yalepatents.org

I’ve neglected the blog here at yalepatents.org for the last several weeks as graduation, moving, etc. have taken their toll on my attention.  I’m leaving Yale in the next few months, so it is fitting to bring this collection of posts to a close.  For over a year, I’ve used yalepatents.org to jot down some of my thoughts about the intersection of law, politics and biomedical science. My goal has been to present these topic from a researcher’s perspective.  My next blog will correspond with my transition to law school, where I’m excited to have the chance to think more deeply about technology law, regulation and the use of scientific data in legal decision-making.  I’ll link to that blog when it’s live, but for now, please peruse the yalepatents.org archives, by month:

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.

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I’m back from defending my thesis (apparently successfully), just in time for  big news in the biomedical patent world.  The summary judgment ruling against Myriad Genetics and its BRCA gene patents, announced yesterday, brings up many questions about the future of patents covering genes and, potentially, other biological phenomena.   Obvious, however, is that the US patent office (USPTO) was shamefully uncritical of the claims from the original patent applications, a problem that extends to many, many similar patents.

Valid patent claims are meant to be narrow and novel but, by claiming invention of a short (15 nucleotide) DNA sequence, the BRCA1 patent clearly violates these criteria.  This is the conclusion that Duke researchers elaborate in a recent investigation, where they elegantly demonstrate what should be obvious to anyone with a minimal understanding of statistics (which was clearly not the case for the patent examiner).  The BRCA1 patent claims (in language similar to many gene patents): “An isolated DNA having at least 15 nucleotides of the DNA of claim 1″ (claim 1 being the protein sequence BRCA1).  Thomas B. Kepler, Colin Crossman, and Robert Cook-Deegan at Duke calculated that BRCA1 contains 5,575 individual 15-nucleotide sequences (15-mers).  Since the same protein sequences can be encoded in different DNA sequences, there are actually 1.6 × 10⁶ 15-mers that could encode the patented sequence of BRCA1.  As there are only 1.07 × 10⁹ possible 15-mers (DNA only has four letters), the patent could actually cover 1 in 600 of all possible 15-nucleotide DNA sequences (1.6 × 10e6/1.07 × 10e9).  The authors calculate that an average human gene would have 15 of the 15-mers covered by the patent! It should be noted (and this is a compliment, not a criticism) that this theoretical analysis requires nothing more than a calculator.  Searching for DNA or protein sequences can be done, for free, by anyone with a web browser; it was a bit more difficult, but not impossible, when the Myriad patents were filed in the late ’90s.  The merit of patenting such sequences may be debated as a point of policy; their novelty and uniqueness may not.

The court didn’t look into such specifics, but rather at the broader applicability of patent law to genetic information   Yesterday’s ruling focuses on whether the BRCA patents fall within the realm of “products of nature”, which have been held to be non-patentable.  The court found the genes to, indeed, be such a natural product.

Though there will certainly be much to debate in the ruling (which, no doubt, will be appealed), one of my favorite parts is a not-so-subtle rebuke of the USPTO, as well as Myriad’s argument that the government’s wisdom in granting patents should be respected:

The Federal Circuit has previously held that it owes no deference to USPTO legal determinations.  See, e.g., Arnold Pship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004) (“This court reviews statutory  interpretation, the central issue in this case, without deference.”).  While Congress has created a presumption of validity for issued patents, approximately 40% of patents challenged in the courts have been found invalid, demonstrating that this presumption is far from absolute.

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?”

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The Obama administrations’s Office of Science and Technology Policy has extended the deadline for comment about new rules requiring the results of government-funded research be available to the public.  These rules will, most likely, undercut the current system of research journals, which make money by charging both authors and readers (subscriptions run in the thousands of dollars).  The Electronic Freedom Foundation has weighed-in on the issue, calling public access “so blindingly, obviously good that you have to wonder why it hasn’t already been implemented.”  At Techdirt, Mike Masnick, who writes about the economics and politics of new media, says of science journals: “It’s a great scam, and they don’t want it to end.”

Open-access journals have come into their own recently; some of the titles from the Public Library of Science (PloS) have even broken even, showing that quality, peer-reviewed journals can operate with an open model.  However, as I wrote a few days ago, there is a spectrum possibility when it comes to “public access”.  Public repositories such as PubMed Central provide access to publications (i.e. text, figures, and supplementary data that is included in the original paper).  As research becomes more data intensive, the real challenge is going to design systems to hold extremely large data sets, and provide the public access to that data in the form of useful, interpretable “information”.