Allison M. Whelan, J.D. Senior Fellow, Center for Bioethics and Global Health Policy, University of Minnesota Guest Blogger
On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs. A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.
Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.
I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2) “Synthetic Biology & Intellectual Property Rights”:
1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.
Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.
I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.
A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.
As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.
Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.
But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided. Continue reading →
With the emergence of new techniques in the field of reproductive technology, applications arise that seem more the realm of science fiction than reality. While many have considered stem cells to be the next frontier of modern medicine, reproductive technology may offer hope to many individuals suffering with rare and unique genetic diseases.
The term “savior siblings” refers to the use of pre-implantation genetic diagnosis (PGD) and other forms of in-vitro fertilization (IVF) in order to create a sibling for the purpose of providing biological material (bone marrow, blood, etc.) that can help treat or cure an existing terminally ill child. It is estimated that up to one percent of PGD in the United States is used to create children that are tissue matches for their siblings. See here.
There has been little meaningful discussion about savior siblings in bioethical or legal circles, and there is no formal regulation governing their use or creation in the United States. This stands in stark contrast to other countries, particularly England, France, and Australia, where a regulatory framework for the use of savior siblings has arisen along with debate over their acceptability. These countries are already discussing how to ethically deal with this extremely complicated issue. Continue reading →
In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).
Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.
One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.
Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.
Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized” by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.
Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013) and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.
When the Human Genome Project began in 1990, the National Center for Human Genome Research – now the National Human Genome Research Institute (NHGRI) – created a research funding program for evaluation of the ethical, legal, and social implications (ELSI) of genomics. ELSI scholars study a wide range of issues, from the responsible conduct of genomic research, to implementation and outcomes of genetic testing programs, to intellectual property challenges. But how should this research be evaluated? In particular, what impact should we expect for this kind of research? These questions are particularly challenging for those of us who work in the multidisciplinary Centers of Excellence in ELSI Research (CEERs) funded by the NHGRI, because these centers have been given a programmatic charge to consider policy-relevant questions and help to inform the policy-making process. A group of ELSI researchers, representing seven CEERs, have been deliberating these questions and recently published a paper with recommendations.
We noted, first of all, that policy-making occurs in many venues. Although discussions often focus on governmental policies, policy-making in other venues often influences genomic translation, including actions as diverse as Institutional Review Board (IRB) decisions about consent and return of results; guidelines promulgated by professional organizations; funding decisions of health insurers; and investment decisions of venture capital. In addition, policy-making in one arena may influence the need for policies in another. For example, practice guidelines influence the use of genetic testing and may in turn influence how clinical data are accessed to evaluate test outcomes, or how IRBs decide what genetic results should be returned to research participants. Continue reading →
The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.
JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.
The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless. The July 2014 issue of Health Affairs, “Using Big Data To Transform Care,” examines this new era for research and patient care from every angle.
You are invited to join Health Affairs Editor-in-Chief Alan Weil on Wednesday, July 9, for an event at the National Press Club, when the issue will be unveiled and authors will present their work. Panels will cover:
Emerging Issues and New Frontiers for FDA Regulation
Monday, October 20, 2014
We are currently seeking abstracts for academic presentations/papers on the following topics:
Stem cell therapies
Genetic (and biomarker) tests
Comparative efficacy research
Drug resistant pathogens
Mobile health technologies
Other related topics
Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at email@example.com by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.
We will notify selected participants by the end of June. Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ). Publication decisions will be made based on usual FDLJ standards.
Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent. After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards' valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014). Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.
While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.
Nonmedical sex selection is a thorny topic. Usually used to favor males, it has harmed women and resulted in sex ratio disparities in India, China, and other nations where son preference is strong. Sex selection is also troubling because it relies on infanticide, abortion, or the discarding of embryos based on their sex.
Since sex ratio imbalances are not a danger in the United States and equal rights and opportunities for women, though imperfect, are increasingly well-established, nonmedical sex selection in some circumstances, e.g., for gender variety in a family, may be more acceptable. That position, however, runs into the claim that any deliberate choice or preference about the sex/gender of offspring, even for a girl, is inherently sexist or gendered (see Glenn Cohen’s recent post). That position, however, is controversial.
Today two very interesting questions were raised about a common argument raised about sex selection, the risk that it will result in unbalanced sex ratios. Our discussion, I would say, “queered” the typical claim in two interesting ways, and I am curious what others think (to be clear these were my thoughts on questions raised, not putting words in their mouths).
Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission. Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative. The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.
This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director. Bring your questions!
This event is free and open to the public. Lunch will be served.
In the past few months, the Copenhagen Zoo has killed a giraffe and four lions in order to protect the genetic health of their breeding populations, generating significant international backlash and highlighting difficult questions about the value of species preservation.
The international controversy surrounding the zoo’s actions began in February, when it killed a healthy 18-month old giraffe with a bolt pistol, performed a public autopsy on his body (video), and then fed his remains to the zoo’s lions and other big cats in front of the public (video). A bolt pistol was used, rather than an injection, so that his meat would be safe to eat. A statement from the zoo explained that it had decided to kill this giraffe because his genes were “well represented in the breeding programme,” such that allowing him to grow into an adult and breed was “unwanted.” Zoo officials turned down adoption offers from other zoos on the grounds that this would have left open the door to inbreeding and potentially removed a place for a giraffe whose genetic makeup was more valuable in terms of future offspring in captive breeding programs. (The statement also addresses a variety of other interesting “health law” questions, such as “Why are the giraffes not given contraceptives?”).
The controversy gained further momentum two weeks ago, when the zoo announced that it had killed four lions—a 16 year-old male lion, a 14 year-old lioness, and their cubs—to clear the path for a newly arrived young male lion. (It is unclear whether these specific lions were among those who had previously eaten the giraffe). A statement from the zoo explained that it had decided to kill these lions based on several population-level concerns, including that the 16 year-old male might have someday mated with his female offspring creating a problem of inbreeding, or that the new young male might have mated with the 14 year-old lioness instead of younger females with greater reproductive fitness.
While the idea that these types of killings can be justified on the grounds that they protect the health of the genetic populations of which the individual animals are a part is fairly common, it is unclear whether “health” is actually an appropriate concept to apply to an entity such as an animal’s species. Continue reading →
Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.
Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute
This event is free and open to the public, but space is limited and registration is required. Register here.