The U.S. Supreme Court’s ruling Thursday that companies cannot patent naturally occurring human genes is good news for many local biotechnology companies and patients, representatives of biotech companies and a Bethesda-based plaintiff in the case said.
In 2002, patent lawyers contacted Sherri Bale, a founder and managing director of GeneDx of Gaithersburg, which specializes in genetic diagnostic tests for rare inherited disorders, and demanded her company stop conducting tests for a cardiology-related disorder.
“No one else was offering that kind of testing,” Bale said.
With the high court’s unanimous decision, which reverses decades of patent awards, GeneDx plans to launch comprehensive genetic tests for inherited cancers that include the BRCA1 and BRCA2 genes, Bale said.
Myriad Genetics of Salt Lake City, Utah, had patented those genes, which are linked to hereditary forms of breast and ovarian cancer, and the Bethesda-based Association for Molecular Pathology and others sued to challenge the patents.
Two of Myriad’s patents on the BRCA1 and BRCA2 genes were ruled invalid in a New York district court ruling in 2010. A federal appeals court reversed that decision in 2011, and plaintiffs appealed to the Supreme Court.
The decision will create a “tremendous opportunity for companies like mine to perform these genetic tests that were restricted in the past,” said Bale, who has testified before Congress on the issue and whose company filed a legal brief in the case. “But the real benefit will be to patients who will be able to access these tests.”
The Supreme Court decision does allow companies such as Myriad to patent synthetically created DNA.
“It’s good news all around,” Bale said.
Myriad has more than 500 valid and enforceable claims in 24 different patents, and the high court “appropriately upheld our claims” on the synthetic DNA, said Peter D. Meldrum, president and CEO of Myriad, in a statement.
“We are collaborating with the medical and scientific communities to improve patient access to genetic testing and facilitate research worldwide. … Myriad will continue to encourage and support academic research studies conducted on the BRCA genes,” Meldrum said.
He added that the company’s tests were covered by many insurance plans, though plaintiffs said many people were not covered for the tests, which cost $3,000 to $4,000.
“Biomedical researchers, clinicians and, most importantly, patients will see great benefit from this development,” said Jennifer L. Hunt, president of the Association for Molecular Pathology. The organization’s members include pathologists, clinical laboratory scientists, clinicians and government regulators.
Gail Herman, president of the American College of Medical Genetics and Genomics of Bethesda, said she wished the court had “gone even further and found that any form of a gene is not patentable because it is the information content that is naturally occurring regardless of whether it’s genomic” or synthetic.
The college has more than 1,600 members, who are biochemical, medical and molecular geneticists, genetic counselors and other health care professionals.
In the court’s decision, Justice Clarence Thomas wrote that a naturally occurring DNA segment is a product of nature and not eligible for a patent “merely because it has been isolated.” Myriad had found an “important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention,” he said.
Synthetically created DNA could be patented “because it is not naturally occurring,” Thomas said.
GeneDx, a subsidiary of Bio-Reference Laboratories of Elmwood Park, N.J., has about 240 employees and will boost its workforce in Gaithersburg, Bale said.
“We just added a lot of space with the anticipation that this decision will happen,” she said.
GeneDx has developed comprehensive panels to test all the important genes associated with inherited cancers rapidly, accurately and at typically no additional cost when compared to testing for a single gene, Bale said. The company offers testing for more than 350 genetic disorders, and has more than 30 board-certified geneticists and genetic counselors on staff available to physicians and others.