Millenium Pharmaceuticals, Inc. v. Sandoz Inc., et al., C.A. No. 12-1011-GMS, August 20, 2015.

Sleet, J.  Post-trial memorandum opinion finding the patent-in-suit is obvious and therefore invalid under 35 U.S.C § 103

This ANDA case  concerns generic versions of bortezomib, marketed as Velcade® and used to treat multiple myeloma and mantle cell lymphoma.  One prior art patent identifies bortezomib as a potent anti-cancer drug.  The parties dispute whether lyophilization of the drug, a technique well-known in the field of formulation, would have been obvious.  The decision to lyophilize bortezomib with mannitol was not inventive.  It was a suitable option from which the prior art did not teach away. Defendants further argue that a bortezomib-mannitol ester is an inherent result of that combination and the court agrees.  It is an inherent property that falls under the rare exception to the rule that every limitation of a claim must have been known to the inventor at the time of the alleged conception.  Defendants’ prima facie case of obviousness is clear and convincing and is not overcome by secondary considerations of unexpected results, commercial success and long-felt need.