September 2, 2011
Federal Circuit Rules that Immunization Optimization Methods are Patentable
Following on the decisions in Prometheus v. Mayo and AMP v. USPTO, both of which presented method patent claims to methods for diagnostic or therapeutic applications relying on the use of biochemical correlations - but both of which presented the critical question of whether a scientific correlation or abstract idea (either one unpatentable) was patented (Prometheus: no; AMP: yes), the Federal Circuit has added more layers to the controversy. The Federal Circuit has added In re Classen, in which the applicant claimed methods of determining whether an particular immunization schedule was beneficial in deterring later-developed immune disease. The claims that linked the scientific reasoning to an actual immunization step were found patent-eligible, while the claims that only recited the scientific thought process were not. A vigorous dissent by Judge Moore characterized the patents as creating "preemption by these staggeringly broad and abstract claims" and further stated her conclusion that the patents covered "a fundamental scientific principle(s) so basic and abstract as to be unpatentable subject matter." Thus, in the landscape of litigated method claims with relevance to biotech patenting, Prometheus is now slated for Supreme Court review next term, AMP is in the post-appellate stages of attempted rehearings, and Classen may be appealed further up. Great turmoil in life science method claims, all of which await their Bilski-level review.