Anne Elise Herold Li

On June, 26, 2015, the U.S. Court of Appeals for the Third Circuit held that non-cash "payments"​ made by a patentee drug manufacturer to a prospective generic drug manufacturer in exchange for delayed entry of a generic drug is an actionable "reverse payment"​ and may be subject to antitrust scrutiny under the Supreme Court's decision in FTC v. Actavis, 133 S. Ct. 2223 (2013). King Drug Company of Florence, Inc. v. Smithkline Beecham Corp., et al., Case No. 14-1243 (Smithkline).

On June, 26, 2015, the U.S. Court of Appeals for the Third Circuit held that non-cash "payments"​ made by a patentee drug manufacturer to a prospective generic drug manufacturer in exchange for delayed entry of a generic drug is an actionable "reverse payment"​ and may be subject to antitrust scrutiny under the Supreme Court's decision in FTC v. Actavis, 133 S. Ct. 2223 (2013). King Drug Company of Florence, Inc. v. Smithkline Beecham Corp., et al., Case No. 14-1243 (Smithkline).

In a decision applying two recent Supreme Court decisions, the Federal Circuit on Thursday held that the claims to Teva's patents covering the multiple sclerosis drug Copaxone® were invalid for the second time. Teva Pharm.USA, Inc. v. Sandoz, Inc., 2012-1567, slip op. at 18 (Fed. Cir. June 18, 2015). Judge Moore, writing for the court again, found that the claim term "molecular weight" was indefinite because a person of ordinary skill in the art would not understand with reasonable certainty to… Show more

In a decision applying two recent Supreme Court decisions, the Federal Circuit on Thursday held that the claims to Teva's patents covering the multiple sclerosis drug Copaxone® were invalid for the second time. Teva Pharm.USA, Inc. v. Sandoz, Inc., 2012-1567, slip op. at 18 (Fed. Cir. June 18, 2015). Judge Moore, writing for the court again, found that the claim term "molecular weight" was indefinite because a person of ordinary skill in the art would not understand with reasonable certainty to which type of molecular weight the claim language referred. Show less

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the U.S. Court of Appeals for the Federal Circuit invalidated Sequenom's patent claiming methods of detecting paternally-inherited fetal DNA in a mother's blood serum or plasma, affirming the district court's decision. The decision highlights that discoveries to new, even "revolutionary," methods of detecting and analyzing naturally occurring phenomena may be ineligible for patent protection under 35 U.S.C. § 101 absent some… Show more

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the U.S. Court of Appeals for the Federal Circuit invalidated Sequenom's patent claiming methods of detecting paternally-inherited fetal DNA in a mother's blood serum or plasma, affirming the district court's decision. The decision highlights that discoveries to new, even "revolutionary," methods of detecting and analyzing naturally occurring phenomena may be ineligible for patent protection under 35 U.S.C. § 101 absent some additional contribution to the state of the art. In so holding, the court considered and rejected arguments by Sequenom that (1) limited preemption of the natural phenomenon by the claims at issue rendered the claims patent eligible; and (2) that a new application of already known steps or processes to a newly discovered natural phenomenon is itself patent eligible. Show less

On Thursday, March 19, 2015, a district court ruling paved the way for the first biosimilar product approved by the U.S. Food and Drug Administration (FDA) to enter the market. Judge Seeborg in the Northern District of California granted a victory to Sandoz in its fight with Amgen, Inc. over Zarxio, Novartis AG's generic version of Amgen Inc.'s cancer drug Neupogen® (the "reference product") by denying Amgen's request for a preliminary injunction. In the order, the court sided with Sandoz on… Show more

On Thursday, March 19, 2015, a district court ruling paved the way for the first biosimilar product approved by the U.S. Food and Drug Administration (FDA) to enter the market. Judge Seeborg in the Northern District of California granted a victory to Sandoz in its fight with Amgen, Inc. over Zarxio, Novartis AG's generic version of Amgen Inc.'s cancer drug Neupogen® (the "reference product") by denying Amgen's request for a preliminary injunction. In the order, the court sided with Sandoz on its interpretation of the portion of the Biologics Price Competition and Innovation Act (BPCIA) governing the disclosure requirements imposed on biosimilar manufacturers prior to sale of a biosimilar product. The court also rejected Amgen's interpretation of the statute that would have required Sandoz to wait 180 days from approval of the biosimilar product before going to market. Amgen (the "reference product sponsor") has said that it will appeal the ruling. Show less