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”.

Update 2/10: There has been much more commentary as the Myriad case has progressed.  For starters, a Bob Carlson wrote this news piece, summarizing the court case and discussing the implications.  A case study from 2008 chronicles the longer-term legal and business context.  For one critique of the patents, based on their fundamental biological nature, see David Koepsell’s post on the subject.

A recent controversy involving a biomedical patent has gotten extensive coverage in the media.  The New York Times reported that a cancer patient in Austin, Texas, assisted by the ACLU, is suing Myriad Genetics and the US Patent and Trademark Office for granting a monopoly on testing for an allele of BRCA-2, highly correlated with some types of cancers.

The patent on genotyping BRCA-2 is a classic intellectual property case because the discovery of the BRCA-2-cancer correlation was a biomedical breakthrough, but the diagnostic technology Myriad markets for genotyping BRCA-2 is cheap, even mundane.   Myriad agrues it needs the patent to protect itself from free-riding companies who wish to offer the diagnostic technology, but didn’t have to pay for its development.

• ACLU page on the case.
• Myriad BRACAnalysis.