Case: Alcon Research Ltd. v. Barr Labs., Inc., No. 2012-1340, (Fed. Cir. Mar. 18, 2014) (precedential). On appeal from D. Del. Before Newman, Lourie, and Bryson.

Procedural Posture: Plaintiff, patent holder appealed judgments of noninfringement and invalidity for lack of enablement and lack of adequate written description in an ANDA case. Defendant cross-appealed denial of judgment as a matter of law (“JMOL”) of noninfringement with respect to other patents that Plaintiff withdrew before trial.

  • Infringement: The district court did not clearly err in finding that the accused generic product did not infringe the claims asserted at trial. The plaintiff had not tested the defendant’s product but relied instead on an accelerated stability study conducted by the plaintiff during its development work. The district court found, and the parties did not dispute, that the composition of the generic product proposed by the defendant was significantly different than the composition of the product tested by plaintiff during the study. Given that the formulations were “meaningfully different” the formulations in the plaintiff’s study provided no basis from which to draw any reliable inference regarding infringement by the defendant’s product.
  • Enablement: The district court erred because its enablement analysis did not address the determinative question of whether the defendant made the threshold showing that any experimentation was necessary to practice the claim. To prove that a claim is invalid for lack of enablement, a challenger must show that a person of ordinary skill in the art at the time of filing would not be able to practice the claimed invention without “undue experimentation.” The defendant failed to proffer evidence at trial that the claimed invention was inoperable or that any experimentation, let alone undue experimentation with certain variables, was necessary to practice the claimed invention.
  • Written Description: The district court erred by failing to apply the proper test for determining whether the patents included an adequate written description. The district court concluded that the asserted claims did not comply with the written description requirement for the same reason they failed to meet the enablement requirement. However, unlike enablement, the written description requirement does not require the patentee to disclose how to make the invention work; it requires that the disclosure demonstrate that the inventors were in possession of the claimed subject matter. The defendant did not present evidence that the inventors were not in possession of the claimed methods.
  • Judgment as a Matter of Law: The district court did not abuse its discretion in denying JMOL of noninfringement for two patents that were asserted in the complaint, but not litigated at trial. The plaintiff had informed the defendant of its decision to drop the claims of these two patents and the defendant subsequently omitted those claims from the pretrial order. A formal motion or stipulation is not required to remove claims from a case. Instead, a patentee’s announcement that it is no longer pursuing the claims, coupled with its ceasing to litigate them is sufficient to remove the claims from the case. The defendant had neither filed a counterclaim for declaratory judgment of noninfringement nor sought leave to do so once plaintiff announced it would not assert the patents. Had the defendant invoked that right, the district court might have exercised its discretion differently.