Document Type


Publication Date

February 2011


In Bilski v. Kappos, the U.S. Supreme Court continued to require that patentable subject matter eligibility determinations under Section 101 be made by reference to three historic, categorical exclusions, for scientific principles, natural phenomena, and abstract ideas. This excluded subject matter must be treated as if already known even when newly discovered by the applicant. Unlike in other jurisdictions, the excluded subject matter thus cannot contribute creativity to the claimed inventions, either for eligibility or for patentability evaluations. The Federal Circuit has reluctantly applied eligibility doctrine after Bilski, holding in Prometheus v. Mayo that claims to treatment methods applying the new medical discoveries are eligible inventions, even though those claims include a mental step and do not require any action following that step. In Association for Molecular Pathology v. U.S. Patent and Trademark Office (commonly known as the Myriad case, and which was filed by the American Civil Liberties Union and the Public Patent Foundation), which is pending in the Federal Circuit, the District Court found that isolated DNA molecules are not patent eligible inventions. The United States Government has now admitted that for decades it has been issuing such claims without legislative authority to do so. This article uses the Prometheus and Myriad cases to describe the line-drawing decisions regarding patent eligibility that the courts, patent office officials, and the public now have to make in regard to medical and biotechnological inventions. It explains why the Federal Circuit’s approach will remain unsatisfying unless and until it explicitly confronts the requirement for invention in the application of the categorically excluded discoveries of science, nature, and abstract ideas that underlie the claimed applications and must be treated as if they were already known prior art. The article also describes the important deontological and utilitarian moral concerns that apply to such controversial subject matter as medical and biotechnological inventions. It concludes with a brief discussion of the need for greater clarity regarding the required degree of creativity and greater international understanding (if not harmonization) of differing contribution approaches.

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