In a decision that could have wide-ranging impacts, the highest U.S. court ruled Thursday biotech companies can’t patent your genes. But they can stake their claim to derivatives made from the building blocks of nearly all living things.
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Humans, penguins, bacteria … and basically all manner of life share a common bond: DNA. The double helix that was discovered by scientists in the middle of the twentieth century is nature’s roadmap. At its simplest, it tells organisms how to make proteins, which, eventually, define everything from what an individual cell does to how complex organ systems work, and beyond.
DNA is actually made up of units called nucleotides – essentially the language of DNA. Genes are sequences of these nucleotides that define characteristics of organisms. Unraveling genes – finding out what they do, and how changes impact them – has spurred incredible medical breakthroughs.
BRCA: A Key Discovery in Cancer Research
One such discovery came in the form of the BRCA1 and BRCA2 genes in 1990. A team of national and international scientists found mutations to these so-called cancer suppressors greatly increase the chances of breast and ovarian cancer for women, according to the American Bar Association. They also can increase breast cancer risk in men.
Myriad Genetics (NASDAQ:MYGN) sequenced those genes between 1994 and 1995, and then was granted a U.S. patent for it three years later, in 1998, according the Bar Association. The Salt Lake City, Utah-based company also found and patented methods of testing for the gene mutation – something that has proved both lifesaving and lucrative.
Because of this set of patents, Myriad is the only company that can test for mutations to the BRCA1 and BRCA2 genes. Critics said that gave Myriad outsize market power in testing for something that is essentially a product of nature. The tests can cost several thousand dollars, according to multiple media reports.
Can a Gene Be Patented?
The American Civil Liberties Union, on behalf of the Association for Molecular Pathology, sued Myriad in 2009 in what became an important test case for genetics-related patents.
“The government should not be granting private entities control over something as personal and basic to the human body as our genes,” the group argued. The legal basis for the argument is genes are the “product of nature,” and, therefore, can’t be patented.
Myriad has fought back strongly against the suit, writing in a letter to physicians that “allowing patents on isolated DNA would severely impact the private investment that has fueled the explosion of advances in biotechnology and jeopardize many of the jobs created during this timeframe.”
The case made its way through the court system, with the U.S. Court of Appeals for the Federal Circuit broadly backing Myriad. The plaintiffs pushed back against the decision, and appealed to the U.S. Supreme Court.
“Myriad defends its claims on the grounds that a gene becomes a human invention when removed from the human body,” the group wrote in a brief to the Supreme Court. “Under this rationale, a kidney ‘isolated’ from the body would be patentable, gold ‘isolated' from a stream would be patentable, and leaves ‘isolated’ from trees would be patentable.”
The Supreme Court agreed, and disagreed, with that argument in a unanimous decision.
“Myriad did not create anything,” Associate Justice Clarence Thomas wrote in the Supreme Court’s opinion of Myriad’s patent on the two genes. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
However, America’s highest court did back Myriad’s claims to so-called cDNA, or synthetic DNA. That backing essentially rested on the argument that it needs to be created in a laboratory by removing certain portions.
“The lab technician unquestionably creates something new when cDNA is made,” Thomas wrote. “As a result, cDNA is not a ‘product of nature’ and is patent eligible.”
Victory for All?
Both sides took a victory lap on the heels of the ruling.
Investors cheered the news, sending Myriad’s shares surging some 10% as the company retained its rights to the key lab methods.
“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,” Peter Meldrum, the company’s chief executive, said in a statement.
Meanwhile, the Association for Molecular Pathology said it was “very pleased” with the ruling.
“The Court’s decision that human genes are not patentable is a great step forward in for the field of molecular pathology, for genomic science, and most important for our patients,” the group said in a statement to FOX Business.