Digest of Ferring B.V. v Watson Labs., Inc.No. 2014-1416 (Fed. Cir. Aug. 22, 2014) (precedential). On appeal from D. Nev. Before Lourie, Dyk, and Reyna.

Procedural Posture: ANDA applicant Watson appealed holding of non-obviousness and finding of infringement. CAFC affirmed the non-obviousness holding and reversed the infringement finding.

  • Obviousness:The court held that claims to an amount of active ingredient combined with a modified release material and a specified dissolution rate were not obvious because the prior art did not disclose the claimed limitations and did not provide motivation to combine the references to derive the claimed formulations with the specified release profiles. Further, evidence of long-felt but unmet need supported the finding of non-obviousness.
  • Infringement: The infringement analysis turned on whether defendant Watson’s ANDA product met the claimed dissolution rate. The ANDA itself did not contain data or specifications about dissolution rate. Thus, it was correct to rely on testing of the tablet product that was sold in an at-risk launch under the ANDA. The testing showed that the tablets did not meet the dissolution rate limitations in the vast majority of tablets tested. While a few outlier tablets met the dissolution limitation, defendants’ experts explained that those outlier tablets “lacked coating integrity,” and therefore, these outliers were not representative of the product sold. The district court erred in finding infringement by comparing the claims to data presented in the ANDA for uncoated tablets that were not approved for sale and would not be sold.