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.

Continue reading

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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Translating “ELSI” into Policy

by Guest Blogger Wylie Burke MD, PhD.

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

Call for Submissions: Journal of Law and the Biosciences

JLB coverCall for Submissions: Journal of Law and the Biosciences

Deadline: Rolling.

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.

For more information about JLB, click here. To submit a manuscript, click here.

Using Big Data To Transform Care: A Briefing on the July 2014 Special Issue of Health Affairs

HealthAffairsJournal

Register online now!

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:

  • Using Big Data At The Point Of Care
  • Research Issues
  • The Role Of The Federal Government
  • Obstacles/Challenges Of Using Big Data

Among the confirmed speakers are:  Continue reading

Journal of Law & Biosciences publishes HLS student work

JLB coverThe 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:

Check out these articles, and learn more about the Journal of Law and the Biosciences!

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

            PFC_Logo_300x300                    FDLI_Logo_380

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 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Continue reading

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

PFC_Logo_300x300FDLI_logo_pink

 

 

 

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 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org 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.

On Patents, Patients and the Public Interest

By Michael Young

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.

Continue reading

Is Nonmedical Sex Selection Always Sexist?

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.[1]

Continue reading

Sex Selection or Gender Selection? Queering the Ratio Question

I am at a fantastic event at Yale I co-organized on Intersections in Reproduction: Perspectives on Abortion, Assisted Reproductive Technologies, and Judicial Review with some amazing scholars present and excellent papers being presented. Like many people who have thought about sex selection, I would have imagined I have thought through most of the issues from most perspectives. What I love about these gatherings is that they always prove me wrong.

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).

Continue reading

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.

Killing for Species Health

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

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.

Genetic Mugshots

Dov Fox

New technologies can put pressure on the logic of the law. Consider the well-settled legal conclusion that equal protection rights don’t apply when police use race-based descriptions to look for suspects. An emerging forensic technique called DNA phenotyping makes it hard to defend this reliance on racial proxies–rather than appearance itself–in the investigation of crime.

Phenotyping promises to use a piece of hair or skin left at a crime scene to infer an unknown person’s physical characteristics like eye color, nose shape, and cheekbone width. A groundbreaking new study – featured in last week’s NatureNew Scientist, and Time Magazine – used high-resolution 3D images and facial recognition software to approximate the facial features of almost 600 people of mixed ancestry from their DNA.

I consider the scientific, constitutional, and criminological implications of this technology in The Second Generation of Racial Profiling. I argue that reliable DNA phenotyping would force us to rethink whether race-based suspect descriptions are the kind of racially classifying state action subject to strict scrutiny–and it would lean on the narrow tailoring requirement that the state use race-neutral alternatives when possible. I summarized my replies to the best policy objections in a short piece on The Future of Genetic Privacy:

Critics of the forensic technique argue that its adoption would imperil individual privacy and facilitate racial profiling. These objections are important, but they’re overstated. What “a person knowingly exposes to the public,” the Supreme Court has held, “is not a subject of Fourth Amendment protection” against unreasonable searches and seizures. And statutory safeguards could be afforded for sensitive external traits about whether a suspect has changed genders, for example, or had plastic surgery.

Racial profiling is another concern. That the technology could be used to target minorities at disproportionate rates, however, gives no reason to think that such misuse is probable or any more likely than DNA dragnets or stop-and-question sweeps based on race-based suspect descriptions. The adoption of more precise physical markers in place of notoriously unreliable eyewitness observation would improve arrest accuracy and enhance police legitimacy.

The more serious worry is that DNA phenotyping might resurrect discredited conceptions of racial biology. If the [National Institute of Justice-funded] technology works as well as the government is banking it will, however, then replacing race-based suspect designations with the colors and shapes of facial features could, to the contrary, loosen the hold that race has on the way that people think about crime. Today’s all-points-bulletin for a “black man” could give way to tomorrow’s search for a suspect with dimples, copper complexion, and green eyes.

Wouldn’t police just filter these markers into racial terms? Maybe not, if they’re trained like clerks at a makeup counter are to trade in racial identifiers for face shapes and color tones. Besides, measures short of prohibition would likely soften whatever risk the adoption of DNA phenotyping would pose to egalitarian norms — for example, requiring higher burdens for investigatory use, or racial impact assessments of the kind that gained national prominence after the Supreme Court struck down a key provision of the Voting Rights Act.

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.

Continue reading

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.

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.