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Supreme Court Clears the Way for Generic Patent Challenges

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The United States Supreme Court this week handed down another decision affecting patent law in biotechnology. This decision follows a string of patent decisions during a Supreme Court session that has featured an unusually large number of cases involving healthcare. In two separate decisions in March, the Court severely limited the ability of universities and biotechnology organizations to patent genes or other biological facts and relationships, which were deemed to be observations of natural processes rather than patentable inventions. The cases in question involved the Mayo Clinic versus Prometheus, in which the former successfully claimed that a diagnostic test using a drug metabolite to help with dosing could not be patented. Following that case, a case involving Myriad’s patents on two genes associated with breast cancer and ovarian cancer was sent back to lower courts for consideration. This left the implication that the Court wanted the patents overturned using the reasoning from the Prometheus case. It remains to be seen what effect those decisions will have on the pharmaceutical and in vitro diagnostics business.

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