Myriad Genetics, Inc. is an American molecular diagnostic company based in Salt Lake City, Utah, United States. Many use a number of proprietary technologies that enable physicians and patients to understand the genetic basis of human disease and the role that genes play in early, disease progression and treatment. This information is used to guide the development of new molecular diagnostic products that assess individual risks for developing future illness (predictive drugs), identifying possible patients to respond to specific drug therapy (personalized medication), assessing the patient's risk of disease progression and recurrence of the disease (personal medication ), and measure disease activity. The myriad discoveries of breast cancer genes, BRCA1 is universally recognized as a monumental achievement: "There is no more interesting story in medical science." Myriad is a subject of scrutiny after being involved in a lawsuit over his patent practice, which led to the Supreme Supreme Court's decision Association for Molecular Pathology v. Myriad Genetics, Inc. .
In August 2016, Myriad announced it would acquire Assurex Health up to $ 410 million, extending the company's genetic testing for psychotropic drug selection.
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Histori
The global search for the genetic basis of breast and ovarian cancer began in 1988. In 1990, at the American Society of Human Genetics Meeting, a team of scientists led by Mary-Claire King, Ph.D., of the University of California, Berkeley announced localization through analysis linked genes associated with increased risk of breast cancer (BRCA1 ) to the arm of chromosome 17. In August 1994, Mark Skolnick and researcher at Myriad, together with colleagues at the University of Utah, the US National Institute of Health (NIH), and McGill University sorts BRCA1 . In 2013, actress Angelina Jolie had her ovaries removed because she tested positive for mutations in the BRCA1 gene. This causes a surge in demand by women for genetic testing.
Founder
The founders of Myriad are Peter Meldrum (former President and CEO of Agridyne and former CEO and President of Myriad Genetics, Inc.), Kevin Kimberlin (Spencer Trask & Co Chairman). Walter Gilbert (Biogen Founder) and Mark Skolnick (Professor Adjunct at the Department of Medical Informatics at the University of Utah).
Subsidiaries
The subsidiaries of Myriad Genetics include Myriad Genetic Laboratories, Inc., Myriad RBM, Crescendo Bioscience, Sividon Diagnostics, and, most recently, Assurex Health.
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Products
Among the prognostic tests developed and marketed by Myriad is "Prolaris", which uses gene expression profiles to provide 10-year risk of special prostate cancer death. Another prognostic test, marketed as "MyRisk Hereditary Cancer", examines the genetic markers associated with an increased risk of developing one of eight hereditary cancers.
Controversy
Various intentions of Genetics to patent human genes led to intense controversy. Although patent genes have been a well-established practice since the start of genetic research, it is suspected that since genes appear naturally in every human, patenting them would be an obstacle to biomedical research around the world. It does create an obstacle for competitors 'business in gene testing, but it does not interfere with scientists' ability to study genes. This is one of the most studied genes with more than 10,000 papers.
Secondly, because the discovery of their relevance to breast cancer is funded by the public.
Third, because the company sells diagnostic tests of breast cancer at a price that is described as "outrageous": $ 4000, the overall genome sequencing price (about 20,000 genes are analyzed), when the test sees only two genes. Some also state that the price for breast cancer diagnostic tests is "outrageous" from $ 2,500 to $ 4,000.
USA: Association for Molecular Pathology v. Myriad Genetics (2013)
Myriad Genetics is a defendant in the case of Association for Molecular Pathology v. Myriad Genetics (formerly Association For Molecular Pathology et al. V. United States Patent and Trademark Office ). Attorneys in the ACLU served as advisers to plaintiffs. In the lawsuit, medical associations, doctors and patients sued Myriad Genetics to challenge seven US patents on genes related to breast cancer and ovarian cancer.
Two company patents on the BRCA1 and BRCA2 genes were decided not to take effect on March 29, 2010 by Judge Robert W. Sweet in US District Court for the Southern District of New York. On appeal, the Court of Appeal for the Federal Circuit reversed the court in its opinion of 29 July 2011 and stated that the gene qualifies for the patent.
On 7 December 2011, the ACLU filed a petition for a certificate to the Supreme Court. On March 26, 2012, the Supreme Court cleared the decision of the Federal Circuit and submitted the case for further consideration taking into account Collaboration Services Mayo v. Prometheus Laboratories, Inc. , in which the Supreme Court has decided, just six days earlier, that more stringent rules are required to patent observations about natural phenomena.
On August 16, 2012, the Federal Circuit reaffirmed Segudang's right to patent genes even though they rejected patent comparisons of DNA sequences. On November 30, 2012, the Supreme Court agreed to hear the second challenge to two gene patents held by Myriad. The oral argument takes place on April 15, 2013. On 13 June 2013, in the Association for Molecular Pathology v. Myriad Genetics (No. 12-398), the US Supreme Court unanimously ruled that "The naturally occurring DNA segment is a product of nature and is not patentable simply because it has been isolated", canceling Myriad's patents on the BRCA1 and BRCA2 genes. However, the Court also stated that gene manipulation to create something not found in nature - such as synthetically produced synthetic strands of DNA (cDNA) - can still qualify for patent protection.
Australia: D'Arcy v Myriad Genetics Inc (2015)
Myriad Genetics has also been involved in litigation in Australia on DNA sequence patents. Regarding BRCA1, the company succeeded in the Federal Court, both on the first and in the appeal to a full court, but in October 2015 lost in the decision of the High Court, D'Arcy v Myriad Genetics Inc.
In Australia a discovery can be patented if, to begin, it is a "way of making". Plurality in the Court of Appeal formulates the key question as: "Whether the invention as claimed is for the product made, or the process that produces the result as a result of human action" (para [28]). It argues that the product in problem continues to essentially consist of genetic information that occurs naturally, has not been altered as a result of human actions, since it has not been "produced" and consequently is not patented. Plurality reflects that broader patent concepts can, either by creating a virtual monopoly and by blurring the boundaries of what might be patented, resulting in a terrifying effect on research and applications, contrary to the purpose of patent protection.
The applicant has cited a recent US Supreme Court ruling for comparison. The Court of Appeal is also aware that its decision may be contrary to recent court decisions, as well as patent laws, in other countries, and possibly with Australia's international obligations; However, this is considered a problem for the legislature, as well as denying that its decision in this case is intended to set precedents relating to genetic patenting in general. In addition, the remainder of the court disagrees with Gordon J's final observation: "It is important to note that claims made in patents are consistent with those in the United States considered in the Association for Molecular Pathology v. Genetics of Enclosures Inc. 186 L Ed 2d 124 (2013) is a claim for a specific genetic sequence and therefore very different from the disputed claim in this appeal "(note 232).
See also
- Biological patents in the United States
References
External links
- Genetics home page
- Court documents for ACLU settings
Source of the article : Wikipedia
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