Monday, December 31, 2012

Farish Alston Jenkins, Jr. (1940-2012)

My doctoral advisor, Farish A. Jenkins, Jr., passed away on November 11, 2012.  Farish did many great things in this life.  He was an artillery captain in the U.S. Marine Corps, the finest teacher that Harvard University has ever known, one of the foremost biologists and palaeontologists in the world, and an exemplary gentleman in the very best and Victorian sense of that term.  Whatever his students needed, he generously provided.  Braving polar bears and arctic blasts, Farish made sure that the holy grail of evolutionary biology, the elusive missing link, Tiktaalik roseae, would be missing no longer.  When his beloved Harvard was threatened by a tyrant, Farish took up rhetorical arms, and, echoing Cato the Elder, destroyed a menace every bit as dangerous as Carthage.  Farish poured greatness into every step he took.

Farish was my hero and my friend.  During my first two years at Harvard, I studied insects.  Whenever Farish saw me, he would fire "Come see me when you're ready to study vertebrates."  He knew my mind better than I did myself.  Inevitably, I accepted his invitation.  He became my advisor.  On my behalf, he took arms against a sea of troubles, and, by opposing, ended them.  My four years as his doctoral student were a joyful time and the best part of my education.  I will always treasure my graduation day in 1998 because Farish spent it with my family and me in the courtyard of Eliot House.  After eating lunch with us, and sharing reminiscences with my grandfather, a former tail-gunner in the Royal Canadian Air Force, Farish presided at my hooding ceremony, conferring on me the doctorate I owe to him.  A decade later, he graciously allowed my six-year old daughter to interview him for a school project she decided to do on Tiktaalik.  Farish treated her with the gentlest of dignity, delighted in the fact both she and his own daughter share virtue names, and gave her an enduring memory of a singular scholar she cherishes still.

Farish is an example I will always strive to follow, a true gentleman I will always remember, and a friend I will always miss.  Vale, Farish!

Wednesday, November 7, 2012

Beauty Fades

In a recent article, entitled Beauty Fades:  An Experimental Study of Federal Court Design Patent Aesthetics (available for free download on SSRN), I presented experimental evidence that aesthetic factors have declined in importance as criteria used by courts to judge design patent validity.  The leading patent blog, Dennis Crouch's Patently-O, invited me to write a guest post highlighting these findings, and the post, Moving Away from Beauty as a Factor in Design Patent Validity, is now available at Patently-O.  Here is the abstract of my article:
Courts are rarely asked to judge beauty. Such a subjective practice would normally be anathema to the ideal of objective legal standards. However, one area of federal law has a long tradition of explicitly requiring courts to make aesthetic decisions: the law of design. New designs may be protected as design patents, but only if they are “ornamental” in nature. As the U.S. Supreme Court has noted, “a design must present an aesthetically pleasing appearance. . . .” This study uses empirical and experimental approaches to test the hypothesis that courts tend to favor more attractive patented designs over less attractive ones. It relies upon a data set that includes all design patent decisions from 1982 until 2010 in which a court made a final determination of validity or infringement, with every design patent at issue therein classified as valid or invalid and infringed or not infringed. In a controlled experiment, human subjects rated the attractiveness of all designs at issue in all of these court decisions. The results show that, although the average attractiveness of patented designs has been stable over the past three decades, the average attractiveness of those designs found invalid has risen markedly. Where courts once appeared to impose a penalty on unattractive designs, they now seem not to discriminate between attractive and unattractive designs in terms of validity. This shift in empirical court outcomes matches a doctrinal shift away from aesthetic considerations by the Court of Appeals for the Federal Circuit, as a result of which the “ ‘ornamental’ requirement of the design statute means that the design must not be governed solely by function. . . .” Thus, both legal doctrine and empirical data reflect a decline in the importance of aesthetic considerations in design patent decisions by federal courts over the last three decades.
Despite Dr. Oliver Wendell Holmes' contention that “Wisdom is the abstract of the past, but beauty is the promise of the future, any promise beauty now holds for design patents may prove hollow.

