Myriad Genetics

History

The global search for the genetic basis of breast and ovarian cancers 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. In 2013, the actress Angelina Jolie had her ovaries removed because she tested positive for a mutation in the BRCA1 gene. This led to a surge in demand by women for genetic testing.

Founders

The founders of Myriad are Peter Meldrum (past President and CEO of Agridyne and past 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).

Subsidiaries

Subsidiaries of Myriad Genetics include Myriad Genetic Laboratories, Inc., Myriad RBM, Crescendo Bioscience, Sividon Diagnostics, and, most recently, Assurex Health.

Products

Myriad has launched twelve commercial molecular diagnostic products, including one hereditary cancer risk product, three personalized medicine products, two prognostic products, one diagnostic product and one disease activity product. The company currently offers Myriad myRisk Hereditary Cancer®, which is a multi-gene panel test that identifies an elevated risk for eight important cancers including breast, colon, ovarian, endometrial, pancreatic, prostate and gastric, and melanoma. Myriad offers the following personalized medicine tests: BRACAnalysis CDx®, the only FDA-approved companion diagnostic for use with AstraZeneca’s Lynparza™; myChoice® HRD, the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors; and EndoPredict, a next-generation, multigene prognostic test for patients diagnosed with breast cancer that provides physicians with information to devise personalized treatment plans. In addition, Myriad has two prognostic medicine products: the Prolaris® test, which assesses the aggressiveness of prostate cancer and Myriad myPlan® Lung Cancer, which measures how fast a lung cancer tumor is growing. Myriad myPath® Melanoma is a clinically validated diagnostic test that is used as an adjunct to histopathology when the distinction between a benign skin lesion and a malignant melanoma cannot be made confidently by histopathology alone. Vectra® DA is an advanced blood test for rheumatoid arthritis (RA) that measures the levels of 12 protein biomarkers known to be important in RA and combines these levels into a single score, which can be used to provide a quantitative measure to objectively assess and track RA disease activity.

Timeline

BRCA1

BRCA2

Controversies

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.

USA: Association for Molecular Pathology v. Myriad Genetics (2013)

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.

Australia: D'Arcy v Myriad Genetics Inc (2015)

Myriad Genetics has also been involved in litigation in Australia over the patentability of DNA sequences. Regarding BRCA1, the company succeeded in the Federal Court, both at first instance and on appeal to the full court, but in October 2015 lost in a unanimous decision of the High Court, D'Arcy v Myriad Genetics Inc.

In Australia an invention is patentable if, to begin with, it is a "manner of manufacture". The plurality in the High Court formulated the key question as: "Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action" (para [28]). It held that the product in issue continued to consist basically of genetic information that occurs naturally, had not been altered as a result of human action, therefore had not been "manufactured" and consequently was not patentable. The plurality reflected that a broader conception of patentability could, both by creating virtual monopolies and by blurring the boundaries of what might come to be patented, produce a chilling effect on research and application, contrary to the purposes of patent protection.

The appellant had cited the recent US Supreme Court decision for comparison. The High Court was also aware that its decision could conflict with recent judicial decisions, as well as patents legislation, in other countries, and possibly with Australia's international obligations; however, it considered these to be issues for the legislature, as well as denying that its decision in this case was intended to set a precedent with regard to genetic patenting generally. In addition, the rest of the court did not dissent from Gordon J's concluding observation: "It is important to notice that the claims made in the patents in suit in the United States of America considered in Association for Molecular Pathology v Myriad Genetics Inc 186 L Ed 2d 124 (2013) were claims to the particular genetic sequences and therefore radically different from the disputed claims in this appeal" (note 232).