ortho-McNeil (now OMJPI) and Daiichi that the patent
term extension covering LEVAQUIN®(levofloxacin) is valid.
Thereafter, Lupin requested rehearing en banc, which was denied.
In the ULTRAM® ER actions, Ortho-McNeil, Inc. (now OMJPI),
filed lawsuits (each for different dosages) in the U.S. District Court
of Delaware against Par Pharmaceuticals, Inc. and Par Pharmaceuti-
cals Companies, Inc. (Par) in May, June and October 2007, on two
Tramadol ER formulation patents owned by Purdue Pharma Prod-
ucts L.P. (Purdue) and Napp Pharmaceutical Group Ltd. (Napp).
OMJPI also filed lawsuits (each for different dosages) against Impax
Laboratories, Inc. (Impax) on a Tramadol ER formulation patent
owned by Purdue and Napp in August and November 2008. Purdue,
Napp and Biovail Laboratories International SRL (Biovail) (the NDA
holder) joined as co-plaintiffs in the lawsuits against Par and Impax,
but Biovail and OMJPI were subsequently dismissed for lack of
standing. The trial against Par took place in April 2009. In August
2009, the Court issued a decision finding the patents-in-suit invalid.
Purdue has appealed that decision. In November 2009, the case
against Impax was stayed with the consent of all parties. In Septem-
ber and October 2009, respectively, Purdue filed suits against
Paddock Laboratories, Inc. (Paddock) and Cipher Pharmaceuticals
Inc. (Cipher) on its Tramadol ER formulation patents. In June 2010,
the Federal Circuit Court affirmed the District Court’s decision in the
Par case. The case against Cipher, Impax and Paddock were dis-
missed based on the collateral estoppel effect of the Par decision.
In January 2010, Purdue filed a suit against Lupin Ltd. on its
Tramadol ER formulation patents.
In November 2010, the Company’s subsidiary Tibotec, Inc.
(Tibotec) filed suit in Federal District Court in New Jersey against
Lupin, Ltd., Lupin Pharmaceuticals, Inc. (collectively Lupin), Mylan,
Inc. and Mylan Pharmaceuticals, Inc. (collectively Mylan) in response
to Lupin’s and Mylan’s respective ANDA’s regarding PREZISTA®.
In January 2011, Tibotec, Inc. (Tibotec) received a Paragraph IV
Notification from Teva Pharmaceuticals, Inc. advising that Teva has
filed an ANDA seeking approval to market a generic PREZISTA®
product before the expiration of certain patents owned or licensed
by Tibotec. Tibotec is evaluating this Notification.
GENERAL LITIGATION
In September 2004, plaintiffs in an employment discrimination
litigation initiated against the Company in 2001 in Federal District
Court in New Jersey moved to certify a class of all African American
and Hispanic salaried employees of the Company and its affiliates in
the U.S., who were employed at any time from November 1997 to
the present. Plaintiffs seek monetary damages for the period 1997
through the present (including punitive damages) and equitable
relief. The Court denied plaintiffs’ class certification motion in
December 2006 and their motion for reconsideration in April 2007.
Plaintiffs sought to appeal these decisions and, in April 2008, the
Court of Appeals ruled that plaintiffs’ appeal of the denial of class
certification was untimely. In July 2009, plaintiffs filed a motion for
certification of a modified class, which the Company opposed. The
district court denied plaintiffs’ motion in July 2010, and the Court
of Appeals denied plaintiffs’ request for leave to appeal the denial
of certification of the modified class. The Company will continue to
defend against the plaintiffs’ individual claims of discrimination.
In September 2009, Centocor Ortho Biotech Products, L.P.
(COBLP) intervened in an inventorship dispute between Kansas
University Center for Research (KUCR) involving certain U.S.
Government-owned VELCADE® formulation patents. KUCR brought
this action against the U.S. Government in the District of Kansas seek-
ing to add two Kansas University scientists to the patents. The U.S.
Government licensed the patents (and their foreign counterparts)
to Millennium Pharmaceuticals, Inc. (MPI), who in turn sublicensed