Wednesday, October 31, 2012

Synthesizing Law For Synthetic Biology

Earlier this year, I was commissioned by the National Academies to write a report on synthetic biology, standards setting, and intellectual property, which I co-authored with Linda Kahl, and presented at the National Academies in Washington, D.C., on October 4, 2012, as part of the Symposium on Management of Intellectual Property in Standard-Setting Processes.  Our report, entitled Synthetic Biology Standards and Intellectual Property, as well as my presentation, are both freely available here.  On October 31, 2012, the University of Kansas released this press release describing my involvement with the National Academies in preparing and presenting our report.  Among the findings in our report was the following:

Patent rights that encumber components and methods have long been a concern among those in synthetic biology, especially as a perceived threat to the field’s prominent ethos of open biological innovation. Currently, there is little evidence that patent rights adversely affect synthetic biological research...In fact, the patent-eligibility of DNA molecules has been put in doubt by several conflicting U.S. court decisions...What is certain is that the synthetic biology community is unusually attuned to debates surrounding intellectual property and standards setting, and views its engagement in these debates as vital to ensure the continued success of synthetic biology. 

Anyone interested in learning more about synthetic biology, biotechnology, and intellectual property law is welcome to download free copies of the following articles:  (1) Synthesizing Law for Synthetic Biology, (2) Gene Concepts, Gene Talk, and Gene Patents, (3) DNA Copyright, and (4) Planted Obsolescence:  Synagriculture and the Law

Sunday, September 30, 2012

Meme Supreme

LEXVIVO is about genes, demes, and memes.  Rarely has a meme risen as rapidly or attained such commanding heights of attention as Korean rapper Park Jae-Sang ("PSY")'s music video of Gangnam Style.  With help from his fellow Korean popstars Kim Hyun-A ("Hyuna"), Kang Daesung (Daesung), and Lee Seung-Hyun ("Seungri"), and comedians Yoo Jae-Suk and No Hungchul, PSY's magnum opus is at once original, mesmerizing, bewildering, catchy, and bizarre.  Gangnam Style is now ubiquitous, with even Saturday Night Live paying tribute.  How far will PSY's imaginary horse carry him.  Get Ye Up!

Thursday, August 30, 2012

The Capitalist Tool On Synthetic Biology

Forbes published an article on August 29, 2012, warning the European Union ("EU") against excessive regulation of synthetic biology.  The article, entitled "Will Overregulation In Europe Stymie Synthetic Biology," cautions that
if the EU applies to synthetic biology its existing dysfunctional approach to genetic engineering, the former will join the latter in bypassing the continent and depriving its citizens of prodigious scientific, health and economic benefits.
The authors are Henry I. Miller, a fellow at the Stanford University Hoover Institute and the first Director of the Food and Drug Administration's Office of Biotechnology, and Drew Kershen, the Earl Sneed Centennial Professor at the University of Oklahoma College of Law and international authority on the law of genetically-modified agriculture.  The article cites my article "Planted Obsolescence:  Synagriculture and the Law," discussed earlier here on Lexvivo.

Saturday, August 4, 2012

Diamond On Romney On Diamond

Mitt Romney, the presumptive 2012 Republican Party presidential candidate, recently invoked the scholarship of UCLA Professor Jared Diamond while visiting Israel.  On July 29, 2012, in a speech at a fundraiser in Jerusalem, he interpreted Diamond's book Guns, Germs and Steel as "basically say[ing that] the physical characteristics of the land account for the differences in the success of the people that live there."  Diamond, winner of Japan's Cosmos Prize, the National Science Medal, and the Pulitzer Prize, disagreed with this characterization of his work.  In an August 1, 2012, New York Times opinion-editorial entitled "Romney Hasn't Done His Homework," Professor Diamond pulled no punches, punctuating his critique of Romney's Weltanschauung with
Mitt Romney may become our next president.  Will he continue to espouse one-factor explanations for multicausal problems, and fail to understand history and the modern world?  If so, he will preside over a declining nation squandering its advantages of location and history.
One suspects that Romney may not win Diamond's vote come November.

Sunday, July 22, 2012

Moxy Frivolous In Spain

Spain is suffering from record unemployment.  A real estate boom has gone to bust.  Its banking sector is near collapse, and will have to be bailed out by the European Union.  With his country in such dire straits, one might expect a wise monarch both to express sympathy with the travails of his subjects and to avoid conspicuous Gatsbian excesses.

