In the past month, there have been a slew of prominent Supreme Court decisions covering such contentious topics as affirmative action, same-sex marriage, and voting rights. We held our breath as we waited for the results of Fisher v. University of Texas, Windsor v. U.S., and Shelby County v. Holder. Given that all of these cases received significant media attention, a fourth Court ruling that occurred this month has flown relatively under the radar, though its significance is comparable to that of the more high-profile cases. This highly scrutinized decision is merely the beginning of a conversation; however, it is indicative of the direction in which scientific patent law is headed. Courts are ruling against large pharmaceutical companies who seek to hold monopolies in their respective fields of research, allowing the market to open up to more potential innovators.
On June 13th, the Supreme Court ruled unanimously against the patenting of human genes in the case Association of Molecular Pathology v. Myriad Genetics, a decision with numerous consequences—good and bad—for healthcare and research. The case centered on the research company Myriad Genetics, which patented the gene BRCA1—a gene that often indicates a heightened risk for breast cancer—shortly after becoming the first to isolate it successfully. Then, Myriad isolated, sequenced, and patented the gene BRCA2, and has since held a monopoly on any commercial use of the two genes. That means the company has been able to charge exorbitant prices of up to $3,000 for what would otherwise be inexpensive and routine tests. While Myriad may be the most notable company to seek such patents, it certainly isn’t the only one, as over 4,000 patents were held on isolated human genes at the time of the ruling, protecting over twenty percent of the genome. The Association of Molecular Pathology, seeking to protect many of its member physicians and researchers from these monumental costs and roadblocks in research, has long fought Myriad’s ability to patent these genes. With lawyers from the American Civil Liberties Union and the Public Patent Foundation acting as legal representation, the Association filed a claim in 2009 to prevent human genes from being patented—which eventually became the Supreme Court case that led to this ruling.
The Supreme Court’s decision was based on the concept that Myriad did not actually engage in any act of creation and therefore, lacked any ability to patent their work. Justice Clarence Thomas, writing for the Court, stated that while Myriad had identified a gene very important to breast cancer research, “separating that gene from its surrounding genetic material is not an act of invention…[since] a naturally occurring DNA segment is a product of nature.” However, the decision left open several loopholes for companies seeking to profit from their research. Synthetic DNA—genes that aren’t found naturally in nature and are altered by researchers—can still freely be patented, as can innovative methods of isolating a gene. The distinction drawn upon by the Court, then, is that of natural occurrence vs. invention. Since the BRCA genes are present in nature, they do not require invention and thus can’t be patented.
By making this ruling, the Court has nullified every patent made on naturally occurring genes or pieces of DNA—and that’s a very good thing for patients. Patents like the ones previously held by Myriad allow for monopolistic situations in which a single company holds the rights to a given medical test and can raise the prices as they see fit. By making such patents illegal, the Supreme Court makes it possible for these tests to decrease significantly in cost and allows for a more highly competitive marketplace—and for more individuals to get tested, increasing the quality of available healthcare. In the week immediately following the decision, several companies were already offering alternative BRCA tests that cost as little as $995. With more companies able to utilize this type of testing for lower costs, it’s far less likely that a low-income patient will be unable to access this and similar types of tests.
The jury’s still out though – pun intended – on the implications for scientific research. Critics of the decision argue that research in the sciences is already suffering from underfunding and a decline in students obtaining degrees in scientific fields, and that the removal of patents will further undermine critical innovation since it eliminates major possibilities for profit. This comes a time when government funding is especially low, making profitability especially important in research. The National Institute of Health lost $1.7 billion and 700 grants due to the sequestration alone, which is merely one event in an overall downward trend in funding for medical and scientific studies. Gene patents incentivize investment in research, allow research companies to remain profitable, and keep many of these companies on the cutting edge of scientific advancement in an age when money is becoming increasingly tight. Furthermore, many of the most groundbreaking advances in scientific research involve naturally occurring chemical substances like penicillin. It remains to be seen whether this ruling will affect these and other natural substances outside of the human genome, like proteins, which have traditionally been patentable. Additionally, the Court’s nebulous definition of synthetic DNA has received a very mixed reception from the scientific community. Many scientists have claimed that complementary DNA (cDNA), an artificial enzyme that can still contain the same sequence as a naturally occurring gene, was wrongly listed by the Court as a form of synthetic DNA.
Those who decry this ruling also say it comes at a dangerous time, as research investment is becoming an increasingly risky expenditure; these new restrictions on gene patents could remove incentives to pursue basic science. Entangled with these concerns for the implications of gene patent law is the more philosophical debate about what rights a scientific discovery grants its creator. Myriad felt that by being the first to isolate the BRCA genes, they should be granted the effective ownership of that genetic material. And, of course, as budgetary concerns become ever more pressing, the viability of scientific research must be taken into consideration. Does the removal of these patents sufficiently incentivize research in an increasingly important field? The answer is yes—as more researchers can pursue their studies without fear of infringing upon the intellectual property of another, the future of scientific research looks increasingly bright. Those who fear that this ruling will discourage scientific research ignore that with these patents in place, would-be scientists are effectively crowded out from even participating in this field.
In this sense, then, the Court’s ruling can be seen as a victory for scientific research in that it will allow for a freer and more competitive marketplace. Myriad, for example, will no longer have a stranglehold on the BRCA genes, making them available to any individual or organization. Instead of relying on their patent to maintain dominance in BRCA testing, Myriad will be forced to innovate and make continual advancements in their field. This will also open the door for smaller biotech companies to prosper in a pharmaceutical industry that has been traditionally controlled by large, abusive corporations. Almost exactly a year ago, pharmaceutical giant GlaxoSmithKline (GSK) pled guilty to charges of fraud that included deceiving consumers and regulators about the safety of certain drugs, bribing doctors, and extorting money from Medicare and Medicaid. This was the largest case of healthcare fraud in history, and GSK simply pled guilty, paid $3 billion in fines—a fraction of their overall profits—and went back to business. Not surprisingly, GSK is a major proponent of gene patenting, as they happen to hold the second-most gene patents in the United States. Patents allow companies such as GSK to shut out smaller biotech companies, who usually seek either to produce cheaper, generic versions of a drug or try to improve on an already existing product. Therefore, the prohibition of many of these patents will surely weaken imposing pharmaceutical powerhouses, and permit smaller startups to remain competitive. Between this ruling and last year’s Mayo v. Prometheus, which similarly found that methods of administering a drug cannot be patented, patents in research are quickly falling by the wayside. The removal of these restrictions will hopefully facilitate an environment in which scientific advancement occurs faster and becomes more accessible to the general public.
To be sure, the pharmaceutical giants aren’t going down without a fight—and given that this debate is relatively new to the courts, its future remains unclear. Less than a month after the decision, Myriad already began a copyright infringement lawsuit against Gene by Gene, the company offering the $995 alternative BRCA tests. What is definite is that in the coming years, the intersection of science and law will become more thoroughly mapped out by court rulings, and it is clear that a trend is emerging in scientific patent law. As both healthcare consumers and as humans who benefit from greater scientific advancement, we need to hope this trend continues.