QIAGEN Files Appeal in Patent Case
Gaithersburg, Maryland, June 11, 2008 - QIAGEN Gaithersburg, Inc. (formerly Digene Corporation), a wholly-owned subsidiary of QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), today announced that it has filed its initial brief with the United States Court of Appeals for the Federal Circuit in QIAGEN's appeal to reinstate its patent infringement lawsuit against Third Wave Technologies, Inc. The appeal moves the case originally heard before the District Court for the Western District of Wisconsin to the Federal Circuit.
"QIAGEN's global leadership in products for the detection of human papillomavirus (HPV), the cause of cervical cancer, is built upon a strong portfolio of intellectual property," said Peer Schatz, Chief Executive Officer of QIAGEN. "We have spent considerable resources to develop the most extensive HPV intellectual property portfolio in the industry. We believe in the strength of our claims and remain committed to vigorously enforcing our intellectual property rights and to continuing our efforts to save women's lives with our innovative products."
Mr. Schatz continued, "The QIAGEN digene HPV Test is the only CE- and FDA-approved test available and has demonstrated clinical detection of cervical disease and cancer in a multitude of large studies, each typically comprised of between 5,000 to more than 20,000 women. Today the QIAGEN digene HPV Test serves as the industry gold standard in HPV testing, and has been validated in more than 100 studies published in peer-reviewed journals and in clinical trials involving more than 350,000 women worldwide."
In the appeal filing, QIAGEN outlines several specific claim constructions - definitions of the terms of the patents - that it is looking to have changed from the District Court's ruling. Third Wave has 40 days to respond to QIAGEN's filing.
"We will continue to develop and market the best HPV testing product to aid early detection of cervical cancer. Our test is backed by years of extensive clinical studies and experience in the field," concluded Mr. Schatz.
On Jan. 11, 2007, Digene (now QIAGEN) filed a patent infringement action against Third Wave Technologies, Inc. in the United States District Court for the Western District of Wisconsin. In this action, QIAGEN/Digene alleged that Third Wave infringed one or more claims of United States Patent No. 5,643,715 ("the ‘715 patent"), for which QIAGEN/Digene is the exclusive licensee. On Feb. 28, 2007, Third Wave filed an answer to QIAGEN/Digene‘s complaint, in which it denied infringing the claims of the ‘715 patent.
In response to QIAGEN/Digene's suit, Third Wave asserted counterclaims against QIAGEN/Digene, alleging violations of federal antitrust laws. In response, QIAGEN/Digene filed a reply on April 5, 2007, denying all of Third Wave's counterclaims.
On Oct. 19, 2007, QIAGEN/Digene filed a motion for summary judgment seeking judgment against all of Third Wave's antitrust claims. This motion was granted in January 2008. The District Court dismissed the antitrust claims against QIAGEN/Digene, noting that Third Wave had "failed to show any violations." However, the District Court also dismissed QIAGEN/Digene's patent suit based on the court's construction of the patent claims - constructions with which QIAGEN/Digene disagrees and is now appealing in the Federal Circuit.
QIAGEN N.V., a Netherlands holding company, is the leading provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA, and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing, and pharmaceutical process control. QIAGEN's assay technologies include what is considered to be the broadest panel of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,600 people in more than 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com.
SAFE HARBOR STATEMENT
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
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