Myriad Genetics

Myriad Genetics

Type	Public
Traded as	NASDAQ: MYGN) foundation = Salt Lake City, Utah, USA (1992)
Industry	Health Care biopharmaceutical biotech
Headquarters	Salt Lake City, Utah, USA
Key people	Peter Meldrum, President and CEO
Website	www.myriad.com

Myriad Genetics, Inc. is a molecular diagnostic company based in Salt Lake City, Utah. 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). Myriad was the subject of scrutiny after it became involved in a lengthy lawsuit over its controversial patenting practices.^[1][2][3]

History[edit]

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.^[4] 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.^[5]

Founders[edit]

The founders of Myriad are Mark Skolnick (Adjunct Professor in the Department of Medical Informatics at the University of Utah), Walter Gilbert (1980 Nobel Laureate in chemistry and Professor in the Department of Molecular and Cellular Biology at Harvard University) and Peter Meldrum (past President and CEO of Agridyne and current CEO and President of Myriad Genetics, Inc) and Kevin Kimberlin of Spencer Trask & Company^[6]

Subsidiary[edit]

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).

Timeline[edit]

• 1991 - BRCA1 was linked to chromosome 17 by UC Berkeley scientists
• 1991 - Myriad Genetics was founded by Dr. Walter Gilbert, Mark Skolnick, Kevin Kimberlin and Peter Meldrum
• 1994 - BRCA1 was cloned at the University of Utah in Mark Skolnick’s lab and published by 40 collaborators
• 1994 - First BRCA1 U.S. patent was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics
• 1994/1995 - Development of process and laboratory to perform high throughput sequencing by Myriad
• 1995 - BRCA2 was resequenced based on unpublished information at the Myriad facility and the University of Utah by Mark Skolnick and collaborators
• 1995 - First BRCA2 patent filed in the U.S. by the University of Utah and other institutions
• 1996 - Myriad launched BRACAnalysis, a predictive medicine product for hereditary breast and ovarian cancer
• 1997 - First BRCA1 patent was granted in the U.S. to the University of Utah, NIEHS and Myriad Genetics ^[7]
• 1998 - First BRCA2 patent was granted in the U.S. to the University of Utah, NIEHS and Myriad Genetics
• 2000 - Myriad launched COLARIS, a predictive medicine product for hereditary colorectal and uterine cancer
• 2002 - Myriad launched COLARIS AP, a predictive medicine product for adenomatous polyposis colon cancer syndromes
• 2002 - Myriad launched MELARIS, a predictive medicine product for hereditary melanoma
• 2007 - Myriad launched TheraGuide 5-FU, a personalized medicine product to predict toxicity to 5-FU-based chemotherapy
• 2008 - Myriad launched PREZEON, a personalized medicine product to assess the status of the PTEN gene
• 2009 - Myriad launched OnDose, a personalized medicine product to measure a patient’s exposure to 5-FU chemotherapy
• 2010 - Myriad launched PANEXIA, a predictive medicine product for hereditary pancreatic and related cancers

In July, 2009, the spin off, Myriad Pharmaceuticals, was completed. Myriad Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of therapeutic products.^[8]

BRCA1 Co-discoverers[edit]

• National Institute of Environmental Health Sciences (NIEHS)
• University of Utah Research Foundation
• Université Laval/Endo Research – Quebec
• Hospital for Sick Children – University of Toronto
• University of Tokyo
• Myriad Genetics, Inc.

BRCA2 Co-discoverers[edit]

• University of Utah Research Foundation
• Hospital for Sick Children – University of Toronto
• University of Pennsylvania
• Myriad Genetics, Inc.

Legislation and litigation[edit]

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^[9]). 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.^[10]

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.^[1][2][3] This was the first time a U.S. court had declared a gene patent invalid.^[1] 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.^[11]

On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.^[12] 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.^[13]

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.^[14] On November 30, 2012, The Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.^[15] Oral argument took place on April 15, 2013.^[16] 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.^[17][18]

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.^[19] An appeal was quickly announced and the case will be heard by the Full Bench of the Federal Court later in 2013.^[20] 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.^[21] 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.

See also[edit]

• Association for Molecular Pathology v. Myriad Genetics
• Biological patents in the United States
• Mayo Collaborative Services v. Prometheus Laboratories, Inc.

References[edit]

External links[edit]

• Myriad Genetics home page
• Court documents for ACLU suit