Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the March 20th 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.

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KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

For more on news and events at Petrie-Flom, see the full newsletter.

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the March 6th 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.

Featured in this edition:

KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

For more on news and events at Petrie-Flom, see the full newsletter.

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the February 20th 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.

Featured in this edition:

child_pediatrician_slide_270_200_85_c1FREE REGISTRATION!
Families Matter: Ethically, Legally, and Clinically

March 18 – 20, 2015
Harvard Medical School
Boston, MA

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter. Continue reading

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the February 6th 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.

Featured in this edition:

genderreassignment_slideGender (Re)assignment:Legal, Ethical, and Conceptual Issues

Tuesday, February 10, 2015, 12:00 PM

Pound Hall 102 1563 Massachusetts Avenue, Cambridge, MA [Map]

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion. Panelists include: Noa Ben-AsherElizabeth F. EmensGerald L. NeumanMatthew J.B. Lawrenceand I. Glenn Cohen.

For more on news and events at Petrie-Flom, see the full newsletter.

Check out the latest news from the Petrie-Flom Center!

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Happy New Year! Check out the January 9th 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.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                Thursday, January 15, 2015, 12:30 PM                         Hauser Hall 102,                                     1575 Massachusetts Avenue, Cambridge, MA

 

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

A Physician Fights Surgery

Physician and bioethicist Carla C. Keirns described the potentially dangerous impact of medicalization on her own childbirth in the Narrative Matters section of Health Affairs this month. A segment of that writing was reproduced in the Washington Post yesterday.

In each piece, Keirns outlines the challenges she faced in vaginally delivering her son in a hospital environment that seemed committed to performing a caesarian section. Particularly given Keirns’ expertise in and familiarity with health care, the lack of patient-centered care in the story is striking. Several staff suggested that surgery was a foregone conclusion while others appeared unprepared for her son’s long-awaited arrival.

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Check out the December 19th 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.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                                                                                            Thursday, January 15, 2015, 12:30pm                           Hauser Hall 102,                                                   1575 Massachusetts Avenue, Cambridge, MA

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

Check out the latest news from the Petrie-Flom Center!

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Check out the December 5th 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 latest news from the Petrie-Flom Center!

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Check out the November 14th 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 latest news from the Petrie-Flom Center!

10-31_Newsletter_ScreenshotHappy Halloween! Check out the October 31st 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 latest news from the Petrie-Flom Center!

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Check out the October 17th 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 latest news from the Petrie-Flom Center!

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Check out the October 3rd 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 latest news from the Petrie-Flom Center!

Check out the September 19th 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 latest news from the Petrie-Flom Center!

9.5 ImageCheck out the September 5th 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 latest news from the Petrie-Flom Center!

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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.

The Revival of Phage Therapy to Fight Antimicrobial Resistance (AMR) – Part III: What about patent protection and alternative incentives?

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.

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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.

The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part II: What about patent protection and alternative incentives?

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.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part I: What are the legal implications?

Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report “Phage therapy gets revitalized” by Sara Reardon concentrates on the use of viruses (bacteriophages) to battle bacteria. The idea is not new, but apart from some applications in the former Soviet Union, it never was established as a major research area elsewhere. In particular the paper examines the European Phagoburn project, which is the first large, multi-centre clinical trial of phage therapy for human infections, funded by the European Commission. It involves a phase I-II trial of using viruses for the treatment of bacterial infection following burns. The European Union (EU) is contributing €3.8 million (US$5.2 million) to the Phagoburn study demonstrating that it is taking the approach seriously. Meanwhile, the US National Institute of Allergy and Infectious Diseases announced in March 2014  that it regards phage therapy as one of seven key areas in its strategy to fight antibiotic resistance.

So far Western practice has concentrated on treating complex or unidentified infections with broad-spectrum antibiotics. These antibiotics would typically eliminate multiple types of bacteria, including those who have beneficial effects to the human organism. Despite resulting in direct negative consequences for patients, e.g. gastrointestinal disorders, these “atomic bomb” approaches can result in biological niches where resistant “bad bugs” can prosper. This is the reason why scientists are turning towards more targeted approaches. This is where phage therapy comes into play. Like “guided missiles”, phage-therapy has the ability to kill just species of bacteria or strain. Quoting the US virologist Ryland Young and the head of the scientific council at the Eliava Institute in Tblisi (Georgia), Mzia Kutateladze, the Nature report explains how nature offers an almost unlimited source of different phages and that so far no identical phages have ever been found. For this reason it is fairly simple to identify a particular phage for a bacterial target. If the bacterium should become resistant against that particular phage, researchers would modify the viral cocktails that are used for treatment by adding or substituting phages. At the Eliava Institute such updates occur – according to the report – approximately every 8 months and the scientists would not be fully aware of the precise combination of phages in the cocktail.

In light of these advantages the recent interest of US and EU stakeholders in phage therapy comes as no surprise. However, the scientific and legal challenges confronting these projects are complex. After all we are talking about viruses here, which triggers alarm bells with regard to public perception, safety concerns, and the regulation of relevant research. It also appears questionable if – or under what circumstances – regulatory authorities would be willing to grant market approval for such a rapidly changing product like in the case of e.g. influenza vaccines. Another significant problem for the development of new phage therapies, also addressed in the paper, lies in the reluctance of pharmaceutical companies to invest into the field. The potential obstacles for more private involvement in phage therapy are many and range from considerable risks of failure, reputational damage, and unforeseeable side-effects to insufficient certainty with regard to intellectual property protection and guarantees of a profit.

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The Fight Against Antimicrobial Resistance: Important recent publications

One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.

A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.

This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.

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