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Cepheid Asks Federal Court to Rule Two Roche PCR Patents Invalid

NEW YORK (GenomeWeb News) – Cepheid is asking a federal court to declare two patents held by Roche invalid.

In a lawsuit filed last week in the US District Court for the Northern District of California, Cepheid asked the court also to find that it does not infringe US Patent Nos. 5,804,375 and 6,127,155 held by Roche.

The '375 patent, titled "Reaction mixtures for detection of target nucleic acids" pertains to a method for detecting a target nucleic acid using labeled oligonucleotides based on the "5' and 3' nuclease activity of a nucleic acid polymerase to cleave annealed labeled oligonucleotide from hybridized duplexes and release labeled oligonucleotide fragments," according to the patent abstract.

The '155 patents, titled "Stabilized thermostable nucleic acid polymerase compositions containing non-ionic polymeric detergents," relates to purified thermostable nucleic acid polymerase.

As GenomeWeb Daily News' sister publication PCR Insider reported previously, Cepheid terminated a licensing agreement with Roche last fall after determining that the patents covered by the deal "were not pertinent to Cepheid's future business plans." In response, Roche sought an arbitration hearing with the International Chamber of Commerce to settle the dispute between the firms.

In the complaint filed last week, Cepheid said that in May 2010 Roche sent a letter to its licensees, including Cepheid, stating that while some patents were set to expire in August of that year, the '375 and '155 patents would remain valid and would be enforced.

In July 2010, Cepheid told Roche that it would be terminating its license to the '375 patent and any royalty obligation under the patent would end on Aug. 5, 2010. Roche subsequently sent letters to Cepheid saying that the '375 patent would not expire until August 2015 and that Cepheid's sale of it Xpert kits required a license from Roche.

Cepheid, though, contends that the '375 patent is invalid and noted that in January 2012 the US Patent and Trademark Office rejected "all of the claims of the '375 patent as unpatentable due to non-statutory double patenting," the Sunnyvale, Calif.-based company said in its complaint.

Roche has filed a preliminary amendment and is seeking reissuance of the patent. It also has asked the USPTO to reexamine the patent. In the meantime, though, Cepheid has asked the district court to find that the '375 patent "is expired and invalid."

Similarly, Cepheid alleges it is not infringing the '155 patent because it is "expired, unenforceable, and invalid." Specifically, it claims the patent cannot be enforced because "it was procured through false declarations and egregious misrepresentations in its specification and prosecution history," Cepheid said.

The company claims that the patent is a "descendant" of an earlier patent, No. 4,889,818, "which was judicially found to have been procured through inequitable conduct," when it was found that Roche's attorney intentionally misrepresented certain claims of the '818 patent.

The "inequitable conduct that occurred in the '818 patent also occurred in the preparation and prosecution of the '155 patent application," Cepheid added. That included the portrayal of a protocol being performed as part of the '155 patent application, which Cepheid contends was not performed.

Roche "has admitted that [the protocol] of the '155 patent application was not practiced by the named inventors," Cepheid said in its complaint, and, "[u]pon information and belief [the protocol] was material, was presented with the intent to deceive the [USPTO] and renders the '155 patent unenforceable due to inequitable conduct."

It added that had Roche's misrepresentations been disclosed to the USPTO in a timely manner, the patent would have expired in 2008.

In morning trading shares of Cepheid on the Nasdaq were up about 2 percent to $37.07.

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