Tuesday, January 24, 2017

Brexit Becomes Bruncertainty

The United Kingdom ("U.K.") Supreme Court has ruled that the U.K. government needs the approval of Parliament before it can trigger divorce proceedings from the European Union ("E.U.) by invoking Article 50(2) of the Treaty on European Union.  On June 23, 2016, a majority of voters in the United Kingdom European Union membership referendum voted yes to the question
Should the United Kingdom remain a member of the European Union or leave the European Union?

 Subsequently, the U.K. government has been preparing to inform the E.U. of its intention to "Brexit" under Article 50(2).  The January 24, 2017, Supreme Court decision found the government lacked the prerogative power to effect Brexit without Parliament's formal consent, stating that
121.  Where, as in this case, implementation of a referendum result requires a change in the law of the land, and statute has not provided for that change, the change in the law must be made in the only way in which the UK constitution permits, namely through Parliamentary legislation.
The disarray caused by the Brexit referendum vote has now been compounded by the question of how, of even if, Parliament will actually achieve Brexit.  After all, Parliament could decline to invoke Article 50(2), or, it could decide to vote against Brexit.  Only time will tell.

Meanwhile, Brexit has become Bruncertainty.

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.