College of American Pathologists
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March 20, 2012
© 2012 College of American Pathologists
Special Report
Supreme Court Invalidates Prometheus Diagnostic Patents
Decision Likely to Affect Myriad Gene Patent Challenge

March20—In a landmark decision, the Supreme Court unanimously ruled in favor of Mayo Collaborative Services today and invalidated the medical patents challenged in the case Mayo Collaborative Services v. Prometheus Laboratories.

The College and about 10 other medical organizations supported Mayo in its most recent effort with the Supreme Court and at various points throughout the litigation with amicus briefs.

These organizations include the American College of Medical Genetics, the American Medical Association, 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, and the Minnesota Hospital Association.

The Supreme Court cited the medical organizations’ amicus brief in its opinion yesterday culling out the following, if “claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.”

In its ruling, the Supreme Court invalidated patents held by Prometheus for a diagnostic method to observe changes in a patient’s body to determine the best drug dosage for certain diseases, in this case, synthetic thiopurine compounds to treat gastrointestinal disorders and other auto-immune illnesses. The court concluded the patent claims at issue effectively claim the underlying laws of nature themselves and were therefore invalid.

“If a law of nature is not patentable, than neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself,” Justice Stephen Breyer wrote regarding the process claims at issue in this case.

The case began as a patent infringement suit brought by Prometheus against Mayo in early 2008 which intended to use its own version of the test in question.

Today’s ruling and the arguments made in the court’s written decision may provide insight into the Supreme Court’s position on gene patents, although this case focused on process patents.

The CAP is a co-plaintiff in the case against Myriad Genetics and its patent claims for the BRCA1 and BRCA2 genes. Both genes are known to contain important information about breast and ovarian cancer, and critical to developing new and effective treatments. The CAP, joined by AMP, ACMG, ASCP and other co-plaintiffs in that case contend the genes are naturally occurring phenomena which cannot be patented, and the patents are unconstitutional restrictions on knowledge.

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