Association for Molecular Pathology v. Myriad Genetics, Inc.

Association for Molecular Pathology v. Myriad Genetics, Inc.
Name	Association for Molecular Pathology v. Myriad Genetics, Inc.
Court	Supreme Court of the United States
Decided	June 13, 2013
Citations	569 U.S. 576 (2013)
Docket	12-398
Judges	John G. Roberts Jr. (opinion), Antonin Scalia, Anthony Kennedy, Clarence Thomas, Ruth Bader Ginsburg, Stephen Breyer, Samuel Alito, Sonia Sotomayor, Elena Kagan

Association for Molecular Pathology v. Myriad Genetics, Inc.. The case addressed whether isolated human genes and complementary DNA (cDNA) are eligible for patent protection under United States patent law, specifically under 35 U.S.C. § 101, and clarified boundaries between natural phenomena and human-made inventions. The decision generated consequential debate among United States Supreme Court observers, biotechnology firms, clinical laboratories, patient advocacy groups, and academic researchers.

Background

The dispute arose after Myriad Genetics obtained patents on the BRCA1 and BRCA2 genes, associated with hereditary breast cancer and ovarian cancer, and enforced exclusivity over diagnostic testing. Plaintiffs included the Association for Molecular Pathology, clinical geneticists from institutions such as Columbia University and New York University School of Medicine, patient advocates including Alyssa Dweck-style litigants, and organizations like the American Civil Liberties Union challenging patent claims that affected access to testing. The controversy intersected with policy debates involving the United States Patent and Trademark Office, the National Institutes of Health, and biotech companies such as Ambry Genetics and GeneDx.

Litigation and Lower Courts

The initial lawsuit was filed in the United States District Court for the Southern District of New York where plaintiffs argued patents on isolated DNA and methods inhibited clinical practice and research. The district court issued a mixed ruling, prompting appeals to the United States Court of Appeals for the Federal Circuit, where panels addressed claims to DNA molecules, isolated nucleic acids, and diagnostic methods. Litigants invoked precedents including Diamond v. Chakrabarty and Mayo Collaborative Services v. Prometheus Laboratories, Inc., and cited amici such as Biotechnology Industry Organization and academic centers including Harvard University. The Federal Circuit issued decisions that largely sustained Myriad's patent claims, setting up Supreme Court review.

Supreme Court Decision

On June 13, 2013, the Supreme Court of the United States held that naturally occurring DNA segments are products of nature and not patent eligible merely because they have been isolated, but that cDNA is patent eligible because it is not naturally occurring. The opinion, authored by Chief Justice John G. Roberts Jr., reversed part of the Federal Circuit and affirmed in part, distinguishing between genomic DNA and complementary DNA synthesized via laboratory methods. The ruling referenced earlier decisions such as Mayo v. Prometheus and Diamond v. Chakrabarty in delineating judicial exceptions to patent eligibility for laws of nature and natural phenomena.

Legal Reasoning and Impact on Patent Law

The Court's statutory interpretation of 35 U.S.C. § 101 emphasized that patent law does not encompass products of nature, laws of nature, or abstract ideas, aligning with the framework in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and guided by precedent from Diamond v. Chakrabarty. The majority concluded that isolated genomic DNA retains the information content of natural DNA and thus falls within the product-of-nature exception, whereas cDNA, lacking noncoding introns, is a human-made molecule. The decision influenced patent procurement strategies for firms like Genentech and Amgen, prompted revisions to claim drafting by corporations including Myriad Genetics and generated guidance for the United States Patent and Trademark Office on examination of nucleic acid claims. Scholars from institutions such as Stanford University and Yale Law School debated doctrinal implications, and bar associations analyzed effects on patent litigation and innovation incentives.

Scientific and Medical Implications

Clinicians at centers including Memorial Sloan Kettering Cancer Center and Mayo Clinic adjusted genetic testing practices as laboratories such as Ambry Genetics expanded BRCA testing, increasing competition and reducing costs. Researchers at universities like Massachusetts Institute of Technology and University of California, San Francisco highlighted that the decision protected basic research using genomic DNA sequences, while companies developing therapeutics and diagnostics reassessed portfolios involving nucleic acid technologies, including patents on cDNA constructs and synthetic biology platforms. Patient advocacy groups such as Breast Cancer Now and Susan G. Komen welcomed broader access to testing, and policy analysts at National Academies of Sciences, Engineering, and Medicine examined downstream effects on translational research and clinical care.

Aftermath and Subsequent Developments

Post-decision, the United States Patent and Trademark Office issued examination guidance clarifying treatment of natural product claims, and lower courts applied the ruling in subsequent cases involving genomic and molecular patents. The decision influenced litigation strategies in matters before the Federal Circuit and federal district courts, and shaped licensing negotiations among entities like Myriad Genetics, Quest Diagnostics, and academic technology transfer offices at Columbia University and University of Utah. Internationally, patent offices including the European Patent Office and the Japan Patent Office followed the debate, prompting comparative policy discussions. Academic commentary in journals from Harvard Law School to Nature Biotechnology assessed long-term impacts on innovation, leading to legislative and regulatory proposals debated in the United States Congress and among stakeholders in the biotechnology ecosystem.

Category:United States Supreme Court cases Category:Biotechnology law Category:2013 in United States case law