Patenting Medical and Genetic Diagnostic Methods

Patenting Medical and Genetic Diagnostic Methods

Eddy D. Ventose

This well-researched book explores in detail the issue of patenting medical and genetic diagnostic methods in the United States. It examines decisions of the Patent Office Boards of Appeal and the early courts on the question of whether medical treatments were eligible for patent protection under section 101 of the Patents Act. It then traces the legislative history of the Medical Procedures and Affordability Act that provided immunity for physicians from patent infringement suits. After considering the Supreme Court’s jurisprudence on patent eligibility, the book then comprehensively sets out how the Federal Circuit and the Supreme Court have dealt with the issue, paying close attention to the Supreme Court’s recent decision in Bilski and Prometheus.

Chapter 6: Consideration by the Supreme Court

Eddy D. Ventose

Subjects: environment, biotechnology, innovation and technology, biotechnology, law - academic, health law, intellectual property law


As was seen in Chapter 5, in the 1980s the Federal Circuit had initially considered the issue of patent protection for diagnostic and medical treatment methods without much success. In the main, they ruled that such methods were not patentable under section 101. The Court’s decisions in Benson, Flook and Diehr provided some guidance on the issue of patent-eligibility which were used by the CCPA and the Federal Circuit, especially in recent years, to determine the question of whether patent protection should be provided for medical methods, in particular, diagnostic methods. None of these decisions reached the Court. However, one unremarkable decision which raised the question of patent protection for diagnostic methods only tangentially reached the Court. That decision was Laboratory Corporation, where the Court, although granting certiorari to determine the issue of whether a diagnostic method essentially fell afoul of section 101, rejected the claim without deciding the issue. However, a dissent by Breyer J provided an initial view of three members of the Court on the issue of patent protection for medical and diagnostic methods. Although the dissenting opinion in Laboratory Corporation has no precedential value, it was, nonetheless, used by some District Courts to justify rejecting similar claims as unpatentable subject matter, but the Federal Circuit made clear that that opinion has little value. The reliance on Laboratory Corporation was, however, short-lived since the Court has handed down its decision in Prometheus.

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