yalepatents.org is on temporary hiatus while I finish my dissertation, but I thought I’d share some relevant sources of procrastination from the past few weeks.  First of all, On Point, the news program from WBUR-Boston, hosted a discussion on gene patenting and the Myriad/BRCA case.  Tom Ashbrook and his guests hold an accessible discussion, providing a nice starting point for those interested in gene patenting and biotech industry.  Notably, Chris Hansen of the ACLU defends his organization’s side in the case, arguing that a ruling in favor of the plaintiffs will not hinder biotech patents, but will promote competition and innovation in the industry.

Getting away from the economic immediacy of biotech intellectual property, some recent literature begs the question: what is professional bioethics good for?  Some of the recent discussion has been prompted by a new book, Observing Bioethics, by Renee C. Fox and Judith P. Swazey.  Though I look forward to reading it as soon as possible, Sally Satel provides a provocative review in The New Republic. Satel, a resident scholar at the conservative American Enterprise Institute, has written that the political and professional wing of the bioethics movement (in government and on hospital staffs) has distracted attention from its academic soul, transforming a philosophical field into an activist one.

Arriving as populist movements battle healthcare reform, this critique of bioethics is quite timely.  However, the anti-bioethics position conveniently, and attractively, avoids anti-elitism.  Satel argues in a recent essay from the Hoover Institution that bioethicists simply don’t have an expert advantage over average citizens the way geologists do in the climate change debate.  Rather, when they participate in the political discussion or on hospital review boards, “their value is mainly cosmetic or bureaucratic”.

Book Review: Who Owns You? The Corporate Gold Rush to Patent Your Genes, by David Koepsell.

Common wisdom holds that, at this historical moment of economic upheaval, war, and the broad threats to the relative homeostasis of our natural world (including from climate change and modern pandemics), the deliberation of law and policy occurs under a firm utilitarian mandate to maximize welfare with the inexact tools of government.  As political instruments, patents and copyrights are the utmost in means-to-an-end: “a highly pragmatic invention”, David Koepsell calls intellectual property rights, not entirely as a compliment.  In his newest book, however, Koepsell argues for a holistic reexamination of an increasingly far-reaching policy—the issuing of human gene patents.  His analysis is not limited to economic arguments for or against our current intellectual property regime.  Rather, he interjects with a question that many brush-off in the heated debate about scientific intellectual property: “is the current treatment of DNA as intellectual property consistent with its nature?”

The artificial, pragmatic nature of patent law makes it a fruitful policy realm to debate,  and the economic importance of patents make the system an attractive one to optimize.   This is a point made by many who argue that our current system of intellectual property protections is broken.  Koepsell goes a step further, however, in his philosophical analysis of gene patents and their relationship to justice.  Patents, because they have no status in natural law, must be judged solely by their economic effectiveness.   That does not mean, however, that patent protections are disconnected from a more fundamental notion of justice.  Gene patents, Koepsell argues from several philosophical and legal perspectives, actually “tend toward injustice”.

Koepsell provides historical context for intellectual property laws, and his treatment of gene patents is a useful primer on the subject.   He firmly argues that, pragmatic considerations or no, DNA sequences are not patentable because they are not intellectual property.  Even individuals who disagree with his philosophy cannot deny, as Koepsell demonstrates, that patents on human DNA sequences are a haphazard policy created without real political discussion.  In reality, they have were born largely of rulings by the judiciary, without legislative debate.  Because of the novelty of biological technologies, the judicial branch and society-at-large have been side-swiped by the collision of intellectual property and basic biology, and Koepsell writes that the results of this unpreparedness are increasingly shocking.  The ability of universities and companies to patent genes is a reflection of the blunt fact that “under most legal systems you do not own your body as authoritatively or completely as you own, for instance, a tennis racket or car.”

I predict that the accessible philosophical theory in Who Owns You will resonate with biologists, in spite of the utterly pragmatic operation of modern biomedical science—focused (as it should be) on delivering products and, even in the academy, profits.   True, biologists might not need an education in the ontology of DNA but, if they wish to have a place in the debate over intellectual property, they desperately need to be reminded that though the laws they investigate may be universal, the laws that govern our society are artificial and, by definition, suboptimal.

