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Panelists speaking on April 15, the day of the Myriad gene patent oral arguments before the Supreme Court, expressed concern that a decision that the patents are ineligible as products of nature could lead to decades of uncertainty about what is patentable and what is not.
Dr. James D. Watson, Noble laureate and co-discoverer of the double helix structure of DNA, said at the panel discussion sponsored by and held at Wiley Rein L.L.P., Washington D.C.,, that he is opposed to gene patenting. “Genes are too important to our lives to put in the hands of one individual or one company,” he said.
But others on the panel said that a consequence of a ruling that the Myriad patents are ineligible might be that the decision would later be broadened to include anything extracted from natural products, such as antibiotics.
John Whealan, dean of intellectual property law studies at George Washington University Law School, gave the background of the Myriad case, formally known as Association for Molecular Pathology v. Myriad Genetics, No. 12-398 (U.S.). He said that the American Civil Liberties Union and others are challenging the patent claims for the BRCA1 and BRCA2 genes, which are associated with breast cancer, to obtain a declaratory judgment that the claims are not patent eligible because they are products of nature. At issue were composition of matter claims for isolated DNA and cDNA (complementary DNA).
A federal district court agreed with the ACLU, finding that the patent claims fell within the three, court-developed exceptions to patent eligibility under 35 U.S.C. §101: laws of nature, physical phenomena, and abstract ideas. The U.S. Court of Appeals for the Federal Circuit reversed, deciding 2-1 that the Myriad claims were patent eligible(159 PTD, 8/17/12).
The Supreme Court granted review, and among the amicus briefs was the U.S. government's, which argued that Myriad's cDNA claims were patent eligible and the isolated DNA claims were ineligible (45 PTD, 3/7/13). The government's brief labeled cDNA “synthetic molecules built by scientists” and isolated or genomic DNA “isolated but otherwise unmodified human genomic DNA.”
The physical changes that occur in isolating DNA, the government's brief said, “do not significantly alter the structure or function of the relevant DNA segments” and instead “are simply inherent consequences of removing the original substance from its natural environment.”
Another important factor in the Supreme Court's decision, Whealan suggested, was the Supreme Court ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012) (55 PTD, 3/22/12) that overturned the Federal Circuit's decision that diagnostic method claims are eligible for patenting under Section 101. The claims in Mayo covered processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The court held in Mayo that the patent claims did not do “enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.”
“And so, the Myriadcase comes down to this: when you take the gene out, do things to it to be able to test it, after all that, was enough done to the DNA to make it patent eligible?” Whealan said.
Three panelists addressing the science expressed conflicting views.
Dr. Laurie Hill, vice president of intellectual property for MedImmune Biologics, said, “If the people who litigate and/or the judges who decide don't understand the science that's at issue, the law can get twisted up. When you look at science and the law, there's a lot of subjectivity. Things looked different 20 years ago when the claims were made, and since then the science has improved. The problem is, the judges may be looking at the claims made 20 years ago with today's eyes.”
Dr. Carol Nacy, chief executive officer and co-founder of Sequella Inc., said that if the decision goes against patents related to human genes, her company, which focuses on the development of small molecules, may not be affected that much right away. “But if it is ultimately broadened to all natural products like antibiotics, we are all going to suffer.”
Watson submitted an amicus brief in the case, which was drafted by Wiley Rein, opposing gene patenting. He said that his views have changed over the years. “When I was involved in the Human Genome Project, I was interested in the patenting idea because we were trying to get money to fund the project. But then we got the money elsewhere, and later I was fired from the project for opposing the patenting of cDNA when no function had been given to it.”
Watson, who turned 85 two weeks before the panel discussion, said he is opposed to gene patenting. “It's monopolistic capitalism. The $4,000 Myriad gets for its BRCA1 and BRCA2 test could be done for $400. Genes are too important to our lives to put in the hands of one company or one individual.”
Hans Sauer, associate general counsel for intellectual property for the Biotechnology Industry Organization, said that very few BIO members and few biotech companies provide genetic diagnostics the way Myriad does. “And when talking about gene patents today, we're really only talking about Myriad. And yet I am still getting phone calls from members worried about this case, members who may be working with patents and enzymes.”
Sauer said the worry is that a Supreme Court ruling on patent eligibility can have significant consequences. “The ACLU could have asked for declaration of noninfringement for companies besides Myriad who want to give the BRCA1 and BRCA2 genetic tests. Instead, they challenged the very eligibility of the Myriad patents, which gives the Supreme Court an either-or choice: the patents are eligible or they are not. And if the Supreme Court strikes down Myriad's patents it will affect a whole raft of other patents.”
BIO's concern is not that biotech products will fall into the public domain but that uncertainty will be created in patent law about what is patentable, Sauer said. “Companies that have robust franchises like Myriad today will be just fine if the Supreme Court finds the Myriad patents are patent ineligible. But those without robust franchises, like Myriad 15 years ago, will be hit very hard and maybe put out of business. We may be looking at 10, 15, or more years of uncertainty about what is patentable and what is not,” Sauer said.
Whealan suggested that the question the ACLU presented to the court--Are human genes patentable?--may predetermine the court's decision. “The answer to the question as raised is, no. But are cDNA and isolated or genomic DNA human genes? It is disconcerting that the question itself is something of a red herring,” he said.
Judge Paul Michel, former chief judge of the Federal Circuit, said that courts are at a disadvantage due to the structure of a lawsuit. “There is an inherent limitation in the presentation by the parties. It's yes or no, black or white, win or lose. The broader the question, the more hesitant judges should be in making a broad decision.”
Michel continued, “There is a sense among the general public that when the Supreme Court provides an answer to a question, then we will know. I predict that the court's ruling will not end the debate and will not draw a clear line as to patent eligibility.”
The most important question, Michel suggested, is who should be deciding this on behalf of the country? “The decision will be made by nine individuals whose claim to authority is judicial. In In Re Bilski (124 PTD, 6/30/10) and Mayo, the Supreme Court took a murky area of law that was not very predictable and made it murkier and even less predictable. Perhaps Congress, after the massive input it acquires during hearings, would be the better choice to decide. Congress has the better capacity to map this out because it can look anywhere for answers. Supreme Court law, in contrast, is isolated from other matters of law in that the court only cites itself, leaving it trapped in its own language.”
Panelists who attended the Myriad oral arguments suggested that the court did seem reluctant to make a broad, blanket ruling. “But they did appear to be leaning to ruling that cDNA is patent eligible and that isolated or genomic DNA is not,” Whealan said.
Arti K. Rai of the Duke University Institute for Genomic Sciences and Policy said from the audience that she was struck by how interested the justices were in the U.S. government brief that had made that argument.
Sauer said that such a ruling by the court might not be a bad thing “because cDNA is more important to protect. If the proposition is that cDNA should be patentable because it is made in a lab as opposed to genomic DNA which is extracted from natural sources, we can probably work with that,” Sauer said.
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