Alcon Research Ltd. V. Barr Laboratories, Inc.

When Barr challenged Alcon's patent, it did not show with clear and convincing evidence that a person of ordinary skill in the art could not practice the claim without undue experimentation, which is required to prove lack of enablement.

Opinion (Lourie): Alcon Research Ltd. (”Alcon”) owns the ‘287 and ‘062 patents describing methods of using polyethoxylated castor oil (“PECO”) to stabilize prostaglandin compositions used in various drugs. Alcon filed suit against Barr Laboratories, Inc. (“Barr”) alleging Barr’s ANDA filing infringed on ‘287, ‘062, ‘383, and ‘052. However, Alcon never asserted its ‘383 or ‘052 patents at trial. The trial court found that Barr’s ANDA did not infringe either ‘287 or ‘062 because Alcon did not present evidence that tested Barr’s product directly and that the test results Alcon did rely upon to prove infringement could be attributed to a number of factors other than the use of PECO. The trial court also held Alcon’s claims as invalid for lack of enablement and lack of written description, and denied Barr’s motion for JMOL of noninfringement of ‘383 and ‘052. Everyone appealed. The Court of Appeals found that the composition of Barr’s generic ANDA product was significantly different from the compositions tested in Alcon’s study and that Alcon itself admitted that variations in composition can have a substantial impact on the chemical stability of a prostaglandin formulation. Therefore, the Court affirmed noninfringement of ‘287 and ‘062. Under §112 of the patent statute, a patent must contain a written description of the invention, and specify the manner of making and using it "to enable any person skilled in the art to which it pertains, . . . to make and use the same . . . ." Regarding any lack of a written description, the Court found that Alcon’s ‘287 and ‘062 patents both had sufficiently detailed written descriptions. Regarding any lack of enablement, the Court found that Barr did not present any evidence to show that a person of ordinary skill in the art could not practice the claim without undue experimentation. Therefore, the Court reversed the §112 invalid claim holding. Finally, because Barr never filed counterclaims seeking declaratory judgment of non-infringement, they did not preserve their ability to seek an adjudication of the ‘383 and ‘052 patents after neither party litigated them. Because neither party fairly placed the ‘383 and ‘052 patents in issue during trial, the Court found the lower court did not abuse its discretion in denying Barr’s motion for JMOL. AFFIRMED IN PART and REVERSED IN PART.