Indeed, as is painfully obvious in the evolution of biological patent jurisprudence, policy is often outpaced by science. Though a useful point of discussion, the fundamental significance that Koepsell gives to “genes” already seems a bit outdated. Technology developed since the genome and HapMap projects is delivering a much more complicated picture of how the molecules that make up our cells and bodies go about their business—providing a much larger potential pool of patentable material than was known even a few years ago.  If patenting DNA sequences is ontologically perverted, what about patents that cover other molecules and fundamental biological processes? This year’s Nobel Prize in chemistry, revealing the structure of the ribosome is, for all intents and purposes, locked up in patents.  Patents covering signaling molecules relevant to disease are no less a part of ourselves than DNA. And yet, as patentable objects, they blur the lines between universal biological entities and the artificial pharmaceutical designs that Koepsell and others accept as legitimate intellectual property.

The debate over patenting biological discoveries is so fascinating because it lies at the very intersection of controversial and emotional discussions such as economic growth and public health policy, social justice and privacy. It is all too easy to characterize the disagreement over intellectual property law (especially patents) as and elite feud among wealthy corporations, tech-savvy researchers and legal policy wonks.   Koepsell makes an extensive argument that gene patents should be recognized as a social justice and human liberty issue, yet still this leads to uncomfortable assertions. He qualifies his carefully argued grievances about bio-patenting by stating that, as an issue, it is “not comparable in scale to debates over civil rights leading to the abolition of slavery, or the civil rights laws of the 1960′s”. Such a “non”-comparison is no such thing; by staking moral ground somewhere below the largest dilemmas our society has confronted, Koepsell leaves the reader wondering how they should order gene patenting among their moral outrages.  Channeling ethical concerns over gene patenting is work of a more political sort, but Who Owns You provides a real philosophical foundation to anyone interested in the debate—including scientists who often consider (wrongly, I argue) the realm of legal and political philosophy outside of their purview.

Book: Who Owns You? The Corporate Gold Rush to Patent Your Genes, by David Koepsell.  Wiley-Blackwell, 2009.

In their book, Patent Failure, James Bessen and Michael J. Meurer provide a sober critique of the U.S. patent system, focusing on doctrinal and technological shifts that have fundamentally disrupted the efficiency of the rights we bestow on technological inventions.  Their conclusion: during the last decade, our patent system has broken down because it failed to operate as a transparent system of property rights for inventions.  As a result of, among other factors, the huge cost of identifying relevant, competing patents–often claiming broad, early-stage innovations–the authors argue that patents cost industry more than they deliver, especially in high-tech sectors.

Bessen, a former software executive and currently lecturing at Boston University and Meurer, a law professor at BU, base their evaluation of the modern patent system on cost-benefit estimates for inventors of different scales in different industries.  Their conclusion, that patents do not provide the clear boundaries that are necessary in a workable system of property rights, is based heavily on a comparison of different industries.  Their research indicates that one modern industry where patents are particularly efficient–in that they impose very little cost on the profits they provide–is the chemical industry, where there is very little to argue about when it comes to a specific molecule that is patented.

Though they focus on software patents as an example the deleterious effects of overly vague patent claims, they highlight biotechnology as an industry similarly fraught with bad patent practices.  They blame the legacy of the Bayh-Dole act, encouraging universities to patent basic research, as well as a reduced requirement that patents be shown to have “utility”, a legacy of sometimes-conflicting rulings by the Federal Circuit during the ’90s.  The reduced burden of demonstrating that an invention is useful, or that it has been developed beyond the discovery stage has at least two negative implications: (1) that patents on basic scientific discoveries have become overly vague and discouraging to future inventors and (2) an oft-cited “flood” of patents has overwhelmed both the patent office and the ability of inventors and firms to search for patents that might compete with their ideas or research.

From the perspective of biomedical patenting, Bessen and Meurer’s contrasting characterization of chemical-pharmaceutical patents from those in the  biotech/biologic drug industry highlights one broad confusion over drug patents.  Contrary to many claims, the apparent success of traditional chemical patents does not portend the same happy fate for patents on complex biological drugs, much less patents on gene sequences or discoveries about basic biological systems.  When patent apologists claim that patents are essential for the drug industry, their enthusiasm may be outdated.

————————

Book – Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators At Risk, by James Bessen and Michael J. Meurer (Princeton, 2008).