AMP v. Myriad: Gene Patents
On May 12, 2009, the Public Patent Foundation (PUBPAT) and the American Civil Liberties Union (ACLU) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers.
The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.
Since the PTO granted patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to use other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.
The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed on May 12, 2009, in the United States District Court for the Southern District of New York in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. On March 29, 2010, Judge Robert Sweet issued his opinion holding all of the challenged patents invalid. Myriad has appealed Judge Sweet's decision to the Court of Appeals for the Federal Circuit, where PUBPAT and the ACLU are fighting to defend it. The U.S. Government has filed an amicus brief in the appeal siding with PUBPAT/ACLU.
In July 2011, the Appeals Court unanimously upheld the invalidation of the patents on human gene analysis, but divided of whether genes themselves may be patented, with two judges ruling they could, and one judge dissenting. In March 2012, the Supreme Court reversed the decision of the Court of Appeals regarding the patentability of human genes and remanded the matter back to the Court of Appeals for a new ruling. In August 2012, the Court of Appeals again upheld patents on human genes in a 2-1 split decision. PUBPAT and the ACLU petitioned for Supreme Court a second time and the Supreme Court granted that petition on November 30, 2012.
Support for this project comes from the Nathan Cummings Foundation.
Watch our video on why we're fighting to Liberate the Breast Cancer Genes
PUBPAT Executive Director, Dan Ravicher, Discusses the Case on PBS NewsHour
- Second Petition for Certiorari to the Supreme Court (September 24, 2012)
- Court of Appeals decision on remand (August 16, 2012)
- Supplemental Brief to Court of Appeals After Remand by Supreme Court (June 15, 2012)
- Petition for Certiorari to the Supreme Court (December 7, 2011)
- Court of Appeals decision (July 29, 2011)
- PUBPAT/ACLU Brief to Court of Appeals (December 1, 2010) (PDF; 2.0MB)
- U.S. Government Brief to Court of Appeals (October 29, 2010) (PDF; 200KB)
- Opinion by Judge Robert Sweet Holding Patents on Human Genes Invalid (March 29, 2010) (PDF; 859KB)
- Court Decision Denying Motions to Dismiss and Allowing Case to Proceed (November 2, 2009) (PDF; 1.4MB)
- Summary Judgment Motion Filed by PUBPAT and ACLU Against Breast Cancer Gene Patents (August 26, 2009)
- Complaint Filed by PUBPAT and ACLU Against Breast Cancer Gene Patents (May 12, 2009)
- April 15, 2013: SUPREME COURT HEARS ARGUMENTS CHALLENGING PATENTS ON BREAST AND OVARIAN CANCER GENES
- April 9, 2013: Voices on Human Gene Patents: An Agonizing Decision Made More Difficult Because of Gene Patents
- April 2, 2013: "Can We Patent Life?" ~ New Yorker
- March 23, 2013: "US Supreme Court To Hear Arguments On Pay-For-Delay Drug Deals" ~ Intellectual Property Watch
- January 24, 2013: PUBPAT and ACLU File Opening AMP v Myriad Brief With Supreme Court Detailing Why Human Genes Are Not Patentable
- November 30, 2012: SUPREME COURT TO HEAR PUBPAT CASE CHALLENGING PATENTS ON BREAST AND OVARIAN CANCER GENES: PUBPAT and ACLU Filed on Behalf of Medical Associations, Geneticists, Patients and Breast Cancer and Women’s Health Groups
- September 25, 2012: ACLU and PUBPAT Ask Supreme Court to Rule that Patents on Breast Cancer Genes Are Invalid
- August 20, 2012: "Gene patent ruling highlights tension between SCOTUS, Fed Circuit" - Reuters
- August 16, 2012: DIVIDED APPEALS COURT AGAIN RULES THAT COMPANIES MAY PATENT BREAST CANCER GENES, BUT INVALIDATES PATENTS COMPARING THE GENES: Supreme Court Sent Case Back for Consideration After Ruling in Similar Case
- July 19, 2012: "Human Genes as Company Property Tested by [AMP v.] Myriad Patent Case" - Bloomberg
- June 15, 2012: Case Challenging Patents on Breast and Ovarian Cancer Genes Returns to Appeals Court: After Being Sent Back by Supreme Court, PUBPAT and ACLU File on Behalf of Medical Associations, Geneticists, Patients and Women’s Health Groups
- March 26, 2012: Supreme Court Vacates Decision Upholding Gene Patents, Remands PUBPAT/ACLU Case to Appeals Court: Justices Order Court that Hears Patent Cases to Reconsider Decision That Limited Access to Crucial Genetic Testing
- December 13, 2011: "Can a Company Own Your Genes?" -- Mother Jones
- December 7, 2011: PUBPAT and ACLU Ask Supreme Court to Rule that Patents on Breast Cancer Genes are Invalid
- October 13, 2011: ACLU, PUBPAT to Ask Supreme Court to Take up Gene Patenting Case
- July 29, 2011: Appeals Court Unanimously Invalidates Patents on Human Gene Analysis, Divides of Whether Genes Themselves May Be Patented
- April 4, 2011: PUBPAT, ACLU AND U.S. SOLICITOR GENERAL IN FEDERAL APPEALS COURT TODAY CHALLENGING PATENTS ON HUMAN GENES LINKED TO BREAST CANCER: Groups Urge Court To Uphold Ruling That Patents On Genes Are Illegal
- February 24, 2011: U.S. Solicitor General to Make Unprecedented Federal Circuit Appearance in PUBPAT Gene Patent Case
- October 30, 2010: U.S. GOVERNMENT FILES BRIEF IN PUBPAT/ACLU GENE PATENTING CASE
- April 2, 2010: PBS' NewsHour Interviews PUBPAT Executive Director, Dan Ravicher, Regarding Gene Patents and the Myriad Case
- March 29, 2010: PATENTS ON BREAST CANCER GENES RULED INVALID IN PUBPAT/ACLU CASE
- February 2, 2010: PUBPAT AND ACLU ARGUE TODAY THAT PATENTS ON BREAST CANCER GENES ARE UNCONSTITUTIONAL AND INVALID: First Hearing In Federal Court About The Patentability Of Human Genes
- December 11, 2009: NPR Hosts Discussion of Breast Cancer Genes Patent Case with PUBPAT Executive Director, Dan Ravicher
- November 2, 2009: COURT UPHOLDS RIGHT OF SCIENTISTS AND PATIENTS TO CHALLENGE GENE PATENTS: PUBPAT/ACLU Lawsuit Challenging Patents On Breast Cancer Genes Can Go Forward
- August 27, 2009: AMA, MARCH OF DIMES AND OTHERS SUPPORT PUBPAT/ACLU CHALLENGE TO PATENTS ON BREAST CANCER GENES: Briefs Filed In Support Of PUBPAT/ACLU Motion To Declare Patents Unconstitutional
- May 12, 2009: ACLU AND PUBPAT CHALLENGE PATENTS ON BREAST CANCER GENES: Gene Patents Stifle Patient Access To Medical Care And Critical Research