Saturday, January 7, 2017

Great Grouper Groups

The Caribbean Sea once teemed with Nassau groupers (Epinephelus striatus), orangey-brown white-striped fish that can reach 25 kgs in size.  For most of the year, these fish are elusive, tending to hide amongst the coral and rocks of reefs to avoid becoming meals for sharks.  However, during full moons in the Northern hemisphere winter, they gather in great numbers in mating aggregations by the ocean bottom to reproduce.  Savvy fishers learned where and when to drop their nets for rich catches, and, over time, Nassau grouper populations plummeted.  Based in large part on remarkable research by brave biologists, who actually dive to the bottom of the ocean, far offshore, in the middle of the night, to observe these mating aggregations and tag their participants, conservation rules now ban the fishing of reproducing Nassau groupers.  As a consequence, populations of these fish have recently risen substantially.  My friend, Dr. Richard Nemeth, who is a Research Professor at the University of the Virgin Islands ("UVI"), has been at the forefront of this research, which was featured in Scientific American on January 5, 2017.  One of the highlights of the Biodiversity Law class I teach in the Virgin Islands will be meeting with Rick next week at UVI to discuss his research and its conservation applications.  In appreciation for the hospitality UVI always shows my students, I will reciprocate by giving a lecture there on the biology, policy, and law of deextinction.

Friday, January 6, 2017

Setting Innovation Free

I was honoured and delighted when the Centre for International Governance Innovation ("CIGI") invited me last year to become a Senior Fellow.  It is a pleasure to work with this talented group of thinkers, including Deputy Director Dr. Bassem Awad, a wonderful scholar who shares my interests in intellectual property and innovation.  As my first project for CIGI, I have written Set Innovation Free, an essay discussing the emerging power of user, open, collaborative, and free innovation (sensu von Hippel).  Here is my essay.  Here is a cool video CIGI produced to accompany my essay:

Thursday, January 5, 2017

Biolawpalooza


Courtesy of Hank Greely:

Law and the Biosciences Conference Announcement:
The Bio Lawlapalooza!

Advances in the biological sciences from such fields as genetics, neuroscience, reproductive biology, and ecology are increasingly challenging society and the laws that attempt to order, regulate, and protect it.  These advances are crystalizing a new area of work: Law and the Biosciences.  We take a very broad view of Law and the Biosciences and see it encompassing the intersections of both fields. It ranges from CRISPR’d babies and head transplants to patent law in the biosciences with intermediate stops at FDA, health plan coverage decisions, torts, property, and more.  It also includes ways in which biology and its models and approaches may help us understand better that living and evolving organism that is “the law.”

The four of us, in conjunction with the open access, Oxford University Press published Journal of Lawand the Biosciences, and the Stanford Center for Law and the Biosciences, will host the first annual Bio Lawlapalooza Conference at Stanford Law School on Thursday afternoon and all day Friday, April 20 and 21.  We hope this will provide a forum for people interested in Law and the Biosciences to gather, talk, and share insights, following the precedent of Patent Con, among other conferences.  Registration is free but participants will be responsible for their own travel and accommodation expenses; much meals will be included.

We welcome scholars who are interested in presenting at the conference as well as those who just want to attend, listen, talk, and schmooze. But we encourage all scholars interested in Law and the Biosciences to apply to present at the Conference.  Titles and abstracts of proposed presentations are due on January 30, 2017; the organizers will make decisions about presentations by February 10.  The peer-reviewed Journal of Law and the Biosciences will welcome submissions coming out of the conference.

Please contact Hank at hgreely@stanford.edu with any questions. We hope to see you all at Stanford in late April 2017!

Wednesday, December 14, 2016

Tuesday, December 13, 2016

Patients Lose Patience

Although December 13, 2016, would not seem the most propitious of dates, it may go down as an important one in the history of United States drug and medical device law.  Today, President Barack Obama signed into law the "21st Century Cures Act", which substantially amends the Food, Drug, and Cosmetics Act ("FDCA") in response, at least in part, to a growing chorus of criticism by patient advocates demanding faster approvals of, and access to, new drugs and medical devices.  Among the highlights are formal recognition by the Food and Drug Administration ("FDA") of "patient experience" data as part of the drug approval process, accelerated decisions on drug approvals, reevaluation of clinical trial design (including consideration of "real world evidence"), enhanced access by patients to information on experimental drugs, accelerated approvals for regenerative medicines (including, presumably, stem cell therapies), and accelerated approvals for medical devices.  The 21st Century Cures Act is one of the most substantial amendments to be made to the FDCA in years.  It may prove one of President Obama's greatest legislative legacies, with wide-ranging and long-lasting effects on medicine and health.

