Fed. Circ. Questions Allergan On Water’s Role In Colitis Patent

By Christopher Cole

Law360 (December 6, 2018, 5:36 PM EST) — The Federal Circuit on Thursday seemed wary of Allergan’s claim that Teva Pharmaceuticals USA Inc. stepped on a patent for the ulcerative colitis drug Delzicol by making a generic in a gel capsule just like the branded medication.

The three-judge panel appeared particularly skeptical of the role Allergan says water plays as capsule gelling agent, saying that characterization doesn’t appear anywhere in the lower court record.

“It feels just a little too vague for me,” Circuit Judge Raymond T. Chen told an Allergan lawyer, referring to the use of water in creating the capsule’s outer film.

Allergan is trying to overturn a Texas federal court’s decision that Teva and Mylan Pharmaceuticals Inc. could not have infringed the patent because the film composition of their drug capsule is different from Allergan’s. While the appeal is ongoing, Teva is also trying to get approval to market the generic.

Oral arguments in the appeals court Thursday focused on how the gel film on the capsule is created, with a lawyer for Allergan telling judges that a thermal gelation process using water is key to what Teva and Mylan allegedly infringed.

But the judges questioned Allergan as to why it thinks water acts as a “gelling agent” for the purposes of the dispute. Circuit Judge Kimberly Moore asked why the lower court ruling would be overturned when the record did not reflect that position by the drug company.

Michael Kennedy of Covington & Burling LLP, representing Allergan, said it was clear from the evidence that water gels the film used in the drug capsules, even if it had not been characterized as a gelling agent in earlier proceedings.

However, Teva’s attorney, John Rozendaal of Sterne Kessler Goldstein & Fox PLLC, told the judges that a person of ordinary skill in the art would not find that water acts as a gelling agent and that there is “overwhelming evidence” the film composition used by Teva could not have infringed Allergan’s patent.

Allergan is fighting an October 2017 decision by U.S. District Judge J. Rodney Gilstrap adopting a magistrate judge’s conclusion that the Teva and Mylan capsules did not have the same outer composition as the patent in question. Mylan has since settled out of the case, according to court records.

At the same time, Judge Gilstrap put off ruling on counterclaims by Teva and Mylan seeking to invalidate the Delzicol patent, saying that dispute involves different facts and legal theories. He said the federal Hatch-Waxman Act was partly motivated by wanting to get generics to market faster and he did not want to let the counterclaims delay the infringement appeal.

Judges Kimberly A. Moore, Jimmie V. Reyna and Raymond T. Chen sat on the panel for the Federal Circuit.

The patent-in-suit is U.S. Patent No. 6,649,180.

Allergan is represented by Michael N. Kennedy, Jeffrey B. Elikan, Jeremy D. Cobb, Philip S. May and David S. Denuyl of Covington & Burling LLP.

Teva represented by John Christopher Rozendaal, Michael E. Joffre, Chandrika Vira, William H. Milliken, Daniel J. Ritterbeck of Sterne Kessler Goldstein & Fox PLLC.

The case is Warner Chilcott US LLC v. Teva Pharmaceuticals USA Inc., case number 18-1241, in the U.S. Court of Appeals for the Federal Circuit.

–Additional reporting by Bonnie Eslinger. Editing by Marygrace Murphy.