David C. Berry on DNA Patent Case
By Steve Thorpe
sthorpe@legalnews.com
The U.S. Supreme Court ruled recently that isolated human genes are not patentable, but synthetically created genetic material may be patented. The result of the ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. could be immediate for companies asserting or challenging patent ownership rights. Thomas M. Cooley Law School Professor David C. Berry is an expert with more than 25 years of experience in patent law and patent litigation. He is also director of the school’s Graduate Program in Intellectual Property Law.
Thorpe: Give us some of the background of how this case ended up in the Supreme Court.
Berry: The Myriad case is one of three cases recently decided by the Supreme Court exploring the limits of patent protection. The U.S. Patent and Trademark Office (USPTO) has issued patents on isolated DNA sequences since at least the 1980’s. Critics have argued that these gene patents restrict genetic research and the availability of products applying the fruits of that research. The case started when the American Civil Liberties Union filed suit against the USPTO and Myriad, contending that the issuance of the Myriad patents was unlawful because the inventions in specific claims were not eligible for patenting. The named plaintiffs were health providers and patients who alleged that Myriad’s patents and licensing practices prevented them from accessing genetic tests for the BRCA1/2 genes, which are associated with an elevated risk of breast and ovarian cancers. So the procedural posture of this case is very different from the typical patent infringement lawsuit. The U.S. District Court for the Southern District of New York ruled that claims in the Myriad patents directed to isolated DNA, complementary DNA (cDNA) and testing methods based on mutations in the BRCA1/2 genes were invalid. The U.S. Court of Appeals for the Federal Circuit reversed that decision in part, holding that the claims to isolated DNA and cDNA were eligible for patenting, but most of the testing methods were not.
Thorpe: There seems to be disagreement on the scope of the decision, with some analysts minimizing it and others saying it will be broader. Your opinion?
Berry: It’s an important case, because the Supreme Court weighs in on patent issues relatively infrequently. Although the Myriad decision itself only applies to patents on so-called “products of nature,” such as naturally occurring DNA sequences and proteins, I think we need to read the case together with two other recent cases, Bilski and Prometheus. In the 2010 Bilski case, the Court ruled that patents on business methods were not patentable if they were merely “abstract ideas.” In Prometheus, in 2012, the Court held that a method for administering a drug was not patentable because it was only a “law of nature.” So when one considers Myriad together with those cases, you can see a willingness by the Court to restrict the availability of patents that are not specific applications of scientific principles, but rather attempts to lock up the principles themselves. In addition, it is important to remember that just because an invention is eligible for a patent does not mean that it is patentable. In addition to eligibility, an applicant must show that the invention is novel, not obvious, has utility, and is adequately disclosed in the application. So many inventions that are “eligible” for patenting might fail to meet those additional requirements.
Thorpe: The court’s “middle ground” approach led both sides to declare victory in the case. Is that a legitimate picture of the outcome, or was there a big winner or big loser?
Berry: I think the plaintiffs succeeded in establishing the point that naturally-occurring human genes are not patentable, even if they have been chemically altered to a small degree through isolation. Naturally-occurring human genes are part of the storehouse of basic scientific knowledge available to all researchers. But there is a huge range of other technologies related to gene discoveries that remain potentially patentable. The biotechnology industry can breathe a sigh of relief that the Court’s analysis, especially with respect to cDNA, leaves plenty of opportunities to secure patents on commercially valuable aspects of genetic research.
Thorpe: Some say that the ruling could stifle innovation in the biotech field? Do you agree? What potential legal pitfalls might a company now face?
Berry: As a result of the Human Genome Project around 2001, applicants filed for hundreds of thousands of patents claiming human DNA sequences. Those patent portfolios are in jeopardy as a result of this ruling. But very few biotech companies limited their portfolios to isolated DNA patents. Therefore patents on cDNA, processes applying the DNA discoveries, physically altered DNA fragments, research techniques, and other consequences of the basic gene discoveries remain potentially patentable. In addition, even if patents are unavailable, some biotech companies may be able to protect their proprietary information as trade secrets. While this decision will cause some biotech companies to reassess their patent strategies, I do not think it will significantly affect the economic incentives to invest in the biotech field. In fact, although the broadest claims in Myriad’s patents were invalidated in this case, the company retains many other narrower patent claims that remain potentially valid.
Thorpe: Justice Thomas stressed what the ruling did not address: the patentability of methods for isolating or manipulating genes, claims involving new applications for genetic material, and the patentability of DNA with components that have been altered. Will cases involving those issues be coming?
Berry: It is inevitable that these issues will be litigated in future cases. The Myriad case was unusual because it was a test case initiated by the ACLU, not a typical infringement case. The claims identified by the ACLU were not necessarily the claims that are the most relevant from a commercial perspective. In light of Myriad, we can expect the limits of the Court’s ruling to be tested in future infringement cases, by Myriad and other patentees, and in declaratory judgment actions brought by accused infringers.
Thorpe: Broader questions on issues outside medicine like genetically modified foods were also not addressed by the ruling. Do you expect this area of law to continue to expand?
Berry: Debates about whether a discovery is patentable will continue as long as human ingenuity pushes back the frontiers of science and innovation. The current Patent Act was enacted in 1952, but Congress was wise to keep the scope of patent eligibility broad enough to cover “anything under the sun that is made by man.” As our economy increasingly emphasizes technological advantage, and rewards companies fueled by innovation, we can expect similar patentability issues to arise in future cases involving patents on new discoveries, including those that we cannot even imagine today.
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