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. 

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!

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.

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.

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?

Synagriculture

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.

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.

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!"

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. 

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.