New Amicus Brief Filed on Behalf of Dr. Eric Lander in the Supreme Court in the Myriad (Gene Patent) Case

I am pleased to announce that Gideon SchorVern Noviel, and I filed an amicus brief on behalf of Dr. Eric S. Lander in a pending Supreme Court case that will address whether human genes are patentable.  The case is Association for Molecular Pathology v. Myriad Genetics, No. 12-398 and will be argued April 15, 2013.  Lander is a leading genomics researcher and is President and Founding Director of the Broad Institute of Harvard and MIT. We think the brief will play a key role in helping the Supreme Court chart a path through this legal thicket.  The full brief can be downloaded here http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf. Here is an excerpt from the brief, the Summary of the Argument:

This case hinges on a scientific question: whether DNA fragments from a human chromosome are (1) products of Nature or (2) at least similar enough to products of Nature that they should not be considered “markedly different.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The members of the Federal Circuit panel below agreed that the DNA of a whole human chromosome was a product of Nature. But the majority held that isolated DNA fragments of a human chromosome were not products of Nature.

Because the majority made (without citing scientific support) a foundational assumption that isolated DNA fragments of the human genome do not themselves routinely occur in Nature, it considered whether they are similar enough to products of Nature. Employing analogies, the panel members debated whether isolated DNA cleaved from a chromosome was akin to a leaf plucked from a tree, or a kidney surgically removed from a human body.

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A Fascinating Reproduction Story in the New York Times, Part II: Creating a Family with a Stranger

About 10 days ago, the New York Times had two fascinating stories about reproduction (on back-to-back days) that I wanted to highlight and comment on. I discussed the first one here. In this post, I will take about the second story about “co-parenting” (though that term has a separate set of meanings related to divorce) through modamily.com. Modamily is a website (one among a series of such websites according to the story) that allows non-romantically affiliated people (i.e., strangers to start with) get together to produce a child and co-parent it, sort of match.com for parenting without any romantic relationship. The story centers on one couple, Ms. Hope and Mr. Williams and reports:

“Neither Ms. Hope nor Mr. Williams is interested in a romantic liaison. But they both want a child, and they’re in serious discussions about having, and raising, one together. Never mind that Mr. Williams is gay and that the two did not know of each other’s existence until last October, when they met on Modamily.com, a Web site for people looking to share parenting arrangements. Mr. Williams and Ms. Hope are among a new breed of online daters, looking not for love but rather a partner with whom to build a decidedly non-nuclear family.”

I find the convergence of assisted reproduction and web 2.0 fascinating. Here are a few thoughts: First, some sub-set of readers will say “well, what about the children” of these liasons? They will express a fear that the interests of these kids will have been set back. I have two responses: how different is this from single parent reproduction, or reproduction by couples likely to divorce? Further, as I have written about some countries’ attempts to limit the use of reproductive technologies as a single individual as well as a number of other kinds of restrictions on reproduction (see this and this and this and this). there are deep intellectual problems with these kinds of Best Interests of the Resulting Child arguments.

Second, there are some interesting, fairly subtle, eugenic impulses expressed (perhaps unintentionally) by the writer of the story in the Times. The story begins by describing “A 6-foot-2 former model who loves animals, Mr. Williams is athletic, easygoing, compassionate and organized.” If I can be slightly info-mercial/Sex and the City about it, the sub-text appears to be along the lines of “Gee, ladies, wouldn’t you like a piece of that for your kids!” This is of a piece with some of the other academic work I have discussed in earlier posts on the sperm ‘donors’ chosen in reproductive technology practices and their uber-mensch characteristics. That said, as I have written elsewhere, under what circumstances such eugenic impulses are wrong as opposed to being the reproductive technology equivalent of some of what many of us do in sexual mate selection remains very much contested ground.

Third, I think the article raises interesting questions about the unbundling of romance and reproduction. One might think that in the current world of “hook-ups” among our youth, that we have already begun to decouple sex and romantic relationships, and anonymous sperm donation uncouples romance and reproduction (through non-sex), but this takes it further still. One interesting wrinkle here is the non-commodified nature of the non-intimate form of reproduction. There are no arms-length doctor and bank mediated relations between the gamete providers, rather they are trying to become intimately involved in a non-sexual way without any money involved.

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Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

By Michelle Meyer

As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to a variety of mood and cognitive disorders, including depression, suicidality, memory loss, dementia, confusion, and aggression. Once thought mostly to afflict only boxers, CTE has more recently been acknowledged to affect a potentially much larger population, including professional and amateur contact sports players and military personnel.

