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Federal Appeals Court Upholds Ruling Invalidating Enzo Biochem Patent

NEW YORK (GenomeWeb) – The US Court of Appeals for the Federal Circuit yesterday handed down a sealed opinion affirming a previous ruling against Enzo Biochem in its patent infringement lawsuit against Roche Diagnostics, Becton Dickinson, Abbott Laboratories, and several of their subsidiaries.

The cases began in 2012 when Enzo filed suits against Roche, Life Technologies, Gen-Probe, Abbott, Becton Dickinson, and Hologic, alleging they infringed a patent pertaining to labeled nucleotides for use as diagnostic tools and as therapeutic agents.

In lawsuits filed in the US District Court for the District of Delaware, Enzo claimed that the companies infringed US Patent No. 6,992,180 titled "Oligo- or polynucleotides comprising phosphate-moiety labeled nucleotides," which was issued to inventors in New York and was been assigned to Enzo.

According to the '180 patent abstract, the invention pertains to a nucleotide comprising a phosphate moiety, sugar moiety, and a pyrimidine, purine, or 7-deazapurine moiety. Also provided is an oligo- or polynucleotide "comprising at least one such phosphate-moiety-labeled nucleotide, and other compositions, including those wherein a polypeptide is terminally ligated or attached to the oligo- or polynucleotide."

The phosphate-moiety-labeled nucleotides can be used to detect analytes and as therapeutic agents, according to the abstract.

In 2016, Enzo reached a settlement with Thermo Fisher Scientific to cover its case against Life Technologies, which had been acquired by Thermo Fisher by that point. Thermo Fisher agreed to pay Enzo $35 million to settle claims of infringement of the '180 patent as well as of another patent owned by Enzo — No. 7,064,197, entitled System, Array and Non-Porous Solid Support Comprising Fixed or Immobilized Nucleic Acids.

In 2017, however, Enzo said the '180 patent had been found invalid for lack of enablement by the US District Court for the District of Delaware, and that the judge had granted summary judgment for the defendants. However, the court had also denied summary judgment that the patent is invalid for lack of written description.

Now, the federal appeals court has upheld that ruling, terminating the case "on the merits" after oral arguments and assessing the costs against Enzo.

In a statement to GenomeWeb, an Enzo spokesperson noted that the company's '197 patent remains valid, and said the firm is exploring all of its legal options and remedies for the '180 patent following yesterday's ruling.

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