Sunday, April 21, 2013

Other people's bodies: a fresh perspective

Admittedly, I have scrupulously avoided making arguments based upon ethical perspectives that are grounded in religious beliefs when discussing gene patents or bioethics in general. This is largely because I am completely non-religious. I also think religious arguments do little to convince those who don't happen to share your beliefs. Nonetheless, Arthur Gershman's book Other People's Bodies offers a fresh perspective on issues in bioethics, with some special relevance to the gene patenting debate. Gershman is himself a registered patent attorney who has weighed in against gene patenting online, and in a number of other fora and media. His blog is here and includes a recent column from the Jewish Daily that opines against gene patents in relation to the Myriad case.

Gershman's short book is chock full of interesting and enlightening essays relating to bioethics in general, and educating the reader about the perspectives offered by Jewish thinkers and theologians. While I am not personally convinced by religious or even culturally-based arguments about the ethics of various biological studies or commercial actions regarding our tissues, bodies, or genes, I think it worth pointing out that the BRCA1 and 2 mutations, as with a number of monogenic mutations, disproportionately affect the Jewish population, just like Canavan's and Tay-Sachs, Ashkenazi Jews appear to have higher percentages of these diseases than other populations, as far as we know. I think that this gives us an obligation to recognize and respect to some degree a Jewish perspective, inasmuch as it offers a unique approach to the ethics of biological materials, bodies, and property emerging from this tradition, and take account of it in our political responses to issues like gene patents. I am happy that Gershman's book gives us this valuable perspective and recommend it to everyone dealing with this issue.

Tuesday, April 16, 2013

JUSTICE KAGAN: "And the PTO seems very patent happy"

I love that quote from Justice Kagan because it pinpoints the root of the issue. She said it when Myriad's attorney tried to justify the practice of patenting isolated genes by referring to the Patent and Trademark Office's past practice of doing so. She is right, and that office, run as it is by patent attorneys, much like the CAFC is dominated by them, is a poor guide for what ought to be the case. They are "patent happy." (see, e.g., the Peanut Butter Sandwich patent).

One should never try to predict what the Supreme Court will do in any given situation. Nonetheless, a brief analysis of the transcript of the oral argument in the Myriad case is revealing. The Justices seem inclined to hold in a way that readers of this blog will be familiar with: isolation of a gene is not enough, only changing the gene suffices to make it patentable. The questioning from the Court right from the start revealed their discomfort with the current "isolation" regime, which is unsurprising in light of their recent decision in Prometheus.

Mr. Hansen did an excellent job in his argument, under some difficult questioning, steering the discussion back to the question of whether a product of nature, merely isolated, should be eligible under Section 101. He cited all the best examples, arguments, and precedent. He also conceded as he should that recombinant DNA is eligible, and that the patents at issue in the Myriad case are not recombinant. He also left the door open for the Justices to do as they seem inclined to do, and follow the lead of the Solicitor General, ruling that the isolated genes alone are ineligible subject matter but that cDNA is. This is also the position I have maintained all along in my book and since. The attorney for Myriad had a tougher time of it, and the questioning of the Justices seemed to have him in a corner a couple times. Instead of recapping the arguments, I urge you read them yourself here. Also, I am providing links to some excellent in-depth and plain English analyses here, at Patently-O and at ScotusBlog. What I wish to do here is highlight sections from my book that made the same argument that seems likely to win the day, a conservative position I have maintained all along, arguing that mere isolation is insufficient to warrant patent, that some degree of intention (and design) is necessary to make something inventive, and that while engineered genes ought to be patent eligible, isolated genes alone ought not to be. Here are some relevant passages:

