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Fulfilling Promise, Enzo Diagnostics Sues Digene for Patent Infringement

NEW YORK, March 21 - Fulfilling its promise, Enzo Diagnostics has filed a patent-infringement suit against Digene that seeks an injunction and monetary damages.
Additionally, Enzo Biochem, Enzo Diagnostic's parent, asked the federal district court to dismiss a declaratory judgment suit that Digene filed on March 14. Enzo claims that the suit "incorrectly named" Enzo Biochem as the adverse party, although it claims never to have owned the patent.

As GenomeWeb reported on Monday, Digene sued Enzo Biochem seeking pre-emptively to free itself from patent claims that Enzo might make against its gene-based pathogen detection kits.


Digene's complaint, filed in the US District Court in Wilmington, Del., asked the court to decide that its diagnostic products do not infringe upon Enzo's patents. According to Digene, Enzo had been threatening litigation.


In its own statement released earlier this week, Enzo Biochem said that the two companies have been in license negotiations for eight months. They last met last Friday, when Enzo made a licensing counteroffer that Digene "indicated they would take under advisement," according to Enzo.


The dispute centers on assay techniques for DNA detection through antibody capture and chemiluminescent signal detection. Digene has adapted this method in a kit that tests for the human papillomavirus, a primary cause of cervical cancer. According to Digene, when used in conjunction with Pap smear testing, its test can pick out "virtually all" cases of cervical cancer.

In its suit, filed in the same court, Enzo Diagnostics on Thursday claims that Digene has known about the patent, No. 6,221,581. Enzo noted that that the patent has been public since October 1985, a date that precedes Digene's founding.

"Digene has for many years known of the chain of patent applications that eventually led to the `581 patent, but knowingly and willfully developed and brought to market its Hybrid Capture products in the face of Enzo Diagnostics' pending applications," Enzo said in a statement.

The statement also said that "despite a good faith effort on Enzo Diagnostics' part to negotiate a business resolution with Digene, there is 'the distinct possibility' that Digene may have attempted to wrongfully induce Enzo Diagnostics to forbear from suing Digene for infringement by misrepresenting an interest in taking a license under the `581 patent to obtain time to negotiate for an acquisition by a third party."

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