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Third Wave responds to Digene patent lawsuit

Madison, Wis. - Responding to a lawsuit filed by Digene Corp., Third Wave Technologies said it has not violated a patent covering a single and rare type of the human papilloma virus (HPV) and would continue to develop products to detect high-risk infections.

The lawsuit alleges that Third Wave is infringing on claims of a U.S. patent - number 5,643,715 - which relates to HPV type 52. Digene, located in Gaithersburg, Md., filed the suit in U.S. District Court for the Western District of Wisconsin in Madison.

The companies, who have tangled in court before, both make DNA and RNA tests for a variety of diseases.

"Third Wave's confidence in its ability to operate in the HPV market remains strong and unchanged," Kevin T. Conroy, president and chief executive of Third Wave, said in a release. "We took great care to create a detection method free from the limited scope of the `715' patent's claims.”

Third Wave offers a number of products based on its Invader chemistry for clinical testing. The company contends the Invader chemistry operates differently from any other nucleic acid analysis chemistry, and is well protected by intellectual property rights of its own.
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Conroy added that customers have told Third Wave that Digene's test “suffers from many challenges,” but he did not elaborate.

He said Third Wave scientists have developed HPV products, now in clinical trials, to address the shortcomings. The target market includes clinical labs and physicians and their patients.

Third Wave notes that the prevalence of HPV 52 is in 0.5 percent of HPV-positive specimens in the United States, according to Digene's package insert.

In early 2006, Third Wave and Digene settled a patent lawsuit, also centered on HPV treatments, without any grants of licenses or money changing hands. At that time, the companies agreed not to sue each other for a year.

To remove ambiguities about its freedom to operate in the HPV and HCV (hepatitis C virus) markets, Third Wave has settled suits with several companies.

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