Supreme Court Invalidates Prometheus’ Patent…How Will This Impact You?
A unanimous Supreme Court yesterday issued an important ruling in Mayo v. Prometheus regarding what constitutes patentable subject matter, especially in the field of personalized medicine and diagnostics. The Court reiterated its long held view that “laws of nature, natural phenomena, and abstract ideas” are not patentable, but “an application of a law of nature” may be patentable if the claims recite sufficient additional steps. Here, the Court determined that because the claimed methods recited a law of nature – a discovered correlation between metabolite levels of a drug in a patient’s blood and the response of that patient to drug therapy – the methods are not patentable, unless they have additional features that ensure that the method is not an attempt to monopolize the law of nature itself.
The Court concluded that the correlation between metabolite levels and optimal drug dosage was merely setting forth the unpatentable law of nature, and that the additional recited steps of administering the drug and determining the level of metabolite added “nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.” Giving no weight to the additional recited steps, the Court held that the claims were not eligible for patent monopoly.
The Court’s holding appears to limit the patentable subject matter for diagnostic inventions. Applying the Court’s ruling correlations between something measured and a physiologic condition may be interpreted as laws of nature, and the technologies for measuring those conditions may be conventional. Similarly, because the discovery of a drug’s action on a patient may also be characterized as a natural phenomenon, method of treatment claims, previously deemed transformative through the step of administering the drug, may also be called into question. It will require careful patent drafting and thoughtful consideration to avoid falling into the “laws of nature” trap.
Besides the obvious impact on patentability of personalized medicine, diagnostics, and methods of treatment, the Court’s reasoning may also be utilized to further limit the scope of patentable subject matter as related to computer implemented methods that involve algorithms, particularly where recited additional computer implemented steps may be well-understood, routine, conventional activities, previously engaged in by those in the field.
Finally, the Supreme Court’s unanimous ruling and broad interpretation of the “laws of nature” exception to patentability may foreshadow a drastic narrowing of gene patent eligibility – an issue that is likely to be before the Court in the future.
For more information on how this Supreme Court ruling could affect you, please contact us at info@knobbe.com.