Tuesday, December 6, 2016

Design Patents Totalled

The United States ("U.S.") Patent Act has long included a special damages provision that applies only to design patents.  Under the relevant part of 35 U.S.C. §289 (tellingly-entitled "Additional remedy for infringement of design patent"),
Whoever during the term of a patent for a design, without license of the owner, (1) applies the patented design, or any colorable imitation thereof, to any article of manufacture for the purpose of sale, or (2) sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit...[emphasis added]

The U.S. Supreme Court disagreed in its decision published on December 6, 2017.  Writing for the unanimous Supreme Court, Justice Sotomayor parsed the meaning of "article of manufacture" to encompass either an entire device or a mere fraction of it, explaining
the term “article of manufacture” is broad enough to encompass both a product sold to a consumer as well as a component of that product.  A component of a product, no less than the product itself, is a thing made by hand or machine.  That a component may be integrated into a larger product, in other words, does not put it outside the category of articles of manufacture.
Applying this logic, she reasoned that "total profit" should be assessed from only that portion of an article of manufacture claimed in an infringed design patent.  Since most modern electronic devices are composed of dozens or hundreds of distinct parts, many of which could be individually-claimed in distinct design patents, the practical implication of this decision will most likely be a substantial decrease in the "total profit" Samsung will owe Apple for design patent infringement.

A broader implication may be a reevaluation of the value of design patents, whose numbers have been climbing rapidly (applications increased by almost 800% from 1963 to 2015).  Now that "total profits" has a totally-new denominator, applying for, acquiring, and maintaining design patents may have become markedly less desirable. 


Monday, November 28, 2016

Deeper Art

BlouinArtinfo ran an article about avante-gard art pioneers Fathomers on November 8, 2016.  Led by peerless Executive Director Stacy Switzer, Fathomers is establishing itself as a locus in quo for perpetrating great art in Los Angeles and beyond.  The article also discusses Problems and Provocations, which chronicles Fathomers' influential 1995-2015 prehistory as Grand Arts through the works of visionary artists, such as Tavares Strahan, Mel Chin, and Michael Jones McKean, and to which I contributed a modest aukwardly-focused pensée entitled "Immortality".

For full disclosure, let me note that I am delighted to serve on the Fathomers board of directors.  In this capacity, I hope for ever more problematic and provocative art to shine through the prism of this wonderful, talented, and challenging organization.

Sunday, November 27, 2016

WIPO Hype O' SIPO

The World Intellectual Property Organization ("WIPO") released its World Intellectual Property Indicators 2016 report on November 23, 2016.  Among various intellectual property data, statistics, and trends, the WIPO report announced that the Chinese State Intellectual Property Office ("SIPO") had become the first national patent office to receive more than one million patent applications in a single year.  In 2015 alone, CIPO logged 1,101,864 distinct applications for patent protection, though these applications included not only applications for "invention patents" (akin to United States ("U.S." utility patents), but also "utility models" ("petit patents") and design patents (similar to U.S. design patents).  In addition, 2015 saw just over one million patent applications filed Chinese citizens.  A breezy overview of the report is available in this WIPO video:



Although it remains unclear whether patents are an accurate metric of innovation, China is on the verge of establishing itself as a patent superpower.

Sunday, October 9, 2016

DNA In The Copyright Office

In an article entitled, "Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses a Matter of First Impression", Chris Holman (who led the effort and was the prime mover of the article), Claes Gustafsson (whose impressive biotechnology company, DNA2.0, designed the DNA sequence submitted to the Copyright Office for registration), and I describe how the United States Copyright Office handled an attempt to register copyright in a synthetic DNA sequence.  Here is the abstract:
In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register engineered genetic sequences. This article reports the outcome of our experiment, and provides as supplementary material the actual letter we submitted to the Copyright Office appealing its initial decision not to register genetic sequences (the “Appeal”), along with the Copyright Office’s letter denying our appeal (the “Denial), which provides a detailed explanation of the Office’s position regarding the copyrightability of engineered DNA. The bulk of the article is devoted to refuting the legal and policy justifications set forth by the Office in its Denial.
Thank you very much to Chris and Claes for including me in this fascinating effort to probe the limits of copyrightable subject matter.  This legal adventure will continue.

Lexvivo Returns

My dear friend, the marvelous Bill Tomlinson, Professor of Informatics at the Donald Bren School of Information and Computer Sciences at the University of California Irvine, has revived Lexvivo from internet purgatory.  Why the website went down remains a mystery, but its resurrection is due to computer maven Bill's internet mojo.  Thank you very much, Bill!