New Joint Project on Law and Applied Neuroscience

Official Press Release

Wednesday, April 16, 2014

FOR IMMEDIATE RELEASE

The MGH Center for Law, Brain and Behavior and Harvard Law School’s Petrie-Flom Center announce joint “Project on Law and Applied Neuroscience” for 2014-2016

The MGH Center for Law, Brain and Behavior and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will collaborate on a joint venture – the Project on Law and Applied Neuroscience – beginning in Fall 2014. The collaboration will include a Senior Fellow in residence, public symposia, and an HLS Law and Neuroscience Seminar.

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5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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Petrie-Flom Intern’s Weekly Round-Up, 4/4-4/11

By Chloe Reichel

Following the release of information on Medicare billing practices, it was revealed that approximately 4,000 physicians each billed over $1 million in 2012. This data may shed light on medical billing procedures.

Despite a proposed 1.9 percent cut to the Medicare Advantage program, these cuts will not be implemented. On Monday the Centers for Medicare and Medicaid Services announced that funding to Medicare Advantage will increase by an average of .4 percent in 2015.

Though genetic testing is becoming cheaper and more accessible, many Americans refrain from getting tested. This is because the Genetic Information Nondiscrimination Act does not protect consumers from discrimination for life, disability, and long-term care insurance plans.

On Friday, Kathleen Sebelius, current Secretary of Health and Human Services, will resign from her role. Sebelius oversaw the oft-criticized implementation of the Affordable Care Act. Sylvia Mathews Burwell, director of the White House Office of Management and Budget, has been selected by President Obama to fill the role. Burwell served in the Clinton administration, and was president of the Walmart Foundation, prior to her work with the Obama administration.

This Thursday the European Parliament debated a petition that would prevent the allocation of EU funds for research, aid, and public health programs that involve the destruction of human embryos. The petition had 1.8 million signatures, and is seen as a sign of popular support for social conservatism.

Hawaii’s extensive health system has led to excellent health outcomes for the state’s residents and the state’s budget, since the state has some of the lowest healthcare costs in the nation. Hawaii has near-universal health insurance coverage, and starting forty years ago, has required employers to provide health benefits to their employees.

On Saturday, Maryland legislators voted to decriminalize possession of small amounts of marijuana. Those found in possession of less than 10 grams of marijuana will now be charged with civil fines, as opposed to criminal penalties.

TOMORROW: Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

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.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from discussions about health care spending and the Affordable Care Act to articles about environmental poisoning of soldiers in Iraq.

  • Amitabh Chandra tweeted that “Healthcare spending growth hits a 10yr high… so much for ‘ACA is bending the cost curve’” and shared an article from USA Today.
  • Frank Pasquale shared a blog entry by Larry Backer about Pennsylvania State University students’ worries about the rise of health care costs.
  • I. Glenn Cohen shared a link to an article in The New York Times entitled “‘Environmental Poisoning’ of Iraq Is Claimed” and states that many veterans suffer from environmental poisoning while the “IOM [is] not sure.”
  • Kate Greenwood retweeted Austin Frakt and an article from The Incidental Economist about the negative impact of the insurance market before the implementation of the Affordable Care Act on entrepreneurship.
  • Stephen Latham tweeted a link to his blog reporting on the recent announcement of the Public Health Committee of the Connecticut Legislature that it does not plan to vote on a bill addressing “Aid-In-Dying” or physician-assisted suicide despite “61% public support for the bill.”

Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

By Michael Young

In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”  This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.

In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.

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Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part IV

Finishing up the event today is Tom Kowalski from Vedder Price, giving a US perspective on section 101 on patentable subject matter.  This post will encompass his presentation and general questions afterward.

Kowalski starts with a brief review of patentable subject matter, and states his view that after Prometheus and Myriad, “the fabric of the patent system has been torn.”  His view is that isolated DNA is a separate chemical entity, and that the Supreme Court simply got it wrong.  Continue reading

Liveblog of 4/2 panel in European Bio-patent Law, Part III

Third up is Dr. Maaike van der Kooij, discussing medical use claims at the EPO.

In general, methods of medical treatment aren’t patentable under Art. 53(c) of the EPC, but the way around is to claim a relevant product either for medical use (if the substance is known but not medically used (Art. 54(4)) or for a specific medical use (Art. 54(5)).  (From my point of view, this seems like another way that the EPO is trying to address its innovation mandate by working around what appears to be pretty clear language in the EPC, a pattern which we certainly see in the US in both PTO and Federal Circuit practice). Continue reading

Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part II

Next up is Dr. Anja Schmitt, comparing Myriad and Mayo to EPO practice, and describing gene patents and diagnostic method patents in the EPO.

Human gene patents

The basic question of human gene patents–as will be familiar to those who followed the Myriad litigation–is whether isolated DNA is a product of nature/mere discovery, or a man-made product with technical character.  In the Myriad case, claims covered isolated DNAs for the BRCA1 and BRCA2 genes which are useful for identifying a predisposition to breast cancer.