CTE is diagnosed by the deterioration of brain tissue and tell-tale patterns of accumulation of the protein tau inside the brain. Currently, CTE can be diagnosed only posthumously, by staining the brain tissue to reveal its concentrations and distributions of tau.[1] According to Wikipedia, as of December of 2012, some thirty-three former NFL players have been found, posthumously, to have suffered from CTE. Non-professional football players are also at risk; in 2010, 17-year-old high school football player Nathan Styles became the youngest person to be posthumously diagnosed with CTE, followed closely by 21-year-old University of Pennsylvania junior lineman Owen Thomas. Hundreds of active and retired professional athletes have directed that their brains be donated to CTE research upon their deaths. More than one of these players died by their own hands, including Thomas, Atlanta Falcons safety Ray Easterling, Chicago Bears defensive back Dave Duerson, and, most recently, retired NFL linebacker Junior Seau. In February 2011, Duerson shot himself in the chest, shortly after he texted loved ones that he wanted his brain donated to CTE research. In May 2012, Seau, too, shot himself in the chest, but left no note. His family decided to donate his brain to CTE research in order “to help other individuals down the road.” Earlier this month, the pathology report revealed that Seau had indeed suffered from CTE. Many other athletes, both retired and active, have prospectively directed that their brains be donated to CTE research upon their death.[2] Some 4,000 former NFL players have reportedly joined numerous lawsuits against the NFL for failure to protect players from concussions. Seau’s family, following similar action by Duerson’s estate, recently filed a wrongful death suit against both the NFL and the maker of Seau’s helmet.

The fact that CTE cannot currently be diagnosed until after death makes predicting and managing symptoms and, hence, studying treatments for and preventions of CTE, extremely difficult. Earlier this month, retired NFL quarterback Bernie Kosar, who sustained numerous concussions during his twelve-year professional career — and was friends with both Duerson and Seau — revealed both that he, too, has suffered from various debilitating symptoms consistent with CTE (but also, importantly, with any number of other conditions) and also that he believes that many of these symptoms have been alleviated by experimental (and proprietary) treatment provided by a Florida physician involving IV therapies and supplements designed to improve blood flow to the brain. If we could diagnose CTE in living individuals, then they could use that information to make decisions about how to live their lives going forward (e.g., early retirement from contact sports to prevent further damage), and researchers could learn more about who is most at risk for CTE and whether there are treatments, such as the one Kosar attests to, that might (or might not) prevent or ameliorate it.

Last week, UCLA researchers reported that they may have discovered just such a method of in vivo diagnosis of CTE. In their very small study, five research participants — all retired NFL players — were recruited “through organizational contacts” “because of a history of cognitive or mood symptoms” consistent with mild cognitive impairment (MCI).[3] Participants were injected with a novel positron emission tomography (PET) imaging agent that, the investigators believe, uniquely binds to tau. All five participants revealed “significantly higher” concentrations of the agent compared to controls in several brain regions. If the agent really does bind to tau, and if the distributions of tau observed in these participants’ PET scans really are consistent with the distributions of tau seen in the brains of those who have been posthumously-diagnosed CTE, then these participants may also have CTE.[4]

That is, of course, a lot of “ifs.” The well-known pseudomymous neuroscience blogger Neurocritic[5] recently asked me about the ethics of this study. He then followed up with his own posts laying out his concerns about both the ethics and the science of the study. Neurocritic has two primary concerns about the ethics. First, what are the ethics of telling a research participant that they may be showing signs of CTE based on preliminary findings that have not been replicated by other researchers, much less endorsed by any regulatory or professional bodies? Second, what are the ethics of publishing research results that very likely make participants identifiable? I’ll take these questions in order. Read More

A Myriad of Options in the Spirit of the Law

by Adriana Lee Benedict

In a couple days, petitioners in AMP v. USPTO will be filing their brief on the merits following the Supreme Court’s grant of certiorari in late November.  For many, the Supreme Court’s ruling in this case will provide a long-awaited answer to the question of whether or not isolated DNA is patentable subject matter under §101.  In August, the Federal Circuit ruled on the case for a second time following a remand from the Supreme Court, in which the Federal Circuit was asked to reconsider its ruling in light of the Supreme Court’s recent ruling in Mayo v. PrometheusThe majority, written by Judge Lourie, found that Mayo did “not control the question of patent-eligibility of such claims. They are claims to compositions of matter” and that while “Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature.  Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature.”  Judge Bryson’s dissent, on the other hand, explained that, “In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done ‘enough’ to distinguish his alleged invention from the similar product of nature,” concluding that Myriad had not made a “substantial ‘inventive’ contribution” or claimed anything more than a combination of “well-understood, routine, conventional” elements.”

It seems likely that the Supreme Court will agree with Judge Lourie that the gene patents in question in Myriad, whether or not they are products of nature, are not laws of nature, as some of the patents in question in Mayo were.  Yet I would be surprised if they took this to mean that Mayo therefore does not control the question of patent-eligibility in Myriad.  In Mayo, Justice Breyer’s majority opinion was incredibly clear that the metabolic correlation at issue was not patentable under §101 because it tied up a law of nature and therefore preempted its use for further research.  Isn’t that exactly what Myriad is about?  Certainly all parties would agree that Myriad’s patents, whether natural products (physical phenomena) or not, serve to preempt breast cancer research on the BRCA1 and BRCA2 genes.

