Court Decides that ANDA Approved Before Patent Issued Cannot Infringe 35 U.S.C. § 271(e)(2)(A)

By Allen Sokal on June 1, 2016 Posted in Patent

Although the Hatch-Waxman Act was passed by Congress decades ago, it still produces new questions. Despite vigorous argument by the patent owner, a district court dismissed a count alleging that the ANDA-filer infringed under 35 U.S.C. § 271(e)(2)(A), leaving in place the unchallenged count for infringement under § 271(a). Ferring B.V. v. Actavis, Inc., Civil Action No. … Continue Reading

Filing an ANDA May Expose Generic Manufacturers to Nationwide Personal Jurisdiction in Patent Infringement Suits

By Laura Gordon on April 4, 2016 Posted in Patent

On March 18, 2016, the Federal Circuit affirmed the District of Delaware’s ruling in two companion cases that West Virginia-based defendant Mylan Pharmaceuticals is subject to specific personal jurisdiction in Delaware. Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 2015-1456 (Fed. Cir. Mar. 18, 2016); AstraZeneca AB v. Mylan Pharm. Inc., 2015-1460 (Fed. Cir. Mar. 18, … Continue Reading

Momenta Pharma., Inc. v. Teva Pharma. USA Inc.

By Stephanie Lodise, Ph.D. on November 19, 2015 Posted in Uncategorized

In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015) (“Momenta II”), the Federal Circuit found that, pursuant to 35 U.S.C. § 271(g), “made” is limited to steps directly related to manufacturing products and excludes isolated quality control steps. The court also revisited its prior … Continue Reading