|Traded as||NASDAQ: MYGN|
|Founded||Salt Lake City, Utah, United States (1992)|
|Headquarters||Salt Lake City, Utah|
|Mark Capone, CEO
Mark Skolnick, Co-Founder
Jerry Lanchbury, CSO
Walter Gilbert, Director, and Vice Chair
Myriad Genetics, Inc. is an American molecular diagnostic company based in Salt Lake City, Utah, United States. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease. This information is used to guide the development of new molecular diagnostic products that assess an individual's risk for developing disease later in life (predictive medicine), identify a patient's likelihood of responding to a particular drug therapy and tailor a patient's drug dose to ensure optimal treatment (personalized medicine), and assess a patient's risk of disease progression and disease recurrence (personalized medicine). The discovery of the breast cancer gene, BRCA1 was universally acclaimed as a monumental achievement: “There is no more exciting story in medical science.” Myriad was the subject of scrutiny after it became involved in a lawsuit over its patenting practices, which led to the landmark Supreme Court decision Association for Molecular Pathology v. Myriad Genetics.
The global search for a genetic basis for breast and ovarian cancer began in earnest in 1988. In 1990, at an American Society of Human Genetics Meeting, a team of scientists led by Mary-Claire King, Ph.D., from University of California, Berkeley announced the localization through linkage analysis of a gene associated with increased risk for breast cancer (BRCA1) to the long arm of chromosome 17. In August 1994, Mark Skolnick and researchers at Myriad, along with colleagues at the University of Utah, the U.S National Institutes of Health (NIH), and McGill University sequenced BRCA1.
The founders of Myriad were Peter Meldrum (past President and CEO of Agridyne and current CEO and President of Myriad Genetics, Inc), Kevin Kimberlin (Chairman of Spencer Trask & Co.), Dr. Walter Gilbert (Founder of Biogen) and Mark Skolnick (Adjunct Professor in the Department of Medical Informatics at the University of Utah).
Myriad Genetic Laboratories, Inc., a wholly owned subsidiary of Myriad Genetics, Inc., has launched eight commercial molecular diagnostic products, including four predictive medicine, three personalized medicine products and one prognostic medicine product.
Myriad currently offers the following predictive medicine products based on DNA testing from blood: BRACAnalysis (assesses risk for hereditary breast and ovarian cancer), COLARIS (assesses risk for hereditary colorectal and uterine cancer), COLARIS AP (assesses risk for hereditary familial adenomatous polyposis colon cancer syndromes) and MELARIS (assesses risk for hereditary melanoma) and PANEXIA (assess risk for hereditary pancreatic cancer).
Myriad currently offers the following personalized medicine tests based on the investigation of blood or tissues: TheraGuide (predicts toxicity to Fluorouracil (5-FU)-based chemotherapy), OnDose (measures a patient’s exposure to 5-FU chemotherapy), PREZEON (assesses the status of the PTEN gene) and a prognostic medicine product: PROLARIS (assesses the aggressiveness of prostate cancer).
Myriad Genetics's intention to patent human genes led to intense controversy. First, because genes occur naturally in every human, and in addition to moral questions raised, patenting them would constitute an obstacle to biomedical research worldwide. Secondly, because the discovery of their relevance to breast cancer was funded by the public. Third, because the company was selling its breast cancer diagnostic test for a price many described as "outrageous": $4000, the price of a whole genome sequencing (around 20,000 genes analyzed), when the test only looked at two genes.
Myriad Genetics was a defendant in the case Association for Molecular Pathology v. Myriad Genetics (formerly Association For Molecular Pathology et al. v. United States Patent and Trademark Office). Lawyers at the ACLU serve as counsel for the plaintiffs. In the suit, medical associations, doctors, and patients sued Myriad Genetics to challenge seven United States patents on genes related to breast cancer and ovarian cancer.
Two of the company's patents on the BRCA1 and BRCA2 genes were ruled invalid on March 29, 2010 by Judge Robert W. Sweet in the U.S. District Court for the Southern District of New York. On appeal, the Court of Appeals for the Federal Circuit reversed the trial court in an opinion dated July 29, 2011 and held that the genes were eligible for patents.
On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court. On March 26, 2012, the Supreme Court vacated the Federal Circuit's judgment and remanded the case for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which the Supreme Court had ruled, just six days earlier, that more restrictive rules were required to patent observations about natural phenomena.
On August 16, 2012, the Federal Circuit reaffirmed Myriad's right to patent the genes although they denied rights to patent comparisons of DNA sequences. On November 30, 2012, The Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad. Oral argument took place on April 15, 2013. On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics (No. 12-398), the US Supreme Court unanimously ruled that, "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," invalidating Myriad's patents on the BRCA1 and BRCA2 genes. However, the Court also held that manipulation of a gene to create something not found in nature—such as a strand of synthetically-produced complementary DNA (cDNA)--could still be eligible for patent protection.
Myriad Genetics has also been involved in litigation in Australia over the patentability of DNA sequences, particularly in regard to BRCA1. In February 2013, in a landmark decision, Judge John Nicholas of the Federal Court of Australia found in favour of a Myriad Genetics patent over the BRCA1 gene. An appeal was quickly announced and the case will be heard by the Full Bench of the Federal Court later in 2013. The U.S. Supreme Court decision invalidating a similar patent came just before submissions for the Australian case were due, and the appellants have indicated that the U.S. decision has been referenced for the upcoming hearing. Irrespective of the decision reached, it will be possible to further appeal to the High Court of Australia (the equivalent of the U.S. Supreme Court). The U.S. decision is not in any way binding on the Australian courts but the decisions of superior courts are routinely considered in other countries when dealing with such cases.
On May 12, 2009, the ACLU and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2, are unconstitutional and invalid. On November 30, 2012, the Supreme Court agreed to hear argument on the patentability of human genes. The ACLU argued the case before the U.S. Supreme Court on April 15, 2013. We expect a decision this summer.