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Millennium Pharmaceuticals, Inc. v. Sandoz Inc.

Failure to Prove Motivation to Combine, and Failure to Overcome Secondary Considerations, Warrant Reversal of Invalidity Judgment

Millennium Pharmaceuticals, Inc. v. Sandoz Inc., (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) (D. Del.: Sleet) (3 of 5 stars)

Fed Cir reverses judgment of invalidity and enters judgment for Millennium. Fed Cir also vacates judgments in separate actions that had been entered based on collateral estoppel. Millennium’s patent claims the structure of Velcade, an anticancer drug. This is a Hatch-Waxman case, and Sandoz stipulated to infringement. The district court clearly erred in concluding that a person of skill would have had a reason to produce the compound in question, based on the references. There was no dispute that a key process was known in the art, but there was nothing in the record to suggest applying that process in the manner required to reach the claimed compound. The opinion discusses the various references and theories, and describes why none of them taught/suggested the required process. The district also cleared erred in determining that the prior art did not teach away from application of the proposed process, and discusses why. The district court also clearly erred in its application of inherency. While it was undisputed that application of the process in question would have led to the claimed compound, that it did so was unexpected prior to the invention. The opinion rejects Sandoz’s argument that because the reactions at issue were “inherent” to the materials and process being used, they could not be inventive.

The district court also clearly erred in its analysis of objective indicia of unexpected results and long-felt need. “These indicia cannot be set aside in the analysis of obviousness.” Op. at 17. The opinion describes how the district court erred in determining what the “closest prior art compound” was for purposes of this analysis; correcting for this, the record showed unexpected results. The district court also erred in concluding that Millennium had failed to show a long-felt need or commercial success. The record demonstrated both.

In view of the above, the district court should not have found invalidity, and its judgment is reversed in the Millennium-Sandoz case. In litigation between Millennium and Apotex and Teva, judgment against Millennium that had been entered based on collateral estoppel is vacated and remanded.

KEYWORDS: INVALIDITY (NO); HATCH-WAXMAN; MOTIVATION TO COMBINE (NO); SECONDARY CONSIDERATIONS; INHERENCY