A few months ago, my friend Professor Greg Dolin, MD, JD, Co-Director of the Center for Medicine and Law at the University of Baltimore and Johns Hopkins University, invited me to join his center on an amicus brief to the US Supreme Court in the matter of Association for Molecular Pathology v. Myriad, Inc. [PDF]. The issue in front of the Court concerned the patentability of isolated DNA sequences and cDNA, specifically those used in the diagnosis of a genetic mutation linked to breast cancer. The brief [PDF] that we submitted supported Myriad's position that both genetic tools qualify as patentable subject matter. There were two opposing views: the Petitioners, under ACLU leadership, argued that neither tool was patentable; the government argued that cDNA was patentable while isolated DNA was not.
As I noted previously, the legal question was easy: inventions are patentable; discoveries are not. All sides of the issue thus understood that the key to victory lay in convincing a majority of the Court that they had drawn the proper line between genetic discoveries and genetic inventions. I predicted in my previous article the Court would rule as we had urged it to rule. In point of fact, the Court adopted the government's position in favor of the middle ground allowing cDNA patents while precluding isolated DNA patents.
I have two general reactions to this ruling. The first comes from my perspective as a lawyer and a scholar; the second from my perspective as a citizen and a policy wonk.
While the headlines immediately trumpeted the Court's ruling that human genes are unpatentable, the truth is somewhat subtler. "Human genes" were never really at issue. The real issue centered on two classes of genetic tools derived from human genes. As I understand, there is really very little that a laboratory scientist can do with human genes unless, and until, they build a genetic tool. So what did the Court actually rule?
An analogy with a more familiar technology might prove enlightening. My own technical training is in computer science, not genetics. As most people know by now, computers respond to instructions coded as "bit strings," or sequences of 0s and 1s. Bit strings even complex ones, such as the one that decodes to Google's search engine are nothing more than numbers. No one would argue that a bit string is patentable because everyone understands that numbers are not patentable. Then again, the number that decodes to a given configuration of Google's search engine is not particularly useful in and of itself. To use it, a programmer must manipulate it, package it and implement it on a machine. At that point and only at that point can it qualify as potentially patentable subject matter.
The Court's Myriad ruling has had a corresponding effect in the genetic world. Gene sequences themselves are not patentable, but tools that transform them into something useful are potentially patentable subject matter. As a factual matter, the Court determined that isolated DNA was too close to a mere sequence, while cDNA made the cut as a useful tool.
From that perspective, this ruling was a narrow factual decision. While it does not comport with my understanding of the facts, it nevertheless represents proper judicial reasoning. In the final analysis and in my opinion the Court got the facts wrong but the law right. Justice Thomas presented a restrained opinion that is likely to effect the future of genetic research, treatment and commercialization but will have few ripple effects in the law. Justice Scalia's proposed formulation was even cleaner. I share his lack of personal knowledge about genetics. However, once he was convinced that isolated DNA was a discovery rather than invention, the inquiry was over.
What does this ruling mean to patients, companies and scientists for whom genetic therapies are more than academic legal exercises? The Court did not address any of these questions which is highly appropriate. Policy concerns are the proper purview of Congress, not the Court. They are important issues that deserve attention in any forum other than the courts.
In a somewhat ironic twist, the policy ramifications of this ruling may prove to be exactly right. The typical debate between proponents and opponents of therapeutic patents hinges on the difference between a short-term and a long-term view. There is no question that high prices on therapies that already exist represent a burden on many people who need them. There is also no question that these same high prices motivate companies and investors to develop and test the therapeutic treatments of tomorrow. Public policy determinations must balance these two concerns.
By ruling as it did, the Court introduced a good deal of uncertainty into the viability of existing patents, while providing ample ammunition to those drafting future patents. For more than twenty years, geneticists and their patent counsel have used language and formulations similar to those at issue in Myriad's patents. By undermining those expectations, the Court undercut many of those patents likely leading to increased competition and reduced prices on the tests and therapies that they protect.
At the same time, however, the Court preserved the patentability of many existing genetic tools. While it may take a bit more litigation for patent prosecutors and examiners to determine precisely which formulations work, they will soon determine a set of "magic words" that protect useful genetic tools without running afoul of the language that got Myriad in trouble here.
From the narrow perspective of the present day, the Court may have made existing therapies more readily available without curbing the incentives for investment. Of course, that's the sort of outcome that can only happen once every few decades. If it begins to become the norm, investors will simply shy away from an industry in which minor legal shifts can imperil massive multi-year investments.
All told, the drag on innovation that arises whenever the Court narrows patent scope is likely to be as small as the headlines are big precisely because of the legal restraint that the Court exhibited.
Bruce D. Abramson is an expert in the law and economics of technology who holds a Ph.D. in Computer Science from Columbia and a J.D. from Georgetown. His work combines expertise in valuation, strategy, technology assessment, and competitive analysis with experience in patents, copyrights, trade secrets, standards, competitive effects and licenses.
Suggested citation: Bruce D. Abramson Protecting Genetic Patentability Through the Myriad Ruling, JURIST - Sidebar, July 10, 2013, http://jurist.org/sidebar/2013/07/bruce-abramson-protecting-genetic-patentability.php.
This article was prepared for publication by John Paul Regan, an Assistant Editor with JURIST's Professional Commentary Service. Please direct any questions or comments to him at email@example.com