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« Federal Circuit to Hear Argument in AMP v. USPTO | Main | Biotech/Pharma Docket »

April 04, 2011

Comments

First, I'm going to presume that this document was either written by young people or from a young person's world-view by old people. This is because of the self-evident modern world view on display.

"This portion of the recommendations highlights a pervasive concern among academic researchers: the unlikely event that merely scientific research will incur patent infringement liability. "

Maybe if we had a broad statutory bar against infringement proceedings against someone merely doing research then we wouldn't have that issue.

"Of course, the other way to view the current situation is that without IPR, universities would see their publicly funded research pirated by corporations, foreign and domestic."

Is that not specifically what the public funded it for in the first instance? I mean, what other reason would the public fund it for?

"which will occur within the next 7-10 years; "

7-10 years? For a person under 30 that seems like an eternity Kev. I know you old guys are like, meh, 7-10 years, but the rest of us growing up in a fast paced world see that as a very long time.

"and the likelihood that successful commercialization of stem cell science will take much longer than the term of even the most recent patents, "

Could be.

"Openness is in fact promoted by the patent system, which requires not only a written description and enabling disclosure but also (at least for now) disclosure of the best mode for practicing the invention."

Young people kind of want a super-enablement requirement. We want to be able to make what you did without experimentation. At least, I'm a young person, I understand the enablement req currently imposed by the courts and I also understand the world-view of young people today and I'm also a person capable of creating many useful inventions and would thus be an interested party if something like this were imposed over in the actual useful arts. We have no patience for someone getting an exclusive right based on a disclosure merely enabled to the point of getting us to the point of being able to do experiments to find a working embodiment. At least I don't. Such seems to us like granting a person a hunting license rather than a reward for the hunt successfully completed. I can barely imagine how the current enablement req came into being save for shinanigans in the court. And perhaps because we had this thing called the best mode req that should supposedly help mitigate this lack of requiring super enablement, but which in practice usually does not due to shinanigans that are very hard to prove but which are apparent to have occurred in every other patent. Oh, and also perhaps because patents used to basically be for manufacturing giants who could do the required experiments without batting an eye.

"None of these requirements exist with regard to scientific journal articles or public grant proposals, and indeed there are significant incentives against such full disclosure in those documents. "

And a shame that is too. Perhaps that coercion they mentioned should be employed?

"One of those possible harms is likely to be reducing or limiting full, frank and enabling disclosure of stem cell technology as it develops over the next decades. Such a cure would be worse that the disease."

It could happen, but that seems doubtful, at least in this arena.


To be fair, it should be pointed out that while Mr Noonan's post lists the observers and participants in the Hinxton Group workshop that led to the report in question, they should not alone bear the very helpful comments and critiques. The post unfortunatly neglects to list the Hinxton Group's Steering Committee and the Executive Committee. These were the convenors of the workshop and were therefore those most intimately involved in the authorship of the report and thus share the responsibility for the consensus statement therein. These include the following:

Steering Committee:

Sarah Chan, BSc(Hons), LLB, MA (Health
Care Ethics and Law)
Deputy Director & Research Fellow in
Bioethics and Law
Institute for Science, Ethics and Innovation
School of Law, University of Manchester

Peter J Donovan, PhD
Professor, Departments of Biological
Chemistry and Developmental & Cell Biology
Co‐Director, Sue & Bill Gross Stem Cell Center
University of California – Irvine

Ruth Faden, PhD, MPH
Philip Franklin Wagley Professor of
Biomedical Ethics
Executive Director, Johns Hopkins Berman
Institute of Bioethics
Professor, Department of Health Policy &
Management , School of Public Health
Professor, Department of Medicine
The Johns Hopkins University

John Harris, FMedSci, BA, DPhil
Lord Alliance Professor of Bioethics
Director, Institute for Science,
Ethics and Innovation
School of Law
University of Manchester

Robin LovellBadge, PhD, FMedSci, FRS
Head, Division of Developmental Genetics,
MRC National Institute for Medical Research
Division of Developmental Genetics
MRC National Institute for Medical Research
Email: rlovell@nimr.mrc.ac.uk

