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Chalk up another huge generic pharma patent win for Winston & Strawn. On Wednesday, Detroit federal district court senior judge Avern Cohn ruled that Novo Nordisk’s patent on a diabetes drug called Prandin is invalid for obviousness and unenforceable because of Novo’s inequitable conduct. Winston & Strawn represents Caraco Pharmaceutical, which filed the challenge to Novo’s Prandin patent way back in 2005. Judge Cohn’s 79-page ruling, which follows a three-week bench trial last summer, concludes that Novo should never have been awarded a patent on the drug, which combines two other diabetes drugs. “The record clearly and convincingly establishes that the prior art supplied the teaching, suggestion and motivation to combine repaglinide with metformin as combination therapy for Type II diabetes,” the judge wrote. “In view of these facts, established by clear and convincing evidence, a person of ordinary skill in the art, as of the critical date, would have found it obvious to try the combination of metformin with repaglinide as a potential treatment for Type II diabetes. As such, the court finds that a prima facie case of obviousness exists.” But Judge Cohn didn’t stop with a finding that Novo’s patent is invalid for obviousness. He went on to consider Winston & Strawn’s argument that the patent is also unenforceable because of Novo’s inequitable conduct. Trial counsel James Hurst, David Bloch, and Charles Klein of Winston argued that Novo deceived the U.S. Patent & Trademark Office with claims about the synergistic effects of combining the two drugs. Judge Cohn agreed. Noting that the patent office had previously rejected Novo’s patent application three times, the judge found that a Novo scientist withheld “highly material information” from a declaration about the synergy of the drug combination “with intent to deceive the patent examiner.” Moreover, an in-house Novo patent lawyer named Richard Bork “both misrepresented and withheld highly material information with intent to deceive the examiner,” Judge Cohn wrote. “Bork’s exaggerated arguments to the examiner…went beyond aggressive advocacy; they misstated key conclusions. As a patent attorney, he had to have known of the materiality of his representations and the significance attached to them by the examiner.” Judge Cohn concluded that Novo deliberately misled the patent office. “Novo knew the obstacles to obtaining a patent, as seen by the several rejections. Knowing what was needed to be shown to establish patentability, in what would be Novo’s final attempt before the patent office, Novo omitted material information,” he wrote. “The only inference which can be drawn from its conduct was that it was done with the intent to deceive the examiner and obtain a patent. Perhaps market forces drove Novo to do what it did; the court can only speculate. In the end, however, the patent cannot be sustained.” Novo announced in a press release that it intends to appeal Judge Cohn’s ruling. Prandin generated $134 million in sales for the company through the first three quarters of 2010. In an interview with us Thursday, Novo North America general counsel James Shehan defended the actions of Bork, the in-house patent lawyer criticized in Judge Cohn’s ruling. “We stand behind our employee,” Shehan said. “Rich has been with us for a decade. He is a well-respected patent attorney and a good employee.” Shehan told us Judge Cohn reached his conclusions on inequitable conduct without hearing testimony on Caraco’s allegations; Bork, for example, did not testify at the trial. Shehan said such gaps in the record will be one of Novo’s arguments on appeal. The Caraco case has a very convoluted history. Judge Cohn previously found that Novo improperly described the drug for inclusion in the Food and Drug Administration’s “Orange Book.” He entered an order and injection requiring Novo to correct the Orange Book listing, but the U.S. Court of Appeals for the Federal Circuit reversed the ruling last year, holding that the Hatch-Waxman Act does not permit Caraco’s challenge to Novo’s Orange Book listing. Caraco has filed a certiorari petition at the U.S. Supreme Court. Novo was represented at the Federal Circuit and in the bench trial by Gibson, Dunn & Crutcher. We left a message with Josh Krevitt of Gibson but didn’t hear back. Caraco counsel James Hurst of Winston declined comment.

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