Andrew W. Torrance

Massively distributed authorship of academic papers

Wiki-like or crowdsourcing models of collaboration can provide a number of benefits to academic work. These techniques may engage expertise from different disciplines, and potentially increase productivity. This paper presents a model of massively distributed collaborative authorship of academic papers. This model, developed by a collective of thirty authors, identifies key tools and techniques that would be necessary or useful to the writing process. The process of collaboratively writing this paper was used to discover, negotiate, and document issues in massively authored scholarship. Our work provides the first extensive discussion of the experiential aspects of large-scale collaborative research.

The Unpatentable Human Being

On June 13, 2013, the Supreme Court placed its imprimatur on a principle that has been gathering force within patent law for several decades: human beings constitute unpatentable subject matter. In Association for Molecular Pathology v. Myriad Genetics, Inc., the court answered the question it had posed itself — “Are human genes patentable?” — decisively in the negative. Synthetic DNA sequences, designed by humans, were excluded from this prohibition, but the invalidation of patents claiming human genes wiped out vast amounts of private investment and was a body blow to the biotechnology industry. Nevertheless, this legal result was predictable, given a careful reading of the entrails of judicial decisions, congressional bills, executive branch pronouncements, and decisions in other countries about patents claiming human-related inventions, all of which have echoed the spirit of the Thirteenth Amendment by proscribing property rights — including intellectual property rights — in human beings. To understand how patent law has evolved toward this result, one may trace the legal treatment of patents claiming human embryonic stem cells, chemical products of human physiology, human thought, and now, human genes. Woven together, these strands of evidence led inexorably toward the ultimate rejection of human gene patents by the Supreme Court, and placed a decisive judicial exclamation mark on the unpatentability of human beings and human bodily structures and functions.

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 USPTO 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 U.S. 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.

Are the Brookhill–Wilk patents impediments to market growth in cybersurgery?

In the past, many surgeons could practise their craft with little or no knowledge of patent law. But in the world of robotic and computerized surgery, this is increasingly a myopic approach, because the principle means of protecting high‐tech surgical instruments is through the application of patent law. The issue is: does the Brookhill–Wilk patent, which covers the performance of remote robotic surgery, impede the growth of cybersurgery?

CRISPR Becomes Clearer

In this pivotal year for gene editing, the breakthrough molecular system CRISPR-Cas9 has advanced on three fronts. In under seven months, an influential scientific body-the National Academies of Sciences, Engineering, and Medicine the National Academies of Sciences, Engineering, and Medicine-cracked open the door to human germline gene editing, ownership of patents covering CRISPR-Cas9 came into much sharper focus as a result of a dispute between two parties, and experiments showing proof of concept of the most controversial of uses-altering germlines of humans-were revealed as having been successfully performed by a mainstream laboratory. Given the vast spoils that await the patent owners, final results of all patent disputes over CRISPR-Cas9 patents may stretch on for years. Meanwhile, bioethical considerations of CRISPR-Cas9 have also been contentious as the United States and other countries grapple with how best to regulate gene editing.

A Natural Experiment on Innovation Without Patents

Innovation occurs within a complex web of law. Of the myriad legal doctrines that affect innovation, the most directly relevant is intellectual property, particularly patent law. Despite the faith many have in the societal benefits afforded by patent protection, a crescendo of recent critics have suggested that the patent system may complicate, slow, or even thwart innovation. Empirical evidence evaluating how well the patent system achieves its stated goals of encouraging innovation is notably scarce. One section in the America Invents Act (“AIA”) – Section 33 – may offer a rare and valuable opportunity to explore how innovation might perform without the protections or constraints of patents. Section 33 of the AIA, which took effect on September 16, 2011, states that “[n]otwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” Although patents claiming inventions “directed to or encompassing” aspects of human organisms, such as human bodies, organs, tissues, cells, genes, chemical products of physiological processes, and even thoughts have often been granted by the United States Patent and Trademark Office (“USPTO”), patents claiming this class of biotechnological inventions have proved increasingly difficult successfully to assert in court. It is too early to know precisely how the United States Patent and Trademark Office (“USPTO”) and the courts will interpret Section 33. Nevertheless, a rich body of judicial decisions on the validity, enforcement, and infringement of patents claiming human genes, human embryonic stem cells, chemicals produced by human physiology, and human thought (especially relating to diagnosis and therapy) do provide valuable insight into how far Section 33 may reach. These decisions suggest that inventions related to the human body and its functions represent a lacuna in patentable subject matter. If interpreted in a manner consistent with this body of court decisions, Section 33 may represent an apotheosis of the marked common law trend against the patenting of inventions relating to the humans, the human body, and human bodily processes. With the addition of Section 33 to the patent law, both statute and judicial precedent have now created a space in which innovation “directed to or encompassing a human organism” may take place substantially unfettered from fears of infringing patent rights. This safe harbor from patent infringement allows a natural experiment to take place in which innovation may operate without interference from patent rights. This natural experiment offers a valuable opportunity to observe whether innovation flourishes, wilts, or reacts with indifference to the rare circumstance of freedom from patents.

Patenting Human Evolution

Patent protection for genetic enhancements would tend to spur genetic innovation, but would tend to limit access to those genetic enhancements through discriminatory mechanisms such as price and favoritism. The patent system would likely ensure high rates of genetic enhancement innovation, research, and development, efficiently mediate access to genetic enhancements, but would also likely allow access to genetic enhancements to fewer members of society. Most importantly, the patent system has the potential to promote the kinds of genetic enhancements that might lead to human evolutionary change. Public policy and the law must grapple with the implications of genetic enhancement before current technological possibilities become societal realities. The patent system is an odd candidate to become a substantial arbiter of parental decisions regarding genetic enhancement of their offspring. It is certain that the implications the patent system has for future human genetic enhancement should be subjected to thorough analysis and debate prior to the imminent arrival of human genetic enhancement technologies. Otherwise, patent law may drive human evolution in directions either unplanned - or worse - undesired.