King Juan Carlos decided on a different strategy.  He went hunting for elephants in Botswana, and was photographed posing, holding a rifle, in front of his dead pachyderm quarry.  Big game hunting in Africa has long been a pastime of European nobility, so what was the problem?  Well, not only does the extravagance of African trophy hunting juxtapose sourly with the current economic malaise in his own kingdom, but the Spanish king also happens to be the president of the World Wildlife Fund ("WWF") in Spain.  The Spanish WWF was not amused, and summarily deposed Juan Carlos from his position as its leader, explaining
Although this type of hunting is legal and regulated, it has been deemed incompatible by many members with the honorary presidency of an international organisation that defends wildlife and the environment like WWF.

Such behavior may not be the best strategy to endear the monarchy to the people of Spain.  For Juan Carlos, it would be no surprise if "Uneasy lies the head that wears a crown."  Perhaps Moxy Früvous was being prophetic when they sang,
Once I was the King of Spain (now I eat humble pie)
A palatial palace, that was my home (now I eat humble pie)
I'm telling you I was the King of Spain (now I eat humble pie)
And now I vacuum the turf at SkyDome (once he was the King of Spain)
Elephants never forget.  Will Spain?

Thursday, June 28, 2012


Agriculture stands on the verge of another technological transformation.  Just as genetically-modified crops and livestock have begun to achieve normality in the eyes of most, an even more radical approach to agriculture has arrived.  Synthetic biology combines de novo design of genes, cells, and organisms with an ethos of user, open, and collaborative innovation.  "Synagriculture" represents as large a departure from GM agriculture as GM agriculture did from traditional agriculture.  "Planted Obsolescence:  Synagriculture and the Law," newly published in the Idaho Law Review, explores the legal implications of synagriculture.  The article can be downloaded for free here.  Here is the abstract:
Supporters of GM agriculture have had a long row to hoe in achieving public acceptance for the safety of this important technology. Controversy has surrounded the foundational technology of recombinant DNA methods, the application of genetic engineering to crop plants and livestock, the safety of GM “Frankenfoods” as sources of human and animal nutrition, the potential environmental threats posed by the possible development of GM “superweeds,” and the corporate control over GM agriculture exercised by a relatively small number of agricultural companies armed with vast financial resources and powerful patent portfolios. Nevertheless, as exemplified by the United States and Canadian Supreme Court cases, Diamond v. Chakrabarty, J.E.M. v. Pioneer Hi-Bred, Monsanto Canada v. Schmeiser, and Monsanto v. Geertson, the law, and the society it reflects, have finally managed to accommodate the important technology of GM agriculture. However, a new paradigm in biological science — synthetic biology — has begun to remake the face of GM agriculture. Synthetic biology seeks to purge biology of some of its fundamental inefficiencies through the rigorous application of engineering principles. Rather than tinkering around the edges, biological engineering would remake living organisms from first principles, and employ standard parts to make qualitatively new biological devices and systems. Traditional arguments that GM crops and livestock are simply slightly-modified versions of their conventional counterparts may no longer be either appropriate or accurate in the face of synthetic biological approaches to engineering new plants. Moreover, both synthetic biology and do-it-yourself biology (“DIYbio”) seek to shift biological research and development out of traditional laboratories and the hands of credentialed biologists, and, instead, allow any interested and motivated user to become a research biologist, biotinkerer, or synthetic biological engineer. Home and community laboratories are already springing up at a rapid rate, and farm laboratories are sure to follow, as participation in this new, open, and democratized movement burgeons. In short, large numbers of individual and collaborating users, spread over many small and local laboratories, are beginning fundamentally to reengineer genes, cells, organisms, and systems composed of organisms or their substituent parts. The comfortable acceptance of GMOs at which society has only recently begun to arrive may soon be misplaced in the face of both fundamentally new scientific approaches and the democratization of innovation. The results for agriculture may be beneficial: enhanced rates of agricultural innovation through new biological approaches and wide participation. Moreover, synthetic biological agriculture (“synagriculture”) may prove to be as safe as GM agriculture or even conventional agriculture. However, assumptions about current GM crops and livestock may not easily apply to synthetic versions, nor may the current paradigm of GM regulation be possible when innovation becomes atomized among millions of farmers. Some of the “settled” legal issues surrounding GM crops and livestock may have to be revisited as new perceived or actual threats and benefits arise. One irony may be that the same patent system that has so often been criticized in the past for providing agricultural companies with too much control over farmers may soon represent one of the most effective methods for monitoring and regulating GM agricultural innovation. Although some farmer innovators may eschew patent coverage for their agricultural inventions, others may opt to seek patent protection for their innovative new synthetic crops and livestock. Because the USPTO will have to examine any new GM crop inventions prior to issuing letters patent, disclosures to the USPTO synthetic biological inventors who opt for patent protection may become a vital centralized locus for monitoring and regulating otherwise highly-decentralized synagricultural innovation. New methods of biological engineering and new models of user, collaborative, and open innovation are soon to affect the trajectory of GM agricultural innovation. Even if such changes turn out to be salutary, they will be changes nevertheless. To ensure that society receives the full benefits of open and democratized synthetic biological innovation in crops and livestock, it would be well and wise for the law to prepare itself to reexamine the brave new world of synagriculture with brand new eyes.
Henri Alain once wrote that "Life on a farm is a school of patience;  you can't hurry the crops or make an ox in two days."  Toutes les bonnes choses ont une fin.

