Johnson & Johnson - Index

Johnson & Johnson - report - Index

The following chart summarizes various patent lawsuits concerning products of Johnson & Johnson subsidiaries that have yet to
proceed to trial:
J&J Plaintiff/
Product Company Patents Patent Holder Court Trial Date Date Filed
Two-layer Cordis Kasten- Boston Scientific Multiple European * 09/07
Catheters hofer Corp.
Forman
Contact Lenses Vision Care Nicolson CIBA Vision M.D. FL * 09/03
Multiple European * 09/07
Stents Cordis Ricci Medtronic and Evysio E.D. TX * 03/07
CYPHER® Stent Cordis Wall Wall E.D. TX * 11/07
CYPHER® Stent Cordis Bonutti MarcTec S.D. IL * 11/07
CYPHER® Stent Coris Saffran Saffran E.D. TX * 10/07
* Trial date to be established.
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG
APPLICATIONS (ANDA)
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 successful 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 2006 and 2007, and will expire in 2008, 2009 and 2010 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
ACIPHEX® Eisai Teva S.D. NY 03/07 11/03 02/07
20 mg delay (for Janssen) Dr. Reddy’s S.D. NY 03/07 11/03 02/07
release tablet
CONCERTA® McNeil-PPC Andrx D. DE 12/07 09/05 None
18, 27, 36 and 54 mg ALZA
controlled release tablet
LEVAQUIN® Ortho-McNeil Lupin D. NJ * 10/06 03/09
250, 500, 750 mg tablets
ORTHO TRI CYCLEN ® LO Ortho-McNeil Barr D. NJ * 10/03 02/06
0.18 mg/0.025 mg
0.215 mg/0.025 mg
and 0.25 mg/0.025 mg
PEPCID COMPLETE® McNeil-PPC Perrigo S.D. NY 02/07 02/05 06/07
RAZADYNE™ Janssen Teva D. DE 05/07 07/05 08/08
Mylan D. DE 05/07 07/05 08/08
Dr. Reddy’s D. DE 05/07 07/05 08/08
Purepac D. DE 05/07 07/05 08/08
Barr D. DE 05/07 07/05 08/08
Par D. DE 05/07 07/05 08/08
AlphaPharm D. DE 05/07 07/05 08/08
RAZADYNE™ ER Janssen Barr D. NJ * 06/06 11/08
Sandoz D. NJ * 05/07 12/08
KV Pharma D. NJ * 12/07 05/10
68 JOHNSON & JOHNSON 2007 ANNUAL REPORT