By Katie Podein & Tommy Wang
Should researchers and scientists be able to claim human DNA as their intellectual property? That is the question the U.S. Supreme Court must now decide after recently hearing oral arguments in the case of Association for Molecular Pathology v. Myriad Genetics. Robert Barnes of the Washington Post reported that the Justices expressed trepidation as they listened to the parties’ explanations of patent law and the complexities of biochemistry. The overriding hesitation by the Supreme Court may be due to the fact that this decision not only has the potential to have profound impact on pharmaceuticals and genetically modified crops, but also has the potential shape the future of medical and genetic research.
In 2009, a coalition of researchers, genetic counselors, cancer survivors, breast cancer support groups, and scientific associations filed suit against Myriad Genetics, a Utah biotechnology company, challenging the company’s patent of genes known as BRCA1 and BRCA2. Myriad discovered and isolated the two genes, which are highly associated with hereditary breast and ovarian cancer. Myriad patented its discovery and the company now has a twenty-year monopoly over the use, research, diagnostics, and treatment of the genes.
The general rule for registering for a patent with the USPTO is that the discovery or idea cannot be a product of nature or a law of nature. No matter how difficult or costly the discovery, a product of nature is ineligible for patent protection. However, to date, the USPTO has granted patents on at least 4,000 human genes to the companies, universities and researchers who have discovered and decoded them.
Despite the large number of patents for human genes, many in the medical profession do not favor patents on DNA. The group of researchers and scientists who filed the Myriad Genetics lawsuit claim that Myriad’s patents claim rights to genes, which are a product of nature and therefore are not patentable. Opponents also contend that patents, such as Myriad’s patents for BRCA1 and BRCA2, improperly put constraints on medical research and diagnostic testing. They view patents for genes as an attempt to monopolize and block future exploration in the field of genetics and personalized medicine.
Myriad, on the other hand, supports the patents, arguing that the company has isolated these specific genes and thus they are a product of human ingenuity, not nature. Myriad’s lawyer, Gregory Castanias, claims that without “the incentives offered by a strong and stable intellectual property system,” companies like Myriad may not receive the capital and support necessary to develop new treatments and introduce them to the medical field.
One possible resolution to the debate is to look to see how other countries handle the issue. Most countries grant patents on genes but with specific exceptions to them, allowing researchers and diagnostic developers to use the genes freely. Although this seems like a basic and logical solution, the process would be arduous for the Supreme Court, as they would have to enlist the help of Congress to change the current Patent Laws.
The Supreme Court’s decision will also determine the effect of patenting human DNA and generics has on scientific research and its patients. Even the Justices verbalized the heavy burden of the decision during oral argument. In questioning whether the Court had to immediately decide on this issue, Justice Samuel A. Alito Jr. appropriately framed the question, “Why should we jump in … and decide the broadest question possible?”
Katie Podein is an associate attorney at Yang & Wang, P.C, practicing Intellectual Property and Business Law. The firm’s practice includes patent; trademark; trade dress; trade secret; copyright; internet & new media; brand protection; and general corporate, organizational, and business law matters.
Tommy Wang is a registered patent attorney and partner at Yang & Wang, P.C. He currently practices Intellectual Property Law, including Patent, Trademark, and Copyright, and Business Law in Southern California and East Asia. His patent practice specializes in securing patents in the medical device, biochemical sciences and life sciences field.