Wednesday, May 2, 2012

Celebrex Celebration For Chemistry Professor

To celebrate Mayday 2012, Pfizer, Inc., announced its settlement of a legal dispute with Brigham Young University ("BYU") and chemistry Professor Daniel Simmons that involved, among other issues, who invented celecoxib, a small molecule drug better known as Celebrex.  Here is the NPR story about the settlement (for which I was interviewed).  This remarkable COX-2 inhibitor, whose full molecular name is 4 - [5 - (4 - methylphenyl) - 3 - (trifluoromethyl)pyrazol - 1 - yl]benzenesulfonamide, is a sulpha non-steroidal anti-inflammatory drug ("NSAID") that has earned Pfizer approximately $35 billion in revenue so far.  The legal settlement appears to involve a payment of $450 million (a charge disclosed in Pfizer's SEC filings) to BYU and Simmons, as well as BYU endowing the Dan Simmons Chair to honor Professor Simmons' scientific contributions.  Pfizer may have decided that taking the bitter pill of a massive settlement payment to BYU would relieve further legal aches and pains.

Sunday, April 29, 2012

You Can Always Tell A Harvard President

President Barack Obama and Republican presidential hopeful Mitt Romney may not admit to sharing much with one another.  One thing they do have in common is a Harvard Law School ("HLS") J.D.:  Obama was graduated from HLS in 1991, and Romney in 1975.  Despite surviving the same One L Paper Chase trauma, Obama gave Romney the third degree about his second degree from Harvard (MBA Harvard Business School 1975) at the White House Correspondents Dinner, on April 28, 2012, where Obama joked that "We both have degrees from Harvard.  I have one, he has two.  What a snob!"  This dropping of the H-bomb notwithstanding, it is almost certain that January 20, 2013, will see Harvard President #8 inaugurated for his second term or Harvard President #9 for his first.  "And when the [inauguration] ends, we'll sing again:  Ten thousand men of Harvard gained vict'ry today!"

