Asserting "undue experimentation" requires first proving that, without experimentation, claim might be inoperable

Fed Cir affirms judgment of noninfringement, reverses judgment of invalidity for lack of enablement and lack of an adequate written description, and affirms denial of motion to amend judgment.

Alcon Research Ltd. v. Barr Laboratories, Inc., __ F.3d. __ (Fed. Cir. March 18, 2014) (Newman, LOURIE, Bryson) (D. Del.: Davis) (2 of 5 stars)

Noninfringement: The claims recited a "method of enhancing the chemical stability" of a composition by "adding a chemically-stabilizing amount of polyethoxylated castor oil [("PECO")] to the composition." Slip Op. at 3. While all agreed that Barr's hypothetical ANDA product had PECO, the Fed Cir agreed with the district court that a stability study on which Alcon relied to prove infringement did not show a "chemically-stabilizing amount" of PECO because the product in that study differed from the ANDA product in ways that could affect stability.

Enablement: The Fed Cir held a defendant must prove, as a threshold, that some experimentation is required before a court can consider the Wands factors, and that Barr had not done so. Barr's expert testimony was "conclusory" on this point, and its identification of variables that might affect chemical stability did not show that addition of PECO might fail to enhance chemical stability (and make the invention inoperable) or that a skilled artisan would be unable to practice the invention without experimentation. Id. at 12-13. The district court erred by not first ruling on the threshold issue. Id.

Written Description: The district court erred by holding the claims invalid "'for essentially the same reasons that they fail the enablement requirement . . . .'" Id. at 17. The patents disclosed details about PECO's enhancement of chemical stability, and Barr did not provide evidence on the relevant inquiry: whether a skilled artisan would have understood from the patents' disclosures that the inventors were in possession of the claimed invention. Id. at 17-18. In reaching its conclusion, the Fed Cir noted that a district court's interpretation of precedent is reviewed de novo.

Motion to Amend Judgment: The district court did not err in denying Barr's JMOL and Rule 59(e) motions on noninfringement for two patents that Alcon stopped pursuing during the litigation: Alcon had told Barr it was dropping the patents, the patents were omitted from the pretrial order and not litigated at trial, and Barr had not filed counterclaims for a DJ of noninfringement. Id. at 19-21.