Court Rulings Threaten Patent Protection For Diagnostic Methods

The nation’s top patent court issued two decisions last fall that signal a sharp cutback in what biomedical method inventions can be patented. Both decisions involved a basic question in patent law: what is patentable? In both cases, the U.S. Court of Appeals for the Federal Circuit decided that a large class of method inventions are no longer protectable with patents. Significantly, methods involving diagnosis, prognosis, determinations of proper treatment, and monitoring of diseases and treatment potentially are all no longer patentable according to the court. This determination would apply to both existing patents and new methods and could dramatically lower or eliminate the value of a significant number of biomedical method patents and inventions.

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