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In the Family: A visit to Myriad Genetics
In the Family: A visit to Myriad Genetics
Published: 2009/05/14
Channel: Kartemquin
Myriad Genetics - DNA Patentability
Myriad Genetics - DNA Patentability
Published: 2013/07/15
Channel: ISCOTUS
Who we are at Myriad Genetics!
Who we are at Myriad Genetics!
Published: 2016/01/15
Channel: Myriad Genetics
Clinton: SCOTUS Myriad Genetics Decision
Clinton: SCOTUS Myriad Genetics Decision 'Terrific'
Published: 2013/06/17
Channel: Bloomberg Law
Myriad Genetics Employee Spotlights
Myriad Genetics Employee Spotlights
Published: 2017/03/20
Channel: Myriad Genetics
Myriad Genetics Presentation
Myriad Genetics Presentation
Published: 2013/06/19
Channel: Laura Mellitt
Myriad Genetics myChoice HRD Companion Diagnostic
Myriad Genetics myChoice HRD Companion Diagnostic
Published: 2016/06/29
Channel: Myriad Genetics
CEO, Mark Capone, Vlog: Company Culture at Myriad Genetics
CEO, Mark Capone, Vlog: Company Culture at Myriad Genetics
Published: 2016/01/21
Channel: Myriad Genetics
Myriad Genetics and Project BioEYES
Myriad Genetics and Project BioEYES
Published: 2017/07/13
Channel: Myriad Genetics
Announcement for Hereditary Cancer - Myriad Genetics
Announcement for Hereditary Cancer - Myriad Genetics
Published: 2017/03/08
Channel: Myriad Genetics
Myriad Genetics, Ben Wheeler
Myriad Genetics, Ben Wheeler
Published: 2015/03/23
Channel: Prophix Software Inc.
Extracting your own DNA at home -- Myriad Genetics
Extracting your own DNA at home -- Myriad Genetics
Published: 2017/04/24
Channel: Myriad Genetics
The GeneSight Test for Depression Treatment Options - Myriad Genetics
The GeneSight Test for Depression Treatment Options - Myriad Genetics
Published: 2017/05/01
Channel: Myriad Genetics
Myriad myRisk  Benefitting Patients and Payers
Myriad myRisk Benefitting Patients and Payers
Published: 2016/09/06
Channel: Myriad Genetics
Myriad Genetics
Myriad Genetics
Published: 2016/07/21
Channel: Mike Amerman
Association for Molecular Pathology v. Myriad Genetics
Association for Molecular Pathology v. Myriad Genetics
Published: 2013/04/12
Channel: ISCOTUS
More than 25 Years of Making a Difference - Myriad Genetics
More than 25 Years of Making a Difference - Myriad Genetics
Published: 2016/05/23
Channel: Myriad Genetics
Association for Molecular Pathology vs. Myriad Genetics - Arti Rai
Association for Molecular Pathology vs. Myriad Genetics - Arti Rai
Published: 2013/09/17
Channel: National Human Genome Research Institute
Our Commitment to Breast Cancer - Myriad Genetics
Our Commitment to Breast Cancer - Myriad Genetics
Published: 2017/10/03
Channel: Myriad Genetics
Myriad Genetics Oncology
Myriad Genetics Oncology
Published: 2017/07/19
Channel: Brian Gow
Myriad Genetic
Myriad Genetic's Gene Case Explanation
Published: 2017/03/10
Channel: Christian Graham
Our commitment to providing the best in genetic testing - Myriad Genetics
Our commitment to providing the best in genetic testing - Myriad Genetics
Published: 2017/09/06
Channel: Myriad Genetics
Association for Molecular Pathology v. Myriad Genetics: Oral Argument - April 15, 2013
Association for Molecular Pathology v. Myriad Genetics: Oral Argument - April 15, 2013
Published: 2016/03/25
Channel: PuppyJusticeAutomated
Myriad Genetics 25th Anniversary
Myriad Genetics 25th Anniversary
Published: 2016/05/26
Channel: Myriad Genetics
Myriad Genetics BRCA1 and BRCA2 patents upheld in court
Myriad Genetics BRCA1 and BRCA2 patents upheld in court
Published: 2012/08/20
Channel: Ian Crossland
Association of Molecular Pathology v.  Myriad Genetics, Inc, SCIPR 2013
Association of Molecular Pathology v. Myriad Genetics, Inc, SCIPR 2013