Thursday, April 12, 2012

Copyright To Life

In his 1993 book, The Language of the Genes:  Biology, History and the Evolutionary Future, British biologist, John Stephen Jones, concisely conveys the linguistic function of DNA, as follows:
The language of the genes has a simple alphabet, not with twenty-six letters, but just four. These are the four different DNA bases—adenine, guanine, cytosine and thymine (A, G, C and T for short). The bases are arranged in words of three letters such as CGA or TGG. Most of the words code for different amino acids, which themselves are joined together to make proteins, the building blocks of the body.
The letters in the alphabet of DNA nucleotide bases can form words that, in turn, can express meaning.  Synthetic biology allows works of expressive authorship to be fixed in the tangible medium of DNA expression.  Thus, DNA may be eligible for copyright protection, as I argue in a recently-published (and freely-downloadable) article, DNA Copyright.  Here is the abstract:
Copyright law has traditionally afforded protection to works of authorship such as books, magazines, photographs, paintings, music, and sculpture. The Copyright Act has proved admirably flexible at accommodating novel categories of authorship, specifically contemplating future developments by covering “original works of authorship fixed in any tangible medium of expression, now known or later developed.” This has led to explicit copyright protection for nontraditional subject matter, such as works of architecture and computer software. Sequences of DNA should also be acknowledged as eligible for copyright protection. Unaltered genomic DNA sequences would seem poor candidates for copyright protection. The case is stronger for copyright protection of recombinant DNA sequences. Strongest is the case for the copyright eligibility of synthetic DNA sequences designed nucleotide by nucleotide and chemically constructed de novo. Whereas DNA copyright has previously remained a largely hypothetical prospect, advances in synthetic biology may now force recognition of copyright protection as an alternative (or complement) to patent protection. A DNA copyright regime would differ substantially from the current DNA patent regime. Notably, acquiring copyright protection for DNA would be less expensive and much more rapid than pursuing patent protection. While patent law recognizes few and weak exceptions to infringement, copyright law offers a robust fair use exception for copying done in contexts such as scholarship and research. Furthermore, copyright protection would be limited in the case of DNA molecules whose structures are dictated by functional constraints, thus providing the public greater and salutary access to useful genes. Copyright protection for DNA lies pregnant within current copyright law. What is required is an effort to make use of this existing protection. A DNA copyright regime would not only allow a more robust set of safe harbors for use of particular DNA sequences, especially in genetic research, it would also facilitate the possibility of an open source biology movement. Finally, just as the prospects of patent protection for at least some forms of DNA have become uncertain, copyright protection could fill any resulting gap by affording a reasonable level of intellectual property protection, while simultaneously allowing society to enjoy some of the benefits of genetic knowledge more freely than patent protection currently allows.
In light of its March 20, 2012, decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc. (U.S. 2012) (previously discussed on LEXVIVO) the United States Supreme Court vacated and remanded the July 29, 2011, Court of Appeals for the Federal Circuit ("CAFC") decision, The Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. (also previously discussed on LEXVIVO), that had upheld the patent eligibility of DNA sequences.

Unless the CAFC can safely navigate gene patents past the patent eligibility perils of Scylla (Bilski v. Kappos (U.S. 2009)) and Charybdis (Mayo v. Prometheus), copyright may soon be seen as the best hope for securing intellectual property protection of DNA inventions. 

Wednesday, March 21, 2012

On Prometheus The Tempest Falls

The article, Physiological Steps Doctrine, published in 2009 in the Berkeley Technology Law Journal (and available free on SSRN), suggested that patents claiming aspects of human physiological processes are not upheld in court.  Here is the abstract of Physiological Steps Doctrine:
In vivo conversion is a process, often metabolic in nature, wherein one substance, usually a chemical compound, is altered significantly by physiological pathways in the body into one or more different substances.  For example, when a patient ingests a therapeutic drug, that drug is often converted by the natural physiology of the digestive system into one or more chemically different metabolites.  The end products of in vivo conversion sometimes possess therapeutic efficacy.  Many patent applications have claimed such therapeutic metabolites, either as compositions per se or as parts of methods of treatment.  Although the United States Patent and Trademark Office has granted patent claims to such products generated by in vivo conversion of ingested drugs, and courts have noted the eligibility of such products as patentable subject matter, never has a United States court of final appeal upheld such a patent claim as valid, enforceable, and infringed.  The unanimity of results in cases involving patent infringement triggered by in vivo conversion is striking.  In fact, its very improbability suggests a common underlying explanation for why in vivo conversion does not ever seem to trigger patent infringement.  Explanations based on inherency or a lack of evidence provide a satisfactory explanation for only a minority of in vivo cases.  The "Physiological Steps Doctrine," which suggests that products and processes of in vivo conversion are unpatentable subject matter under United States patent law, offers an explanation that spans all in vivo conversion cases.  Though the rationales offered to explain the results in a number of in vivo conversion cases are suggestive, there are several advantages for a more explicit recognition of the Physiological Steps Doctrine.  Consistent with much international, European, and U.S. patent law, the Physiological Steps Doctrine provides a theoretical underpinning to explain the results in cases involving products and processes of in vivo conversion.  This theoretical underpinning not only has explanatory power for interpreting previous case law but is also useful in predicting the outcome of future in vivo conversion cases.  In addition, the Physiological Steps Doctrine increases the understanding of where inventions involving human beings, and the biological products and processes thereof, fit within the spectrum of patentable subject matter.
On March 20, 2012, the United States Supreme Court unanimously confirmed Physiological Steps Doctrine by holding invalid Prometheus Laboratories' patent claims to uses of in vivo conversion products in diagnosis and therapy.  The decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc. (U.S. 2012), may not only sound the formal death knell of in vivo conversion patents, but also cast severe doubt on the patent eligibility of wide swaths of the personalized medicine and genomics fields.  LEXVIVO has discussed previous chapters in the Prometheus saga by the Supreme Court and the Court of Appeals for the Federal Circuit ("CAFC").