When the Supreme Court articulated the §101 exception for laws of nature, physical phenomena and abstract ideas in Gottschalk v. Benson, it explained that these kinds of claims were not patentable because they consist of the “basic tools of scientific and technological work.”  It is difficult to dispute that Myriad’s isolated genes are basic scientific tools. But according to Myriad, under this rule, their patents would only be invalid if they claimed real human DNA, and that it is not dispositive that their isolated DNA is nearly identical to real human DNA, because it is not naturally occurring.

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Using Tissue Samples to Make Genetic Offspring after Death

By Yu-Chi Lyra Kuo

Last month, John Gurdon and Shinya Yamanaka were jointly awarded the 2012 Nobel Prize for Medicine for their research on induced pluripotent stem cells (iPSCs).  iPSCs are capturing the public imagination as embryonic stem cells did fifteen years ago, but without the controversy surrounding the destruction of embryos: iPSCs can be garnered instead from living somatic tissue of an organism at any point in its lifespan–even late adulthood.  Yamanaka’s research has shown that somatic cells can be “reprogrammed” to develop into any kind of cell–including an embryo–speaking to the vast research potential of iPSCs.

In light of the research potential of iPSCs, I wanted to highlight the results of a remarkable study (published last month) where scientists induced iPSCs from mice into primordial germ cell-like cells, and aggregated them with female somatic cells to create mature, germinal oocytes. The team was then able to show that these oocytes, after in vitro fertilization, yield fertile offspring. Essentially, the research team created viable mouse embryos from skin cells, and fertilized them using IVF to produce healthy mice, some of which have already produced offspring of their own.

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Reflections on a Recent Study Showing Sperm and Egg Donor as Übermensch/Uberfrau

Last week, I sat on a panel at the Mid-Atlantic Law and Society Association, with my wonderful colleagues Kim Mutcherson, Gaia Bernstein, Rene Almeling, and Cynthia Daniels on sperm donor anonymity. [NB: as in most of my work I will use the term “donor” because it is used in common parlance while acknowledging that “seller” is more accurate].

Among other topics discussed, Cynthia shared with us a new paper she has just published in Signs, co-authored with Erin Heidt-Forsythe, the contents of which I found fascinating and I think some BOH readers may as well. They examined the characteristics of 1,156 sperm donors from the top twelve sperm banks in the U.S., and found them to be very much (in my view) that of the ubermensch and uberfrau (in the Nazi conception of the term, not necessarily the original Neitzchean).

Among other findings they note that 44% of sperm donors are above 6 feet tall compared to 10% of American men; 61.9% have healthy weight in Body Mass Index (BMI) terms, as compared to 32% of the U.S. population; 62% had a college or higher degree compared to 26% in the U.S. population and only 2% of sperm donors had high school as their highest level of educational attainment compared to 32% of American men.

They also found that African-American and Latino donors, both underrepresented groups in sperm donor pools compared to the U.S. population, were much more likely to be listed as being on the light or medium skin tones for those groups rather than the dark side, again in variance with the distribution in the general population

They then compared these findings to a similar review of 359 egg donors recruited from eight fertility clinics.

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PCSBI: Privacy and Progress in Whole Genome Sequencing

Yesterday, President Obama’s Commission for the Study of Bioethical Issues released its fifth report: Privacy and Progress in Whole Genome Sequencing.  I haven’t had a chance to digest it yet, but for now, just wanted to call it to everyone’s attention.  The gist seems to be privacy, privacy, privacy.

Here are the major recommendations, straight from the Commission’s “mouth”:

Recommendation 1.1
Funders of whole genome sequencing research; managers of research, clinical, and commercial databases; and policy makers should maintain or establish clear policies defining acceptable access to and permissible uses of whole genome sequence data. These policies should promote opportunities for models of data sharing by individuals who want to share their whole genome sequence data with clinicians, researchers, or others.

Recommendation 1.2
The Commission urges federal and state governments to ensure a consistent floor of privacy protections covering whole genome sequence data regardless of how they were obtained. These policies should protect individual privacy by prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample came.

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To Tell or Not to Tell: Should Researchers Contact Anonymous Donors to Help Them?

By Cansu Canca

A recent New York Times article drew attention to an issue with increasing importance as technology develops. Gene samples collected under conditions of anonymity reveal more and more information that may be of crucial importance for the subjects or their relatives. Researchers feel a moral obligation to disclose these important findings, which may even be life-saving, to the subjects. Yet, the anonymity clause in the consent forms prevents them from doing so.

Whether or not researchers can or must disclose the information in spite of the anonymity clause mainly turns on two issues: the scope of the informed consent and the reach of the obligation for beneficence.

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