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Judge Nixes Dako's Motion against UC, Abbott in FISH Patent Suit

NEW YORK (GenomeWeb News) – A California judge has denied a motion by Dako for summary judgment in a patent infringement case against the University of California and Abbott related to in situ DNA hybridization methods.

The judge for the Northern District of California denied the motion in a case filed by the Regents of the University of California, Abbott Molecular, and Abbott Laboratories against Dako North American and Dako Denmark, according to court documents filed Wednesday.

The judge denied motions filed by Dako regarding summary judgment of the invalidity of US Patent No. 5,447,841, "Methods for chromosome-specific staining," as well as a motion for summary judgment of unenforceability for inequitable conduct. The judge also denied the plaintiffs' motion for summary judgment of no inequitable conduct.

The '841 patent is owned by the UC Regents, and Abbott molecular is the exclusive licensee to its rights.

The patent covers methods of identifying target genes through in situ DNA hybridization. Dako makes and sells diagnostic kits that use in situ DNA hybridization to determine the presence and frequency of certain genes, including the HER2 FISH kit for detecting HER2 gene amplification.

The UC Regents and Abbott filed the suit in September, 2005, claiming that the Dako technology infringed its '841 patent.

Dako's invalidity argument was based the assertion that the claims of the '841 patent encompass a broad range of methods of in situ hybridization and that the patent specification covers only one hybridization method that uses a single example of a probe that targets one entire chromosome from one species in one type of sample.

The court disagreed with Dako's argument that because the '841 patent specification only provided one example of a whole chromosome nucleic acid probe for use in in situ hybridization, it does not cover the number of species of components used in the method. The judge found that the argument was inappropriate because the fact that the method functions with a broad range of probes is not the issue, rather, it is the method itself that is a "genus."

"The '841 patent describes a method of in situ hybridization using blocking nucleic acids that has wide breadth and applicability and discloses one detailed, working example of that method," the judge wrote.

"Moreover, contrary to Dako's assertions, plaintiffs are not required to actually have physical possession of the potential universe of probe sets in order to have 'possession' of the invention," the judge continued.

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