A Diagnostics & Imaging Week

Third Wave Technologies (Madison, Wisconsin) reported that it has responded to the U.S. District Court for the Western District of Wisconsin’s recent ruling granting a motion by Qiagen (Venlo, the Netherlands) for dismissal of the antitrust claims brought against Digene (Gaithersburg, Maryland) by Third Wave.

“We respectfully disagree with the court’s ruling Friday on our antitrust claims and are considering our options,” said Kevin Conroy, president/CEO of Digene. “We have completed our HPV clinical trial enrollment and CE marking certification of our 1-type high-risk HPV screening and have appointed our first European HPV-product distributors. We look forward to finishing the clinical trial and to submitting two HPV products — the 14-type high-risk screening test and a genotyping test for types 16 and 118 — to the FDA in the first quarter of 2008. The market continues to seek a higher-quality, more-innovative HPV testing solution, and Third Wave is focused on meeting that unmet need.”

In January 2007, Digene, since acquired by Qiagen, filed suit against Third Wave, alleging infringement of a Digene patent related to the human papillomavirus (PV.) Third Wave responded by denying infringement and alleging anti-competitive business practices and anti-trust violations by Digene.

Digene in October 2007 said it could not prevail in its patent infringement suit against Third Wave without a successful appeal of the court’s July 2007 Markman order favorable to Third Wave. Digene made its statement after it unsuccessfully asked the court to reconsider its Markman order in September 2007.

Conroy said, “Third Wave won the most important battle in our dispute with Digene last October when Digene said it couldn’t win its patent suit unless it successfully appealed the court’s Markman order that constructed the patent claims at issue in Third Wave’s favor.” And he said that this maintains Third Wave’s ability “to operate in the valuable HPV testing market.”

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