Court Decision Means That Patent Dispute between Insmed and Tercica and Genentch Will Have to Be Resolved at Trial
05 Juillet 2006 - 8:15PM
Business Wire
On Friday, June 30, 2006, the U.S. District Court for the Northern
District of California issued a decision in the suit brought by
Tercica Inc and Genentech, Inc against Insmed, Inc.(NASDAQ:INSM)
and two of its subsidiaries alleging infringement of three U.S.
patents. The Court ruled on issues of claim construction and on
motions by both sides for partial summary judgment. The Court
adopted some claim interpretations proposed by Plaintiffs and
others proposed by Insmed. It also adopted some interpretations
that were modifications of those proposed by the parties. The Court
likewise granted certain motions for summary judgment and denied
others. The Court's rulings do not fully resolve all of the pending
issues regarding any of the three patents. The remaining issues
will be resolved at trial, which is currently scheduled to commence
on November 6, 2006. The decision does not have any impact on
Insmed's ability to continue to sell IPLEX. (TM) With respect to
U.S. Patent No. 6,331,414 ("the '414 patent"), the Court granted
Plaintiffs' Motion that Insmed infringes claims 1, 2, and 9 of the
'414 patent. The Court found that due to disputes of material fact,
Insmed's invalidity defenses will need to be resolved at trial and
therefore denied Insmed's motion for summary judgment that the
claims at issue are invalid. . With respect to U.S. Patent No.
5,187,151 ("the '151 patent"), the Court granted Plaintiffs' motion
for partial summary judgment that the patent was not invalidated by
certain prior art. Because of the claim constructions it adopted
and disputes of material fact, the Court denied Insmed's motion for
summary judgment on non-infringement of the '151 patent. The
question of infringement will now need to be resolved at trial.
Also yet to be resolved is Insmed's defense that the '151 patent is
unenforceable due to inequitable conduct. With respect to U.S.
Patent No. 5,258,287 ("the '287 patent"), the Court ruled on the
scope of one disputed claim term. The issue of whether Insmed
infringes the '287 patent or whether the claims at issue are valid
remain to be resolved at trial. The Court also granted Insmed's
Motion for Partial Summary Judgment of no infringement as to
certain allegations made against Insmed, through its wholly owned
subsidiary Celtrix related to activities that occurred prior
Insmed's acquisition of Celtrix or prior to Insmed receiving FDA
approval of IPLEX(TM) Insmed CEO Dr. Geoffrey Allan stated: "We had
anticipated that the Court's decisions would not resolve all the
issues in this matter, which will be the subject of the upcoming
trial. We believe the Court's interpretations seriously call into
question the validity of the '414 patent' and look forward to
presenting that evidence at trial. This decision also permits
Insmed to continue to press its defenses of no infringement and
unenforceability for the '151 patent' and no infringement and
invalidity for the '287 patent.'" About IPLEX IPLEX is approved in
the United States as the only once daily treatment for children
with short stature associated with severe primary IGF-I deficiency
(Primary IGFD). IPLEX, a complex of recombinant human IGF-I and its
binding protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the only
FDA-approved IGF-I replacement therapy that also replaces deficient
IGFBP-3 in these patients. The drug, which was launched in the
second quarter of 2006, is also being investigated for various
other indications with unmet medical needs, including severe
insulin resistance, myotonic muscular dystrophy and HIV Associated
Adipose Redistribution Syndrome (HARS). For more information about
IPLEX please go to www.go-IPLEX.com. About Insmed Incorporated
Insmed is a biopharmaceutical company focused on the development
and commercialization of drug candidates for the treatment of
metabolic diseases and endocrine disorders with unmet medical
needs. For more information, please visit www.insmed.com. The
Company's leading product, IPLEX was approved as an orphan drug by
the United States Food and Drug Administration in December 2005 for
the treatment of growth failure in children with severe primary
IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene
deletion who have developed neutralizing antibodies to GH.
Statements included within this press release, which are not
historical in nature, may constitute forward-looking statements for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. Forward-looking statements in this
press release include, but are not limited to, statements regarding
our IPLEX utilization program, regulatory and business strategies,
manufacturing capabilities, product costs, plans and objectives of
management and growth opportunities for existing or proposed
products. Such forward-looking statements are subject to numerous
risks and uncertainties, including risks that product candidates
may fail in the clinic or may not be successfully launched,
marketed, manufactured or reimbursed, we may lack financial
resources to complete development of product candidates, the FDA
may interpret the results of our studies differently than we have,
competing products may be more successful, demand for new
pharmaceutical products may decrease, the biopharmaceutical
industry may experience negative market trends and other risks
detailed from time to time in our filings with the Securities and
Exchange Commission. As a result of these and other risks and
uncertainties, actual results may differ materially from those
described in this press release. For further information with
respect to factors that could cause actual results to differ from
expectations, reference is made to our reports filed by the Company
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended. The forward-looking statements
made in this release are made only as of the date hereof and Insmed
disclaims any intention or responsibility for updating predictions
or financial guidance contained in this release.
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