Chapter 2: Initial determination
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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