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. —Shobita Parthasarathy
SALT LAKE CITY — Bunny Sterin finds the notion that someone could prevent her from donating part of her genetic makeup to cancer research — or using it in other ways, for that matter — ridiculous.
She recently was diagnosed with breast cancer, had a lumpectomy and completed radiation. Along the way, Sterin, 58, also had genetic testing that found she does not carry a BRCA gene implicated in some breast cancers.
The BRCA1 and BRCA2 genes that prompted actress Angelina Jolie to undergo a double mastectomy in an aggressive effort to avoid breast cancer — and who controls those genes — had been hotly contested until Thursday, when the U.S. Supreme Court ruled DNA is part of nature and no one can patent it. The court's unanimous decision also determined that synthetic DNA can be patented.
The decision in the case Association for Molecular Pathology v. Myriad Genetics settled the question of whether researchers who identify segments of DNA can lay claim to them and control their use in research. The practical effect of the ruling, however, is unclear and may even prove to be somewhat symbolic, experts say.
Salt Lake-based Myriad Genetics identified and patented BRCA1 and BRCA2. Mutations in the two BRCA genes greatly increase the likelihood of developing certain cancers — to between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer. Myriad's patents have allowed it to control research on the genes and bar tests that compete with its own BRACAnalysis(R) genetic test.
"As we have recognized before, patent protection strikes a delicate balance between creating 'incentives that lead to creation, invention, and discovery' and 'imped(ing) the flow of information that might permit, indeed spur, invention,'” the Supreme Court wrote as it upheld part of a previous ruling and struck down another part.
Both sides called the ruling a victory.
"We actually think today's decision is positive for the company," Myriad Genetics spokesman Ron Rogers told the Deseret News. He said the company lost five patents on the genes themselves, but still has 500 claims that are "valid and enforceable" in 24 different patents related to the BRCA1 and BRCA2 genes. "I don't think today's decision will have any negative impact on our operations. It also doesn't change the strong patent protection for intellectual property for our (genetic) test."
AMP hailed the decision as a "great step forward in the field of molecular pathology, for genomic science and, most important, for our patients. We look forward to exciting future advancements in diagnostic testing and therapeutics that will accrue to the benefit of our patients and our field."
One of its spokesmen, Roger Klein, a molecular pathologist at the Cleveland Clinic, told the Deseret News the ruling would provide "better access to testing, likely at lower cost, more choice of providers and also encourage innovation."
The lawsuit, he noted, was "not us vs. Myriad, it was us vs. gene patents."
Those who oppose patenting genes, including the AMP, researchers, physicians and patients, said that granting such patents stifles research, raises the cost of genetic testing, can hamper the search for cures and limits access for patients who cannot afford the genetic testing.
Myriad maintained gene patents are needed to protect the costly investment companies and other researchers must make to reap significant biologically based discoveries. The biotech company countered the test-cost criticism by pointing out it provides testing at reduced cost or sometimes free to those who cannot afford it. More than 1 million women have used its test, including more than 35,000 at-risk patients who received free or reduced-cost testing, it said.
The impact of the ruling goes well beyond Myriad Genetics. As much as 60 percent of the human genome has been patented and there are close to 3,000 genetic tests of various kinds, some patented and some in the public domain.
In an opinion written by Justice Clarence Thomas, the court said that separating the gene from its surrounding genetic material "is not an act of invention. Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the inquiry." But Myriad removed elements of DNA that don't code for proteins. The court said those altered genes Myriad created by removing elements of natural DNA can be patented. That synthetic DNA is called cDNA.
The court "appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection" for the test in the future, said Myriad president and CEO Peter D. Meldrum.
The court said Myriad can continue to make money from its work on the BRCA genes. "Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent," he said. Other patents, including on application of knowledge about the two genes, were not part of the lawsuit.
Time will tell exactly what the ruling means. Expectations are varied.
Removing the patent they hold on the gene itself leaves it open for other companies to develop new ways to test for the genes, which will spur competition, said Brett Parkinson, imaging director of Breast Care Services at Intermountain Medical Center. That's a good thing for patients.
Whenever testing is more available and less costly, which he thinks will be likely following the court decision, more women will avail themselves of the opportunity to be tested. Parkinson also believes it will bring down insurance premiums.
“Myriad did a wonderful job in isolating this gene and it has served women well. But it is time that genetic testing is widely available at an affordable cost and this will let that happen.”
It’s particularly important, he said, for women who have Medicaid, which does not cover genetic testing to look for BRCA mutations, or for women who can’t afford it.
That reduced cost and better access is Sterin's hope. If the ruling "makes the test less expensive, if it makes it easier for people to find out what their risk factors are, that's great," she said. Her mom died of breast cancer, but because she was diagnosed when she was in her 70s, it was not considered likely that it raised the risk for her daughters. Sterin's cancer was detected during a routine mammogram. Because of her mom's breast cancer and the fact that her heritage includes Ashkenazi Jews, who are higher risk of having BRCA mutations, she opted to be tested.
Had she had the genetic mutation, Sterin said it "would very much have changed what I did for treatment."
She did not have the gene — and neither do most women; it's about 1 in 400. That’s still a lot of women. For those with a mother or sister who had breast cancer before menopause, genetic testing is an important part of choosing options. Some with the mutation may, like Jolie, opt to have both breasts removed as a preventive measure. Finding the gene can spur earlier, more consistent screening.
Because there is no screening test like mammography for ovarian cancer, Parkinson said genetic testing is an opportunity to identify women who carry the gene and thus the heightened risk. Some who know they have a BRCA mutation may opt to have their ovaries removed.
“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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