At the EPO, on the other hand–using the same sources of law as Dr. Nichogiannopoulou mentioned before–genes are patentable as long as they disclose the industrial applicability and the function of the gene and/or its encoded protein. Continue reading

Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part I

I’ll be liveblogging today’s panel on Hot Topics in European Bio-Patent Law (co-sponsored by the Broad Institute), with several guest speakers from the European Patent Office (EPO).

Ben Roin, Heiken Assistant Professor of Patent Law here at HLS, is moderating.  Speakers will be Dr. Aliki Nichogiannopoulou on stem cells, and Dr. Anja Schmitt on gene patents, Dr. Maiake van der Kooij, all of the EPO, followed by Tom Kowalski of VedderPrice.

Dr. Nichogiannopolou begins by talking about stem cells, and opens with a few background points about the EPO.  The agency has its own implementing legislation separate from the EU, and includes 38 member states – 10 more than the EU itself, including industry-important Switzerland.  The EPO supports innovation, competitiveness, and economic growth for the benefits of European citizens, and has the mandate to grant European patents for inventions. Continue reading

TOMORROW: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

April 2, 2014, 12:00 PM

Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA

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.

Panelists:

  • Aliki Nichogiannopoulou, Director, Biotechnology, EPO
  • Anja Schmitt, Examiner, EPO
  • Maaike van der Kooij, Examiner, EPO
  • Tom Kowalski, US Patent Attorney
  • 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.

Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Cosponsored by the Broad Institute of MIT and Harvard.

RESCHEDULED: 4/11, Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

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.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

De-extinction

A few weeks ago, the New York Times Magazine ran a fascinating piece titled “The Mammoth Cometh,” which tells the story of a growing number of scientists around the world who are working on projects of “de-extinction.”   Significant progress has been made, and some scientists estimate that we will be able to revive certain species, such as the dodo or the passenger pigeon, within 10-15 years.

But is reviving species from extinction a good thing to do?  The way in which this normative question is treated in the NYT article is interesting.   While some of the key dangers of reviving extinct species are identified and discussed, the underlying narrative seems to accept that if these dangers could be avoided, de-extinction would be a good thing.   What its value is, however, is never spelled out in particularly clear terms.

The primary value identified by many advocates of de-extinction is the environmental value of “conservation.”   Steward Brand, for example, states that de-extinction could provide “a beacon of hope for conservation.”  But two different conceptions of conservation appear to be at work in the entangled arguments about the value of reviving extinct species. Continue reading

New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

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4/2: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

April 2, 2014, 12:00 PM

Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA

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.

Panelists:

  • Aliki Nichogiannopoulou, Director, Biotechnology, EPO
  • Anja Schmitt, Examiner, EPO
  • Maaike van der Kooij, Examiner, EPO
  • Tom Kowalski, US Patent Attorney
  • 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.

Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Cosponsored by the Broad Institute of MIT and Harvard.

Call for Applications: 2014-2015 Petrie-Flom Student Fellowship

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

Biomarker Epistemology, Cognitive Decline, and Alzheimer’s Disease

By Matthew L Baum

This past Sunday, a group of researchers reported in the journal, Nature Medicine, a preliminary technique that uses variation in blood levels of 10 fats to predict the likelihood that elderly individuals would develop mild cognitive impairment (MCI) or Alzheimer’s Disease in the following 2-3 years. The sample size was small and the results may not generalize beyond the narrow age-range and demographics of the study group (i.e. the assay is far from ready for “prime time”), but the study is an important first step towards a lower cost (vs PET imaging) and less invasive (vs spinal tap) predictive biomarker of cognitive decline*. Its publication has also triggered a flurry of discussion on possible ethical ramifications of this sort of blood biomarker. I will not attempt to address these ethical issues specifically here. Rather, I seek to highlight that how ethically troubling one views the technology to be may depend partly on the sort of knowledge one thinks these biomarkers reveal (applied epistemology at its best).

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An interview with I. Glenn Cohen on law and bioscience

With the first issue of Journal of Law and Biosciences now available, the Oxford University Press blog has published an interview with I. Glenn Cohen discussing the journal’s focus and format. From the blog:

There are huge changes taking place in the world of biosciences, and whether it’s new discoveries in stem cell research, new reproductive technologies, or genetics being used to make predictions about health and behavior, there are legal ramifications for everything. Journal of Law and the Biosciences is a new journal published by Oxford University Press in association Duke University, Harvard University Law School, and Stanford University, focused on the legal implications of the scientific revolutions in the biosciences. We sat down with one of the Editors in Chief, I. Glenn Cohen, to discuss the rapidly changing field, emerging legal issues, and the new peer-reviewed and open access journal.

Read the full interview.