Supreme Court's Gene Patent Ruling Could Boost Patient Care

By: CBS (Posted by Melissa Brunner)
By: CBS (Posted by Melissa Brunner)

(CBS News) The Supreme Court's ruling that human genes cannot be patented has been met with excitement from doctors over the implications for patient health. Other experts, however, questioned whether there will be a widespread impact.

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

"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.

The court, however, also ruled that synthetic DNA -- called cDNA -- could be patented by a company.

The full decision of Association for Molecular Pathology et al. v. Myriad Genetics,Inc., et. al can be found on the Supreme Court's website.

The lawsuit against the genetics company included plaintiffs from the American Civil Liberties Union (ACLU), American Society for Clinical Pathology (ASCP) and other medical professional associations, on behalf of researchers, patients and women's health groups.

It stemmed from Myriad's specific patents for the BRCA1 and BRCA2 genes. Mutations of these genes raise risk for breast and ovarian cancer. Not every woman who has a mutated BRCA1 or BRCA2 gene will develop cancer, however they are at much greater risk.

About 12 percent of women will develop breast cancer in their lives, according to the National Cancer Institute, but about 60 percent of women with a harmful BRCA1 or BRCA2 mutation will develop the disease. For ovarian cancer, lifetime risk for most women is 1.4 percent, but for women who inherited the faulty BRCA genes, the risk estimate climbs to 15 to 40 percent.

For some groups, like Askenazi Jewish women, the risk could be as high as 1 in 40 women.

Angelina Jolie recently brought attention to BRCA genes when she announced her decision to undergo a preventive double mastectomy. She tested positive for a "faulty" BRCA1 gene, and her mother had died at a relatively young age of cancer, prompting Jolie to surgically remove her breasts before the cancer developed.

Myriad's genetic test has been covered for some patients with insurance if they meet criteria for being at high risk for the cancers, but not all were covered. Those individuals and people without insurance faced a test upward of more than $4,000 to determine their risk. Experts expect those prices to fall given the Supreme Court's ruling.

"I think that a major barrier to patient care and medical innovation was struck down today with the Supreme Court's ruling," Dr. Myra F. Barginear, a breast medical oncologist at the Cancer Institute of North Short-LIJ Health Systems in New York, told CBSNews.com in an email. "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." Barginear was not involved in the trial.

Some of the plaintiffs agreed with this sentiment.

This [ruling] is correcting something that was probably a bit off-kilter for many years," said Dr. Steve Kroft, a professor of pathology and spokesperson for the American Society for Clinical Pathology, told CBSNews.com Thursday. "In this new age of genetic medicine, it's setting the stage for great advances to come."

Kroft calls the ruling a victory for patients, saying Myriad's patent on the test was not in the best interest of women's health.

"It's going to improve access, lower costs, and allow for innovation that wouldn't have happened otherwise," he said.

The Associated Press reports that not long after the ruling, DNATraits, part of Houston-based Gene By Gene, Ltd., announced plans to offer BRCA gene testing in the United States for $995.

The technology for these tests, or assays, is standard and has existed for some time, Kroft pointed out, but the only limiting factor was the patent protection on the gene itself. Besides a price drop, he predicts some companies may now manufacture genetic tests that look for multiple genetic mutations tied to other diseases, in addition to BRCA.

"What it opens the door to is much cheaper testing for a gene that is very important to understand," Dr. Debu Tripathy, a professor of medicine at the University of Southern California's Keck School of Medicine who also serves as co-leader of the Women's Cancer Program, told CBSNews.com.

"But really the bigger picture is we're going to be using genetic information more and more as time goes on," he said.

Tripathy predicts the market will shift to tests being based on their own merits, e.g. how effective they are, the level of the company's customer service and other like factors, as opposed to a proprietary stake driving the testing. While the ruling could make genetic testing a lot easier, he pointed out the big challenge of finding out how the gene causes cancer and affects patient care will remain.

Besides breast and ovarian cancers, other areas of medicine the ruling may impact are the genetics behind rejection of organ transplants and rare diseases. Patenting concerns over the inherited genetic abnormalities that cause rare diseases may have staved off some companies previously, Tripathy said.

Myriad in a statement pointed out that its test, BRCAAnalysis, is widely reimbursed by private insurers, Medicare and Medicaid. The company emphasized the Court upheld its patent claims on cDNA.

"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 D. Meldrum, president and CEO of the company, said in a press release. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."

"While we are confident that Myriad offers the highest quality genetic tests in the world, we also support patients' rights to seek second opinion tests from any of the many laboratories conducting BRCA testing for the purpose of confirming the Myriad test result," Meldrum added.

Patent lawyers questioned whether the ruling would affect the broader industry's landscape all that much.

Matthew McFarlane a lawyer at Robins, Kaplan, Miller & Ciresi L.L.P., told the AP that most companies by now have moved on from patenting isolated DNA, instead looking at synthetic options to protect their investments.

"On a day-in and day-out basis, I don't see this changing that part of the industry," McFarlane said. "Isolated DNA itself is not something that companies seek to protect anymore."

Tripathy also noted there's concern that the ruling would have a "chilling effect" on the genetic testing industry, and said, "We don't know the answer to that yet."

It is a complicated situation for these companies, Kroft said, but he noted the typical approach has often been to patent the method of finding the gene, instead of the gene itself.

"I don't think this will stifle innovation," he said. "The innovation typically comes in the method."

Mark Bartholomew, professor in the University of Buffalo Law School in New York, who specializes in intellectual property, law and technology, said in an emailed statement that the court's ruling struck a "cautious middle ground" that could negatively impact the research industry.

"Given the high stakes here -- the Court's decision could either result in sky-high prices for potentially lifesaving medical treatments or decimate the incentives for research in the biotechnology industry -- the Court's split-the-baby approach is not surprising," he said.

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