A Diagnostics & Imaging Week

Qiagen (formerly Digene; Gaithersburg, Maryland) reported that a federal appeals court denied an appeal by ThirdWave Technologies, a subsidiary of Hologic (both Bedford, Massachusetts), 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 ThirdWave/Hologic. This decision validates the earlier ruling by the district court and confirms that Qiagen's leadership in the marketplace for human papillomavirus (HPV) testing is the result of customer trust, extensive clinical validation, and the outstanding performance of our solutions," said Qiagen CEO Peer Schatz.

The federal court denied a ThirdWave cross-appeal of the antitrust decision in favor of Qiagen and upheld a January 2008 ruling by Judge Barbara Crabb of U.S. District Court for the Western District of Wisconsin. 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."

The federal appeals court also ruled on Qiagen's patent infringement appeal against ThirdWave, denying the appeal, the company said. Qiagen had alleged that ThirdWave's Invader HPV Oligo Mix product violates one of Qiagen's exclusive patents. Qiagen's exclusive IP on HPV 68 is not affected by this decision, the company noted.

"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," Schatz said. "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."

Qiagen provides sample and assay technologies.

In other disputes involving Qiagen, Gen-Probe (San Diego) said it, along with Roche Molecular Systems (Pleasanton, California), has prevailed in its arbitration with Qiagen concerning the company's supply and purchase agreement with Roche for HPV products.

According to Gen-Probe, a three-member arbitration panel from the International Centre for Dispute Resolution issued an interim award that dismisses with prejudice all of Qiagen's claims. Gen-Probe expects the award to remain substantially unchanged, although it is subject to further proceedings related to its implementation. For example, requests by Roche and Gen-Probe for reimbursement of legal expenses will be submitted and decided in coming weeks, the company noted.

"We are pleased that the arbitration panel confirmed the validity of our agreement with Roche," said Bill Bowen, Gen-Probe's senior vice president and general counsel. "We continue to expect our APTIMA HPV assay, which is available in Europe and is in clinical trials in the United States, to make an important contribution to women's health, and to be a key menu addition for our fully automated, high-throughput TIGRIS system."

Roche and Gen-Probe established a supply and purchase agreement in February 2005. Digene initiated the arbitration against Roche in December 2006. Gen-Probe joined the proceedings in July 2007. The arbitration hearings began in October 2008, and closing arguments were heard in January.