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University of Michigan Law School

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Diagnostic methods

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Diagnostics Need Not Apply, Rebecca S. Eisenberg Sep 2015

Diagnostics Need Not Apply, Rebecca S. Eisenberg

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Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …


Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg Jan 2012

Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg

Articles

In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …