June 13, 2013

Unanimous Supreme Court Invalidates Gene Patents; Genetic Testing Options Will Expand

Today, the Supreme Court ruled that isolated human genes are not patentable. The case is Association for Molecular Pathology v. Myriad Genetics, a challenge to gene patenting based on the patentable subject matter doctrine of 35 U.S.C. 101. Plaintiffs argued that isolated human genes are natural products which cannot be patented, and that Myriad Genetics' patents on the BRCA1 and BRCA2 (breast cancer) genes were thus invalid. U.S. patent law denies patents for products or laws of nature ("laws of nature, natural phenomena, and abstract ideas are not patentable"). Today’s unanimous opinion was written by Justice Thomas.  Most centrally, the opinion states that Myriad’s patent claims to isolated genes fall within the product of nature and law of nature exceptions to patentable subject matter – as a result, they are invalid. In the ongoing debate over whether genes are simply chemicals or genetic repositories of information (see here), the Court clearly chose the genetic characterization: 
Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. 
The Court further noted that “[Myriad’s] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule." I have argued that this is the most relevant characterization to considering the patent eligibility of genes (and did so in the amicus brief that I filed in at the Court). In resolving the issue of whether an actual invention was present, the Court did not find Myriad's work to be inventive, in contrast to the work that produced a genetically engineered bacterium in Diamond v. Chakrabarty
In this case, by contrast, 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. 
This absence of invention was fatal: 
We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material. 
The opinion is helpful in reiterating that discovery and invention are not identical, which is a point that many of us had argued: 
Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.
The Court rejected any deference to the U.S. Patent and Trademark Office’s issuance of patents on isolated genes, noting that Congress had not spoken to the issue and that the executive branch itself was divided, with the U.S. Solicitor General arguing against the patenting of isolated genes. In holding that isolated genes are not patentable, the Court did hold that cDNAs (complementary DNA molecules with exons left in and introns removed) are patentable because they are not naturally occurring; that aspect of the decision will be important for biotech applications using cDNA to produce recombinant proteins (such as pharmaceuticals or gene therapy). In a broader sense, this decision now enters the lineage of patent decisions from the Supreme Court that squarely define the limits on patentable subject matter, but it's also one more opinion that does not elaborate in detail on any required line-drawing. The decision is a reaffirmation that natural subject matter may not be patented - but it contains no shortcuts to defining "products of nature" or "laws of nature" - undoubtedly leading to further eligibility disputes.

This landmark decision invalidates Myriad’s patent claims to the isolated BRCA1 and BRCA2 genes – an outcome which will open up the genetic testing options for patients for the BRCA1 and BRCA2 genes, expand the research opportunities for scientists, and provide physicians with more diagnostic options than they currently have. The constricted clinical climate created by Myriad’s patents have taken a demonstrable toll on the development of the genetic testing field for the BRCA1 and BRCA2 genes, and this clinical field has not enjoyed a competitive testing environment, in contrast to other clinically significant cancer-related genes. That should change quickly, and clinical developments in the BRCA1 and BRCA2 field should rapidly accelerate. Already, researchers (including Dr. Mary-Claire King, whose pioneering research first established a genetic basis for some breast cancers) are declaring that they will expand their testing portfolio to include BRCA1 and BRCA2 gene testing. The consequences of this decision are very real for women who seek BRCA1 and BRCA2 testing in order to determine if they have a high risk of early onset breast and/or ovarian cancer: more testing choices, coupled with likely lower testing costs in a competitive marketplace. The decision now renders all patent claims to isolated genes invalid, using the logic of the opinion, and this outcome will remove a key patent-related obstacle to the progress of clinical genetics.

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