U.S. Court of Appeals (CAFC) Rejects Third Wave/Hologic’s Anti-Trust Claims against QIAGEN
Apr 01 2009

U.S. Court of Appeals (CAFC) Rejects Third Wave/Hologic’s Anti-Trust Claims against QIAGEN

Gaithersburg, Maryland, April 1, 2009 - QIAGEN Gaithersburg Inc. (formerly Digene Corporation), a wholly-owned subsidiary of QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced the U.S. Court of Appeals for the Federal Circuit (CAFC) denied an appeal by Third Wave Technologies Inc. ("Third Wave"), a wholly-owned subsidiary of Hologic, Inc. (NASDAQ: HOLX) and affirmed a lower court decision which was favorable for QIAGEN.

 "We are pleased that the Appeals Court ruled in QIAGEN's favor on the antitrust claims from Third Wave/Hologic. This decision validates the earlier ruling by the District Court and confirms that QIAGEN's leadership in the marketplace for HPV testing is the result of customer trust, extensive clinical validation, and the outstanding performance of our solutions," said Peer Schatz, Chief Executive Officer of QIAGEN.

The CAFC denied a Third Wave cross-appeal of the antitrust decision in favor of QIAGEN and upheld a January 2008 ruling by Judge Barbara B. Crabb of U.S. District Court for the Western District of Wisconsin. Judge Crabb dismissed the antitrust claims against QIAGEN, noting that QIAGEN "is selling a product that many customers prefer over the product the defendant is selling, with the not surprising result that defendant has not captured as many customers as it wishes it had."

In their ruling, the judges noted that "The district court also correctly found the contracts did not have an anti-competitive effect: Instead; as Digene (now QIAGEN Gaithersburg) points out and Third Wave does not dispute, the vast majority of Digene's (now QIAGEN Gaithersburg) contracts were entered into after Third Wave was already competing on the market,[...]".

The Federal Circuit also ruled on QIAGEN's patent infringement appeal against Third Wave, denying the appeal. QIAGEN had alleged that Third Wave's Invader® HPV Oligo Mix product violates a QIAGEN exclusive patent.

"While we are disappointed in the ruling on the claims of one patent within our broad patent estate, we are proud of our strong HPV testing and molecular diagnostic products. We are very pleased that studies continue to confirm the superiority of our products and also take pride in the fact that our customers always could and can continue to feel confident in the full freedom to use our tests. Despite this ruling, we will continue to vigorously defend our unique and broad intellectual property and remain focused on our mission to help save women's lives through early detection of cancer," Schatz said.

"QIAGEN offers a complete product portfolio from sample to result for the full range of molecular diagnostics, applied testing, academic research, and pharmaceutical industries" said Schatz. "We are extremely proud of the work we've done to provide a superior solution for the early detection of cervical cancer. At the same time, our customers value our complete portfolio of solutions, which leads the molecular diagnostics industry in terms of scope and innovation."


On January 11, 2007, QIAGEN (then Digene) filed a patent infringement action against Third Wave Technologies, Inc. ("Third Wave") in the United States District Court for the Western District of Wisconsin. In this action, QIAGEN alleged that Third Wave was infringing one or more claims of United States Patent No. 5,643,715 ("the ‘715 patent"), of which QIAGEN is the exclusive licensee. On February 28, 2007, Third Wave filed an answer to QIAGEN's complaint, in which Third Wave denied infringing the claims of the ‘715 patent. Third Wave further asserted counterclaims against QIAGEN alleging violations of federal antitrust laws pursuant to Sections 1 and 2 of the Sherman Act, the Clayton Act, and the Robinson-Patman Act. In response, on April 5, 2007, QIAGEN filed a reply denying all of Third Wave's counter claims. The court issued claim construction rulings on July 23 and September 26, 2007, narrowly construing the patent. QIAGEN chose not to pursue the infringement claim in the District Court because of the narrow claim construction. 

On January 11, 2008 Judge Crabb from the District Court dismissed Third Wave's antitrust claims against QIAGEN and granted QIAGEN's motion for summary judgment. Third Wave filed a cross-appeal, which was part of this CAFC ruling.


QIAGEN N.V., a Netherlands holding company, is the leading global 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 sample and assay 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 one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the first FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.

Statements contained in this release that are not historical facts are forward-looking statements, including statements about our products, markets, strategy and operating results. Such statements are based on current expectations that involve risks and uncertainties including, but not limited to, those associated with: management of growth and international operations (including currency fluctuations and logistics), variability of our operating results, commercial development of our markets (including applied testing, clinical and academic research, proteomics, women's health/HPV testing and molecular diagnostics), our relationships with customers, suppliers and strategic partners, competition, changes in technology, fluctuations in demand, regulatory requirements, identifying, developing and producing integrated products differentiated from our competitors' products, market acceptance of our products, and integration of acquired technologies and businesses. For further information, refer to our filings with the SEC, including our latest Form 20-F. Information in this release is as of the date of the release, and we undertake no duty to update this information unless required by law.


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