ImClone's Patent Exhaustion Defense Rejected by the Court
WALTHAM, Mass., July 31 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported that on July 28, 2006, the United States
District Court for the District of Massachusetts issued a Summary Judgment
ruling in favor of Repligen and The Massachusetts Institute of Technology
(MIT) and rejected ImClone Systems Incorporated's (Nasdaq: IMCL) defense of
patent exhaustion in the ongoing patent infringement lawsuit over the
production of Erbitux(R). In their complaint, Repligen and MIT allege that
ImClone's production of Erbitux(R) infringes U.S. patent 4,663,281 which
covers certain genetic elements that increase protein production in a
mammalian cell. This patent is assigned to MIT and exclusively licensed to
Repligen. 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, has
paid ImClone $900 million in up-front and milestone payments as well as a
39% royalty on the net sales of Erbitux(R) in the United States.
Repligen and MIT allege that the cell line that ImClone uses to produce
Erbitux(R) employs key technology that is claimed in the patent-in-suit.
Repligen and MIT also allege that the cell line was created under contract
for the National Cancer Institute (NCI) by a predecessor to Repligen and
subsequently transferred from the NCI to ImClone for use in research and
development only. In its ruling, the Court found that neither the transfer
to the 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 has eliminated these arguments as a potential defense for
ImClone at trial. Repligen and MIT intend to seek 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 very pleased by the decision of the court and we look forward
to full adjudication of this matter at trial," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen Corporation.
Erbitux(R) was approved by the FDA in February 2004 for certain types
of colon cancer. In May 2004, Repligen and MIT filed an action against
ImClone for infringement of U.S. Patent No. 4,663,281 based on ImClone's
manufacture and sale of Erbitux(R). Repligen has filed an application with
the U.S. Patent and Trademark Office to extend the term of the
patent-in-suit until 2009.
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
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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
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