Geisinger Health System official lauds Supreme Court ruling

DANVILLE – Geisinger Health System’s chief scientific officer believes Thursday’s unanimous Supreme Court ruling that human genes cannot be patented is a win for scientists and doctors, but most importantly a major victory for patients.

David H. Ledbetter, PhD, FACMG – a plaintiff in the case – said the decision struck down major barriers to patient care and medical innovation.

“This ruling is going to improve access, reduce costs, and allow for innovation that wouldn’t have happened otherwise,” Ledbetter said. “This will be one of those wonderful occurrences in medicine where we improve quality and reduce costs simultaneously and immediately.”

The high court’s ruling specifically threw out patents previously held by Myriad Genetics Inc., a Salt Lake City-based company that had patented a genetic test for two BRCA genes associated with increased risks for breast and ovarian cancers.

Ledbetter was one of the first individual genetics experts to sign on as a plaintiff in the historical case when approached by the American Civil Liberties Union (ACLU) prior to their filing. Additional plaintiffs include the Association of Molecular Pathologists (AMP) and other medical professional associations, on behalf of researchers, patients and women’s health groups.

“Fourteen years ago, I sat on the board of directors of the American College of Medical Genetics and Genomics and we wrote a clear and strong position statement that said genes should not be patentable because they occur in nature and naturally occurring substances should not be patented,” Ledbetter stated, a principle shared by the nation’s highest court.

“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” said Justice Clarence Thomas, who wrote the court’s unanimous decision.

“Genetic test monopolies are bad for a variety of reasons,” Ledbetter added. “There’s no incentive for companies to improve the quality of tests or offer them cheaper. Myriad had maintained a private database and withheld data from the international scientific community which shares data to better understand mutations in order to accelerate clinical research and provide patients the best treatment approach.”