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Qiagen to Appeal Markman Ruling, Press Ahead With HPV Patent Suit Against Third Wave

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
A Qiagen official said this week that the firm intends to appeal at the federal level an unfavorable Markman ruling in an ongoing human papillomavirus patent dispute between Third Wave Technologies and Digene, which Qiagen recently acquired.
Last week, Digene’s legal counsel advised Third Wave that given the Markman ruling, Digene believes it “cannot prevail on its claim of patent infringement” against Third Wave. However, Digene and Qiagen believe the District Court made errors in its ruling and they intend to press forward with Digene’s case against Third Wave.
Digene and Third Wave have been locked in a legal dispute since the beginning of the year over patents covering HPV testing. 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 a countersuit filed in March, 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).
In July, the Wisconsin court agreed with Third Wave’s definitions for each of the disputed patent claims in its suit against Digene. The court subsequently denied a request by Digene to reconsider the ruling.
Given those circumstances, Digene’s legal counsel sent Third Wave’s legal representatives a letter last week saying, “Digene now believes it cannot prevail on its claim of patent infringement regarding Third Wave’s A9 Oligo Mix and that expert reports and further litigation on the patent claims and counterclaims is unnecessary.”
Third Wave sent a copy of the letter to Judge Stephen Crocker of the US District Court, Western District of Wisconsin and publicized the letter in a press release issued this week.
“While this matter is not closed, it is telling that after two unfavorable court rulings and more detailed examination of Third Wave’s chemistry and product, Qiagen, Digene’s new parent, arrived at the same conclusion we did: Third Wave’s product does not infringe,” Third Wave President and CEO Kevin Conroy said in the release.
Qiagen and Digene, however, dispute that that is their conclusion.
Digene also stated in its letter to Third Wave that it “intends to pursue its patent infringement claim if the claim construction is altered on appeal.”
A Qiagen spokesperson told BioCommerce Week via e-mail this week that the steps Digene is taking “are quite standard” and it has no plans of withdrawing its suit against Third Wave.
“As we don’t see any further benefit in continuing discussions at the District Court level in Wisconsin, our legal team has decided to take this litigation to the appellate level, at the Federal Circuit Court of Appeals in Washington, DC,” said the spokesperson. “We remain very confident about the strength of our IP portfolio, including the patent at issue with Third Wave and disagree with the claim definitions set in the district court Markman order.
“More than 40 percent of all district court Markman orders are revised by the Federal Circuit, and in our view there are several significant errors in the district court’s Markman order that require review and revision,” he added.

“As we don’t see any further benefit in continuing discussions at the District Court level in Wisconsin, our legal team has decided to take this litigation to the appellate level.”

Qiagen declined to say whether it would pursue a settlement with Third Wave, whose antitrust suit against Digene is scheduled to go to trial on Feb. 19, 2008, in Madison, Wis.
What’s at Stake?
Digene currently sells the only molecular diagnostic test for HPV that has been cleared by regulatory bodies in both the US and European Union. The test and Digene’s molecular diagnostics salesforce are the primary reasons why Qiagen forked over $1.6 billion to acquire the firm, which had 2006 revenues of $178 million (see BioCommerce Week 6/6/2007).
Qiagen and other players looking to enter the HPV molecular testing market have estimated its worth at upwards of $1 billion. But Qiagen’s CEO Peer Schatz said recently at the UBS Global Life Sciences Conference in New York that HPV testing worldwide has been “extremely limited” thus far, and the market has been largely untapped (see BioCommerce Week 9/26/2007).
In addition to its current HPV test, which is used as a screening tool, Schatz said that Qiagen is developing a multiplex assay and a test specifically for the developing world and remote regions. The latter test is being developed with support from the Bill and Melinda Gates Foundation and the nonprofit healthcare organization PATH.
The firm is aware that several competitors, including Third Wave, Roche Diagnostics, and Cepheid, among others, are planning on marketing their own HPV molecular tests. Third Wave previously said that it plans to submit its HPV molecular diagnostic to the US Food and Drug Administration as early as the fourth quarter of this year.
Meanwhile, Cepheid recently licensed exclusive rights to HPV patents held by Swedish company Quantovir with an eye toward developing a PCR-based diagnostic test that will predict a woman’s risk for developing cervical cancer by measuring HPV viral load (see BioCommerce Week 9/26/2007).

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