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 2: Initial determination

Eddy D. Ventose

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


The question of patent protection for medical patents has long engaged the attention of the courts in the United States. There was no question that substances and compositions of matter for treating the human body were patentable. The question, then, was whether methods of medical treatment were patent-eligible; although, in some cases, the issue did not directly arise for consideration by the court. The Board of Patent Appeals (BOPA) initially held that methods of medical treatments were not protected under United States patent laws but their decisions were not well reasoned. Ex parte Brinkerhoff was based on a dubious legal analysis and the subsequent decisions did not strictly adhere to the supposed rule enunciated therein. The retreat from the ex parte Brinkerhoff decision was crystallised in ex parte Scherer, where the BOPA expressly overruled Brinkerhoff to the extent that it held methods of medical treatment were unpatentable subject matter. There was no consideration of the nature of the exclusion, or whether it only applied to methods of medical treatment or covered all methods of treatment. Similarly, there was no discussion as to whether the exclusion covered humans only, or whether it extended to animals. It seemed that only methods for the medical treatment of humans were excluded from patent protection before the decision in ex parte Scherer. Diagnostic methods of treatment were, however, considered to be patentable subject matter.

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