Johnson and Johnson 2009 Annual Report Download - page 61

Columbia, COBI filed a Complaint for Review of a Patent Interfer-
ence Decision granting priority of invention on one of the two
asserted patents to Abbott GmbH. In August 2009, Abbott GmbH
and Abbott Laboratories Limited brought a patent infringement suit
in Canada alleging that STELARA™ infringes Abbott GmbH’s Cana-
dian patent. The cases filed by COBI in the District of Columbia have
been transferred to the District of Massachusetts.
In August 2009, Bayer Healthcare LLC filed suit against COBI
in Massachusetts District Court alleging infringement by COBI’s
SIMPONI™ product of its patent relating to human anti-TNF anti-
bodies. Bayer has also filed suit under its European counterpart to
these patents in Germany and the Netherlands.
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 District 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 find-
ing of willfulness. Judgment in the amount of $1.9 billion was
entered in favor of Centocor in December 2009 and Abbott has
filed an appeal to the Court of Appeals for the Federal Circuit. The
Company has not reflected any of the $1.9 billion in its consolidated
financial statements. Centocor has also filed a new lawsuit in the
Eastern District of Texas seeking damages for infringement of the
’775 patent attributable to sales of HUMIRA subsequent to the jury
verdict in June 2009.
N O T E S T O C O N S O L I D A T E D F I N A N C I A L S T A T E M E N T S 59
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 Cordis Saffran Saffran E.D. TX Q2/11 10/07
Blood Glucose Meters and Strips LifeScan Wilsey Roche Diagnostics D. DE * 11/07
REMICADE®, ustekinumab, Centocor/COBI Cabilly II Genentech C.D. CA * 05/08
golimumab, ReoPro®
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/DC * 08/09
* 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 a
ruling 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.
As noted in the following chart, 30-month stays expired during 2009, and will expire in 2010, 2011 and 2012 with respect to ANDA
challenges regarding various products:
Brand Name Patent/NDA Generic Trial Date 30-Month
Product Holder Challenger Court Date** Filed Stay Expiration
CONCERTA® McNeil-PPC Andrx D. DE Q4/07 09/05 None
18, 27, 36 and 54 mg controlled ALZA KUDCO D. DE * 01/10 05/12
release tablet
LEVAQUIN® 250, 500, 750 mg tablet Ortho-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 * 06/09 10/11
and 0.25 mg/0.025 mg D. NJ * 06/12
ULTRAM ER® 100, 200, 300 mg tablet Ortho-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 tablet Ortho-McNeil/Biovail Impax D. DE Q2/10 08/08 01/11
11/08 03/11
ULTRAM ER® 100, 200, 300 mg tablet Ortho-McNeil/Biovail Paddock D.DRD. Minn. * 09/09 01/12
ULTRAM ER® 100, 200, 300 mg tablet Ortho-McNeil/Biovail Cipher D. DE * 10/09 03/12
ULTRAM ER® 100, 200, 300 mg tablet Ortho-McNeil/Biovail Lupin D. DE * 01/10 06/12
* Trial date to be scheduled.
** Q reflects the Company’s fiscal quarter.