On August 31, 2011, the Federal Circuit issued its long-awaited decision in Classen Immunotherapies, Inc. v. Biogen Idec et al. The case was remanded by the Supreme Court back to the Federal Circuit with instructions to consider the Court’s earlier Bilski decision on patent-eligibility under 35 U.S.C. § 101. At issue was the district court’s application of common-law exclusions from patent eligibility, i.e., “laws of nature, natural phenomena, and abstract ideas.” Diamond v. Diehr, 450 U.S. 175, 185 (1981). The district court had granted summary judgment finding all claims ineligible because they were directed to the “abstract idea” that there is a relation between the infant immunization schedule for infectious diseases and the later occurrence of chronic immune-mediated (non-infectious) disorders. The Federal Circuit reversed its prior decision for two patents, now finding them patent eligible and affirmed its prior decision for the third patent, finding its claims patent ineligible.

Three Classen patents were at issue, No. 6,638,739 (“the ’739 patent”), No. 6,420,139 (“the ’139 patent”) and No. 5,723,283 (“the ’283 patent”), all titled “Method and Composition for an Early Vaccine to Protect Against Both Common Infectious Diseases and Chronic Immune Mediated Disorders or their Sequelae” and based on Classen’s discovery that vaccines administered at an early age can substantially decrease incidence of chronic immune mediated side effects.

Claims of the ’139 and ’739 patents are directed to methods whereby information on immunization schedules and occurrence of chronic disease is “screened” and “compared,” a lower risk schedule is “identified,” and a vaccine is “administered on that schedule.