It would now be unsurprising if the Supremes were to vacate and remand the July 29, 2011, CAFC decision in The Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. (previously discussed on LEXVIVO) that upheld the patent eligibility of gene patents.  If so, genome-derived DNA patents could be the next domino to fall in the recently turbulent game of patentable subject matter.

Thursday, January 26, 2012

Heresy In The Patent Cathedral

Study Suggests Stronger Patent Protection May Dampen Innovation

LAWRENCE (University of Kansas Press Release) — Results of a new study by researchers from the University of Kansas and University of California-Irvine suggest that, contrary to popular belief, greater amounts of innovation, productivity and social wealth may occur when infringers are simply required to pay damages for illegally using an invention rather than prohibited altogether from using it.

The study reinforces the findings of an earlier paper by the researchers — Law Professor Andrew W. Torrance of KU’s School of Law and Informatics Professor Bill Tomlinson of UCI’s Donald Bren School of Information and Computer Sciences — offering experimental evidence that the greatest amounts of innovation may result when inventors receive no protection at all from the legal system.

Using the Patent Game, an interactive computer-based model that attempts to simulate patent systems, Torrance and Tomlinson conducted a series of controlled experiments to evaluate the merits of property rules (which expressly prohibit infringers from using the patent owner’s invention) and liability rules (which require infringers to pay damages without being prohibited from using the invention).

“Conventional wisdom says people will invent less if property rights are not strongly enforced,” said Torrance. “However, we found that the threat of prohibition actually dampened innovation.”
The pair’s latest study, just published in the spring issue of the Yale Journal of Law and Technology, expands on earlier collaborations related to the scientific study of the U.S. patent system. In 2009, they published a paper challenging the traditional view that patents foster innovation — suggesting instead that patents may harm new technology, economic activity and societal wealth.

The new study focuses on the effectiveness of the two kinds of remedies usually available in patent infringement litigation — injunctions vs. monetary damages — and is the first experimental test in the intellectual property realm of a seminal theory of law, outlined in the 1972 paper, "Property Rules, Liability Rules, and Inviolability:  One View of the Cathedral," which suggests that liability rules (damages) and property rules (injunctions) may lead to different outcomes in the law.

“Complex human institutions, such as our legal system, are traditionally very hard to assess in a scientifically rigorous way,” said Tomlinson, who credits two of his undergraduate students with writing much of the code for the Patent Game. “By using an interactive simulation to create a model of the way human systems function, we are able to offer a new perspective on one of the fundamental theories of law — that amounts of innovation vary across patent systems emphasizing different kinds and different levels of protection for the inventor.”

The Patent Game allows multiple players to engage in simulated business transactions. They can create, patent, dedicate as open source, make and sell inventions, and assign, buy, license-in, license-out and litigate patents.

As part of the study, a group of first-year law students who assumed the roles of inventors and patent owners in the game were offered various remedies for infringement — permanent injunctive relief (property), monetary damages (liability), both or neither. Based on the players’ behavior, the system found that amounts of innovation, productivity and social utility were:

• lowest in patent systems where remedies for infringement included both injunction and damages,
• higher in a system that enforced injunction only,
• higher still in a system that enforced damages only, and
• highest where no protection from infringers was available.

Torrance and Tomlinson's latest paper, “Property Rules, Liability Rules, and Patents: One Experimental View of the Cathedral,” is available for free download here.