Who Owns Your DNA? What Innovators Need to Know About the Supreme Court's Decision

July 12, 2013

Daniel W. Young PhD

(as published in BostInno)

What This Means To You

  • The Supreme Court sided with the ACLU holding that claims to isolated DNA segments that exist in nature are not patent eligible claims to certain synthetic molecules relevant to genetic testing, as well as certain method of use patents likely remain patent eligible.
  • Because the Court emphasized that "isolation" is not sufficient to render natural DNA fragments patent eligible, the implication of this decision on the patent eligibility of other isolated products such as isolated cells, RNAs, polypeptides (including antibodies and therapeutic proteins), and others is unclear and likely will be addressed in future litigations. Indeed, the patent eligibility of isolated stem cells has recently been challenged under Myriad.

Recent news of Angelina Jolie’s elective mastectomy has flooded the media, with article after article commenting on her decision to undergo surgery after a genetic test showed that she carried a mutated version of a gene called BRCA1. Mutations in BRCA1, as well as another gene called BRCA2, are associated with an increased risk of developing breast cancer and/or ovarian cancer and by choosing surgery, Jolie significantly reduced her risk. This news propelled a controversial Supreme Court case back into the general public limelight: The Association for Molecular Pathology v. Myriad Genetics. Various stakeholders, from diagnostics professionals and the biotech community, to doctors and patients, long awaited a decision to clarify underlying patent eligibility issues at stake.

Myriad Genetics, the company at the center of the controversy, controls patents relating to the BRCA genes, including claims to the isolated DNA encoding BRCA, synthetic molecules and methods of use. Myriad had essentially been the only entity offering genetic testing to evaluate whether individuals have mutations in BRCA genes, and has leveraged its patents to stop others from practicing similar tests. This lawsuit began when a group of researchers, medical patients, advocacy groups, and doctors interested in Myriad's testing sought to challenge the validity of its patents. In particular, the case questioned whether or not it was legal for companies like Myriad to patent human “genes.”

On June 13, the Supreme Court unanimously ruled that human genes cannot be patented because they are “a product of nature.” The Court stated that Myriad did not create anything new or alter the gene and simply isolating a gene is not enough to obtain a patent. The court announced that certain types of synthetic DNA (referred to as cDNA) are patent eligible provided they are distinguishable from natural DNA. The verdict received mixed reactions from the biotech industry, and both parties in this case have claimed victory. The American Civil Liberties Union, which represented the petitioners, touted “our genes belong to us, not companies;” whereas Myriad focused on patent eligibility of cDNA and emphasized that it still has valid and enforceable claims conferring strong patent protection for its BRACAnalysis® test.

There was an immediate perception that the Supreme Court’s ruling would allow other companies to develop and ultimately provide similar testing, reducing the cost and making the test more accessible to patients. Indeed, the day after the Supreme Court’s decision, Ambry Genetics announced the launch of BRCA1 and BRCA2 analysis as part of their comprehensive cancer-testing menu. But this perception will likely be short lived because Myriad responded by filing an infringement suit against Ambry and seeking preliminary injunctive relief to stop Ambry from offering its BRCA testing. Myriad protested that “before the ink on the Supreme Court’s decision was dry, Ambry publicly announced and put an order form on its web site offering BRCA1 and BRCA2 genetic testing” and asserted it was filing the lawsuit because Ambry’s testing requires use of methods and synthetic DNA over which Myriad has exclusive patent rights. Myriad emphasized the Supreme Court’s decision only impacts 5 of its 520 patent claims relating to BRCA1 and BRCA2 testing and took the position that “[w]hile the Court invalidated a small number of claims, it clearly affirmed the patent eligibility of synthetic DNA and underscored the importance and applicability of method-of-use patents for gene-based diagnostic tests.”

Many view the landmark decision in the Myriad case as marking a new era for the medical and biotech communities. While the decision is significant, it does not mean the end for the diagnostics industry and other industries utilizing genomic techniques. The bottom line is: claims to isolated DNA segments that exist in nature are not patent eligible, but claims to certain synthetic molecules relevant to genetic testing—as well as certain method-of-use patents—likely remain patent eligible. Moving forward, leading companies, many in our own backyard here in Boston, will continue to test the waters under a new landscape, pursuing development of cutting-edge technologies across industries. Time and future litigation, including Myriad’s suit against Ambry and a similar suit it filed against Gene-by-Gene, will reveal how the decision shakes out in practice.