By Tania Simoncelli

On June 13th, the Supreme Court issued a unanimous decision in Association for Molecular Pathology v. Myriad Genetics that held that genomic DNA cannot be patented. Specifically, the opinion, written by Justice Thomas, found that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."1

Some initial news reports portrayed the decision as "mixed"2 or "a partial win"3 for Myriad.4 But make no mistake: The Court's decision is an extraordinary victory for the 20 national medical societies, medical geneticists, genetic counselors, advocacy groups and individual women who became plaintiffs in this effort four years ago. As a result of the ruling, Myriad will no longer maintain a legal monopoly over any use of the BRCA1 and BRCA2 genes, Myriad will no longer dictate the standard of care and extent of testing for these genes, and Myriad's tests - on Myriad's terms and at Myriad's prices - will no longer be the sole choice for women who wish to obtain their BRCA status.

More importantly, this decision reaches far beyond Myriad. In fact, the goal of this case was never to invalidate only Myriad's patents (or bankrupt the company, for that matter, as some financial news stories that focused obsessively on the rise and fall of its stock price might have led some to believe). The goal instead was to end the U.S. Patent and Trademark Office's (PTO's) fundamentally misguided gene patenting policy that had allowed for thousands of patents to be issued on naturally occurring "isolated" DNA sequences over the past 30 years.5 Indeed, as a result of the decision, all existing claims to naturally occurring DNA sequences have effectively been invalidated, and no future claims of this sort will be granted.

Justice Thomas's opinion itself is short (18 pages). Its straightforward, matter-of-fact tone is in contrast to the oral argument, where each of the justices (with the exception of Thomas, who didn't speak) grappled with the meaning of "isolated DNA" through a series of colorful analogies and feisty exchanges. Isolating DNA was likened to extracting a medicinal substance from a tree in the Amazon, and distinguished from carving a baseball bat from a tree. In a wonderful moment, Justice Sotomayor proclaimed isolated DNA to be "just nature sitting there." And Justice Breyer, in a terse exchange with Myriad's attorney, demanded to know whether he agreed with the scientific fact that isolated DNA fragments do in fact occur naturally in the body.

The notion that a company could be awarded a patent on a part of the human genome is fundamentally at odds with basic intuitive sense. It is no doubt difficult for those who have not followed the twists and turns of the gene patent debate to appreciate the full ramifications of the decision. But for those of us who have been in this fight for several years, an ultimate win on gene patents - and a unanimous one at that - was truly astounding.

This case began approximately seven years ago. It grew out of an effort I had the privilege of leading as ACLU's Science Advisor at the time. My work involved identifying emerging and important issues in science and technology that had implications for civil liberties. The patenting of human genes was one of several issues that I identified as worthy of further exploration. Chris Hansen, a senior ACLU attorney who eventually became the lead litigator for the plaintiffs, was immediately taken by the idea of challenging this fundamentally flawed policy and practice. A multi-year exploration and analysis ensued, during which time Chris and I - joined along the way by Sandra Park, an attorney in ACLU's Women's Rights Project - spoke with dozens of researchers, pathologists, medical geneticists, genetic counselors, activists, and others around the country to get their take on whether a legal challenge in this area was a worthy endeavor and what it would need to achieve.

Most everyone we spoke with was supportive of our taking action, and some went on to become plaintiffs or experts in the case. But almost no one thought we had anything more than a sliver of a chance of winning. Patents had been issued on genes for more than 20 years, the biotech industry had grown up around this practice, the patent bar was deeply entrenched in the status quo, and several had tried and failed to change PTO's policy through a formal comment process associated with the agency's issuance of its utility examination guidelines for gene patent applications in 2001. Industry's claims that the patents were necessary for encouraging investment would no doubt be a force to reckon with: in 1999, a joint statement by Bill Clinton and Tony Blair affirming that human genome data should be freely available to all scientists sent biotech stock prices plunging, apparently because some interpreted the statement to mean that gene patenting might be banned.6

Given these and other challenges, how and why did our side ultimately prevail? These are questions I will no doubt be probing for at least another seven years, but for now, I will offer a few initial insights.

First, this effort didn't begin with the filing of the case in 2009, or even the 3-4 years that led up to it. It was preceded by - and benefitted tremendously from - years of analysis, publication and advocacy that served as a foundation for our case. The Council for Responsible Genetics, in particular, had been on the record for more than 25 years as opposing gene patents and deserves significant credit for having helped to build a coalition of scientists, academics, environmentalists, and others who have written and spoken extensively on this issue over the years.

Central to this case were our plaintiffs and key experts, an exceptional and diverse group of individuals and organizations directly impacted by Myriad's (and in some cases others') patents. They included clinical geneticists who had received "cease and desist" letters ordering them to stop offering BRCA testing in their labs, women who couldn't access testing or who wanted to obtain a second opinion, genetic counselors who wanted to provide their patients with multiple options for testing, researchers who felt that unfettered access to the genome is essential for scientific progress, and national scientific and medical organizations whose members wanted to develop better, more comprehensive tests than the one offered by Myriad. Each of these participants demonstrated extraordinary courage in joining this effort and their compelling stories about how gene patents were impacting their lives and their work were the core fabric of the case.

