BIO-IPCC Spring 2013

The Biotechnology Industry Organization Intellectual Property Counsels Conference is holding its spring meeting in San Diego from March 25-27, 2013.  This conference provides invaluable analysis of the most important issues currently of moment in biotechnology intellectual property law.  Here are the spring 2013 sessions:

Session 1 - Seeds of Exhaustion: Analysis of Bowman v. Monsanto & the Shifting Doctrine of Patent Exhaustion 

Session 2 - Any Port in a Storm - Section 271(e)(1) and the Continuing Debate Over Boundaries of Safe Harbor Exception 

Session 3 - The Method Patent Rollercoaster 

Session 4 - Patent Opinions Revisited: New Risks, New Rewards 

Session 5 - The AIA and APA: Oversight of Patents and the Agency That Grants Them

Lurking behind many of these topics are the Supreme Court's trilogy of biotechnology patent cases, Prometheus, Bowman, and Myriad, which are disrupting and refashioning the legal landscape for biotechnology.

Deextinction

One of the hottest topics today in biology and biolaw is deextinction.  Here is the February 13, 2013, TED Talk by Stewart Brand that catalyzed the current explosion in interest in the topic.  LEXVIVO will be following deextinction closely.

Design Patents At Stanford Law School

Design patent law is suddenly hot, hot, hot!  I have previously published an experimental study of design patents entitled "Beauty Fades: An Experimental Study of Federal Court Design Patent Aesthetics" (available free here).  The ongoing intellectual property litigation between Apple Inc. and Samsung Electronics Company, Ltd. involves, among other legal issues, numerous design patents claiming computer-generated imagery.  Stanford Law School is holding a two day conference on design patent law, called Design Patents in the Modern World, on April 5th and 6th, 2013.  I have been invited to present my research on April 6th as part of The Design Patent Conference Academic Day.  My talk is entitled “(R)evolution in Design Patent Subject Matter:  The Shifting Meaning of ‘Article of Manufacture,’” and is based on an eponymous article my co-author, William J. Seymour, of the Cambridge, Massaschusetts, intellectual property law firm, Lando & Anastasi, LLP, and I are writing.  Bill is a leading authority on design patent law, and his blog, The Ordinary Observer, heads the field.  The ordinary observer will find the conference designed to be replete with new, original, and ornamentally-manufactured articles.

Grey Markets No Longer A Grey Area

In a remarkable decision on March 19, 2013, the United States Supreme Court held that the first sale doctrine applies sales both inside and outside the United States.  The Court decided that the first sale doctrine provision of the Copyright Act (17 U.S.C. 109(a)) supersedes a second, import-control, provision of the Copyright Act (17 U.S.C. 602(a)(1)).  The case, Kirtsaeng v. John Wiley & Sons, arose when Supap Kirtsaeng, a Thai mathematics student at Cornell University, asked friends and family to send him versions of textbooks lawfully marketed in Thailand, and then sold these textbooks in the United States at a profit.  Publisher, John Wiley & Sons, sued Kirtsaeng, alleging that the first sale of these textbooks had occurred within the United States, constituting copyright infringement.  Kirtsaeng countered by arguing that the first sale of these textbooks had occurred in Thailand, and the publisher's copyrights had thus been exhausted prior to the sales subsequently made by Kirtsaeng.  The Supremes agreed, holding that

The "first sale" doctrine applies to copies of a copyrighted work lawfully made abroad.

Absent action by Congress to eliminate grey market imports, this decision will severely hamper current practices of price discrimination between different countries for copyrightable goods.  This 6-3 decision augurs well for farmer, Vernon Hugh Bowman, a 75-year old Indiana soybean farmer currently defending his farming practices against Monsanto Corporation in the Supreme Court on grounds of patent exhaustion, a doctrine related to copyright first sale doctrine.  Supap Kirtsaeng may now have sowed the seeds of victory for Vernon Hugh Bowman.

Mes Amis A AMIA 2013

On March 19 and 20, 2013, I had the privilege of speaking at American Medical Informatics Association ("AMIA") 2013 Summit on Translational Bioinformatics in San Francisco.  Organized by the brilliant and masterful Dr. Jessica D. Tenenbaum, Associate Director of Bioinformatics at the Duke Translational Medicine Institute ("DTMI"), the Summit was a huge success.  Here is the abstract of the March 19, 2013, panel on which I spoke:

TBI-LB03: Late Breaking Session - That's My Data! Navigating Ownership, Sharing, and Translation in the Genomic Era 

Panelists:  Kelly Edwards, University of Washington; Hank Greely, Stanford University; Barbara Koenig, University of California at San Francisco; Andrew W. Torrance, MIT Sloan School of Management/University of Kansas School of Law 

In this era of big data, genomic medicine is enabling personalized approaches to diagnostics and therapeutics in ways never before possible. But with these advances come critical ethical, legal, and social issues around data use. Who owns this data and the new knowledge to which it gives rise? What obligations do researchers have toward participants? What information should researchers be sharing with patients, participants, and society more broadly? Are there novel models of partnership and engagement that can build trust? Where does nature end and intellectual property begin? How are parallel efforts on the consumer market disrupting usual clinical care? These questions must be addressed by researchers and society alike if we are to harness the power of genomic and large-scale clinical data capabilities in ways that are trustworthy and impactful. 