Published: 2013/10/14
Channel: Chicago-Kent College of Law at Illinois Institute of Technology
Myriad Genetics | Learn How I Turned $15,253 Into $1,613,442 Trading Biotech Stocks
Myriad Genetics | Learn How I Turned $15,253 Into $1,613,442 Trading Biotech Stocks
Published: 2017/03/02
Channel: Biotech Stocks 1202
2014 Zuoz, March 1: Steven Stone, Myriad Genetics, Salt Lake City, UT
2014 Zuoz, March 1: Steven Stone, Myriad Genetics, Salt Lake City, UT
Published: 2014/03/02
Channel: oncoletter
Myriad Patient Education - HBOC syndrome
Myriad Patient Education - HBOC syndrome
Published: 2013/08/19
Channel: MySupport360 Hereditary Cancer
The Fight To Take Back Our Genes
The Fight To Take Back Our Genes
Published: 2013/03/26
Channel: acluvideos
Myriad Genetics 25th Anniversary
Myriad Genetics 25th Anniversary
Published: 2017/03/03
Channel: Hereditary Colon Cancer Foundation
D
D'Arcy v Myriad Genetics Inc [2015] HCA 35
Published: 2016/04/22
Channel: Bec Casanovas
Myriad Genetics Slashes Outlook - Mar 6, 2015
Myriad Genetics Slashes Outlook - Mar 6, 2015
Published: 2015/03/09
Channel: Projection
Rules-Based Medicine / Myriad Genetics to merge
Rules-Based Medicine / Myriad Genetics to merge
Published: 2011/04/28
Channel: RulesBasedMedicine
Myriad Genetics (NASDAQ: MYGN) Announced Federal District Court Ruled That 7 DNA Patents Are Invalid
Myriad Genetics (NASDAQ: MYGN) Announced Federal District Court Ruled That 7 DNA Patents Are Invalid
Published: 2010/03/30
Channel: TradeTheTrend
MYRIAD GENETICS - COURT: Synthetic DNA may be patented
MYRIAD GENETICS - COURT: Synthetic DNA may be patented
Published: 2013/06/14
Channel: webmasterofri
Myriad Genetics - Breast Cancer Awareness Month
Myriad Genetics - Breast Cancer Awareness Month
Published: 2011/10/18
Channel: MySupport360 Hereditary Cancer
News Update: Myriad Genetics Sees Biggest Decline in Russell 1000 on Unfavorable Patent Litigation
News Update: Myriad Genetics Sees Biggest Decline in Russell 1000 on Unfavorable Patent Litigation
Published: 2010/03/30
Channel: TradeTheTrend
.@fordschool - Shobita Parthasarathy: ACLU v. Myriad Genetics case and implications
.@fordschool - Shobita Parthasarathy: ACLU v. Myriad Genetics case and implications
Published: 2011/03/09
Channel: Ford School
Myriad Genetics recommends Mesa Moving and Storage
Myriad Genetics recommends Mesa Moving and Storage
Published: 2011/06/08
Channel: Mesa Moving and Storage - Salt Lake City
Erklärung: Myriad Genetics
Erklärung: Myriad Genetics
Published: 2013/04/16
Channel: anduruco
Myriad Genetics
Myriad Genetics
Published: 2017/02/11
Channel: Why Invest In
Javier Ramirez Gene Patenting case: AMP v. Myriad Genetics.
Javier Ramirez Gene Patenting case: AMP v. Myriad Genetics.
Published: 2017/05/08
Channel: Javier Ramirez
Huntsman Hometown Heroes - Myriad Genetics Team
Huntsman Hometown Heroes - Myriad Genetics Team
Published: 2012/02/01
Channel: RickOrtenburger
Myriad Genetics
Myriad Genetics
Published: 2016/11/23
Channel: Why Invest In
Myriad Genetics
Myriad Genetics
Published: 2017/04/17
Channel: Jennifer Swenson
AgileRoots 2009 - Agile at Myriad Genetics Lab by: Jeff Trost
AgileRoots 2009 - Agile at Myriad Genetics Lab by: Jeff Trost
Published: 2015/04/14
Channel: Confreaks
Craig Venter on Myriad Genetics gene patent ruling
Craig Venter on Myriad Genetics gene patent ruling
Published: 2013/06/13
Channel: Bradley Fikes
Myriad Genetics
Myriad Genetics
Published: 2016/03/22
Channel: Why Invest In
Breast cancer survivor hails High Court win in gene patent case
Breast cancer survivor hails High Court win in gene patent case
Published: 2015/10/07
Channel: Dhani Entertainment
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WIKIPEDIA ARTICLE

