Dinosaur Tail Tip Tale

WOW! 6 News, a Lawrence, KS, television station, did a story on the tip of befeathered dinosaur tail discovered embalmed in amber.  Although my biology is long out of date, they interviewed me anyway.  Fortunately, the reporter, Dan Garrett, also interviewed a real palaeontologist.  Law or no law, I have to admit being associated with anything dinosaurian is super cool.

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.

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]

In the epic patent litigation royale between Apple Inc. ("Apple") and Samsung Electronic Co., Ltd. et al ("Samsung"), the Court of Appeals for the Federal Circuit ("CAFC") interpreted §289 to mean that Samsung Electronic Company, Ltd., owed Apple, Inc., profits from entire devices, even where the Apple design patents Samsung was found to have infringed claimed only portions of the infringing devices (that is, smartphones) Samsung sold.

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. 

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.

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.

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!

Governing Biotechnology

As noted last year by Lexvivo ("Recoordinated Framework", July 2, 2015), the United States federal government has been considering how to update its policy on biotechnology regulation.  On September 16, 2016, the White House released a draft revision of the "Coordinated Framework for the Regulation of Biotechnology" (commonly known as the "Coordinated Framework").  (Thank you to the brilliant Brian Mannix for alerting me about the draft's release.)  The original policy, in force since June 26, 1986, can be found here.  The draft new policy, entitled "Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology", can be found here.  The White House described its reformulated biotechnology regulatory policy as follows:

[It] sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In the [draft new policy], the Federal agencies demonstrate their sustained commitment to ensure the safety of future products of biotechnology, increase public confidence in the regulatory system, and prevent unnecessary barriers to future innovation and competitiveness.

Biotechnology has evolved rapidly and radically over the past three decades, so a comprehensive review of the policies that oversees its regulation would seem overdue, especially in light of signal innovations like de novo gene synthesis and in toto genome editing.  Let's hope that this proposed recoordination of policy on that most complex of technologies avoids tripping over its own feet.

Sometimes A Cigar Is Just A Trademark

On September 9th and 10th, 2016, I participated in "The Psychology and Sociology of Creativity and IP" at Stanford Law School.  Rebecca Tushnet, author of the superb 43(B)log, summarized each of the sessions:

Session 1: Why do people create? 

Session 2: Why do companies patent? 

Session 3: What can we learn from IP-free zones?

Session 4: The sociology and psychology of brands 

Session 5:  Fairness, efficiency, and distributive justice

Thank you very much to Mark Lemley for organizing and hosting this fascinating meeting.

2016 Freeman Prize

Sampsa Hyysalo, Torben Elgaard Jensen, and Nelly Oudshoorn just let us know that the book they edited, entitled New Production of Users - Changing Innovation Collectives and Involvement Strategies (Routledge), has received the 2016 Freeman Prize, which is awarded "for a publication which is a significant collective contribution to the interaction of science and technology studies with the study of innovation" by the European Association for the Study of Science and Technology ("EASST").  This award honors "Professor Chris Freeman, renowned expert on the social and economic consequences of developments in science and technology".  Eric von Hippel and I were invited to contribute a chapter, which we coauthored and named "Protecting the Right to Innovate:  Our Innovation "Wetlands"".

Thank you very much to Sampsa, Torben, and Nelly for their wonderful leadership in producing this book!  They deserve the lion's share of the congratulations for winning the Freeman Prize.