Last week, the Supreme Court issued a unanimous decision on Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which Mayo had challenged Prometheus’ patent claims covering diagnostic biomarker methods for personalized medicine, specifically as a companion diagnostic for autoimmune disease treatment with thiopurine drugs. In a reversal of the Federal Circuit’s decision, the Court invalidated Prometheus’ patent claims on the grounds of “effectively claim[ing] underlying laws of nature”, stating that “laws of nature, natural phenomena, and abstract ideas are not patentable subject matter.”
The decision provoked strong reactions both supporting and opposing the ruling, represented by two starkly contrasting statements submitted to Patent Docs:
The American Medical Association (AMA) fervently supported the invalidation of Prometheus’ patent claims. Dr. Robert Wah, AMA Board Chair, issued a statement maintaining that the ruling “prevented irreparable harm to patient care”, arguing that upholding “exclusive rights over the body’s natural responses to illness and medical treatment” would stand in the way of physicians’ unbiased collection and analysis of diagnostic data. The AMA has garnered support from several other physician organizations and medical associations.
The Biotechnology Industry Organization (BIO) landed firmly on the other end of the spectrum, staunchly opposed to the Court’s decision. In a short statement, BIO Deputy General Counsel for Intellectual Property Hans Sauer said, “We are surprised and disappointed in the Court’s decision…to strike down these patents for biomarker-based diagnostic methods.” Sauer went on to explain that “it introduces new and confusing concepts into the traditional body of patent law, which…fail to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.”
BIO’s concern may stem from the fact that FDA requires parallel development testing and regulatory submission for companion diagnostics. What does this ruling mean for diagnostic companies and biopharma alike if they aren’t able to protect intellectual property, secure royalty streams, etc?
With very little guidance accompanying the Supreme Court’s ruling, it is difficult to predict what the long-term impact will be on the field of companion diagnostics in the wake of this patent invalidation. More reactions are expected, and the US Patent and Trademark Office (USPTO) has already distributed a short memorandum to patent examiners to help prepare for the implementation of changes in response to Mayo v. Prometheus. To say the least, the discussion on subject matter eligibility, natural phenomena in patent claims, and companion diagnostics has not yet concluded.
To read the Court’s decision, click here. To read the AMA amici curiae brief, click here. To read the BIO amici curiae brief, click here. For more on reactions to and impact of this ruling, check back with Pearl soon. Send us your comments!