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.

CANCELED: 3/3 Panel on Presidential Commission for Study of Bioethical Issues

UPDATE, 3/1: DUE TO THE STORM THAT IS CURRENTLY AFFECTING THE EAST COAST, OUR SPEAKER MICHELLE GROMAN HAS HAD TO CANCEL HER TRAVEL FOR MONDAY, 3/3. THE EVENT WILL BE RESCHEDULED FOR LATER IN THE SPRING.

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

TO BE RESCHEDULED

Austin Hall West (111), Harvard Law School

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.

Caplan: Three-Parent Babies Are an Ethical Choice

Art Caplan has a new op-ed out on the three-parent baby issue.  Here’s an excerpt:

In my view, trying the technique to fix a terrible disease even with risks of failure makes ethical sense. The FDA may ask for more studies in monkeys, but that really wont settle the safety issue in humans. Given the severity of mitochondrial diseases it is worth trying the technique.

The big worry is not so much safety, but where will allowing this form of genetic engineering lead. If we let doctors try to repair defective eggs today, who is to say they won’t be trying to make superbabies or designer babies tomorrow by transferring other genes into eggs?

The answer to that is that how far we go in engineering future generations through genetic manipulations is up to us. We can enact laws and treaties that say yes to gene therapies but no to cosmetic genetic engineering. Holding families hostage by saying they cannot try to repair broken genes to treat diseases because we worry that we cannot put steps or handrails on the slippery slope to designer babies seems wrong to me.

Take a look here.

Inaugural Issue of the new Journal of Law and the Biosciences Now Online (Free Access)

I am very pleased to announce the the first-ever issue of The Journal of Law and the Biosciences is now online. I serve as one of three Editors In Chief (along with Nita Farahany and Hank Greely). The journal is a co-production of Harvard, Duke, and Stanford Law schools and Oxford University Press and is the first peer-reviewed journal of its kind.

Here is the table of contents for the first issue:

Edward S. Dove, Bartha M. Knoppers, and Ma’n H. Zawati, Towards an ethics safe harbor for global biomedical research, J Law Biosci (March 2014) 1 (1): 3-51 doi:10.1093/jlb/lst002

Rebecca Dresser, Public preferences and the challenge to genetic research policy, J Law Biosci (March 2014) 1 (1): 52-67 doi:10.1093/jlb/lst001

Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, and Julian Savulescu, The regulation of cognitive enhancement devices: extending the medical model, J Law Biosci (March 2014) 1 (1): 68-93 doi:10.1093/jlb/lst003

Timothy Caulfield, Sarah Burningham, Yann Joly, Zubin Master, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, Amy McGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, Helen Wallace, and Ma’n H. Zawati, A review of the key issues associated with the commercialization of biobanks, J Law Biosci (March 2014) 1 (1): 94-110 doi:10.1093/jlb/lst004

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Dov Fox quoted on pre-natal DNA testing

Dov Fox is quoted in a story in this morning’s Boston Globe on a new study recommending pre-natal DNA testing as a superior method for detecting chromosomal abnormalities in a fetus. 

“This technology is certainly only in its infancy as the range of testable conditions expands, physical conditions, cognitive conditions, even behavioral ones,” said Dov Fox, an assistant professor of law at the University of San Diego School of Law. “That will only further complicate how parents decide what counts as healthy or acceptable in the children that they have.”

Read the full article.

 

TOMORROW: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and BioethicsEdmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.

Dov Fox on the FDA’s ruling on 23andMe

Dov Fox has a new piece up at the Huffington Post on the 23andMe controversy: “Genetic Testing Needs a Nudge.” From the article:

Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease — no doctors needed.

Splashed across TV sets nationwide this past summer was 23andMe’s invitation to discover “hundreds of things about your health,” including that you “might have an increased risk of heart disease, arthritis, [or] gallstones.”

Since the company’s inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a “first step in prevention” to “mitigate[e] serious diseases.”

But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had “suspended” all sales of its “health-related genetic tests to comply” with the FDA directive, consumers brought aclass action lawsuit against the company, alleging that it “falsely and misleadingly advertises” the genetic test “as providing ‘health reports on 240+ conditions’” in the absence of “analytical or clinical validation.”

The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.

You can read the full piece here.

FDA, Mitochondrial Manipulation, Three Parent Children, and the NY Times

In yesterday’s NY Times Op-Ed page Marcy Darnovsky writes about FDA’s consideration of mitochondrial manipulation therapies later this week. As she describes it:

The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor. 