Importantly, the law was on our side. Full-length genes, genomic DNA sequences, and genetic mutations - whether "isolated" or not - are clearly products of nature. The Court's decision affirms what it has made clear through 150 years of precedent; namely, that products of nature, laws of nature, and abstract ideas are not patentable subject matter under Section 101 of the Patent Act. Furthermore, something is not patent-eligible simply because it is commercially useful or because its discovery required intensive work and resources, or because it has been removed from its natural environment. As the decision makes clear, "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."

We were also right as a matter of policy. We argued throughout this case that patent protection at the level of the gene is not necessary for stimulating investment in gene discovery or ensuring the development of genetic tests; instead, gene patents have served to inhibit research, data sharing, and innovation in diagnostic testing. That argument was supported with new evidence in the immediate aftermath of the decision: Within 24 hours, at least 5 labs had announced that they would begin offering testing for the BRCA1 and BRCA2 genes. Some of the labs promised to offer testing at a lower price than Myriad's. Mary-Claire King, the researcher who is credited by the scientific community for having mapped the BRCA1 gene onto chromosome 17, announced that she will take steps to immediately add BRCA1 and BRCA2 to a multi-gene panel that will provide a more personalized assessment of cancer risk than is currently offered through Myriad's testing.

Timing was also key. We filed this case amidst an increasing drumbeat of promises that the $1,000 personal genome was on the horizon. The notion that we would soon be able to sequence our entire genome for $1,000 made Myriad's charge of nearly $4,000 for only two genes seem outlandishly expensive. At the same time, a number of multi-gene tests were coming onto the market, but with them came increasing concerns and stories about patent thickets interfering with their development. Science had clearly outpaced a policy that was nonsensical from the start, and some in the biotech community could no longer agree with the trade organization's position that gene patents were necessary or even good for innovation. Three diagnostic manufacturers went so far as to join the side of the plaintiffs in the final stage of the case.

The timing of our initial filing also coincided with the first year of the Obama Administration. In 2011, when the case was before the US Court of Appeals for the Federal Circuit, the Solicitor General filed an amicus brief on behalf of the United States that outright rejected the PTO's longstanding policy and supported plaintiffs' position that isolated DNA is not patentable. In arguing before the Court, the Solicitor General stated: "We couldn't write a brief that allowed the patentability of isolated DNA, for to do so would be to make lithium patentable, uranium, coal from the earth, and a whole variety of other substances ... It was just impossible to do given the Supreme Court's clear guidance." The U.S. Government's shift in position was a pivotal moment in the case, and no doubt an important factor in the Supreme Court's decision to hear it.

Finally, we had a little luck along the way. Perhaps most important was the random drawing of Judge Sweet in the District Court. Judge Sweet not only engaged thoroughly in the case, but had the support of a clerk who happened to have a PhD in molecular biology. The result was a beautifully written, well-reasoned, scientifically accurate, 126-page opinion that set the course for the remainder of the case.

Myriad attempted at every stage of the case to confuse and complicate the issue at hand. The company argued that it had "created" and "designed" a new molecule that had never existed before and attributed inventiveness to techniques in molecular biology that were standard even at the time that Myriad isolated the BRCA1 and BRCA2 genes. Ultimately, our side prevailed by maintaining focus on the relatively simple and straightforward legal and scientific questions at hand. The Court's decision is a victory for women, patients, researchers and the future of medicine that should serve as a reminder to us all that with the right coalition, well timed action, support of the law, and a little luck, change is possible.


Tania Simoncelli served as Science Advisor to the ACLU from 2003-2010 where she played a lead role in developing the Myriad litigation. She is also coauthor with Sheldon Krimsky of Genetic Justice: DNA Data Banks, Criminal Investigations and Civil Liberties and a former board member of CRG.


1. Justice Scalia wrote a 1-paragraph concurring opinion, stating more or less that while he could not affirm all of the "fine details of molecular biology" he agreed with the upshot of the opinion.

2. Stohr, G. et al., "Gene patents limited by Court in mixed ruling for Myriad," Bloomberg, June 13, 2013.

3. Holland, Jesse J., "High Court says human genes can't be patented, partial win for Utah company," Associated Press, June 13, 2013.

4. These initial reports were no doubt referring to the second part of the Court's main holding, namely that complementary DNA (cDNA) "is patent eligible because it is not naturally occurring." But while the cDNA question was an important one, it was not the central question in this case. The central question was whether genomic DNA was patent eligible.

5. The PTO made clear its policy to allow patents on DNA sequences in 2001, stating that an "isolated and purified DNA molecule that has the same sequence as a naturally occurring gene" is patentable subject matter. In justification of its policy, the PTO stated that "[A]n excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature." Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001).

6. Reynolds, T., "Genome data announcement fuels stock plunge, misunderstanding," Journal of the National Cancer Institute, Vol 92(8): 594-597. Available at:

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