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.

Patent Heresy On The Six O'Clock News

As proof positive that January 26, 2012, was a very slow news day, 6 News Lawrence, a Kansas television station, led its evening news with this story about a new article just published on patent law, entitled "Property Rules, Liability Rules, and Patents:  One Experimental View of the Cathedral".

Heresy In The Patent Cathedral

Study Suggests Stronger Patent Protection May Dampen Innovation

Professor Andrew W. Torrance

Professor Bill Tomlinson

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.

Go Daddy's Bizarre Trunk Show

Elephants, both African and Asian, are endangered.  The ivory trade, big game hunting, and slow gestation periods all play a role in decimating pachyderms.  Most people appear to find elephants endearing, and worth protecting.  However, in one of the strangest videos of 2011, Go Daddy CEO, Bob Parsons, claims to have shot and killed a Zimbabwean elephant because of the dire threat it posed to the food supply of local villagers.  Despite overwhelming evidence that famine stalks Zimbabweans due to the ruthless policies of their dictator, Parsons appears to view marauding elephants as significant threats to the food supply.  Here's Parson's video confession of pachydermicide, which invites comparison with Teddy Roosevelt, another famous elephant hunter.  Other similarities between Parsons and the great President Roosevelt are not apparent.  Based on his other videos, often promoting himself personally, and Go Daddy as a domain name registrar, some of Parsons non-elephantine views are also eccentric.  As a permanent home for his various musings on bull elephants, Parsons might consider acquiring www.elephantbull.com, if it is still available.

Secret Salmon Science

As one of the brothers in Lewis Carroll's The Two Brothers laments,

Take my friends and my home - as an outcast I'll roam: Take the money I have in the bank: It is just what I wish, but deprive me of fish, And my life would indeed be blank.

This ichthyophile brother would surely be alarmed at the crisis now facing wild salmon stocks on the Pacific coast of North America.


Salmon can contract an influenza-related virus that causes infectious salmon anemia ("ISA").  For the past few decades ISA has been devastating salmon populations from Norway and Scotland to the Canadian Maritimes and Chile, sometimes killing more than 9 out of every 10 fish.  Critics of salmon farming have blamed the spread of ISA on the high densities of fish kept together in ocean-borne cages, along with frequent piscine jailbreaks into the wild.

In October, 2011, ISA was diagnosed among wild pacific salmon in British Columbia by the ISA Reference Laboratory at the Atlantic Veterninary College, in Prince Edward Island.  Although these diagnoses were quickly disputed by the Canadian Food Inspection Agency, it now appears that Canada may have made similar diagnoses as long ago as 2002.  If so, it seems that Canada failed in its obligations to inform the United States and the World Organization for Animal Health.

Salmon farming is especially controversial on the Pacific coast of North America, because of the existence of a thriving wild salmon fishery.  Fears that escapees from fish farms there could spread diseases to these wild populations have generally been dismissed by fish farmers.

If ISA has indeed infected wild Pacific salmon populations, Carroll's other, ichthyophobic, brother would surely be delighted:

What? a higher delight to be drawn from the sight of fish full of life and of glee? What a noodle you are! ‘Tis delightfuller far to kill them than let them go free!

Too bad Dudley Do-Right did not do right by the salmon.

IPAT Baby Seven Billion

With the seven billionth living human being imminent, it is important to consider that numbers of people alone do not explain the environmental impact Homo sapiens have on the earth.  Developed by Stanford biologist Paul Ehrlich, Assistant to the President for Science and Technology John Holdren, and others back in the 1970s, the IPAT formula provides a useful lens through which to view Mr. or Ms. Seven Billion ("Giga Septem").

The I=PAT formula is an identity.  I represents environmental impact, P population, A affluence, and T technology.  While human population (that is, number of people) and affluence (that is, wealth per person) have tended to push I upwards over the last few thousand years, the technology factor (impact per wealth) has tended to decrease I by providing increasingly efficient means for accomplishing tasks.  Because I is calculated as the product of P, A, and T, each factor is equally important.

Thus, while population growth certainly contributes to environmental impact, so do affluence growth and technological improvement.  Welcome, G. Septem.  Now that you have joined us, we will watch with fascination how wealthy you become, and how quickly technology improves during your lifetime.

Weldon Amendment Welded Onto The Patent Act

In 2004, the Consolidated Appropriations Act (Public Law Number 108-199, Section 199) was passed with the "Weldon Amendment" (named for its sponsor, former Republican Congressman Dr. Dave Weldon), a rider stipulating that "[n]one of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism."  On September 16, 2011, when President Barack Obama signed into the law the America Invents Act, the Weldon Amendment became an integral part of the Patent Act.  Effective immediately, here is what this new patent law requires:

SEC. 33.  LIMITATIONS ON ISSUANCE OF PATENTS
(a) LIMITATION.-Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(b) EFFECTIVE DATE.-
(1) IN GENERAL.-Subsection (a) shall apply to any application for patent that is pending on, or filed on or after, the date of the enactment of this Act.
(2) PRIOR APPLICATIONS.-Subsection (a) shall not affect the validity of any patent issued on an application to which paragraph (1) does not apply.

No one yet knows what "directed to or encompassing a human organism" means.  The United States Patent and Trademark Office will have the first opportunity to apply this restriction as the initial arbiter of patent applications.  Inevitably, the federal courts will weigh in to provide more authoritative interpretations.  Eventually, Congress may have to amend this provision to clarify it.  Meanwhile, the inclusion of this restriction on patenting "a human organism" directly within the patent statute strongly signals that at least some biotechnological advances have unsettled both Congress and the President.