Myriad Genetics

Myriad Genetics
Public
Traded as NASDAQ: MYGN
Industry Health Care
Biopharmaceutical
Biotechnology
Founded Salt Lake City, Utah, United States (1992)
Headquarters Salt Lake City, Utah
Key people
 Mark Capone, President and CEO
Mark Skolnick, Co-Founder
Jerry Lanchbury, CSO
Walter Gilbert, Director and Vice Chair
Website www.myriad.com

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.”[1] Myriad was the subject of scrutiny after it became involved in a lawsuit over its patenting practices,[2][3][4] which led to the landmark Supreme Court decision Association for Molecular Pathology v. Myriad Genetics.

History

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.[5] 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.[6]

Founders

The founders of Myriad were 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).[7][8]

Subsidiary

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

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.[12]

Co-discoverers

BRCA1

BRCA2

Controversies

Myriad Genetics's intention to patent human genes led to intense controversy.[13][14] 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[15][16] was funded by the public. Third, because the company was selling its breast cancer diagnostic test for a price many described as "outrageous":[17] $4000, the price of a whole genome sequencing[18] (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[19]). 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.[20]

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.[2][3][4] 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.[21]

On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.[22] 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.[23]

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.[24] On November 30, 2012, The Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.[25] Oral argument took place on April 15, 2013.[26] 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.[27][28]

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.[29][30][31]

In Australia an invention is patentable if, to begin with, it is a "manner of manufacture".[32] 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).

See also

References

  1. ↑ Batt, Sharon. Patient No More: The Politics of Breast Cancer. p 176
  2. 1 2 Begley, Sharon (March 29, 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". Newsweek. Retrieved March 29, 2010.
  3. 1 2 Schwartz, John and Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved March 29, 2010.
  4. 1 2 "ACLU v. Myriad Genetics opinion" (PDF). 2010-03-29. Retrieved 2010-03-30.
  5. ↑ Hall, J.; Lee, M.; Newman, B.; Morrow, J.; Anderson, L.; Huey, B.; King, M. (1990). "Linkage of early-onset familial breast cancer to chromosome 17q21". Science 250 (4988): 1684–1689. doi:10.1126/science.2270482. PMID 2270482.
  6. ↑ Miki, Y.; Swensen, J.; Shattuck-Eidens, D.; Futreal, P. A.; Harshman, K.; Tavtigian, S.; Liu, Q.; Cochran, C.; Bennett, L. M.; Ding, W.; Et, A. (1994). "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1". Science 266 (5182): 66–71. doi:10.1126/science.7545954. PMID 7545954.
  7. ↑ "Breakthrough: The Race to Find the Breast Cancer Gene," page 199, by Kevin Davies and Michael White John Wiley & Sons.
  8. ↑ Ghosh, Shubha "Identity, Invention, and the Culture of Personalized Medicine Patenting", Cambridge University Press, 10 September 2012, Pages 41 and 42, ISBN 978-1107011915
  9. ↑ Pub. (19 December 2000) Boliven, Retrieved 13 June 2013
  10. ↑ Walker, Joseph (4 February 2014). "Myriad Genetics to Buy Crescendo Bioscience". The Wall Street Journal. Retrieved 21 October 2015.
  11. ↑ "Myriad Genetics and Sividon Diagnostics Announce Exclusive Co-Marketing Agreement for EndoPredict Outside of the United States". Global Newswire. 20 January 2014. Retrieved 21 October 2015.
  12. ↑ Staff (2 July 2009) Myriad Pharmaceuticals, Inc. Established As An Independent Pharmaceutical Development Company Pharmaceutical Online, Retrieved 21 January 2013
  13. ↑ Tamar Lewin (1996-05-21). "Move to Patent Cancer Gene Is Called Obstacle to Research". Nytimes.com. Retrieved 2014-03-06.
  14. ↑ Pollack, Andrew (November 1, 2010). "Gene Patent Ruling Raises Questions for Industry". The New York Times. Retrieved 2014-03-06.
  15. ↑ "Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. The Breast Cancer Linkage Consortium". Ncbi.nlm.nih.gov. 2014-01-24. Retrieved 2014-03-06.
  16. ↑ "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1". Sciencemag.org. 1994-10-07. Retrieved 2014-03-06.
  17. ↑ Agus, David B. (May 20, 2013). "The Outrageous Cost of a Gene Test". The New York Times. Retrieved 2014-03-06.
  18. ↑ Karabaliev, Ivan. "The - Scientific American,000 Genome Is Almost Here-–Are We Ready? | Guest Blog, Scientific American Blog Network". Blogs.scientificamerican.com. Retrieved 2014-03-06.
  19. ↑ "Association For Molecular Pathology et al v. United States Patent and Trademark Office et al". Justia.com. May 12, 2009.
  20. ↑ "ACLU Challenges Patents on Breast Cancer Genes". American Civil Liberties Union. June 6, 2008.
  21. ↑ "Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting". Myriad Genetics. 2011-07-29. Retrieved 2011-11-20.
  22. ↑ "Paper Chase: ACLU asks Supreme Court to rule on gene patent case". JURIST. 2011-12-08. Retrieved 2014-03-06.
  23. ↑ Pollack, Andrew (March 26, 2012). "Supreme Court Orders New Look at Gene Patents". The New York Times.
  24. ↑ "Court Reaffirms Right of Myriad Genetics to Patent Genes". New York Times. August 16, 2012.
  25. ↑ "Myriad Genetics slips on Supreme Court review". Bloomberg Business Week. December 3, 2012.
  26. ↑ "Association for Molecular Pathology v. Myriad Genetics". ACLU. Retrieved 17 May 2013. 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.
  27. ↑ Liptak, Adam (June 13, 2013). "Supreme Court Rules Human Genes May Not Be Patented". New York Times. Retrieved June 13, 2013.
  28. ↑ Kendall, Brent; Bravin, Jess (June 13, 2013). "Supreme Court Says Human Genes Aren't Patentable". Wall Street Journal. Retrieved June 13, 2013.
  29. ↑ D'Arcy v Myriad Genetics Inc [2015] HCA 35.
  30. ↑ Harrison, Dan (16 June 2015). "Genetic patents: Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics". Sydney Morning Herald. Retrieved 14 October 2015.
  31. ↑ Corderoy, Amy (7 October 2015). "Landmark High Court ruling on BRCA1 gene patent as pensioner wins legal case". Sydney Morning Herald. Retrieved 14 October 2015.
  32. ↑ Patents Act 1990 (Cth) s 18(1)(a) in ComLaw. For the expression "manner of manufacture", the Patents Act refers to s 6 of the Statute of Monopolies 1624 (Eng).

External links

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