Check out the August 22nd edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
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.
Check out the August 8th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
Check out the July 25th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
In a video interview with Reuters in conjunction with Harvard School of Public Heath’s Health Reform Watch, Petrie-Flom Center Executive Director Holly Fernandez Lynch analyzes the impact of the Supreme Court’s recent decisions in Hobby Lobby and Wheaton College.
To watch the interview please click here.
Call for Submissions: Journal of Law and the Biosciences
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.
Check out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman. We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space. We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.
Take a look and let us know what you think!
Fairbanks School of Public Health and McKinney School of Law, Indiana University, Indianapolis.
This has been a big year for outbreaks of Vaccine-Preventable Illnesses (VPIs) in the United States. While we are only halfway through 2014, there have been more measles cases this year than we have seen since before 2000, when the Federal government officially declared the United States “measles free” (in other words: there are no more domestically-generated measles cases; all of our outbreaks are imported). We’ve also seen large mumps and whooping cough outbreaks. You can follow all the disease outbreak action, both here and worldwide, via the Council on Foreign Relations’ very cool interactive map.
States use their police power authority under the Constitution to try to minimize our risk of exposure to VPIs. First, every state requires that children demonstrate proof of immunization against many VPIs as a condition of entry into schools, preschools and day cares. States also permit exemptions to these laws – every state allows a child who may be medically susceptible to injury from vaccines to receive an exemption (with proper documentation of vulnerability), and most states allow parents to apply for an exemption based on either religious or broader philosophical grounds. A combination of factors, including: a nearly two decade trend of increasing numbers of families obtaining exemptions and clustering in particular communities (or avoiding vaccine requirements by taking advantage of law loopholes, such as if a state’s vaccine law does not cover private schools); waning effectiveness of vaccination protections over time (as has been seen with whooping cough); increased international travel facilitating ready reimportation of VPIs from abroad; and many more immunocompromised individuals living in our communities; have slightly weakened our overall protection against VPI outbreaks. Continue reading
Thursday, September 18, 2014
Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.
This event is free and open to the public, but due to limited seating registration is required. Please register online.
Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions. Areas that currently lack clarity include:
- What types of interventions or resources should be included within post-trial responsibilities?
- What is a reasonable duration for post-trial responsibilities to extend?
- What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?
This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.
Harvard Law Today has posted a feature on Cass Sunstein’s keynote address at the 2014 Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy.” Sunstein, who is the Robert Walmsley University Professor at Harvard Law School and the co-author of Nudge: Improving Decisions About Health, Wealth, and Happiness, addressed the opening day of the conference on May 2, 2014, on the subject of “Choosing Not to Choose.”
The Journal of Law and the Biosciences, the new open-access journal launched this year by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has published several articles in recent weeks by Harvard Law School students:
- Nicholas Meyers, Cook v. FDA and the importation and release of lethal injection drugs, J Law Biosci first published online May 2, 2014.
- Ashish M. Bakshi, Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics, J Law Biosci first published online May 2, 2014.
- Adriana Lee Benedict, State-level legislation on follow-on biologic substitution, J Law Biosci first published online May 2, 2014.
- Komal Karnik, FDA regulation of clinical decision support software, J Law Biosci first published online April 28, 2014.
Check out these articles, and learn more about the Journal of Law and the Biosciences!
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the fall 2014 semester. Availability to start by August 4, 2014 is preferred, but later start dates will be considered on an individual basis; please indicate your availability in your application materials. We may consider extension through Spring 2015 if there is mutual interest.
Who is eligible?
Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available at our website. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences. We are also interested in receiving applications from students interested in technology and communications.
What will the internship entail?
Check out the Friday the 13th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
Check out the May 30 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
We hope to see you there!
Thursday, June 5, 2014, 6:30pm
Bin 55 (restaurant), lobby level, Marriott Marquis
780 Mission St.
Looking for new opportunities in the fields of health law, policy, and bioethics? Look no further!
This spring, we’ve added a new opportunities section to the resources on the new Petrie-Flom website. This page features opportunities in health law and bioethics including jobs, fellowships, graduate programs, seminars, calls for abstracts and submissions—and more! These opportunities are updated in real time, full posts remain active on the website until their deadline passes, and past posts are visible in our opportunities archive.
If you have opportunities that you would like to share with the Petrie-Flom community via our website and/or our biweekly e-newsletter, please contact us at email@example.com.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:
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: Continue reading
Please join us for a day-long conference at Harvard Law School on September 18, 2014, which will include presentations by leading experts and varied stakeholders as well as small group discussion and break out sessions that will work toward developing consensus in this difficult area.
Key questions include:
- How should post-trial access be defined?
- What type of interventions should be included in post-trial access obligations?
- What are the responsibilities of various stakeholders?
More information, including the developing agenda, will be posted on the Petrie-Flom Center’s website as it becomes available.
Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.
Check out the May 16 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
THE PETRIE-FLOM CENTER
STUDENT FELLOWSHIP PROGRAM, 2014-2015
CALL FOR APPLICATIONS
The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. For more information on our current fellows and their work, see our website.
Eligibility. The student fellowship program is open to all Harvard graduate students who are committed to undertaking a significant research project and fulfilling other program requirements without exception during the year of their fellowship: Continue reading