Association for Molecular Pathology v. Myriad Genetics

Association for Molecular Pathology v. Myriad Genetics is a landmark United States Supreme Court case that dealt with the issue of gene patents and their implications on genetic research and medical diagnosis. The case involved a challenge by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) on behalf of the Association for Molecular Pathology (AMP) and other organizations to the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast cancer and ovarian cancer. The case was closely watched by the National Institutes of Health (NIH), the American Medical Association (AMA), and the Biotechnology Industry Organization (BIO). The European Patent Convention and the World Health Organization (WHO) also had a significant interest in the outcome of the case.

Background

The case has its roots in the Human Genome Project, an international research effort led by Francis Collins and Craig Venter to map the entire human genome. The project was completed in 2003 with the help of Celera Genomics and the National Human Genome Research Institute (NHGRI). During this time, Myriad Genetics developed a test for the BRCA1 and BRCA2 genes, which are associated with an increased risk of breast cancer and ovarian cancer. The company was founded by Peter Meldrum and Mark Skolnick, and it received funding from the National Cancer Institute (NCI) and the Department of Defense (DoD). Myriad Genetics was granted patents on these genes by the United States Patent and Trademark Office (USPTO), which gave the company exclusive rights to the genes and the test. This led to concerns among genetic researchers and medical professionals, including Mary-Claire King and Francis Collins, that the patents would stifle genetic research and limit access to genetic testing.

The Case

The case was filed in 2009 by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) on behalf of the Association for Molecular Pathology (AMP) and other organizations, including the American College of Medical Genetics (ACMG) and the American Society of Clinical Oncology (ASCO). The plaintiffs argued that the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes were invalid because they covered products of nature, which are not eligible for patent protection under United States patent law. The case was heard by the United States District Court for the Southern District of New York, where Judge Robert Sweet ruled in favor of the plaintiffs, invalidating the patents. The decision was appealed by Myriad Genetics to the United States Court of Appeals for the Federal Circuit, which reversed the decision and upheld the patents. The case was then appealed to the United States Supreme Court by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT).

Supreme Court Decision

The United States Supreme Court heard the case in April 2013 and issued its decision on June 13, 2013. The court ruled in a unanimous decision that naturally occurring DNA sequences, such as the BRCA1 and BRCA2 genes, are not eligible for patent protection because they are products of nature. The decision was written by Justice Clarence Thomas and was joined by all eight other justices, including Chief Justice John Roberts and Justice Ruth Bader Ginsburg. The court's decision was seen as a major victory for genetic researchers and medical professionals, including Francis Collins and Mary-Claire King, who had argued that the patents would stifle genetic research and limit access to genetic testing. The decision was also welcomed by organizations such as the National Institutes of Health (NIH), the American Medical Association (AMA), and the Biotechnology Industry Organization (BIO).

Impact and Aftermath

The decision in the case had a significant impact on the field of genetic research and genetic testing. It allowed other companies to develop tests for the BRCA1 and BRCA2 genes, which increased access to genetic testing and reduced the cost of the tests. The decision also had implications for other gene patents, including those held by Genentech and Biogen Idec. The case was seen as a major victory for patient advocacy groups, including the Breast Cancer Action and the Ovarian Cancer National Alliance, which had argued that the patents would limit access to genetic testing and stifle genetic research. The decision was also welcomed by international organizations such as the World Health Organization (WHO) and the European Patent Office (EPO).

Legal Implications

The decision in the case has significant legal implications for the field of patent law and intellectual property law. It clarifies the rules for patent eligibility and provides guidance for patent examiners and courts on how to determine whether a patent claim covers a product of nature. The decision also has implications for other areas of law, including tort law and contract law. The case was cited by the Federal Circuit in subsequent cases, including Alice Corp. v. CLS Bank International, and has been the subject of numerous law review articles and academic studies. The decision has also been discussed by legal scholars, including Lawrence Lessig and Richard Epstein, and has been the subject of congressional hearings and legislative proposals.