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70 JOHNSON & JOHNSON 2006 ANNUAL REPORT
could potentially adversely affect the ability of those subsidiaries
to sell those products, or require the payment of past damages
and future royalties. With respect to all of these matters, the
Johnson & Johnson subsidiary involved is vigorously defending
against the claims of infringement and disputing, where appro-
priate, the validity and enforceability of the patent claims
asserted against it.
In July 2005, a jury in Federal District Court in Delaware
found that the Cordis CYPHER®stent infringed Boston Scien-
tific’s Ding `536 patent and that the Cordis CYPHER®and BX
VELOCITY®stents also infringed Boston Scientific’s Jang `021
patent. The jury also found both of those patents valid. Boston
Scientific seeks substantial damages and an injunction in that
action. In June 2006, the District Court denied motions by
Cordis to overturn the jury verdicts or grant a new trial. Cordis
has moved for re-consideration of those decisions. If reconsider-
ation is denied, Cordis will appeal to the Court of Appeals for
the Federal Circuit. The District Court indicated it will consider
damages, willfulness and injunctive relief after the appeals have
been decided.
Trial of Boston Scientific’s case asserting infringement by
the CYPHER®stent of Boston Scientific’s Grainger patent,
which had been scheduled for March 2006, has been adjourned
pending a decision on Cordis’ motion for summary judgment.
In that case as well, Boston Scientific seeks an injunction and
substantial damages.
Boston Scientific has brought actions in Belgium and the
Netherlands under its Kastenhofer patent to enjoin the manufac-
ture and sale of allegedly infringing catheters in those countries,
and to recover damages. The Belgian case is pending and no
hearing date has been set. A decision by the lower court in the
Netherlands in Boston Scientific’s favor is on appeal.
In Germany, Boston Scientific has several actions based on
its Ding patents pending against the Cordis CYPHER®stent.
Cordis was successful in these actions at the trial level, but
Boston Scientific has appealed.
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
Catheters and Cordis FitzmauriceMedtronic AVE E.D. Tex 09/07 06/03
stent delivery
systems
Drug Eluting Cordis Grainger Boston Scientific D. Del. *12/03
Stents Corp.
Drug Eluting Cordis DingBoston Scientific Germany *04/04
Stents Corp. 11/04
Two-layer CordisKasten- Boston Scientific N.D. Cal *02/02
Catheters hofer Corp. Belgium * 12/03
Forman
StentsCordisIsrael Medinol Multiple E.U. * 05/03
jurisdictions
Contact Lenses Vision Nicolson CIBA Vision M.D. Fla. *09/03
Care
* Trial date to be established.
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG
APPLICATIONS (ANDAs)
The following chart indicates lawsuits pending against generic
firms that filed Abbreviated New Drug Applications seeking to
market generic forms of products sold by various subsidiaries of
the Company prior to expiration of the applicable patents cover-
ing 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 intro-
duce 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 will expire in 2007 or 2008 with respect to ANDA
challenges regarding various products:
Brand Name Patent/NDA Generic Trial Date30-Month
Product Holder Challenger Court DateFiled Stay Expires
ACIPHEX® Eisai Teva S.D. N.Y. 03/07 11/03 02/07
20 mg delay (for Janssen) Dr. Reddy’sS.D. N.Y. 03/07 11/03 02/07
release tablet Mylan S.D. N.Y. 03/07 01/04 02/07
AXERT® 6.25 Almirall Teva S.D. N.Y. * 03/06 11/08
and 12.5 mg Ortho-McNeil
Neurologics
CONCERTA® McNeil-PPC Andrx D. Del. *09/05 None
18, 27, 36 and 54 mg ALZA
controlled release tablet