Family, Privacy, Secrets, & The Law

By Michele Goodwin

The Family, Privacy, Secrets, & The Law Roundtable (March 7-8. 2013) was a great success.  Kudos to the brilliant presenters and commentators who came together for this important, groundbreaking session, including Lori Andrews, Glenn Cohen, June Carbone, Laura Rosenbury, Camille Gear Rich, Martha Field, Deborah Epstein, Martha Ertman, Gaia Bernstein, Taunya Banks, Naomi Cahn, Michael Pinard, Karen Czapanskiy, and Eleanor Brown.  Thanks to all who attended and contributed to this excellent meeting.    Coverage can be found here and here.

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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Twitter Round-Up 1/1-1/13

By Casey Thomson

Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:

  • Frank Pasquale (@FrankPasquale) posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
  • Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
  • Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
  • Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
  • Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
  • Michelle Meyer (@MichelleNMeyer) posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
  • Michelle Meyer (@MichelleNMeyer) also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
  • Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]”. (1/8)
  • Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
  • Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
  • Frank Pasquale (@FrankPasquale) posted an article discussing the recent move by  various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

TODAY: Stem Cell Therapy and Medical Tourism

TODAY, September 28, 2012
3-4:30 pm (reception to follow)
Austin 111, Harvard Law School

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide.  Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies.

This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy.  Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children.

The event will be moderated by M. William Lensch, Harvard Stem Cell Institute.  Speakers and topics include:

  • Brock Reeve, Harvard Stem Cell Institute
    Welcome and Introductions 
  • George Q. Daley, Harvard Stem Cell Institute
    Stem Cells: The Gap Between Current Science and Clinical Implementation 
  • Jill Lepore, Harvard University
    Resurrection, Past and Present 
  • Tim Caulfield, University of Alberta
    Stem Cell Tourism: Is the Problem Getting Worse? 
  • Insoo Hyun, Case Western Reserve University School of Medicine
    Therapeutic Hope and Its Challenges for Rational Ethical Discourse 
  • I. Glenn Cohen, Petrie-Flom Center, Harvard Law School
    Stem Cell Tourism, Children, Abuse, and Reporting

There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception.

This event is free and open to the public.  Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Upcoming Event – Stem Cell Therapy and Medical Tourism: Of Promise and Peril? 11/28/12

Wednesday, September 28, 2012
3-4:30 pm (reception to follow)
Austin 111, Harvard Law School

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide.  Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies.

This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy.  Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children.

The event will be moderated by M. William Lensch, Harvard Stem Cell Institute.  Speakers and topics include:

  • Brock Reeve, Harvard Stem Cell Institute
    Welcome and Introductions 
  • George Q. Daley, Harvard Stem Cell Institute
    Stem Cells: The Gap Between Current Science and Clinical Implementation 
  • Jill Lepore, Harvard University
    Resurrection, Past and Present 
  • Tim Caulfield, University of Alberta
    Stem Cell Tourism: Is the Problem Getting Worse? 
  • Insoo Hyun, Case Western Reserve University School of Medicine
    Therapeutic Hope and Its Challenges for Rational Ethical Discourse 
  • I. Glenn Cohen, Petrie-Flom Center, Harvard Law School
    Stem Cell Tourism, Children, Abuse, and Reporting

There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception.

This event is free and open to the public.  Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

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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Sherley v. Sebelius and the Future of Stem Cell Research

Glenn Cohen, and his co-authors Jeremy Feigenbaum and Eli Adashi, have a new piece out in JAMA today, Sherley v. Sebelius and the Future of Stem Cell Research.  Here’s a brief excerpt:

While enactment of “personhood” bills would constitute the most significant threat to hESC research, the outcome of the 2012 presidential election will also play a large role in where the science goes. Should President Obama be reelected, the status quo will in all likelihood be maintained. Much less is known as to policies that might be pursued by a potential Romney Administration. Still, former Governor Romney is on record opposing the proposition of creating a human embryo through “cloning” or “farming” for the sole purpose of research, ie, “when the sole purpose of its creation is its sure destruction.” Romney is also on record in support of a constitutional amendment that establishes life as beginning at conception. All told, these positions, seconded by Congressman Paul D. Ryan (R, Wisconsin), the Republican vice presidential candidate, and echoed by the Republican Party platform, could substantially alter the prospects of hESC research.

Apart from the aforementioned considerations, the future success of stem cell research cannot be ensured absent the following provisions. First, the derivation of hESC cell lines, especially disease-specific lineages, must proceed apace. Such in vitro models permit a detailed interrogation of the molecular pathology of recalcitrant maladies, allow for the identification of druggable targets, and enable the testing of candidate therapies. Policies intent on limiting publicly funded hESC research to existing cell lines—as advocated by former President George W. Bush—run the risk of curbing progress while shifting the onus of underwriting to the private sector. Second, hESC lines, the current gold (if ideologically contentious) standard, cannot as yet be replaced by the (ideologically more neutral) human-induced pluripotent stem cell (hiPSC) lines of adult origin. Indeed, the molecular signatures and the safety profile of current hiPSC lines are sufficiently distinct from those of hESC provenance so as to qualify their imminent application in the clinical arena. Policies designed to favor hiPSC research—as espoused by Romney—may prove premature and unduly proscriptive.

Take a look at the whole Perspectives piece here.

New Product Liability Regime for Stem Cell Products?

By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. Read More