[author: Donald Zuhn]

Following the Supreme Court's unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., issued earlier today, in which the Court reversed the Federal Circuit and found Prometheus' claims to be invalid for "effectively claim[ing] underlying laws of nature," few organizations have thus far decided to issue public statements regarding the decision.  In fact, Patent Docs has received only two statements from organizations, each representing a different side of the issue.

In a statement by Dr. Robert Wah, Board Chair for the American Medical Association (AMA), the group welcomed the Supreme Court's decision invalidating Prometheus' patents.  Asserting that the Court had "prevented irreparable harm to patient care with today's unanimous decision to invalidate two patents that gave Prometheus Laboratories exclusive rights over the body's natural responses to illness and medical treatment," the AMA declared that the decision was "a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research."

Had the Court found the patents to be valid, the AMA argued that "physicians would have encountered a vast thicket of exclusive rights that would prevent them from considering all relevant scientific information when reviewing diagnostic test results."  The group also suggested that a finding of validity would have "inhibit[ed] future discoveries."

The AMA, together with the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, the Association for Molecular Pathology, the Association of Professors of Human and medical Genetics, the College of American Pathologists, the Florida Hospital Association, the Minnesota Hospital Association, and the Minnesota Medical Association, submitted an amici curiae brief in support of Petitioners Mayo Collaborative Services and May Clinic Rochester.

The Biotechnology Industry Organization (BIO) viewed the Court's decision in a decidedly different light.  In a statement that the group distributed this afternoon, but had not yet posted to its website, Dr. Hans Sauer, BIO Deputy General Counsel for Intellectual Property, noted that BIO was "surprised and disappointed in the Court's decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods."

While the group indicated that it was still analyzing the Court's opinion, BIO expressed "concern[] that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement."  In addition, BIO noted that "[w]hile the opinion's lack of guidance may limit its practical impact, we are troubled that the Court's opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases."  The group ended its response to the decision by offering to "work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier."

BIO submitted an amicus curiae brief in support of Respondent Prometheus Laboratories.