Thursday, June 13, 2013

Professional Societies Applaud Supreme Courts Decision

ACMG Applauds Supreme Court Decision on Gene Patents

June 13, 2013 –Bethesda, MD – Today,
The Supreme Court of the United States (SCOTUS), in a unanimous decision, held that natural isolated DNA is not patentable. This is a thrilling victory for patients and ACMG is proud to have been a plaintiff on this important case.

“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas said.

As background, with breast cancer affecting an estimated one in eight women, ACMG has expressed grave concern for more than 15 years over the human cost of patents on genes such as BRCA1 and BRCA2 that are important in diagnosis, management, risk assessment and prevention.  Myriad's patent reduces consumer choice, negatively impacts price and reduces availability of testing to the public.

"Imagine if your wife, sister or daughter needed to make a decision about surgery to remove her breasts after a genetic test result placed her at high risk for breast cancer.  Thanks to this Supreme Court decision today, there will now be choices and options to get an independent test done to confirm the results," said Michael S. Watson, PhD, FACMG, executive director of the American College of Medical Genetics and Genomics.

While finding that natural isolated DNA is not patentable, the Court found that synthetic DNA (cDNA) is patent - eligible. Gail Herman, MD, PhD, FACMG, president of the ACMG stated, "While this is indeed, great news, our preferred outcome would have gone even further and found that that any form of a gene is not patentable because it is the information content that is naturally occurring regardless of whether its genomic or cDNA.  It is ACMG's long-standing position that genes and their mutations are naturally occurring substances that should not be patented.  On behalf of both patients and genetics health professionals, we applaud the decision that human genes are not patentable and hope that this will eventually include cDNA also."

For many years, ACMG has publicly stated that patenting of genes, and especially the practices that limit testing to a single laboratory, stand firmly in the way of good patient care, interfere with informed decision-making by patients, impede training of the next generation of lab professionals and restrict the flow of information that is critical to advancing medical knowledge and better medical care accessible to all.

"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.