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To Deflect Impending Patent Suit, Digene Files Pre-emptive Court Strike Against Enzo Biochem

NEW YORK, March 18 - Diagnostics company Digene filed suit against Enzo Biochem on Friday seeking to free itself from patent claims that Enzo might make against its gene-based pathogen detection kits.


Digene's pre-emptive complaint, filed in the US District Court in Wilmington, in Delaware, seeks a declaratory judgment and asks the court to decide that its "hybrid capture" line of diagnostics does not infringe upon Enzo's patents.


According to Digene, Enzo had been threatening litigation.


Enzo Biochem, in a statement, said that the two companies have been in license negotiations for eight months. They last met on 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.


Digene, a publicly owned company based in Gaithersburg, Md., also sells test systems for cytomegalovirus, chlamydia, gonorrhea, and hepatitis B.


In 1995, Enzo was granted a patent for a process to detect polynucleotides and genetic mutations that also relies on separating nucleic acids from samples and capturing a hybrid complex.


The company, which is based in Farmingdale, NY, is publicly owned. Its diagnostics division sells DNA probe tests for a range of viruses.


"Enzo's patent is valid and infringed by Digene, and we intend to seek monetary damages from Digene that our company has incurred as a result," the company said in a statement.


Enzo will also seek a permanent injunction against Digene, the statement said.