Court Sets Erbitux(R) Patent Infringement Trial for September 10, 2007
WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) announced today that the United States District Court for
the District of Massachusetts issued a favorable ruling on the sanctions
motion filed by Repligen and the Massachusetts Institute of Technology
(MIT) against ImClone Systems, Incorporated (Nasdaq: IMCL) based on conduct
that in Repligen's view constituted intimidation of a central witness in
the Erbitux(R) patent infringement case. The Court found that one of
ImClone's in-house and one of ImClone's outside counsel violated
Massachusetts Rules of Professional Conduct that prohibit lawyers from
unlawfully obstructing access to evidence or otherwise engaging in conduct
that is prejudicial to the administration of justice. The Court further
found that the actions of ImClone's counsel were intended to block the
cooperation of a key witness and that these actions prejudiced Repligen and
MIT from fully prosecuting their case. As a remedy, the Court barred one of
ImClone's in-house counsel from any further access to, or use of,
confidential information in this case. The Court also prohibited ImClone
from any further communication with the witness or his employer regarding
this case without permission from the Court. The Court further granted
Repligen and MIT permission to introduce evidence of the improper conduct
of ImClone's attorneys at trial to lay the foundation for the jury to infer
that ImClone itself believed that the witness's testimony supported
Repligen's and MIT's claims in the litigation.
The Court has set a trial date of September 10, 2007. Repligen and MIT
are seeking damages adequate to compensate Repligen and MIT for ImClone's
unlicensed use of the patented technology and we will also seek a
multiplier of any damage award based on ImClone's willful infringement.
"We are pleased that the Court has given us relief for this misconduct
and has set the case for trial," stated Walter C. Herlihy, President and
Chief Executive Officer of Repligen Corporation. "We look forward to fully
prosecuting our claim against ImClone in September."
In May 2004, Repligen and MIT filed an action in the United States
District Court for the District of Massachusetts against ImClone for
infringement of U.S. Patent No. 4,663,281 based on ImClone's manufacture
and sale of Erbitux(R). The patent covers the use of certain genetic
elements that increase protein production in a mammalian cell and is
assigned to MIT and exclusively licensed to Repligen. In the complaint,
Repligen and MIT allege that the cell line that ImClone uses to produce
Erbitux(R) employs the technology that is claimed in the patent-in-suit.
In July 2006, the Court issued a ruling on Summary Judgment in this
case in favor of Repligen and MIT that rejected ImClone's defense of patent
exhaustion. In its ruling, the Court found that neither the transfer of the
cell line to the National Cancer Institute (NCI) by Repligen's predecessor
nor the subsequent transfer to ImClone by the NCI exhausted the proprietary
rights of Repligen and MIT. The Court's ruling eliminated these arguments
as a potential defense for ImClone at trial.
Separately, Repligen and MIT have filed an application with the U.S.
Patent and Trademark Office to extend the term of the patent-in-suit until
May 2009. ImClone has previously reported that it produced approximately $1
billion worth of Erbitux(R) prior to the expiration of the patent-in-suit
in 2004 and that Bristol-Myers Squibb, ImClone's commercial partner in the
U.S., has paid ImClone $900 million in license payments as well as a 39%
royalty on the net sales of Erbitux(R) in the United States which have
totaled approximately $1.5 billion to date.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the
development of novel therapeutics for diseases that affect the central
nervous system. In addition, we are the world's leading supplier of
recombinant Protein A, the sales of which partially fund the advancement of
our development pipeline while supporting our financial stability.
Repligen's corporate headquarters are located at 41 Seyon Street, Building
#1, Suite 100, Waltham, MA 02453. Additional information may be requested
from http://www.repligen.com.
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. The forward-looking statements in this release do not
constitute guarantees of future performance. Investors are cautioned that
statements in this press release which are not strictly historical
statements, including, without limitation, statements regarding current or
future financial performance and position, management's strategy, plans and
objectives for future operations, plans and objectives for product
development, plans and objectives for present and future clinical trials
and results of such trials, plans and objectives for regulatory approval,
litigation, intellectual property, product development, manufacturing plans
and performance such as the anticipated growth in the monoclonal antibody
market and our other target markets and projected growth in product sales,
constitute forward-looking statements. Such forward-looking statements are
subject to a number of risks and uncertainties that could cause actual
results to differ materially from those anticipated, including, without
limitation, risks associated with: the success of current and future
collaborative relationships, the market acceptance of our products, our
ability to compete with larger, better financed pharmaceutical and
biotechnology companies, new approaches to the treatment of our targeted
diseases, our expectation of incurring continued losses, our uncertainty of
product revenues and profits, our ability to generate future revenues, our
ability to raise additional capital to continue our drug development
programs, the success of our clinical trials, our ability to develop and
commercialize products, our ability to obtain required regulatory
approvals, our compliance with all Food and Drug Administration
regulations, our ability to obtain, maintain and protect intellectual
property rights for our products, the risk of litigation regarding our
intellectual property rights, our limited sales and manufacturing
capabilities, our dependence on third-party manufacturers and value added
resellers, our ability to hire and retain skilled personnel, our volatile
stock price, and other risks detailed in Repligen's filings with the
Securities and Exchange Commission. Repligen assumes no obligation to
update any forward-looking information contained in this press release or
with respect to the announcements described herein.
SOURCE Repligen Corporation
 back to top
Related links:
http://www.repligen.com/
CONTACT:
Walter C. Herlihy, Ph.D., President and Chief
Executive Officer, +1-781-419-1900, or Laura Whitehouse, Vice
President, Market Development, +1-781-419-1812, both of Repligen
Corporation
|
