ALCON RESEARCH LTD., Plaintiff-Appellant, v. BARR LABORATORIES, INC., Defendant-Cross-Appellant., 745 F.3d 1180

Summary

HOLDINGS: [1]-District court properly held that patentee failed to prove that the generic product described in an alleged infringer’s Abbreviated New Drug Application (ANDA) did not infringe the asserted claims of two patents where the composition of the generic product proposed in the ANDA was significantly different from the compositions tested in the patentee’s study; [2]-With respect to asserted claims of two other patents, the district court erred in holding that the alleged infringer proved its invalidity case based on nonenablement, as the infringer did not show that any claimed embodiments would be inoperable and that a person of ordinary skill in the art would have been unable to practice the asserted claims without resorting to any experimentation, let alone undue experimentation; [3]-District court properly denied alleged infringer’s Fed. R. Civ. P. 59(e) motion to amend.