Debra JH Mathews, PhD, MA
Assistant Director for Science Programs,
Johns Hopkins Berman Institute of Bioethics
Assistant Professor, Department of Pediatrics
The Johns Hopkins University

Alan Regenberg, MBe
Bioethics Research Manager, Johns Hopkins
Berman Institute of Bioethics
The Johns Hopkins University

Julian Savulescu, BMedSci, MB, BS, MA, PhD
Uehiro Chair in Practical Ethics
Director, Oxford Uehiro Centre for Practical
Ethics
University of Oxford

David Winickoff, JD
Co‐Director, Science, Technology, and Society
Center, University of California Berkeley
Associate Professor of Bioethics and Society
University of California – Berkeley

Executive Committee:

Robert CookDeegan, MD
Director, IGSP Center for Genome Ethics, Law & Policy
Duke University

Gregory Graff, PhD
Assistant Professor, Department of Agricultural and Resource Economics
Colorado State University

Aurora Plomer, BA, MA, LLB, PhD
Chair in Law and Bioethics, Director of SIBLE, School of Law, University of Sheffield
Director, Sheffield Institute of Biotechnology Law and Ethics
University of Sheffield

Kris Saha, PhD
Postdoctoral Fellow, Whitehead Institute for Biomedical Research, MIT
Science Technology and Society Fellow, Kennedy School of Government
Harvard University

Christopher Scott
Director, Program on Stem Cells in Society, Center for Biomedical Ethics, Stanford University
President/CEO, The Stem Cell Advisors

John Sulston, PhD
Chair, Institute of Science, Ethics, and Innovation
University of Manchester School of Law
University of Manchester

Patrick Taylor, JD
Fellow, Petrie‐Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School
Assistant Clinical Professor, Harvard Medical School
Staff Scientist, Children’s Hospital, Boston, MA

Thanks, Gregory - it wasn't clear from the Report that these people were the writers and organizers. I certainly did not intend to ignore their contributions, and we will provide attribution in a revised post as soon as possible.

Recommendation 3: Develop and institute incentives for data and materials sharing through publication, participation in information hubs, and other mechanisms

This recommendation is related to the earlier-noted problem of data accession and efficiencies for sharing materials. The Report cites disincentives to "early publication and distribution, especially in industry".

There are a multitude of disincentives in academia to sharing materials, which are generally not discussed or acknowledged. In the big picture, academics compete for limited resources - e.g., grants, publications, and the resulting "fame" that can lead to more grants and publications. On a more local scale (within an institution), academics compete for space, promotion, students and so on. In my experience, this competition can be a disincentive to share materials and knowledge. And has nothing to do with patents. Even when a colleague would share materials with me, there were often major restrictions on what could and couldn't be done. Although my direct experience is admittedly not recent, I haven't heard or read of any changes in academia that counteract the competitiveness.

In contrast, widespread use of a technology or material has the possibility of leading to a revenue stream. As an example, GUS (beta-glucuronidase) was widely distributed in the field of plant genetics. Researchers and companies used it and then later licensed it. Academics who took jobs in industry were familiar with it and further spread the technology. A non-profit institute developing plant research tools, CAMBIA, was able to operate in early years on the license revenue. Had the material been held closely, others may have looked for alternatives.

"This portion of the recommendations highlights a pervasive concern among academic researchers: the unlikely event that mere scientific research will incur patent infringement liability. This fear informs the Report's assertions that IPR promotes "under-investment in new firms, high barriers to entry for new innovators, and slower progress in the field" than would be the case "if individual research institutions were more constrained and targeting in their seeking of patent rights."

A common theme in the Hinxton report and SACGHS report (among others) is addressing the fear resulting from mis-perceptions of patent litigation for infringement instead of addressing the mis-perceptions. It seems to me that it makes for good publicity (and fund raising for some NGOs), and may be self-serving, but in my opinion, it is markedly unhelpful.

An excellent dissection of the report. Thank you for speaking out.

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