How the Supreme Court’s Gene Patent Ruling Affects Patent Law

The past twenty-five years have seen amazing advancement in scientific understanding of the human body. From cloning to stem cells, major scientific breakthroughs have turned the body itself into a kind of technology to be manipulated and played with. But the crowning achievement of this new research into the human body is arguably the Human Genome Project, a scientific endeavor that sought to map the entirety of the human genetic code and which has largely succeeded in it’s stated goal. Though there remain some leftover fragments to be mapped (around 8-10% of genes have yet to be sequenced according to some estimates), the project has resulted in an increased ability to trace various diseases, physical traits, and behavioral characteristics back to which genetic sequences predispose an individual to inheriting these. And with the ability to understand which genes may cause which defect, there came the ability to manipulate the genetic code resulting in the possibility of treating formerly genetic diseases such as sickle-cell anemia or cystic fibrosis and of replacing genetic sequence that may predispose individuals to other diseases like cancer or various heart diseases. Though the process is highly technical, it is essentially just a matter of separating a problematic gene sequence from the surrounding genetic code, and using that code for research and development of potential cures or treatments.

Many companies separated small sequences from the larger code and began patenting them under intellectual copyright law, arguing that these small sequences qualified as scientific breakthroughs, which can sometimes be patented as a discovery under a nebulously defined subcategory of intellectual copyright. One such company was Myriad Genetics, a company that had filed patents for two separate gene sequences that would reduce the risk of breast and ovarian cancer respectively. However, their patents were challenged in court and the case eventually wound up on the lap of the Supreme Court where, in a stunning and unexpected moment for a group that usually expected to split its vote down political lines, it unanimously ruled that genes could not be patented and thus rejecting the notion that scientific discovery qualifies as a patentable invention with Justice Clarence Thomas penning this opinion for the court: “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” Formerly, only companies that owned patents on gene sequences were allowed to test and research on various sequences, which slowed the rate of potential research that could be done on any gene because companies were unwilling to share their patented gene sequences with each other. However, the new ruling seems to indicate that these gene sequences will no longer be considered property and that any medical research company can have access to the genetic information, which will allow more companies to research the gene leading, presumably, to advancements being made in the field at a quicker pace than they had been previously.

While the ruling reaffirms the sanctity of the human body as being above ownership by any individual or group, there are still some lingering concerns within the community. Some fear that the loss of gene patenting, rather than resulting in increased research, will result in several companies wasting valuable time and money researching the same things that other companies have already researched (since the firms are still under no legal obligation to share the research they’ve already attained when they had a patent on their researched genes) and that the lack of profit incentive will retard medical advancement. In this argument, copyright of genes is a necessary evil, which allows research to be incentivized through potential profit earnings and though it may raise the cost of gene therapy treatments in years to come, proponents of this viewpoint insist that economic motivation is primary driver of invention. However, this is a minority viewpoint and many point out that federal and state governments can still economically incentivize research through subsidies, making gene patents unnecessary. While reactions to the Supreme Court’s ruling continue to be largely, even overwhelmingly positive, some political commentators point out that the opinion reflects growing skepticism towards the state of the national patenting system and some even theorize that a future overhaul may occur in within the next few decades. In the past, the US Patent Office has been viewed as being too liberal in its issuing of patents, leading to what critics call a potential legal monopoly on emerging technological system, specifically pointing to Apple and its various products as the preeminent example of a de facto monopoly because its various patents keep other businesses from adequately competing with it.

This underscores a fundamental tension between the legal system and the patent system. Technology has reached the point where the rapidity and interconnectedness of its development are almost indistinguishable. In other words, technology develops quickly because of how quickly it is connected with and is used by others, but the patent system is seen as slowing the rapid development by allowing companies to monopolize key strategic elements of technology that other companies might need in order to develop competitive products. This prevents or, at the very least, disinclines companies to work with the patented technology because it will cost them more to develop interconnected products, which theoretically slows the development process considerably. If Apple develops a better processor for cheaper, it can monopolize the market with a superior product that it has no legal obligation to share. Thus a de facto monopoly is created from economic and technological superiority even while various anti-trust laws seek to prevent this exact thing from occurring. It is clear from the Supreme Court’s decision that they are firmly of the viewpoint that the patent system has overstepped its bounds and needs to be redefined. What future changes may be made to the patent system is unknowable, but it seems clear that the legal system is keen on lessening the power and importance of patenting.

Kevin James
Intern
JAFARI LAW GROUP®, INC.