Patent Strategy for Personalized Medicine in Light of Bilski

Advanced medical diagnostics, such as those that use information derived from multiple genetic variations or biomarker expression levels, certainly fall within the scope of patentable subject matter, according to the guidance provided by the Bilski decision. Significant investment is required to develop and market complex personalized medicine diagnostics that prognose risk or outcome based on a number of genetic or biological markers. Such methods do not preempt any basic law of nature because alternative predictive models can be developed using different sets of markers. Consequently, they should not be subject to § 101 rejections under current law.


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