Posts Tagged: "Mallinckrodt"

Latest Federal Circuit Ruling on 101 Strikes Down Mallinckrodt Method of Treatment Claims; Newman Dissents

In the most recent exploration of Section 101 by the Federal Circuit, Chief Judge Sharon Prost authored a non-precedential opinion holding the claims of a patent for a method of administering inhaled nitric oxide (iNO) ineligible for patent protection under the Alice/Mayo framework. The ruling paves the way for industrial gas company Praxair Distribution to move forward with its abbreviated new drug application (ANDA) for a nitric oxide delivery system. Judge Pauline Newman dissented in part, stating that the “method that is described and claimed does not exist in nature” and “was designed by and is administered by humans,” so should be patent eligible.

Patent battle over generic Inomax leaves five Mallinckrodt patents invalid as naturally occurring phenomenon

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., a standard affirmed by SCOTUS’ 2014 decision in Alice Corporation v. CLS Bank International. Applying the two-step test for Section 101 patentability, the Delaware court found that the Mallinckrodt patents covered natural phenomenon which did not include an inventive step. The court found that patent claim limitations directed at echocardiography or severe adverse reactions did not satisfy the inventive concept step. “It does not matter what the severe adverse reaction is,” Judge Sleet’s memo reads. “Any reaction to treatment with iNO will be a natural phenomenon, dictated by the patient’s physiological response to the drug.”