Digest of Novartis Pharm. Corp., et al. v. Watson Labs., Inc., et al., No. 2014-1799, 2014-1800; Novartis Pharm. Corp., et al. v. Par Pharm. Inc., No. 2015-1061, 2015-1062, 2015-1120, 2015-1121; Par Pharm., Inc. v. Novartis Pharm. Corp., et al., No. 2015-1141 (Fed. Cir. May 21, 2015) (nonprecedential). On appeal from D. Del. Before Lourie, Taranto, and Hughes.

Procedural Posture: Plaintiff Novartis appealed the District Court’s holding that the asserted claims of the patents were not infringed by Par’s generic rivastigmine products, which is the subject of its ANDA. Defendant Watson appealed the District Court’s holding that the asserted claims of the patents were not invalid as obvious. CAFC affirmed.

  • Non-obviousness: The District Court correctly determined that asserted claims were not obvious. The asserted claims are generally directed to pharmaceutical compositions containing rivastigmine and an antioxidant. Prior art references collectively disclose pharmaceutical compositions comprising rivastigmine and an antioxidant, but failed to provide a teaching that the two should be combined. Without knowledge of the problem— that a rivastigmine formulation was susceptible to oxidative degradation—one of skill in the art would not have been motivated to combine rivastigmine and antioxidants. The District Court credited Novartis’s expert’s testimony that the references do not teach that rivastigmine is susceptible to oxidative degradation. Thus, the District Court held that Watson did not prove by clear and convincing evidence that the asserted claims are invalid as obvious.
  • Infringement: The District Court did not clearly err in holding that Par’s ANDA product did not infringe any asserted claim containing the antioxidant limitation. To prove infringement, Novartis bore the burden of proving that acetaldehyde, which was found in Par’s ANDA product, actually reduces oxidative degradation. The District Court made specific findings on the scientific soundness of Novartis’s expert’s test and concluded that the test results were unpersuasive. The District Court further found that, even assuming that the test methodology was valid, the test results were not statistically significant. Because the District Court found Novartis’s experts’ testing to be unreliable, it correctly found that Novartis provided no basis from which to draw any reliable inference as to whether acetaldehyde acts as an antioxidant.
  • Collateral Estoppel: The District Court did not clearly err in entering final judgment of non-infringement in both Par cases. In the Par trial, the District Court found that Par’s product was not shown to satisfy the antioxidant limitation of the asserted claims. Because the antioxidant limitation is also dispositive of non-infringement in the declaratory judgment action, collateral estoppel applied.