Duke professors and alumni have expressed mixed reactions about the recent Supreme Court decision to outlaw natural genome patenting.
In the midst of a session concerning various controversial topics including affirmative action and same-sex marriage, the Supreme Court ruled unanimously Thursday in Association for Molecular Pathology v. Myriad Genetics that it is not lawful to patent naturally occurring human genomes, even if they are engineered to be isolated. Myriad, a molecular diagnostic company, patented the genes BRCA1 and BRCA2 after isolating them several years ago. The genes have been linked to a higher risk for breast and ovarian cancer.
Because Myriad did not change or create the genes isolated, it is not eligible to claim a patent on BRCA1 and BRCA2. The Court ruled that artificial versions of the genes, however, are eligible for patenting.
Misha Angrist, assistant professor of the practice at the Duke Institute for Genome Sciences and Policy, agreed with the ruling to an extent. He said that while access to screening will now be made widely available by striking down the ruling, a better ruling would have outlawed patenting artificial versions of existing molecules.
“If I consult my imagination and make up a sequence that doesn’t exist in nature, I would say yes, you should be able to patent that,” Angrist said. “But if I take an existing molecule and I reverse engineered it—I simply make the DNA equivalent of that RNA molecule— you could technically say that doesn’t exist in nature. I would say, maybe not, but you didn’t invent it either.”
There is an added complexity to the ruling when taking into account the legality of artificial genes, noted Shamoor Anis, Law ’13. He added that the Court states that even two genes carrying the exact same information that exist only when isolated must be treated differently.
“The cDNA—which holds the same information as the isolated DNA, but without additional irrelevant chemical bonds—is held to be patentable subject matter,” Anis wrote in an email Tuesday. “It seems inconsistent to forbid the patenting of isolated DNA and allow the patenting of cDNA.”
The ruling states that naturally occurring DNA segments are products of nature, not patentable under current U.S. patent law. cDNA, however, is not naturally occurring, regardless of the isolation techniques required to find it.
“It appears that the Court wanted to forbid the patenting of DNA but could not disallow patents of cDNA because that is clearly an artificial product,” Anis said. “So they just went for the next best thing and forbade the patenting of isolated DNA.”
Beyond the intricacies of the decision on artificial versus natural genome patenting, Angrist emphasized the positive implications for health care going forward from the decision. Other genetics diagnostics companies beside Myriad will now be legally permitted to use BRCA1 and BRCA2 in attempting to identify risk for breast and ovarian cancers.
“You will now have a rush of other companies in genetic diagnostics who have been offering everything, but BRCA1 and BRCA2 testing for breast cancer because it has not been allowed,” Angrist said. “They’ve been testing for everything but the elephant in the room. Now they’re free to include the BRCA1 and 2.”
Myriad has been vilified for a long time by the public, media and scientists alike because of its refusal to share valuable information about BRCA1 and BRCA2, its inadvertent policy of “charging people to recover” and its refusal to continue putting its data into the Breast Cancer Information Core database, Angrist said. Patient advocacy groups condemned the blockage of access to what could potentially be a life-saving screening due to patent law.
“These people are taxpayers so they actually funded the initial research that found these genes,” Angrist said. “Then you refuse to share that information with the broader scientific community, with the oncology community and the genetic community who could use it to find predictions.”
Anis also noted that the topic of patenting has been a frequent point of contention at the Supreme Court, which has issued at least one major decision on the subject every year. Additionally, this was an unusual case because it resulted in a unanimous decision from what Anis called “one of the most divided courts” that American history has seen.
Neil Seigel, who is the David W. Ichel professor of law, however, said that the decision was not “terribly surprising” given the government’s arguments.
Rulings concerning same-sex marriage and affirmative action are expected to be released next week before the Court adjourns until October.
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