Johnson and Johnson 2010 Annual Report Download - page 68

66 JOHNSON & JOHNSON 2010 ANNUAL REPORT
The following chart summarizes various patent lawsuits concerning products of the Company’s subsidiaries that have yet to
proceed to trial:
J&J Plaintiff/
Product Company Patents Patent Holder Court Trial Date** Date Filed
CYPHER®Stent Cordis Wall Wall E.D. TX Q2/11 11/07
CYPHER®Stent CordisSaffran Saffran E.D. TX *Trial concluded 10/07
Blood Glucose Meters and Strips LifeScan Wilsey Roche Diagnostics D. DE *11/07
SIMPONI® Centocor/COBI Salfeld Abbott Laboratories MA *05/09
SIMPONI® Centocor/COBI Boyle Bayer Healthcare MA *** 08/09
STELARA® Centocor/COBI Salfeld Abbott GmbH MA *08/09
* Trial date to be scheduled.
** Q reflects the Company’s fiscal quarter.
*** Summary judgment granted.
As noted in the following chart, 30-month stays expired during 2009, 2010, and will expire in 2011, 2012 and 2013 with respect to
ANDA challenges regarding various products:
Brand Name Patent/NDA Generic Trial Date30-Month
Product Holder Challenger Court Date** Filed Stay Expiration
CONCERTA® Ortho-McNeil-Janssen Andrx D. DE Q4/07 09/05 None
18, 27, 36 and 54 mg controlled ALZAKUDCO D. DE *01/10 05/12
release tablet Impax and Teva D. DE *11/10 04/13
LEVAQUIN® 250, 500, 750 mg tabletOrtho-McNeil Lupin D. NJ *10/06 03/09
ORTHO TRI-CYCLEN® LO Ortho-McNeil Watson D. NJ *10/08 03/11
0.18 mg/0.025 mg, 0.215 mg/0.025 mg Sandoz D. NJ *10/11
and 0.25 mg/0.025 mg Lupin D. NJ *01/10 06/12
Mylan D. NJ *11/10 04/13
ULTRAM ER®100, 200, 300 mg tabletOrtho-McNeil/Biovail Par D. DE Q2/09 05/07 09/09
06/07 11/09
10/07 03/10
ULTRAM ER®100, 200, 300 mg tabletOrtho-McNeil/Biovail Impax D. DE 08/08 01/11
11/08 03/11
ULTRAM ER®100, 200, 300 mg tabletOrtho-McNeil/Biovail Paddock D. MN * 09/09 01/12
ULTRAM ER®100, 200, 300 mg tabletOrtho-McNeil/Biovail Cipher D. DE *10/09 03/12
ULTRAM ER®100, 200, 300 mg tabletOrtho-McNeil/Biovail Lupin D. DE *01/10 06/12
PREZISTA® Tibotec Mylan D. NJ *11/10 12/13
Tibotec Lupin D. NJ *11/10 12/13
* Trial date to be scheduled.
** Q reflects the Company’s fiscal quarter.
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG
APPLICATIONS (ANDAs)
The following chart indicates lawsuits pending against generic firms
that filed Abbreviated New Drug Applications (ANDAs) seeking
to market generic forms of products sold by various subsidiaries of
the Company prior to expiration of the applicable patents covering
those products. These ANDAs typically include allegations of
non-infringement, invalidity and unenforceability of these patents.
In the event the subsidiary of the Company involved is not success-
ful in these actions, or the statutory 30-month stay expires before
aruling from the District Court is obtained, the firms involved will
have the ability, upon FDA approval, to introduce generic versions
of the product at issue resulting in very substantial market share
and revenue losses for the product of the Company’s subsidiary.
In June 2009, Centocor’s (now COBI) lawsuit alleging that
Abbott’s HUMIRA®anti-TNF alpha product infringes Centocor’s
’775 patent went to trial in Federal District Court in the Eastern Dis-
trict of Texas. On June 28, 2009 a jury returned a verdict finding the
patent valid and willfully infringed, and awarded Centocor damages
of approximately $1.7 billion. A bench trial on Abbott’s defenses,
of inequitable conduct and prosecution laches, was held in August
2009, and the District Court decided these issues in favor of Cento-
cor. All of Abbott’s post trial motions have been denied except that
the District Court granted Abbott’s motion to overturn the jury
finding of willfulness. Judgment in the amount of approximately
$1.9billion, inclusive of interest was entered in favor of Centocor in
December 2009, and Abbott filed an appeal to the Court of Appeals
for the Federal Circuit; therefore the Company has not reflected any
of the $1.9 billion in its consolidated financial statements. The oral
argument on appeal was held on November 2, 2010. In December
2009, Centocor also filed a new lawsuit in the Eastern District of
Texas seeking damages for infringement of the ’775 patent attribut-
able to sales of HUMIRA®subsequent to the jury verdict in June
2009. On February 23, 2011, the Court of Appeals reversed the June
2009 decision and the $1.9 billion judgement of the District Court.