[Pharm-policy] Two IVAX Press Releases concerning Taxol Patent disputes
James Love
love@cptech.org
Tue, 30 May 2000 15:33:13 -0400
IVAX and Bristol-Myers Squibb are involved in patent disputes over
patents involving Paclitaxel in the US and the EU. Here are two
recent IVAX press releases on this, starting with last week's
decision in the U.K. Court of Appeals. Jamie
http://www.businesswire.com/webbox/bw.052500/201461376.htm
-- BW1376 MAY 25,2000 9:23 PACIFIC 12:23 EASTERN
( BW)(FL-IVAX-2)(IVX) IVAX Prevails Over Bristol-Myers Squibb in U.K.
Patent Suit
Business Editors/Health & Medical Writers
MIAMI--(BUSINESS WIRE)--May 25, 2000--IVAX Corporation (AMEX:IVX)
today announced that the U.K. Court of Appeals unanimously upheld a 1998
lower court's ruling in favor of IVAX in which a Bristol-Myers Squibb
(BMS) patent relating to the use of Taxol(R) (paclitaxel) was
invalidated. In its decision, the Court of Appeals additionally awarded
IVAX an increase in the amount of costs, including legal fees, that it
may recover from BMS.
IVAX' paclitaxel product is approved for marketing in the European
Union as well as Poland, the Czech Republic and Canada. In the U.S.,
IVAX is awaiting FDA approval of its generic paclitaxel, which it
expects to launch this summer.
IVAX Corporation, headquartered in Miami, Florida, is a holding
company with subsidiaries engaged in the research, development,
manufacturing, and marketing of branded and generic pharmaceuticals and
veterinary and diagnostic products in the U.S. and international
markets.
Except for the historical matters contained herein, statements in
this press release are forward-looking and are made pursuant to the safe
harbor provisions of the Securities Litigation Reform Act of 1995.
Investors are cautioned that forward-looking statements involve risks
and uncertainties which may affect the company's business and prospects,
and cause results to differ materially from those set forth in the
forward-looking statements. These risks include, among others, the risks
that other patents that are not part of the current litigation may be
asserted against IVAX in the future, that the FDA may not approve, or
may delay approval of, IVAX' ANDA for generic paclitaxel, that the U.S.
launch of generic paclitaxel will be delayed, and the risks and
uncertainties inherent generally in litigation and in the FDA approval
process. In addition to these factors, the economic, competitive,
governmental, technological and other factors identified in IVAX'
filings with the Securities and Exchange Commission could affect the
forward-looking statements contained in this release. Taxol(R) is a
registered trademark of the Bristol-Myers Squibb Company.
--30--cp/mi*
CONTACT: IVAX Corporation, Miami
Douglas Heller, Ph.D.
Acting Director, Investor Relations and
Corporate Communications
305/575-6005
douglas_heller@ivax.com
www.ivax.com
KEYWORD: FLORIDA INTERNATIONAL EUROPE
INDUSTRY KEYWORD: PHARMACEUTICAL LEGAL/LAW
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http://www.businesswire.com/webbox/bw.040700/200981155.htm
BW1155 APR 07,2000 6:22 PACIFIC 09:22 EASTERN
( BW)(FL-IVAX)(IVX) Federal Court Enters Judgment in Favor of IVAX --
Bristol-Myers Taxol Patents Invalidated; Bristol's Remaining
Ovarian-Related Patent Claims Permanently
Abandoned
Business Editors/Health & Medical Writers
MIAMI--(BUSINESS WIRE)--April 7, 2000--IVAX Corporation (AMEX:IVX)
announced today that the federal judge presiding over the pending
Taxol(R) (paclitaxel) related patent litigation between IVAX and
Bristol-Myers Squibb has entered judgment in favor of IVAX pursuant to
which all of Bristol's patent claims have now been resolved in favor of
IVAX, subject to any appeal by Bristol Myers. Specifically, the court
has entered judgment in favor of IVAX and its co-defendants and against
Bristol-Myers on the basis of its prior ruling invalidating key claims
of the Taxol(R)-related patents being asserted by Bristol-Myers Squibb.
The judge's ruling also incorporates the permanent abandonment of
Bristol's remaining patent claims relating to the use of Taxol(R) in the
treatment of ovarian cancer. As part of the ruling, the parties have
agreed to an expedited appeal of the judgment. IVAX' counterclaims
against Bristol-Myers for antitrust violations and unfair competition
remain pending and will be tried at a later date.
"We are pleased that the district court has now resolved in IVAX'
favor patent litigation which we believe should never have been
instituted in the first place," commented IVAX Vice Chairman and
President Neil Flanzraich. "We have maintained all along that this
litigation was instituted simply for the purpose of delaying the entry
of generic competition for Taxol(R), and now with a permanent
abandonment of the patent claims relating specifically to the treatment
of ovarian cancer, we look forward to obtaining our product approval
from the FDA and then launching our product."
IVAX Corporation, headquartered in Miami, Florida, is a holding
company with subsidiaries engaged in the research, development,
manufacture, and marketing of branded and generic pharmaceuticals and
veterinary and diagnostic products in the U.S. and international
markets. IVAX' co-defendants in the case include Immunex Corporation,
from whom IVAX purchased an earlier filed paclitaxel ANDA.
Except for the historical matters contained herein, statements in
this press release are forward-looking and are made pursuant to the safe
harbor provisions of the Securities Litigation Reform Act of 1995.
Investors are cautioned that forward-looking statements involve risks
and uncertainties which may affect the company's business and prospects,
and cause results to differ materially from those set forth in the
forward-looking statements. These risks include, among others, the risks
that IVAX and its subsidiaries may not prevail in the appeal, that other
patents that are not part of the current litigation may be asserted
against IVAX in the future, that final FDA approval of IVAX' ANDA may be
delayed by the FDA for regulatory or other reasons, that subsequent
litigation or other events may cause IVAX to reconsider an immediate
launch of its product upon obtaining FDA approval, as well as the
general risks and uncertainty inherent generally in litigation or in the
FDA approval process. In addition to these factors, the economic,
competitive, governmental, technological and other factors identified in
IVAX' filings with the Securities and Exchange Commission could affect
the forward-looking statements contained in this release. Taxol(R) is a
registered trademark of Bristol-Myers Squibb.
--30--jd/mi*
CONTACT: IVAX Corporation, Miami
Douglas Heller, Ph.D., Acting Director, Investor
Relations and Corporate Communications
305/575-6005
douglas_heller@ivax.com
www.ivax.com
KEYWORD: FLORIDA
INDUSTRY KEYWORD: PHARMACEUTICAL
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James Love, Director | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org
P.O. Box 19367 | voice: 1.202.387.8030
Washington, DC 20036 | fax: 1.202.234.5176
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