Supremes Raise the Bar, Slightly, for Medical Test Patents

The Supreme Court issued its opinion in Mayo Collaborative Services v. Prometheus Labs., Inc. yesterday (H/T ScienceInsider).  It was a unanimous, single opinion decision by the Court and written by Justice Breyer.  I mentioned this case earlier in the month, noting that a decision in this case would likely determine how the Supreme Court would address a similar case.  That case, Association for Molecular Pathology v. Myriad Genetics, Inc., concerns medical tests connected to genes typically associated with breast cancer.

Before we get into the armchair legal analysis, please remember that I am not a lawyer (IANAL).  I was a legal assistant, but my background is not in patent law or Constitutional law.

The Court ruled that the patents licensed to Prometheus on its medical tests are invalid.  The tests help calibrate drug dosage.  In the opinion of the Court, the processes by which the tests make those assessments do not add enough to the natural law to be patentable.  To quote the opinion (page 28),

“We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid.”

For the more patent law inclined, part of this case and the opinion revolves around which section of the patent laws render the patents at issue invalid.  The Court focused on Section 101, and some have disagreed with the argument (see comments).  The argument, at least in my eyes, reads that the Court does not consider the tests, as currently described in the patent, as being sufficiently ‘new and useful’ to warrant patent protection.

As many have suggested, the status of the Myriad Genetics case would depend in part on the resolution of the Mayo case.  While the Myriad Genetics patents focus on the genes rather than the test, there are sufficient similarities between the two cases that the Supreme Court could direct the Circuit Court of Appeals to review the Myriad case in light of the Mayo decision.  That may just be the next step in the matter, rather than the end.  The Court typically issues rulings up to the end of June for the current term, so there should be some action taken on the Myriad case by then.

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One thought on “Supremes Raise the Bar, Slightly, for Medical Test Patents

  1. Pingback: Biomedical Update Tuesday: Myriad, Medical Isotopes, and Contraception « Pasco Phronesis

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