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Supreme Court Decision – DNA is a product of nature and not patent eligible

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2013-06-14 - CCMG finds Supreme Court Decision on Gene Patents a Step in the Right Direction

CCMG Official Statement on Gene Patents

“In order for Canadians to continue to benefit from the advances of basic and clinical research in health and medicine resulting from the study of the human genome, cost effective health care and optimal interpretation of clinical investigations are needed.  The patenting of DNA and RNA sequences has, and will further, greatly limit the ability of our patients to benefit from progress in the area of human genetics, especially as knowledge continues to rapidly expand with the development of high throughput genomic technologies.  The intention of this document is to highlight the need for a detailed legislative revision of patent laws as they apply to the human genome.” The CCMG Statement on Gene Patents [Clinical Genetics 2012; Volume 82, Issue 5, pages 405–407).


 2013-06-13 - US Supreme Court Decision 

DNA is a product of nature and not patent eligible

No. 12–398. Argued April 15, 2013—Decided June 13, 2013


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US Supreme Court Decision – DNA is a product of nature and not patent eligible

Held: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. Pp. 10-18.

(a) The Patent Act permits patents to be issued to "[w]hoever invents or discovers any new and useful . . . composition of matter," @101, but "laws of nature, natural phenomena, and abstract ideas"" 'are basic tools of scientific and technological work' " that lie beyond the domain of patent protection, Mayo, supra, at ___. The rule against patents on naturally occurring things has limits, however. Patent protection strikes a delicate balance between creating "incentives that lead to creation, invention, and discovery" and "imped[ing]the flow of information that might permit, indeed spur, invention." Id., at ___. This standard is used to determine whether Myriad's patents claim a "new and useful . . . composition of matter," @101, or claim naturally occurring phenomena. Pp. 10-11.

(b) Myriad's DNA claim falls within the law of nature exception. Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U. S. 303, is central to the patent-eligibility inquiry whether such action was new "with markedly different characteristics from any found in nature," id., at 310. Myriad did not create or alter either the genetic information encoded in the BRCA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the @101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible "new . . . composition[s] of matter," @101. Myriad's patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy @101's demands. Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes. Finally, Myriad argues that the Patent and Trademark Office's past practice of awarding gene patents is entitled to deference, citing J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U. S. 124, a case where Congress had endorsed a PTO practice in subsequent legislation. There has been no such endorsement here, and the United States argued in the Federal Circuit and in this Court that isolated DNA was not patent eligible under @101. Pp. 12-16.

The complete Supreme Court Decision can be viewed here.

2013-06-14 - CCMG finds Supreme Court Decision on Gene Patents a Step in the Right Direction

RE: AMP et al. v Myriad

CCMG finds Supreme Court Decision on Gene Patents a Step in the Right Direction

The Supreme Court of the United States (SCOTUS) held: “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring."

The plaintiffs in the case, The Association of Molecular Pathologists (AMP) and the American College of Medical Genetics and Genomics (ACMG), celebrated their win yesterday:

AMP applauds the U.S. Supreme Court on their ground breaking, unanimous decision. There is no question that this is a critical and right decision for the future of medicine and science. Biomedical researchers, clinicians, and most importantly patients will see great benefit from this development," said Jennifer L. Hunt, MD, MEd, AMP President.

"Because of this decision, many patients will no longer need to go through an 'obstacle course' of trying to fully access and understand their own genetic information," said Gail Herman, MD, PhD, FACMG, president of the ACMG.

However, the ultimate impact on the availability of clinical gene testing remains unclear. Myriad, the defendant in the case, also announced a victory, in the belief that it retains enforceable patent protection for its BRACAnalysis(R) test.

"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, president and CEO. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."

The CCMG board of directors considers the implications of these events to be immense.  On the heels of this ruling, several major US companies have already announced the availability of comprehensive gene testing panels that include BRCA1 and BRCA2.  For the first time patients, physicians, and service providers in the US have a better understanding of where the boundaries lie in this regard.  Neither patients nor physicians will be beholden to a monopoly when it comes to selecting a molecular genetics service provider.  While this ruling is not a blanket denial of Myriad’s patent claims, it does, with a few important exceptions, allow for open and fair competition when it comes to the delivery of genetic services within the US.

The Canadian College of Medical Geneticists supports and welcomes the US Supreme Court decision related to genomic DNA, while continuing to oppose the patenting of cDNA sequences.  We anticipate this ruling will be accompanied by a favorable impact on test accessibility, both in the US and Canada.  It remains to be seen to what extent this ruling will materially affect the debate in Canada.

CCMG Official Statement on Gene Patents

“In order for Canadians to continue to benefit from the advances of basic and clinical research in health and medicine resulting from the study of the human genome, cost effective health care and optimal interpretation of clinical investigations are needed.  The patenting of DNA and RNA sequences has, and will further, greatly limit the ability of our patients to benefit from progress in the area of human genetics, especially as knowledge continues to rapidly expand with the development of high throughput genomic technologies.  The intention of this document is to highlight the need for a detailed legislative revision of patent laws as they apply to the human genome.” The CCMG Statement on Gene Patents [Clinical Genetics 2012; Volume 82, Issue 5, pages 405–407).

CCMG BoD
June 13, 2013

2014-04-14 Annual New Developments in Prenatal Diagnosis and Medical Genetics

Wednesday, May 14, 2014
Sadowski Auditorium, Mount Sinai Hospital
600 University Ave.
Toronto, Ontario

2014 Topics

•  NIPT, FTS, IPS, NT:  Current Status
•  ccffDNA - Beyond NIPT:  Prenatal Diagnosis of Submicroscopic Deletions/Duplications, Single Gene Disorders, Cancer Genetics and Possible Fetal Whole Genome Sequencing
•  NIPT – Policy Pitfalls and NIPT:  Regulation, Return of Results and Media Representations
•  The Feasibility of Cell Based Noninvasive Prenatal Diagnosis
•  aCGH in Prenatal Diagnosis
•  Gene Discovery in Young Children with Inflammatory Bowel Disease:  Insights into
    Pathogenesis and Definitive Therapies
•  The Genetics of Hirschsprung Disease
•  Genetics of Cholestatic Disorders of Childhood
•  The Genetics of Pancreatic Cancer
•  The Genetics of Gastrointestinal Cancer

PROGRAM                         

Guest Faculty: 
Arthur L. Beaudet (Houston, Texas), Tim Caulfield (Calgary, Alberta), Philip Frykman (Los Angeles, California), Susan Gross (New York, New York),
Scott Snapper (Boston, Massachusetts), and Ron Wapner (New York, New York)

Local Faculty:    
Melyssa Aronson, Steve Gallinger, and Binita Kamath

TO REGISTER:
http://www.mountsinai.on.ca/education/staff-professionals/cme/new-developments-in-prenatal-diagnosis-and-medical-genetics/new-developments-in-prenatal-diagnosis-and-medical-genetics
Or for more information contact the CME Office of the Department of Obstetrics and Gynaecology  This email address is being protected from spambots. You need JavaScript enabled to view it.
(416) 586-4800(416) 586-4800 ext. 2489

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