In contrast to so many current political debates–climate change, abortion, health care–intellectual property law often appears to occupy a rarefied perch accessible only to patent experts, clerks and judges.  Patent policy is unnervingly complicated, with deceptively simple patent laws that are burdened with complicated webs of judicial interpretations.  It is little wonder, then, that most of us take for granted our government’s policy of granting and enforcing patents–if only as a cognitive coping strategy.  This complexity-induced apathy, by the way, suits patent lawyers just fine, and might be acceptable most of the time because, as in the case of an undersea oil-well blowout-preventer, patents may work pretty well, except when they don’t.

Patents on human DNA sequences (at least 20% of our genes are locked up) are increasingly viewed as deterrents to a new generation of genetic-diagnostic technologies, as well as to basic biomedical research itself.  That is the belief held growing number of physicians, researchers and legal experts, as well as this author.

Why do I use the word, “belief”?  Simply put, though the specifics of patent law are largely excluded from raucous public debate, the costs and benefits of patent reform are nevertheless as hypothetical, and worthy of argument, as in the cases of health-care reform, climate-change strategy or nuclear disarmament.  Proponents of the current system claim that the current patent regime is nothing less than vital to innovation.  As in any debate, those in favor of the status quo can point to experience, arguing that current technology would not have arisen without patent protection.  The apparent conservatism of this position belies the fact that our current patent regime–and any patent regime–is an artificial, legislated concept.  Defending it from alteration by claiming that it is an optimal policy is, thus, rationally unfeasible.

Some of the current momentum behind the reform of gene patent policy results from evidence that future genetic tests will be hamstrung by patents held by universities and companies–patents that give these organizations control over virtually any use of the human genes they claim.  That is the conclusion shared by a recent report from the HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS).  The prediction that patents will impede progress may not, in itself, be sufficient reason to make changes to the policy.  However, the Committee points out the exceptionalism of patient care:

Indeed, in the realm of commodities or consumer electronics it may well be that dramatic harms and a profound lack of benefit should be required to compel any recommendation for change. But genetic tests affect patients’ lives and health.  Thus, the current system’s net negative effects on test development and patient access to these tests argue strongly for the narrowly tailored changes that are proposed.

These proposed changes are two-fold: (1) a diagnostic test exemption, allowing human genes to be analyzed even if they are protected from other uses (i.e. as therapeutics) by patents; and (2) a research exemption, allowing any use of patented genes in the pursuit of biomedical research.  This second exemption may come as a surprise to many, even to scientific researchers themselves.  Many scientists I’ve talked to either assume that common law (or common sense) already exempts their work from violating patents (mostly because it is unbelievable to many genetic researchers that DNA sequences could be patented in this way).  However, court decisions have decreased the research exemption to nil.  The SACGHS report argues for the clear enunciation of the legality of research on patented genes, if only to promote the rule of law.

Agree or disagree with these proposals–that is their major benefit!  They give something concrete to agree or disagree with to those citizens (especially relatively apolitical research scientists) who may have felt sidelined by the complexities of patent law debates.  Furthermore, gene patents are a natural starting point for a more general debate over patent policy because they affect anyone who intends to ever get medical care.

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.

Rebecca Eisenberg, a biomedical patent law expert at the University of Michigan, in a recent paper (available for download), reviews several studies and presents new evidence that reassess some early warnings about overactive biomedical patenting creating an “anticommons”.  She writes:

Most scientists report no difficulties in attempting to acquire IP-protected technologies, and only a small percentage report significant delays in research or having to abandon a project because of IP issues. Even in fields characterized by extensive patenting, many academic researchers seem to be either oblivious to the patents they might be infringing or unconcerned about potential infringement liability. More significant to researchers than patents as such have been practical restrictions on access to materials and data such as requirements for institutional assent to the terms of materials transfer agreements (MTAs).

See also: Rebecca Eisenberg’s faculty page and bibliography.