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Judge Sleet finds asserted claims invalid as obvious in ANDA litigation

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In a recent Memorandum Opinion, Judge Gregory M. Sleet considered the parties’ post-trial proposed findings of fact and conclusions of law following a four-day bench trial in this ANDA litigation, and determined that the asserted claims of U.S. Patent No. 6,713,446 (“the ’446 patent”) were invalid as obvious under 35 U.S.C.  § 103. Millenium Pharmaceuticals, Inc. v. Sandoz Inc., et al., C.A. No. 12-1101-GMS (consol.) (D. Del. Aug. 20, 2015). Defendants successfully argued “that the asserted claims are obvious because the ’446 patent claims the inherent result of an obvious process-namely, that freeze-drying bortezomib with mannitol produces an ester.”  Id. at 5. Moreover, Judge Sleet found that plaintiff failed to rebut defendants’ prima facie case of obviousness with secondary considerations.  Specifically, as to “unexpected results,” plaintiff “failed to present any credible evidence at trial about what a skilled artisan would have expected.” Id. at 17. As to “commercial success and long-felt need,” Judge Sleet explained that “[n]o persuasive evidence was provided to show any advantage attributable to the claimed formulation over the other potential formulations available to [plaintiff].” Id. at 18.  Judge Sleet therefore determined that the defendants “have established by clear and convincing evidence that the asserted claims of the ‘446 patent are obvious.” Id. at 5.

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