As she writes in her opinion:

Some media accounts about these techniques have misleadingly referred to “saving lives,” as if they were aimed at people who are sick and suffering. Others have failed to note how very few women would be candidates for even considering them. And they could turn to safer and simpler alternatives. An affected woman could adopt or use in vitro fertilization with another woman’s eggs. Of course, the resulting child would not be genetically related to her, but neither would the child be put at grave risk by an extreme procedure.

The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any “ethical and social policy issues” are outside its scope. But those are precisely the issues that we must address. Simply being able to do something doesn’t mean we should do it.

That conclusion is a bit pat, though I don’t fault her too much given how tight op-ed word limits are, and maybe a tad reactionary. I do think she raises an interesting point about how this is not saving lives, though I think so for different reasons.

Continue reading

Disclosing Genetic Risks: Lessons from the Philosophy of Language

By Michael J. Young

Earlier this month, landmark findings were published in the American Journal of Psychiatry illuminating the effect of disclosing genetic risk for Alzheimer’s disease on older adults’ cognition and memory.  In a case-control study, researchers administered memory function tests to a group of known carriers of the apolipoprotein E4 allele (one of the best studied genetic risk factors for developing Alzheimer’s disease), half of whom were informed of their carrier status, and half of whom were not informed of their carrier status.  They reported “[s]ignificant genotype-by-disclosure interaction effects were observed on several memory rating scales and tests of immediate and delayed verbal recall. Older adults who knew their ε4+ genotype judged their memory more harshly and performed worse on an objective verbal memory test than did ε4+ adults who did not know. In contrast, older adults who knew their ε4− genotype judged their memory more positively than did ε4− adults who did not know…informing older adults that they have an APOE genotype associated with an increased risk of Alzheimer’s disease can have adverse consequences on their perception of their memory abilities and on their performance on objective memory tests. Similar consequences might be expected if other indices of an increased risk of Alzheimer’s disease are disclosed (e.g., neuroimaging or CSF biomarkers of preclinical Alzheimer’s disease.)”

These findings raise profound questions for practitioners who must make regular decisions concerning how to communicate health risk information to patients, and more fundamentally, about what principles and policies ought to govern which findings should be disclosed or disguised.

The study and its implications bear striking correlates to a set of key issues in philosophy of language relating to the meta-descriptive aspects of speech and discourse.  In a series of lectures later published as How We Do Things with Words, philosopher J.L. Austin persuasively argued against a longstanding philosophical tradition that had conceptualized language as a construct that exists solely to describe reality as it is or is imagined to be; Austin reasoned that language can serve not only to describe facts but can also serve to establish new facts by representing them as such.

Continue reading

Book Review published on SSRN

Three weeks ago I blogged about my recent review of  ”Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN: http://ssrn.com/abstract=2396804.

New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

I am pleased to announce that we have today published the following paper:

Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN.

This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It is currently under review by Edward Elgar.  A longer journal-version will follow.

Abstract: 

An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering recent developments within the software and ICT industries, it seems fair to assume that the process of standardization may also have significant impact on the development and adoption of Synthetic Biology (SB). Within SB different standardization efforts have been made, but few have assumed dominance or authority. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns.

Out of this notion arises i.a. the following questions: How comparable is engineering in SB to more traditional fields of engineering?; What type of standards have emerged and what bearing have IPRs on these?; and, How applicable are the approaches adopted by the standards-setting organizations in the information and communication technology (ICT) to biological standards? These and further legal issues related to IP, regulation, standardization, competition law & open innovation require a careful consideration of new user-generated models and solutions.

Before this background, our paper seeks to describe IP and standardization aspects of SB in order to discuss them in the context of the “open innovation” discourse. We concentrate on describing the technology and identifying areas of particular relevance. Ultimately we also sketch out open questions and potential solutions requiring further research. However, due to the limitation of this paper we do not aim to create elaborated theories or to propose solutions in more detail. Rather this paper, which will be complemented by more extensive follow-up studies, provides a first overview on the complex questions that we are currently dealing with.

To achieve this modest goal, section 1 commences with a brief introduction to the fascinating science of SB and a description of recent technological advances and applications. This will lead us to section 2, in which we will address standard setting efforts in SB, as well as the relevance and governance of various IPRs for specific SB standards. This provides the basis for section 3, in which we debate problematic issues and summarize our conclusions.