The Rules of the Genetics Road: Supreme Court Ruling on Patent Law is Just the Beginning

A few weeks ago I was sitting in a lecture on human genetics by a premier Stanford professor when he stopped to pose a question to the crowd:

“By show of hands, which of you would have your genome sequenced right now?”

It was a crowd of 75 highly educated scientists who are actively engaged in medical research at the University of California, San Francisco, a school known for pushing the boundaries of human health sciences.

Only a smattering of hands went up. Genome sequencing – the process of detailing an individual’s entire DNA code – is cheaper, faster, and more accessible than ever before. The resulting data can be incredibly powerful in predicting disease and analyzing ancestry.  But when the conversation turns to their own genome, my colleagues are often unwilling to commit. In a world where Angelina Jolie goes public with the genetic rationale behind her recent double mastectomy, why are the scientists the skeptics?

This question came back to me as I read last month’s decision by the Supreme Court concerning the patenting of human genes in Association for Molecular Pathology v. Myriad Genetics. Myriad Genetics, Inc. was founded in 1994 by the researchers at UC Berkeley who published the discovery of the human gene BRCA1 and later BRCA2 (BReast CAncer type 1/2 susceptibility). Nearly 20 years later, the BRCA genes are still seen as the best predictor of breast cancer risk.

On June 13, The Supreme Court decided in a 9-0 decision that isolated human genes are not patentable. Photo courtesy of Tufts University.

On June 13, The Supreme Court decided in a 9-0 decision that isolated human genes are not patentable. Photo courtesy of Tufts University.

Having published their discovery and unable to keep the BRCA1/2 sequences a trade secret, Myriad filed several patents on the genes. They were granted and became the basis for the risk-screening technology that Myriad sells to the public for about $4000 a test. In essence, they wanted monopoly rights to BRCA1/2 because they had found and isolated them first. For nearly the entirety of the 20-year protection period (ending in 2014), Myriad has been the sole provider of BRCA screening in the U.S. But the BRCA genes had so much impact on breast cancer health care that eventually disgruntled scientists, alongside the American Civil Liberties Union (ACLU), sued. Filed in 2010 as Association for Molecular Pathology v. Myriad Genetics, the plaintiffs argued that the identification and isolation of a human gene is not an invention. It is a discovery and should not be patent eligible.

As the case made its way up to the Supreme Court, one thing became clear: the patent law was not the problem, the biology was. Under 35 USC § 101, only “new” inventions or discoveries are patentable. The rulings therefore dance around one question: does isolating DNA from nature, but changing nothing about it, constitute a ‘new’ invention?

On June 13, The Supreme Court decided unanimously that isolated human genes are not patentable, while upholding the validity of Myriad’s diagnostic patents and the closely-related cDNA it produces in its screening process. This means that while Myriad retains control of its proprietary cancer risk screening technology, the decision opens the door for other companies or academic labs to use the BRCA1/2 genes to develop alternatives. The landmark element is simple: human genes are part of nature, and you cannot patent nature.

The concurring opinion by Justice Antonin Scalia is what caught my attention, however.

In a one paragraph addition, Justice Scalia says “I join the judgment of the Court, and all of its opinion except Part I-A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge…”.

That statement is why I did not raise my hand when asked about my genome a few weeks ago. I am a curious fellow; I would love to know what is in there. What holds me back is the speed at which our science is outstripping our policy.

Patent law is a small portion of public policy, but it bothers me that the basics of genetics – genes and screens – are just now being properly implemented. The Human Genome Project was funded by Congress in 1987 and its first draft published in 2001. Today thousands upon thousands of unique genomes are being sequenced and analyzed with powerful tools far more complicated than a screen for breast cancer risk. While the Myriad case is not the first canonization of genetic policy, we still ought to stop and ask the question: Are we adequately prepared for the ethical and practical conundrums of the genetic revolution?

In a media scene currently full of news about National Security Agency (NSA) surveillance programs, national security, and Internet freedom, we need to add human genetics to the conversation. I am concerned that the precedents set now will be extremely influential in how our genetic policies continue to take shape. Given the potential dangers of widely available genomic information, it is imperative that as a society we begin to think deeply and carefully about the ethics of human genetics and how the law ought to reflect that.

   "Is the speed of science outstripping our policy?" Photo Courtesy of  U.S. Department of Energy Office of Science.

  "Is the speed of science outstripping our policy?" Photo Courtesy of  U.S. Department of Energy Office of Science.

The Myriad ruling comes down as a reminder that human genetics policy is in its highly malleable infancy. We are in the cautious first steps of defining the rules to the genetics road. How exactly the ubiquitous introduction of genetics to society will begin to impact personalized healthcare, privacy, and business is unclear. As personality, intelligence, health, race and even behavior are assigned genetic explanations, humanity must be valued as something with deeper roots than the 1 percent of our genome which differentiates us from the rest of the animal world. If we discover a test for the genetic signatures of homo/heterosexuality, should the government regulate its use with an age limit? If predisposition to alcoholism can be identified at infancy, is the child already an alcoholic? Who ought to have access to that information? Do we have a right to know the implications of our own genome? Our spouses? Our children?

These are questions about identity and whether our genetic code ought to define our personal and legal lives. These questions are far beyond the scope of The Supreme Court’s ruling on Myriad. But sooner or later information about our lives will become more than a tool for targeting advertisements. Our human genetics policy, from patent law to healthcare and beyond, ought to be guided by a deep respect for human dignity, in the spirit of Imago Dei.

Christians have a chance to bring the core of the Gospel message, God’s delight in individual human persons, and apply it to a brand new area of policy at its most formative moment. We have a chance to dole out a little bit of the Kingdom for the world to see.

Christians ought to remember that The Court serves not as a voice on ethics but as a voice on the law. Myriad is a step in the right direction, but the more important steps will come from informed and engaged people who work to keep human dignity a fundamental goal of genetics policy. I look forward to being a part of the expanding conversation about science, policy, and the how two ought to inform each other.

-Kenneth Hallenbeck is a graduate student at the University of California, San Francisco working at the interface of biophysics and drug discovery. You can follow him on Twitter @kenkhallenbeck.