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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 13, 2005
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
(Exact name of Registrant as specified in its charter)
Delaware 0-26224 51-0317849
(State or other jurisdiction of (Commission File Number) (I.R.S. Employer
incorporation or organization) Identification No.)
311 Enterprise Drive
Plainsboro, NJ 08536
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (609) 275-0500
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
ITEM 8.01. OTHER EVENTS.
On June 13, 2005, the United States Supreme Court vacated the June 2003 judgment
of the United States Court of Appeals for the Federal Circuit, which had
affirmed the judgment of the United States District Court for the Southern
District of California in the case of Integra LifeSciences I Ltd. and The
Burnham Institute v. Merck KGaA.
The Supreme Court held that the Court of Appeals applied an erroneous
interpretation of 35 U.S.C. ss.271(e)(1) when it rejected the challenge of Merck
KGaA to the jury's finding that Merck KGaA failed to show that its activities
were exempt from claims of patent infringement under that statute. On remand,
the Federal Circuit will review the evidence under a reasonableness test that
does not provide categorical exclusions of certain types of activities. As a
result, the trial court's judgment ordering Merck KgaA to pay Integra $6.4
million in damages could be overturned.
The Company has not recorded any gain in connection with this matter, pending
final resolution and completion of the appeals process.
A copy of the press release issued by the Company discussing the ruling is
attached as Exhibit 99.1 to this Current Report on Form 8-K.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
Exhibit Number Description of Exhibit
- ------------------- ---------------------------
99.1 Press release issued June 13, 2005
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
Date: June 17, 2005 By: /s/ Stuart M. Essig
--------------------------
Stuart M. Essig
President and Chief Executive Officer
Exhibit Index
Exhibit Number Description of Exhibit
- ------------------- ---------------------------
99.1 Press release issued Press release issued June 13, 2005
News Release
Contact:
Integra LifeSciences Holdings Corporation
John B. Henneman, III Maria Platsis
Executive Vice President Senior Director of Corporate Development
Chief Administrative Officer and Investor Relations
(609) 936-2481 (609) 936-2333
jhenneman@Integra-LS.com mplatsis@Integra-LS.com
United States Supreme Court Vacates Circuit Court Decision in Integra
LifeSciences -- Merck KGaA Litigation
Reasonableness Test Offered by Integra as Controlling Standard Remains Intact
PLAINSBORO, N.J., June 13, 2005 - Integra LifeSciences Holdings Corporation
(Nasdaq: IART) today announced that the United States Supreme Court vacated the
June 2003 decision of the United States Court of Appeals for the Federal
Circuit, which had affirmed the finding of the United States District Court for
the Southern District of California in the case of Integra LifeSciences I Ltd.
and The Burnham Institute v. Merck KGaA.
The United States Supreme Court today held that the Court of Appeals applied an
erroneous interpretation of 35 U.S.C. ss.271(e)(1) when it rejected the
challenge of Merck KGaA to the jury's finding that Merck KGaA failed to show
that its activities were exempt from claims of patent infringement under that
statute. On remand, the Federal Circuit will review the evidence under the
standard which Integra LifeSciences proposed at trial and which has been its
consistent position on the proper interpretation of ss.271(e)(1) throughout this
litigation.
The Supreme Court held, consistent with Integra's position throughout the
litigation, that pre-clinical experiments are not categorically excluded from
the scope of the exemption. The Supreme Court also agreed with Integra, and with
the Federal Circuit, that the exemption does not globally embrace all
experimental activity that at some point may lead to an FDA approval process.
The Supreme Court's opinion today emphasizes that the scope of the Section
271(e)(1) exemption is determined under a reasonableness test. Integra's
position that Merck's activities are not exempt under the reasonableness test,
which it urged as the controlling standard throughout the litigation, remains
intact.
The underlying lawsuit, which was filed in 1996, alleged that Merck KGaA and a
non-profit research institution under contract from Merck KGaA had infringed
various United States patents held by The Burnham Institute of San Diego that
have been licensed to Integra.
Those patents include No. 4,792,525, No. 4,879,237, No. 5,695,997, and No.
4,789,734, each in various ways relating to technology involving peptides
containing an arginine-glycine-aspartic acid (RGD) sequence or related cell
surface receptors.
Compounds containing the RGD sequence promote or inhibit cell adhesion by
binding receptors called integrins found on the surface of almost every cell in
the body.
"We look forward to a successful resolution of the case on remand before the
Federal Circuit," said John B. Henneman, III, Executive Vice President and Chief
Administrative Officer. "In any case, neither these patents nor this decision
implicates any product that we sell, and the outcome - whether favorable or
unfavorable - will not have any impact on our operations."
Integra LifeSciences Holdings Corporation is a diversified medical technology
company that develops, manufactures, and markets medical devices for use in a
variety of applications. The primary applications for our products are
neuro-trauma and neurosurgery, reconstructive surgery and general surgery.
Integra is a leader in applying the principles of biotechnology to medical
devices that improve patients' quality of life. Our corporate headquarters are
in Plainsboro, New Jersey, and we have research, manufacturing and distribution
facilities located throughout the world. We have approximately 1,200 employees.
Please visit our website at (http://www.Integra-LS.com).
This news release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such forward-looking
statements involve risks and uncertainties that could cause actual results to
differ materially from predicted or expected results. Forward-looking statements
that may be discussed include, but are not limited to, the results of litigation
and related appeals and the value of intellectual property. In addition, the
economic, competitive, governmental, technological and other factors identified
under the heading "Factors That May Affect Our Future Performance" included in
the Business section of Integra's Annual Report on Form 10-K for the year ended
December 31, 2004 and information contained in subsequent filings with the
Securities and Exchange Commission could affect actual results.
Source: Integra LifeSciences Holdings Corporation