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Roche, Life Tech, Gen-Probe File Counterclaims Against Enzo in Nucleic Acid Probe Infringement Suit

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Roche, Life Technologies, and Gen-Probe have each filed responses to a lawsuit brought against them by Enzo Life Sciences claiming that various nucleic acid probe-based research and diagnostics products infringe a patent owned by Enzo.

Further, the three defendants have filed counterclaims against Enzo requesting that the court deem the Enzo-owned patent in question invalid and unenforceable, and asserting that Enzo's patent counsel on several occasions misrepresented information relevant to patentability in applications for the patent.

The responses, filed separately last month by Roche, Life Tech, and Gen-Probe with the US District Court for the District of Delaware, address separate lawsuits filed by Enzo against the three defendants in late March (PCR Insider, 2/2/2012).

In those lawsuits, Enzo alleged that Roche, Life Tech, and Gen-Probe (currently pending acquisition by Hologic) all currently 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."

Specifically, Enzo charged that Roche 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. Similarly, Enzo alleged that various Life Tech products involving TaqMan probes — including gene expression assays; SNP genotyping assays; protein assays; copy number assays; microRNA assays; and non-coding RNA assays — infringe the '180 patent.

In its complaint against Gen-Probe, Enzo claimed that Gen-Probe infringes the '180 patent by making and selling products using Gen-Probe's hybridization protection assay technology, including a variety of diagnostic products sold under the Aptima brand name.

In general, the three defendants have all claimed non-infringement of the patent, and have invoked the same defenses to Gen-Probe's claims in their response filings. These defenses include assertions that the '180 patent is invalid and void for failing to comply with one or more requirements for patentability specified in 35 USC sections 101, 102, 103, and 112; that it is invalid and void under the doctrine of obviousness-type double patenting; and that it is unenforceable due to prosecution laches (an unreasonable and unexplained delay in prosecution) and inequitable conduct.

The defendants also claim that Enzo's prayers for injunctive and monetary relief should be barred, particularly considering that "Enzo will not suffer any irreparable harm or injury if no permanent junction is issued."

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

In their counterclaims, Roche, Life Tech, and Gen-Probe have all accused Enzo's patent counsel, and specifically Ronald Fedus, misrepresented to the US Patent and Trademark Office material information relevant to the patentability 0f the '180 patent.

Specifically, the defendants note in their counterclaims and assertion of inequitable conduct that at least Fedus misrepresented to the USPTO on several occasions, in several patent applications, that the patent applicants "were in possession of claims directed at a signaling moiety [covalently] attached to a phosphate moiety" — a necessary innovation for patentability, according to the defendants. However, the defendants note that Enzo allegedly knew that these claims were "prophetic" and not actual examples, having never been carried out by scientists at the company.

In general, Roche, Life Tech, and Gen-Probe have asked for a judicial declaration of non-infringement of the '180 patent; and that the patent be declared invalid and unenforceable under these circumstances.

All three defendants also seek judgment that their counterclaims constitute "an exceptional case under 35 USC section 285," thus making the defendants entitled to an award of all attorney's fees, costs, and disbursements associated with the lawsuit.

It remains unclear whether the '180 patent covers specific products currently sold or in development by Enzo.

In December, the company disclosed a pair of assay technologies that it said would play a major role in future products: AmpiProbe, a nucleic acid amplification chemistry and method that may be 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; and a next-generation version of Enzo's branched DNA signal amplification assay that the company says has the ability to detect a single virus copy.