Sound the Alarm?—The Supreme Court’s Renewed Interest in Life Sciences Patents Could Create Additional Hurdles Across the Field


First, there was Mayo v. Prometheus, where the Supreme Court found the medical diagnostic methods at issue were not patentable subject matter. Then, the Court sent Myriad back to the Federal Circuit, for further consideration of whether isolated DNA sequences are patentable. It could soon hear that case again — a petition for certiorari is currently pending. More recently, the Supreme Court granted review in Bowman v. Monsanto on whether patent exhaustion applies to self-replicating plant seed technologies. And now a new petition is pending before the Supreme Court in Beineke regarding whether discovered plants are patentable. Are life sciences inventions under assault?


On March 20, 2012, the Supreme Court delivered its unanimous opinion in Mayo. Prometheus’s claims in that case involved methods of determining the levels of thiopurine drug metabolites in patients with autoimmune disorders and comparing those levels to threshold values that indicate the drug’s efficacy or toxicity. Mayo purchased and used diagnostic tests based on Prometheus’s patents, but in 2004, Mayo decided to try to develop and market its own version of the test. Prometheus sued for infringement, and while the district court found the patents were infringed, it granted Mayo’s motion for summary judgment that the claims covered subject matter that is not patent-eligible. The Federal Circuit reversed, but that decision was vacated and remanded by the Supreme Court for reconsideration in light of Bilski. On remand, the Federal Circuit again sided with Prometheus, spurring a second petition to the Supreme Court, which was granted. In its unanimous opinion, the Supreme Court noted that Prometheus’s claims sat at the intersection between those that encompass non-patentable “laws of nature, natural phenomena, and abstract ideas,” and those that describe a patent-eligible “application of a law of nature or mathematical formula to a known structure or process.” The Court viewed the claims as applying natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage would be ineffective or would induce harmful side-effects. The Supreme Court found the claims invalid because the act of correlating that they covered was either conventional or obvious over the natural laws themselves, i.e., the application was not the point of novelty. The Court concluded that a claimed process must do more than simply instruct users to apply a natural law, but it was vague as to what exactly constitutes a patent-eligible application of such a law.

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