Patent Safe Harbor Applies To Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application and Citizen’s Petition. However, the Federal Circuit remanded the case to the district court to determine whether other allegedly infringing activities, such as using the information to file a patent application, also were shielded by the statute. Continue reading this entry

Federal Circuit Finds No Direct Infringement Of Akamai Patents

The Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., this time affirming the district court decision that Limelight was not liable for infringing Akamai’s patents because Limelight had not performed each step of the method claims and was not responsible for the actions of its customers. In reaching its decision, the majority refused to interpret 35 USC § 271(a) broadly, instead finding the statute to require a principal-agent relationship, contractual relationship, or joint enterprise to hold a party liable for the actions of another.   Continue reading this entry

First Look At False Marking Under The AIA

In Sukumar v. Nautilus, Inc., the Federal Circuit took its first look at the standing requirements to bring a false marking case under the America Invents Act (AIA). The court rejected Nautilus’ arguments that only “market participants” could bring suit, but required plaintiffs to at least have taken action to enter the market in order to possibly have suffered a “competitive injury.”  Continue reading this entry

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for delay” settlements). Although the court’s decision interprets state antitrust laws, it may influence other states applying similarly structured laws and could be of interest to district courts applying federal antitrust laws, since it purports to follow the Supreme Court’s guidance in FTC v. Actavis. Continue reading this entry

Federal Circuit Keeps Sandoz Biosimilar Off The Market For Now

The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until it renders its decision. Amgen’s appeal relates to the district court decision that denied its motion for a preliminary injunction, and decided that virtually all of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA) are optional. (I wrote about the district court’s decision in this article.) Continue reading this entry