In this panel, legal, social, and ethics scholars will speak to issues of data sharing, community engagement, returning results, gene patenting and ownership, and direct-to-consumer movements. Each member of the panel consults actively on large-scale data-driven research projects and is at the front lines of shaping governance processes that will facilitate, rather than hinder, our ability to utilize big data to impact health. 

In order for the best technology and science in the world to come to bear on human health issues, partners across clinical groups, researchers, policymakers, and society at large must be engaged. This panel discussion will frame emerging issues in the field with researchers and advance further stakeholder engagement.

My fellow panelists were superb.  It's comforting to know that a field as vitally important to the future of medicine as bioinformatics is being actively studied by scholars as insightful as Kelly, Barbara, and Hank.  The challenges and opportunities presented by the dawning age of big biological data need their considerable talents and expertise.

Hot News

On March 8, 2013, one of the most prestigious peer-reviewed science journals, the eponymously-named Science, published research by four climate scientists (Shaun A. Marcott, Jeremy D. Shakun, Peter U. Clark, and Alan C. Mix) entitled "A Reconstruction of Regional and Global Temperature for the Past 11,300 Years."  Perhaps their most striking finding is that

Surface temperature reconstructions of the past 1500 years suggest that recent warming is unprecedented in that time...Global temperature...has risen from near the coldest to the warmest levels of the Holocene within the past century, reversing the long-term cooling trend that began ~5000 [years before present].

Marcott et al. might offer a piece of Ronald Reagan's wisdom to those who disagree with their findings:  "When you can't make them see the light, make them feel the heat."

C, Eh, N, Eh, D, Eh!

Stompin' Tom Connors, the great Canadian troubadour of the tundra, died on March 6, 2013.  Among his most famous songs are "The Hockey Song," "Big Joe Mufferaw," and "Sudbury Saturday Night," and "Bud the Spud."  With the loss of Stompin' Tom, a great era in Canadian music has ended.

Pharmaceutical Fantasy Fails As Free Speech

The Court of Appeals for the Ninth Circuit decided the case of United States v. Harkonen on March 4, 2013.  The Court affirmed a jury conviction for wire fraud, triggered by publication of a press release allegedly announcing false clinical trial results for interferon gamma-1b ("Actimmune").  In this case, the Court appears to have poured cold water over the notion that the First Amendment right to free speech may authorize factually-false commercial speech, particularly in the realm of marketing pharmaceuticals.  Caveat vendor.

A Wellcome Genetics Archive

The Wellcome Trust has announced it is setting up a massive, million-page digital archive covering the history of genetics.  The Trust describes its "Codebreakers:  Makers of Modern Genetics" archive as follows:

[It] contains more than one million pages of first-hand notes, letters, sketches, lectures, photographs and essays from the circle of brilliant minds responsible for uncovering the structure of DNA. The site lays bare the personal and professional thoughts, rivalries, blind alleys and breakthroughs of the scientists whose ideas transformed our understanding of the matter of life.

Among the treasures in the archive will be notebooks and correspondence of Francis Crick, who, along with James Watson and Maurice Wilkins, won the 1962 Nobel Prize for Physiology of Medicine for elucidating the double-helix structure of DNA.

The history of genetics is among my interests as well.  I have discussed the history of genetics and gene patents in a 2010 article, "Gene Concepts, Gene Talk, and Gene Patents," published in the Minnesota Journal of Law, Science & Technology.

The archive will make available the good, the bad, and the ugly of modern genetics, including the views of leading genetics on such controversial topics as eugenics, genetic determinism, and human genetic engineering.  Genes may not be destiny, but genetics is destined to be more fully understood once its primary documents are made available to one and all for first-hand review.

Pope Emeritus Rapped By Rapper?

The New Yorker reported on February 27, 2013, that a trademark dispute had arisen over former Catholic Pope Benedict's use of the new title "Pope Emeritus."  According to the article, Oakland rapper "Pope Emeritus" owns trademark rights in his moniker, is "[f]urious at what he is calling a clear case of trademark infringement" by the ex-Pope, and "won't let anybody mess with [his] brand."  Naturally, the article, by Andy Borowitz, is a joke.

There are no United States trademark registrations for "Pope Emeritus."  Among a number of other trademarks, there is a registered trademark for "POPE OF SLOPE," an abandoned trademarks for "POPESOAP," a canceled trademark for "ELECTAPOPE," and an abandoned trademark for "POPE BENEDICT PRETZEL").  There is no word yet on whether Joseph Aloisius Ratzinger finds the joke (or any of the actual trademarks) at all funny.