Family Feuds on Intellectual Property

The med-bio-tech blogosphere is bubbling with commentary on intellectual property issues following last week’s polemical op-ed on gene patents by Michael Crichton in the New York Times, Denise Caruso’s article the week previous (free here), and the recent introduction of the Genomic Research and Accessibility Act in the House (H.R. 977). All three pieces are unanimous, more or less, in their disdain for gene patents.

The general sentiment among my RSS feeds (here, here, here, here, here), especially in regards to Crichton’s piece, is that any outright dismissal of gene patents is foolhardy since it takes an important, complex issue and turns it into a soundbite that is so overly simplistic (“gene patents are bad”), that large numbers of people may actually come to believe it. Much like test tube babies or genetically modified organisms, gene patents are in the category of things that just sound wrong to many people, regardless of whether there is any merit to the belief.

While bold pronouncements like “gene patents are bad” (and the inverse) can be gratifying for the sense of clarity they provide, more often than not their progenitors are guilty of some sort of intellectual cheapness.

If you are interested in dipping your toe in waters of intellectual property and genomics, and you want to an even-handed analysis of many of the big issues, my advice is to forget Michael Crichton and the blogosphere, instead do yourself a favor and read Misha Angrist and Robert M. Cook-Deegan’s very thoughtful recent article in The New Atlantis entitled “Who Owns the Genome?”. Here is a snip:

The race to map the human genome seemed to embody two rival ways of doing science: the public pursuit of human knowledge paid for with public dollars and the private pursuit of useful knowledge paid for with private investments. Each way of doing science has its purist adherents, but in reality the relationship between “public” science and “private” science is a complicated thicket, especially when it comes to the brave new world of genomics. Nation by nation, laboratory by laboratory, regulation by regulation, we are still trying to figure out who “owns” the genome, what the owners actually own, and how best to balance the pursuit of knowledge, the allocation of rewards, and the development of life-improving biotechnologies. Innovation continues apace, but no one really knows how close we are to the optimum policies. The system works, but no one knows how well, because no one can address the crucial question: compared to what?

…And given a realm with so much complexity, so many interests, and so many unknowns, tinkering with the parts is probably the best we can do. But it is also possible that the gathering enthusiasm for “open and collaborative” research, even in the private sector, signals an inflection point. Perhaps we have moved beyond the impassioned rhetoric of public versus private; perhaps we no longer regard the human genome as either “the common heritage of all mankind” immune from IP rights or as a Wild West for speculative patents and endless court fights.

If you do want to get into the details of the impact of patents on genomics, there are many juicy places to start shining your light. The juciest, in my opinion, is a recent court case that involved exactly zero gene patents: LabCorp vs. Metabolite.

Why is it the juiciest? Even though this case did not directly involve gene patents at all, the enforcement of one of the claims in Metabolite’s patent (and others like it) will undoubtedly have a major impact on the development of genomics and personalized medicine as we know it. This is why major players in the genomics industry hired attorneys and got involved when the case was escalated to the Supreme Court.

Even more interesting, two major genomics companies wrote briefs for opposing sides. And even more interesting than that, these two companies are family members (but clearly not kindred spirits on this issue).  One of the companies, Perlegen, is a recent spin-out of the other company, Affymetrix. It was a family feud of the sort that usually only takes place on daytime TV.

To get to the bottom of why this patent case is so important, you probably need to be a legal scholar (which I most definitely am not). Short of that, here are a couple things you can do:

  1. Read a brief history of the LabCorp v. Metabolite case, a good one is here

  2. Familiarize yourself with Claim 13 in Metabolite’s patent (the so-called ‘658 patent) and commit to memory the phrase "test plus correlate", a.k.a. “assay plus correlation”

  3. Read the Supreme Court briefs (thanks Patently-O) and Breyer’s dissent. If you only interested in the gossip, then you can focus on the Perlegen-MDV brief and Affymetrix brief

  4. Understand the concept of inducing patent infringement and understand that this lawsuit was brought by Metabolite because LabCorp purportedly induced infringement by educating physicians about a physiological fact (high amino acid X means low vitamin Y).

  5. Figure out how wide the liability net could be cast for inducing patent infringement via correlations. You might go about this by first figuring out how to get your hands on Lori Andrew’s 2006 piece in the Chronicle (the article is for subscribers only), then figure out if you think this case has the potential of creating a scenario as dire as the one she predicted.  Thought police?

  6. Figure out how high throughput sequencing affects “assay plus correlation”, knowing that today the two steps are closely coupled (I get assay X specifically for correlation Y) and that in the future the two will be uncoupled (I get assay X, like a full genome sequence, for an evolving set of correlations A-Z), and that the actors involved are going to change (hello web)…then revisit #5 above.

  7. Write to me and tell me what you think ;)

For a more thorough look at gene patenting controversies, I also recommend this article:

Caulfield T, Cook-Deegan RM, Kieff FS, Walsh JP. Evidence and anecdotes: an analysis of human gene patenting controversies. Nat Biotechnol. 2006 Sep;24(9):1091-4. (sorry subscribers only)

Want more? Check out Robert Cook-Deegan’s publication page.

Epstein on Genetic Privacy

Not everyone agrees that legally enforced genetic privacy, i.e. GINA (H.R. 493), is a good idea.  One of the earliest voices of opposition to genetic privacy was Richard Epstein (dating back to a 1994 paper, see below).  At the University of Chicago Law School Faculty Blog, he makes his case against genetic privacy:

The larger point here is that genetic information is in principle no
different from any other kind of information that can be asked about a
given person…Does it really make sense to prohibit the use of genetic information
that might explain why a person has shortness of breath and then allow
the employer to look at medical records that reveal that condition. The
claims of privacy are the same in both cases, and both should be
rejected. Sure, you can keep anything quiet if you don’t want to get a
job, but if you do, then the employer could require the disclosure in
order to allow it to control its costs and to make intelligent
decisions. Do we really want work[er]s with heart conditions to conceal
their risk when a simple reassignment might forestall a catastrophic

If you’re following GINA, Kaiser published a nice summary of the current status of the bill today.

Richard A. Epstein, The Legal Regulation of Genetic Discrimination: Old Responses to New Technology, 74 B.U. L. Rev. 1 (1994)

Genetic Alliance’s policy page on GINA