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Myriad Genetics, Inc.
Public
Traded as NASDAQMYGN
Industry Healthcare
Molecular Diagnostics
Biotechnology
Personalized Medicine
Founded Salt Lake City, Utah, United States (1991)
Headquarters Salt Lake City, Utah
Key people
Mark Capone, President and CEO
Mark Skolnick, Co-Founder
Pete Meldrum, 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 (personalized medicine), assess a patient's risk of disease progression and disease recurrence (personalized medicine), and measure disease activity. Myriad's 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, Inc..

In August 2016 Myriad announced it would acquire Assurex Health for up to $410 million, expanding the company's genetic testing for psychotropic medicine selection.[5]

History[edit]

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 the 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.[6] 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.[7] 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.[8]

Founders[edit]

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).[9][10]

Subsidiaries[edit]

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

Controversies[edit]

Myriad Genetics's intention to patent human genes led to intense controversy.[11][12] Though patenting genes has been an established practice since the beginning of genetic research, it was alleged that because genes occur naturally in every human, patenting them would constitute an obstacle to biomedical research worldwide.[13] It did create obstacles for competing businesses in testing for the gene, but did not interfere with scientists’ ability to study the gene. It was one of the most widely studied genes with more than 10,000 papers.[14]

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.Some also stated that its price for the breast cancer diagnostic test was "outrageous"[19] ranging from $2,500 to $4,000.

USA: Association for Molecular Pathology v. Myriad Genetics (2013)[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[20]). Lawyers at the ACLU served 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.[21]

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.[22]

On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.[23] 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.[24]

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.[25] On November 30, 2012, the Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.[26] Oral argument took place on April 15, 2013.[27] 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.[28][29]

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

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.[30][31][32]

In Australia an invention is patentable if, to begin with, it is a "manner of manufacture".[33] 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[edit]

References[edit]

  1. ^ Batt, Sharon. Patient No More: The Politics of Breast Cancer. p 176
  2. ^ a b Begley, Sharon (March 29, 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". Newsweek. Retrieved March 29, 2010. 
  3. ^ a b Schwartz, John; Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved March 29, 2010. 
  4. ^ a b "ACLU v. Myriad Genetics opinion" (PDF). 2010-03-29. Retrieved 2010-03-30. 
  5. ^ http://www.genengnews.com/gen-news-highlights/myriad-to-acquire-assurex-health-for-up-to-410m/81253047/
  6. ^ 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. 
  7. ^ 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. 
  8. ^ Check Hayden, Erika. "Gene counsellors expect resurgence of 'Jolie effect'". Nature. doi:10.1038/nature.2015.17184. 
  9. ^ "Breakthrough: The Race to Find the Breast Cancer Gene," page 199, by Kevin Davies and Michael White John Wiley & Sons.
  10. ^ Ghosh, Shubha "Identity, Invention, and the Culture of Personalized Medicine Patenting", Cambridge University Press, 10 September 2012, Pages 41 and 42, ISBN 978-1107011915
  11. ^ Tamar Lewin (1996-05-21). "Move to Patent Cancer Gene Is Called Obstacle to Research". Nytimes.com. Retrieved 2014-03-06. 
  12. ^ Pollack, Andrew (November 1, 2010). "Gene Patent Ruling Raises Questions for Industry". The New York Times. Retrieved 2014-03-06. 
  13. ^ "A Brief History of DNA Patents | DNA Science Blog". DNA Science Blog. 2013-06-20. Retrieved 2017-08-15. 
  14. ^ "U.S. top court weighs patentability of human genes". Reuters. 14 April 2013. Retrieved 2017-08-15. 
  15. ^ Easton DF, Bishop DT, Ford D, Crockford GP (2014-01-24). "Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. The Breast Cancer Linkage Consortium". Am. J. Hum. Genet. 52: 678–701. PMC 1682082Freely accessible. PMID 8460634. 
  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. ^ Agus, David B. (2013-05-20). "The Outrageous Cost of a Gene Test". The New York Times. ISSN 0362-4331. Retrieved 2017-08-15. 
  20. ^ "Association For Molecular Pathology et al v. United States Patent and Trademark Office et al". Justia.com. May 12, 2009. 
  21. ^ "ACLU Challenges Patents on Breast Cancer Genes". American Civil Liberties Union. June 6, 2008. 
  22. ^ "Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting". Myriad Genetics. 2011-07-29. Retrieved 2011-11-20. 
  23. ^ "Paper Chase: ACLU asks Supreme Court to rule on gene patent case". JURIST. 2011-12-08. Retrieved 2014-03-06. 
  24. ^ Pollack, Andrew (March 26, 2012). "Supreme Court Orders New Look at Gene Patents". The New York Times. 
  25. ^ "Court Reaffirms Right of Myriad Genetics to Patent Genes". New York Times. August 16, 2012. 
  26. ^ "Myriad Genetics slips on Supreme Court review". Bloomberg Business Week. December 3, 2012. 
  27. ^ "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. 
  28. ^ Liptak, Adam (June 13, 2013). "Supreme Court Rules Human Genes May Not Be Patented". New York Times. Retrieved June 13, 2013. 
  29. ^ Kendall, Brent; Bravin, Jess (June 13, 2013). "Supreme Court Says Human Genes Aren't Patentable". Wall Street Journal. Retrieved June 13, 2013. 
  30. ^ D'Arcy v Myriad Genetics Inc [2015] HCA 35.
  31. ^ Harrison, Dan (16 June 2015). "Genetic patents: Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics". Sydney Morning Herald. Retrieved 14 October 2015. 
  32. ^ 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. 
  33. ^ 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).

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