Chapter 6 - The Supreme Court's Dilemma - Isolated Gene Patenting and Laws of Nature


    Laws of Nature

    In the past few months the Supreme Court of the United States has been in the headlines for all the wrong reasons. With the swearing in of Brett Kavanaugh as the newest justice and the bitter battle that raged through his confirmation hearings, I have to conclude that the partisan politics of Washington DC and the polarization of America's citizens are preventing the Supreme Court and the government from making actual policy decisions that affect real change. In spite of this backdrop it is important to remember that the Supreme Court has been quietly and conscientiously making non-partisan (or less partisan) decisions on healthcare and technology lawsuits that influence how we do science and business. The Supreme Court has made judgements on a long list of patent litigations over the years. Three years ago I wrote about one such case, AMP v Myriad, Naturally occurring isolated DNA is not patentable subject matter; cDNA is (2013 case). This case had wide ranging consequences and stood out for me as a landmark because it drew the line in biotechnology between what is patentable (a gene that has been altered in the lab) vs what is not patentable (a naturally occuring gene in its native unaltered form). It is a shame that such cases are not highlighted more in the media, on social media or draw out huge crowds of protestors.


    A few years ago a company named Myriad Genetics filed 23 patents for breast cancer genes their scientists had isolated, known as BRCA1 and BRCA2.  Myriad offers a business to exclusively carry out diagnostic testing for the BRCA genes which would indicate a person's propensity for developing cancer. The patent would have given Myriad exclusive rights to charge a premium on breast cancer diagnosis and grow the company.  However, many people opposed this patent, citing issues of patent infringement and arguing that licenses would impinge restrictions on other diagnostic healthcare services. Groups such as the Association of Molecular Pathology (AMP) together with the University of Pennsylvania's Genetic Diagnostic Laboratory filed suit with the American Civil Liberties Union against Myriad's BRCA gene patent.

    This case was initially brought to the District Court in 2010 in which the plaintiffs (AMP) were of the position that isolated genes are "unpatentable products of nature" and that diagnostic claims or drug screening claims by Myriad are just describing the basic process of doing science.  Myriad argued in defense that the BRACA genes were man-made "isolated sequences" just like chemical compounds and that any isolated DNA sequences are rendered a different character from DNA present in the human body. To some extent, Myriad are correct. Current medical research has shown that genes in the human body are subject to epigenetic modifications which depend on the environment, lifestyle and situation the person is in. If the gene is isolated from the body and placed into a test tube, it would behave differently because it would not be subject to those epigenetic changes. In a laboratory, one could also modify isolated genes using chemicals to synthesize something analogous to epigenetic modifications in the body.

    However, the case by Myriad was rejected by the District Court who ruled that the existence of DNA in isolation does not alter its fundamental quality as existing in the body. Myriad appealed to the Federal Circuit Court and in 2011, the Federal Circuit overturned the District Court's decision.  In response, AMP petitioned for a writ of certiorari to the Supreme Court asking for a review of their case.  In 2013, Justice Clarence Thomas ruled that naturally occurring DNA could not be patent eligible unless it had been altered outside the body.  Furthermore, Myriad had not created any new innovative methods to isolate this DNA, nor had they altered the natural genetic code in any way to satisfy patent eligibility.  Thus, all the Supreme Court justices at the time ruled unanimously against Myriad's patent file.

    Differing public opinions

    The differences of opinion between the Federal Circuit Court, the District Court and the Supreme Court reflect the high level of contention over gene patenting technology in the general public.  Although there are now over 5,000 US patents on human genes, many people believe that genes, passed along as traits from one generation to the next, should not be patentable because they are in some sense, private property. Breast cancer advocates often argue that a successful patent on BRACA genes would give Myriad the sole power to dictate all scientific and medical uses of the gene. This would take away power from cancer patients to choose where and how they get diagnosed.  On the other hand, many argue that gene patenting would allow greater competition among genetic diagnostic companies, such as Myriad and this would spur economic growth. Use of the patent system would also help disseminate information to society within the bounds of the legal system, providing a better framework for future innovation. Furthermore, a ruling in support of patenting genetic disease diagnosis could fund investment incentives to improve personalized medicine, an initiative prioritized by the National Institutes of Health.  Interestingly when this case against Myriad was raised in Australia, the courts held in Myriad’s favor.

    The fact that the US Supreme Court, comprising judges from non-scientific backgrounds with relatively little knowledge about the latest discoveries in medical sciences are put through the test ruling on topics such as gene patenting, adds fuel to the controversy.  When Justice Thomas gave his decision for the AMP v Myriad Case he wrote that, "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…" However, he later wrote on the same judgment, "by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule…" His two sentences contradict one another, suggesting that isolated DNA claims could simultaneously cover naturally occurring and nonnaturally occurring molecules. Thus one is led to believe Justice Thomas does not truly understand what a gene is.  It is also conceivable that the Supreme Court is not familiar with the field of epigenetics which would add another layer of complexity to whether a naturally occurring gene can be patented when it is completely altered inside of the body!  Then again one can argue that having judges who do not have scientific training decide on legal issues concerning science is good practice since they can apply an unbiased opinion when making rulings.

    Whatever the public opinion may be on isolated gene patentability, one thing is for sure, more patents will be filed in the future as more discoveries are made about diseases caused by faulty genes. Thus the legislative issues of AMP vs Myriad are likely to remain at the forefront.

    How does this affect you?

    If you are a scientist planning to file patent on a new disease associated gene, you must familiarize yourself with AMP vs Myriad and with similar cases, such as Mayo vs Prometheus and the Australian court ruling on Myriad.


    AMP vs Myriad,_Inc.

    Myriad case in Australia

    Mayo vs Prometheus,_Inc.


    NIH Grant funding priorities