Supreme Court says no patent on natural DNA, upholds other Myriad patents
“It doesn’t change everything, but I think it changes the outlook for genetic diagnostic testing,” said Michael Burstein, assistant professor of law at Cardozo School of Law in New York City, who trained in molecular science, as well. Whether the changes are good or bad depends on who is asked, he said, but he believes it serves the social good, opening up competition. It will not spell the end of biotech at large, as some predicted.
Genetic testing that doesn’t involve the making, selling or use of a synthetic BRCA1 or BRCA2 DNA would likely not infringe Myriad’s patent. Anyone has a right to do full-length sequencing of the genes and compare them with the known mutation, Burstein said. He said he thought that “the full-length gene opens up space for other companies and particularly nonprofits to offer genetic testing.”
"It is splendid news for patients, for physicians, for scientists and for common sense," Mary-Claire King, the geneticist who in 1990 discovered the abnormality on chromosome 17 that proved to be the breast cancer gene (BRCA), told USA TODAY. "The marketplace will now be open."
"Today, the court struck down a major barrier to patient care and medical innovation," Sandra Park, a lawyer for the American Civil Liberties Union Women’s Rights Project, wrote on the ACLU website. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
Some observers don't expect dramatic change.
"It's not clear that this is going to affect Myriad's business practice much," said Shobita Parthasarathy, associate professor in the Ford School of Public Policy at the University of Michigan. "That remains to be seen. But I think it will be pretty difficult for other researchers or testing providers to do research and create a test that would not infringe Myriad's cDNA patents.
"The reason a lot are saying (the ruling) will have bigger impact is that it may be more difficult to get cDNA patents in the future. If you have one ... I think it will be pretty difficult to invent around it."
"The decision is likely to have the greatest impact on diagnostic/genetic screening patents similar to those at issue in Myriad, but the ruling will impact the patent-eligibility of other newly discovered compounds that are 'isolated' from nature, such as medicinal compounds isolated from plants, beneficial proteins isolated from human or animal sources, and beneficial microorganisms isolated from soil or the deep sea," said Courtenay Brinckerhoff, a partner in Foley & Lardner's intellectual property practice group, in a written statement. "Further, while the Supreme Court leaves open the possibility of obtaining patents directed to 'new applications' of 'discoveries' like the BRCA1 and BRCA2 mutations, the patent-eligibility of diagnostic methods is limited by its decision in Mayo v. Prometheus.”
“It’s interesting how the Court did this, as it’s a fairly straightforward and purposefully narrow decision directed to the patentability of naturally occurring isolated and purified genomic DNA," said Dr. Michael S. Tuscan, co-chair of Cooley's Patent Counseling & Prosecution practice group. "While a fair number of existing patent claims are now likely invalid, many of these patents are at or near the end of their term. The decision is actually not too disruptive for the industry, as it leaves open many ways for companies to build patent exclusivity around manipulated nucleic acids, methods of using even naturally occurring nucleic acids, etc. Much of what this decision pertains to is research and discoveries that took place more than 10 years ago, not what is generally new to the life sciences industry in this day and age.”
A broader effect could be a cooling down of a tendency by some researchers to apply for patents on anything they isolate from the body, Parthasarathy said. "That might end up being good news for researchers and patients" because it might allow more study without fear of infringing on patents.
The case has symbolic impact, Parthasarathy said, because it has galvanized the public on the question of whether a company can control elements of a human body. And it is notable as well that the suit was led by public interest groups. Finally, "it's quite important in terms of public engagement with the patent system."
The ruling is also significant because where to draw the line has been hotly contested when it comes to providing the incentive of a patent versus promoting access to materials needed for innovation, like genes. This is the high court’s attempt to draw that line, Burstein said.
The ruling doesn't impact the large proprietary database of information that Myriad Genetics has gathered. Several experts agree that gives the company a competitive advantage.
Still, at its heart, both sides in the case were after the same thing, Burstein said. They wanted to create “lots of incentives for innovation. Innovation improves lives, grows the economy, all that good stuff.”
Myriad Genetic's stock (NASDAQ:MYGN) volleyed up and down Thursday. It started at $33.84 and rose as high as $38.27 before closing out down 5 percent at $32.01.
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