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Digene Denies Third Wave 'Monopoly' Charge In HPV IP Case, Asks Court to Dismiss Claims

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
Digene last week denied allegations made by Third Wave Technologies early last month that the company had “abused its monopoly power to thwart competition” in the HPV diagnostics market, and it asked the court to dismiss the charges.
Third Wave’s allegations were made in a countersuit that is part of the firms’ ongoing dispute over a Digene patent covering an HPV diagnostic test.
Beside asking the court to dismiss the counterclaims, Digene asked the court to award it costs and attorneys’ fees associated with its defense against the claims.
The dispute comes roughly one year after the firms had settled related litigation brought by Third Wave against Digene. The settlement included a clause that the firms would not sue each other for one year — a deadline that expired in January.
That month, Digene sued Third Wave in the US District Court for the Western District of Wisconsin, alleging that Third Wave has infringed one or more claims of US Patent No. 5,643,715, entitled “Human Papillomavirus Type 52 DNA Sequences and Methods for Employing the Same.” The patent is assigned to Georgetown University and has been exclusively licensed to Digene.
In its countersuit filed last month, Third Wave said its claims “are based on Digene’s repeated abuse of its substantial market power … and the direct and substantial antitrust injury to Third Wave and consumers resulting directly from Digene’s anti-competitive conduct.” (see BioCommerce Week 3/7/2007).
“Digene could not maintain its substantial market power in the relevant markets but for its unlawful conduct, including its exclusive dealing arrangements, its false statements about Third Wave in the marketplace, and the objectively baseless and sham litigation it has pursued in this court,” Third Wave alleges in the countersuit.
In addition, Third Wave claims that in several discussions with Digene over the past couple of years, Digene officials have said they would “place ‘landmines’ in the way of Third Wave’s attempts to compete.”
According to Third Wave, it has gained less than 2 percent of the HPV genetic testing market thus far, due largely to what it calls Digene’s monopoly.
In its filing last week, Digene denied all of Third Wave’s allegations.
“Digene denies that it has engaged in any anticompetitive conduct or violated the antitrust laws,” the firm said. “Digene’s success is due to its superior product offerings and its business acumen.”
Digene claims that it “has not misused its patent rights or sued Third Wave for any improper purpose. Digene brought suit only after conducting a reasonable investigation into Third Wave’s infringing activities.”

Digene claims that it “has not misused its patent rights or sued Third Wave for any improper purpose. Digene brought suit only after conducting a reasonable investigation into Third Wave’s infringing activities.”

Digene noted that its HPV test is the only such test approved by the US Food and Drug Administration, while Third Wave sells analyte specific reagents for HPV. “Digene markets and sells an FDA-approved complete diagnostic test system for HPV screening, while Third Wave is legally barred from doing so,” according to Digene’s filing.
However, Third Wave has said that it is currently conducting clinical trials on its HPV reagents and intends to submit an application for FDA approval this year.
Among the remedies Third Wave is seeking from the court is a $20 million judgment against Digene, a denial of all relief sought by Digene, and a declaration that Digene’s patent at the center of the case be declared invalid.
In defending itself against Third Wave’s countersuit, Digene said, “Third Wave’s counterclaims fail to state a claim upon which relief can be granted; Third Wave lacks standing to bring its antitrust claims; and Third Wave’s counterclaims are barred because the conduct alleged was justified by legitimate business reasons.”
In addition, Digene said that Third Wave “is not entitled to injunctive relief because any alleged injury is not immediate or irreparable, and an adequate remedy at law exists.”
Digene asked the court to dismiss Third Wave’s counterclaims and award it costs and attorneys’ fess associated with defending itself against the countersuit. It also asked for “other and further relief as the court deems just and proper.”
If the case is not settled, it is expected to go to trial in early 2008.

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