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Enzo Sues Roche, Life Tech, Gen-Probe for Alleged Infringement of Nucleic Acid Probe IP

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Enzo Life Sciences has filed three separate lawsuits against Roche, Life Technologies, and Gen-Probe claiming that various nucleic acid probe-based research and diagnostics products from those companies infringe a patent owned by Enzo.

In the complaints, filed this week in the US District Court for the District of Delaware, Enzo alleges that Roche, Life Tech, and Gen-Probe all make and sell products that infringe US Patent No. 6,992,180, awarded in 2006 and entitled "Oligo- or polynucleotides comprising phosphate-moiety labeled nucleotides."

In its complaint against Roche, Enzo claims that the company is infringing the '180 patent by making and selling certain nucleic acid probe products, including but not limited to products involving TaqMan probes, and including a variety of products sold under the Cobas brand name. These include versions 1.0 and 2.0 of the AmpliPrep and TaqMan HIV-1 tests; AmpliPrep and TaqMan HCV tests; AmpliPrep and TaqMan HBV tests v2.0 for use with the High Pure System; TaqMan HBV test for use with the High Pure System; TaqScreen MPX test; and TaqScreen West Nile Virus test.

Similarly, in its complaint against Life Tech, Enzo claims that various Life Tech products involving TaqMan probes infringe the '180 patent. These products, all sold under the TaqMan brand name, include gene expression assays; SNP genotyping assays; protein assays; copy number assays; microRNA assays; and non-coding RNA assays.

Meantime, Enzo claims that Gen-Probe infringes the '180 patent by making and selling products that involve the company's hybridization protection assay technology. These products include a variety of products sold under the Aptima brand name, including the Combo 2 assay for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC); CT assays; GC assays, Trichomonas vaginalis assays; HPV assays; HIV-1 assays; and HCV assays.

In all cases, Enzo is seeking judgment that the parties named have infringed the '180 patent; that it be awarded damages adequate to compensate it for past and any continuing infringement; that the parties receive an injunction preventing further infringement of the '180 patent; and that Enzo be awarded a compulsory ongoing licensing fee in the event that a permanent injunction is not obtained.

It is unclear whether the '180 patent covers any specific products that Enzo currently sells or is developing. An Enzo spokesperson said that company officials were not immediately available for comment.

In December, Enzo disclosed a pair of assay technologies that it said are expected to drive future growth at the company and set new standards for how certain molecular diagnostics are performed (PCR Insider, 12/15/2011).

The first technology, called AmpiProbe, is a nucleic acid amplification chemistry and method that Enzo claims is up to 50 times more sensitive than TaqMan-based real-time PCR, and may allow as many as 20 molecular assays for different targets to be performed on a single clinical sample.

The second innovation is a next-generation version of the company's branched DNA signal amplification assay that the company says has the ability to detect a single copy of a virus, such as human papillomavirus, that has integrated into a host cell's chromosome, which may allow clinicians to detect HPV-associated cancers earlier than can any existing method.

Roche and LifeTech's TaqMan technology uses a fluorogenic oligonucleotide probe having a 5'-attached fluorophore and a 3'-attached quencher that enable the quantitative measurement of specific PCR products as they accumulate during PCR cycles.

Meantime, Gen-Probe's HPA assay technology features an acridinium ester molecule that is protected within the double-stranded helix that is formed when the probe binds to its specific target, according to Gen-Probe's website. By adding a reagent that rids unhybridized probes of the AE molecule; then adding a detection reagent that produces a signal from only intact AE molecules, a signal is produced that indicates the presence of target DNA or RNA.

According to the specific claims of Enzo's '180 patent, the technology describes nucleotides modified in a certain way and incorporated into oligo- and polynucleotides that may be used as probes in biomedical research, clinical diagnosis, and recombinant DNA technology.

"These various utilities are based upon the ability of the molecules to form stable complexes with polypeptides which in turn can be detected, either by means of properties inherent in the polypeptide or by means of detectable moieties which are attached to, or which interact with, the polypeptide," the patent states.

The patent is a continuation of a series of applications dating back to 1982, all of which were abandoned prior to being granted.

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