October 03, 2013
Experts in the fields of law, science, and technology gathered at Harvard Law School Sept. 23 for a panel discussion, co-sponsored by the Broad Institute of MIT and HLS' Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, examining the impact of the U.S. Supreme Court's recent decision that naturally occurring DNA cannot be patented.
On June 13, the court issued its opinion in Association of Molecular Pathology et al v. Myriad Genetics, finding unanimously that isolated genomic DNA is not patent eligible under the Patent Act. The ruling reversed a decision by the U.S. Court of Appeals for the Federal Circuit that several genomic-DNA patents obtained by Myriad Genetics on two isolated genes for purposes of developing breast-cancer drugs were valid.
HLS Dean Martha Minow, the moderator, set the stage for the discussion by relating that assessments of the decision's impact on research, personalized medicine, and civil liberties have been widely varied, and she asked panelists to offer their own reactions.
Tania Simoncelli, who spearheaded the development of the litigation against Myriad as former science adviser to the American Civil Liberties Union, called the ruling "a tremendous victory, not only for our plaintiffs, but for patients, for the future of biomedical research, and for personalized medicine; and I think it's a victory few would have predicted when we started this case seven years ago."
Before the suit, the U.S. Patent and Trademark Office had been granting patents on genes for more than 20 years. But a broad coalition came together to file the Myriad case in 2009, Simoncelli said, after several studies suggested that gene patenting is not necessary to stimulate research and that it has in fact inhibited research, testing, and data sharing.
Panelist Eric S. Lander, founding member of the Broad Institute of MIT and Harvard, filed an amicus brief supporting neither party and also shared Simoncelli's approval of the court decision.
Lander traced his own interest in the case back to the work that he and the Institute did in the development of the Human Genome Project and the emergence of Celera Corp., which sought to commercialize genomic information, toward the end of that project. "It was very concerning to us that people would go out and try to ring-fence pieces and say, 'Thou shalt not be able to use this piece of information,'" he said.
Lander explained that he was prompted to file an amicus brief by his reading of the Federal Circuit ruling upholding Myriad and his discovery that the court provided little or no scientific support for its finding.
"Myriad went on and on in its (Supreme Court) brief about how brilliant they were for having discovered this," Lander said. "But I think the Supreme Court sorted out pretty clearly that a discovery might win a Nobel Prize, but it isn't an invention of a thing. Myriad's brief was basically a recitation of how hard it was and important it was to discover this product of nature. Well, that's great. But they didn't invent it."
Panelist Claire Laporte (HLS '89), a partner in the law firm of Foley Hoag in Boston, wrote an amicus brief in the Supreme Court case for the Federal Circuit Bar Association, whose constituency includes a large number of companies holding patents and with an interest in maintaining the Patent Office position. She said the brief pointed out technical differences between DNA fragments in nature and those that have been isolated, but also the importance of these patents. "The reach of the products based on these patents is very, very significant, ranging from practically every early drug that Genzyme made to human insulin and all kinds of drugs that are very, very important," she said.
Panelists agreed that both the Supreme Court and the Federal Circuit didn't seem to fully grasp the science upon which they issued their opinions.
Panelist Benjamin N. Roin, HLS Heiken assistant professor of patent law and co-director of the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, said he's troubled by the Supreme Court ruling.
"Regardless of whether you think DNA should be patentable or not, the rule that we're getting here is not a good rule," he said. "It may work well in one case, but it's not going to work well when there's a drug we want that's floating around in a cell in a leaf somewhere and it gets struck down on that basis."
HLS professor I. Glenn Cohen, co-director of the Petrie-Flom Center, posited whether these decisions might better be suited for an administrative agency similar to the Food and Drug Administration. "Would an innovation agency that did the same thing for patent law be as stable and offer as much certainty? Or would it be run ceding control to lobbyists? We just don't know the answer to that."
Lander, however, concluded that traditional courts are still the best venues for making these decisions.
"I've got to say there's something to be said for courts doing this because the experts get themselves wrapped up in the details," Lander said. "Courts at least step back sometimes and say, 'The result is just plain wrong.'"