Classen Immunotherapies, Inc. v. Biogen Idec

659 F.3d 1057 (2011)

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Nature of the Case

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Facts

The appeal reached the court remand from the Supreme Court. The remand concerns the question of patent-eligibility, 35 U.S.C. §101. The district court granted summary judgment that all of the claims in P's patents are ineligible for patenting because they are 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 district court granted summary judgment that the claims were not infringed, based on P's failure to allege facts sufficient to establish infringement based on the safe-harbor provision of 35 U.S.C. §271(e)(1) as to other Ds. P charged Ds with direct infringement on the ground that both companies participated in studies 'to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether the timing of vaccination influences risk.' P claimed that D induced infringement by licensing technology and 'providing instructions and/or recommendations on a proper immunization schedule for vaccines.' The district court granted summary judgment that these activities are within the safe-harbor provision of the Hatch-Waxman Act: §271(e)(1). It shall not be an act of infringement to make, use, offer to sell, or sell within the United States . . . a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products. P argues that §271(e)(1) is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, before patent expiration. Ds respond that their reporting of vaccine relationships, or recommendations in view of the relevant literature, or other activity in conformity with FDA regulations, are within the infringement safe-harbor of §271(e)(1).