In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the U.S. Court of Appeals for the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that favors biosimilar applicants in one respect while favoring reference product sponsors (e.g., owners of original biologic products) in another. The result for Amgen and Sandoz is that Sandoz can start selling Zarxio™, its biosimilar version of Amgen’s Neupogen® (filgrastim) product, on September 2, 2015. The result for other biosimilar applicants is less clear, since the court’s decision leaves open more questions than it answers.
The Patent and Trial Appeal Board erred in dismissing Airbus S.A.S.’s appeal for lack of jurisdiction based on a lack of substantial new question of patentability because the Director had already ordered inter partes reexamination, according to the U.S. Court of Appeals for the Federal Circuit (Airbus S.A.S. v. Firepass Corporation, July 17, 2015, Lourie, A.).
The Federal Circuit has issued its long-awaited decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., but the decision is not good news for those seeking to obtain or enforce U.S. patents on diagnostic methods. The appeals court affirmed the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101, applying the analytical framework set forth in the U.S. Supreme Court’s Mayo decision in a way that could have a ripple effect across the diagnostic and personalized medicine industry.
The Claims At Issue
The Sequenom patent at issue was U.S. Patent 6,258,540. The claimed technology relates to diagnostic methods for determining certain fetal characteristics such as [...]
Proxyconn, Inc. was able to show that the Patent Trial and Appeal Board erred in construing certain claims of a patent challenged by Microsoft Corporation in inter partes review petitions, according to the U.S. Court of Appeals for the Federal Circuit (Microsoft Corporation v. Proxyconn, Inc., June 16, 2015, Prost, S.).
An accused party’s belief in the invalidity of a patent is not a defense to a claim that the party induced infringement of the patent, the U.S. Supreme Court has held. In a dispute between Commil USA and accused infringer Cisco Systems, the Court reversed a holding of the U.S. Court of Appeals for the Federal Circuit that “evidence of an accused inducer’s good-faith belief of invalidity may negate the requisite intent for induced infringement.” The case was remanded for further proceedings consistent with the Supreme Court’s decision (Commil USA, LLC v. Cisco Systems, Inc., May 26, 2015, Kennedy, A.).
The U.S. Court of Appeals for the Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., and this time affirmed the district court decision that Limelight was not liable for infringement of Akamai’s patents because Limelight had not performed each step of the method claims and was not responsible for the actions of its customers. The decision sets a high bar for joint infringement of method claims, requiring a principal-agent relationship, contractual relationship, or joint enterprise to hold a party liable for the actions of another.
Liability For U.S. Patent Infringement
Liability for U.S. patent infringement is provided for in 35 [...]