"Each instance of the un-engineered human genome is a naturally occurring object. Its existence as an abstracted ideal which is instantiated in you, me, and every other human, in its present form has no element of the type of expression described above. There is no mixing of labor with any present human genome’s form, nor is there any human intention involved." (Who Owns You? p. 111-12)
"All copyrightable and patentable objects are intentionally produced man-made objects and they are not merely ideas. Your DNA, or mine, or any other non-engineered being, is not an expression according to this description of intellectual property, and neither is any naturally-occurring subset of a genome (such as a gene or a SNP)." (Ibid, p. 112)
"Chemical formulas, for example, or natural laws, cannot be copyrighted or patented. The seminal Supreme Court case Diamond v. Diehr, specifically excluded from patentability “laws of nature, natural phenomenon and abstract ideas.” (Ibid, p. 113)
"Many gene patents are perfectly valid both legally and ethically. All valid patents use products of nature in some form, but they do not extend to protect the naturally-occurring parts of the invention. Most patents on new chemicals involve not just a patent on the new compound, but also a patent on the process of synthesizing the compound.These sorts of patents provide guidance for how gene patents can legally issue and still also promote innovation. New genes could of course be patented if they are man-made. New combinations of genes can also be patented if they are the products of human intention." (Ibid, p. 114)
"Many gene patents issue now in which the current use of the gene is in merely finding the same gene. This is quite absurd. It is like patenting the element iron, and then claiming that the use of iron is in finding iron, or patenting the Rock of Gibraltar and then claiming that the utility of the patent is in locating the Rock of Gibraltar." (Ibid., p. 115)

I quote these sections because they show that the arguments I made anticipated the same ones made in the Myriad case which began a couple months after my book was published. These same arguments have been to a large degree echoed by the questioning of the Justices. Together with Myths About Who Owns You the past year at least has demonstrated just how conservative my arguments have been and how they echo the thinking of at least some Supreme Court Justices as well as precedent, and that perhaps initial claims about how wildly inaccurate, off-base, or whacky my arguments were, were themselves wildly inaccurate, whacky and off-base, or perhaps merely ideologically-motivated.

Now of course, the Court may still rule that all gene patents are just fine, but at least I take comfort in having my arguments made in public court, in language and with examples similar to that I used in 2006 when I first confronted these issues from a philosophical perspective. I'm comforted that now my arguments seem firmly in the mainstream and persuasive to many if not all.

Saturday, April 13, 2013

Next Monday, I Like

This has been a big week leading up to an even bigger Monday. That's the day the Supreme Court finally hears the AMP v. Myriad appeal, and I'll be listening. But this past week I had the opportunity to revisit the issue in a number of venues. One was as a guest lecture for an honors class taught by Robert Zwijnenberg at Leiden University. His class is called "Who Owns Life?" and I was invited to discuss my views on gene patents from my book, Who Owns You. There I gave this talk: "Nature, Genes, and the Commons" with a great reception from the students and faculty. The questions were challenging and the discussion wide-ranging.

Later that same day, I appeared on The Forum, a show on KQED, the National Public Radio affiliate in San Francisco. The panel discussion entitled "Who Owns Your Genes" included: Lauren Sommer, science and environment reporter for KQED Public Radio, Karuna Jaggar, executive director of Breast Cancer Action, Jeffrey Lefstin, professor at UC Hastings College of Law, and myself. Again, this discussion was civil, interesting, in depth, and revealed the fundamental disagreements and agreements in anticipation of the Supreme Court's oral argument next Monday.

Finally, my friend Joanna Rudnick's great film, "In The Family" is being re-released. This film is an important view on the scientific and social role of the BRCA1 and 2 tests that Myriad monopolizes, and features the only taped discussion of those patents from Mark Skolnick, the founder of Myriad. Here is an excerpt from the press release, I urge everyone to watch the documentary online:

"As Supreme Court debates gene patenting linked to hereditary breast and ovarian cancer, POV and Kartemquin release In the Family free online

Emmy-nominated 2008 film by Joanna Rudnick features revelatory video interview with Myriad Genetics, defendant in the SCOTUS case.

Chicago – On April 15, 2013, the Supreme Court of the United States will hear a landmark case on the patentability of genes linked to hereditary breast and ovarian cancer.

To raise public awareness on the issues involved, the documentary In the Family – which helped spark the original case – will be streamed online for free to coincide with the hearing. In the film director/producer Joanna Rudnick tells her story of discovering she carries the BRCA gene mutation. She interviews other cancer “pre-vivors,” and in doing so is led to Myriad Genetics, sole patent holder of the BRCA genes and sole provider of genetic testing for mutations in the genes.

In the Family will be exclusively streamed online at, launching with the Supreme Court hearing of the ACLU’s challenge to the BRCA genes on April 15, 2013 for 30 days (through May 15, 2013), followed by a second streaming window of 30 days around when the verdict is announced.

Rudnick’s exposing video interview with Myriad’s founder Mark Skolnick – in which she questions why the cost of the test is going up despite advances in technology – remains the only on-camera comment Myriad has given on these issues since the case was launched."

On Monday, of course, we'll have some new material to review as the court's arguments become available online. 

stay tuned!