Insmed Provides Response to United States Patent Lawsuit; Seeks Immediate Dismissal or Summary Judgment for All Claims.RICHMOND, Va. -- Insmed Incorporated (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : INSM INSM Initiative Neue Soziale Marktwirtschaft (German) INSM Integrated Network and Systems Management ) today announced that the Law Firm of Foley & Lardner LLP LLP - Lower Layer Protocol has filed on behalf of Insmed a motion to dismiss a complaint alleging infringement of method of use and method of manufacture patents brought by Tercica and Genentech against Insmed in the United States District Court for the Northern District of California The United States District Court for the Northern District of California is the Federal district court whose jurisdiction comprises following counties: Alameda, Contra Costa, Del Norte, Humboldt, Lake, Marin, Mendocino, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa . In response, Insmed's motion to dismiss asserts that all alleged activities fall within the statutory safe harbour provided by 35 U.S.C. ss. 271(e)(1), commonly called the Clinical Trial Exemption. This exemption prevents patent infringements patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. from being filed against activities reasonably related to obtaining FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of a product, such as when the product is still being tested in Clinical Trials. Insmed further asserts, among other things, that the plaintiff's have failed to state a claim for the requested relief, have not sued the proper party, have failed to name all the proper plaintiffs and have failed to establish the existence of a sufficiently real and substantial controversy between the parties. Insmed seeks immediate dismissal or Summary Judgment against the plaintiff's allegation on these grounds. The initial complaint filed on December 23, 2004 was amended on February 16, 2005. In the Amended Complaint amended complaint n. what results when the party suing (plaintiff or petitioner) changes the complaint he/she has filed. It must be in writing, and can be done before the complaint is served on any defendant, by agreement between the parties (usually their lawyers), Tercica and Genentech challenge Insmed's right to commercialize SomatoKine(R) and added allegations of infringement of an additional patent. Geoffrey Allan, Ph.D., Insmed's President and Chief Executive Officer commented, "We believe that this litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. is clearly an attempt to interfere with our ongoing business activities designed to bring IGF-I IGF-I see somatomedin C. IGF-I Insulin-like growth factor I, somatomedin-C A polypeptide hormone structurally similar to proinsulin, synthesized in the liver and fibroblasts, giving fibroblasts a paracrine function; serum levels correlate with therapy to patients with medical need. We continue to maintain our belief that we do not infringe any valid patent claims and do not believe that Tercica will succeed in their efforts to prevent our proprietary IGF-I therapy, SomatoKine(R) from reaching patients with orphan diseases or·phan disease n. A disease that is so rare that it is not considered commercially viable to develop drugs to treat it. orphan disease ." Allan continued, "We perceived that their original December 23, 2004 complaint was filed in an attempt to interfere with our upcoming New Drug Application and other important business activities. The filing and timing of this amendment validates our perception. We strongly reiterate our belief that these allegations are without merit and we intend to vigorously defend our position and right to make SomatoKine(R). We will not allow these repeated interferences to hinder our intent to bring SomatoKine(R) to children with unmet medical need." About Insmed Incorporated Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com. Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provided by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding the expected results of litigation regarding the validity of our patents and our future ability to conduct our business as now conducted and as it is currently proposed to be conducted; clinical trials and goals, our regulatory and business strategies and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including the uncertainty of the outcome of any litigation, the risk that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have. We can give no assurances that we would be successful in any litigation or that such litigation would not have a material adverse effect on our business, financial condition and results of operation. Furthermore, we may not be able to afford the expense of defending against such a claim. 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 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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