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).

June 13, 2013

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