Images by B. Charnley

Patenting Life: genes and generations, round table at ISHPSSB 2013, Montpellier

Monsanto, Myriad and gene patents

Patenting life has returned to the spotlight with two ongoing US Supreme Court cases on the subject. What was apparently settled law has been thrown into new uncertainty. The consensus has been that modifying, isolating or synthesising a life form constitutes a transformative act turning natural phenomena into patentable human artefacts deserving an increasingly absolute form of monopoly protection. Of course an arguable case can be made for expanding patentable subject matter in the ways that have become the norm. But such a case does not deserve to be taken for granted and the present legal challenges are thus both timely and necessary. The first case (Bowman vs. Monsanto) can be considered to re-open the necessary debate about the inherent patentability of 'inventions' capable of replicating themselves, though it does not strictly address the question. One would at least hope to see a necessary assessment of what it means to 'make' an invention, when said invention is a gene, seed or plant. The second case, AMP v Myriad, will refocus attention the established legal interpretation, based on a problematic reading of a century of case law, that the isolation of DNA may constitute the creation of a new patentable 'thing' regardless of whether the sequence of the patented DNA has been altered.

This round table brings together leading law experts with historians, sociologists and philosophers of biology to question what a wider, and indeed, more global, view can add to current debates over the use of patents to protect biological objects. We hope to produce an edited volume based on the discussion at this session and previous events.

The session was held at the 2013 meeting of the International Society for History, Philosophy and Social Studies of Biology, in Montpellier, France. Funding for a conference meal was generously provided by the Australian Centre for Intellectual Property in Agriculture, ACIPA.

Berris Charnley (ACIPA, Griffith University)

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Two features of the Supreme Court's hearing of Bowman v. Monsanto stand out as particularly interesting. The first relates to assumptions made about the way agricultural research is motivated and evaluated. The second is a more specific point about the Supreme Court's particular conceptualisation of what it means to 'make' Monsanto's round-up ready soybeans. One of the biggest surprises about the Bowman v. Monsanto case is just how firmly the court and several groups that filled amici briefs with the court, inhabit a world in which privately funded research is seen as the only means to agricultural development. Essentially the case boiled down, in the court's view, to a competition between Monsanto's rights as a patent holder versus Bowman's ability, as a farmer, to benefit from new technology. If the exhaustion doctrine were to apply, as Bowman claimed, Monsanto would only have patent protection up until the point of the first sale. If patent protection only covered a first sale, it would hardly be patent protection at all, and furthermore, as Justice Roberts pointed out:

Why in the world would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?

This view of agricultural development, that private firms are best placed to provide innovation and the only motivation for them to do so is the promissory carrot of patent protection is particularly unusual given the history of US agricultural development. Government funding for agricultural research was prominent for much of the nineteenth century, through free seed programs and the land grant university system; indeed it remains important today. The sort of argument put forward by Roberts indicates exactly how far perceptions of the importance of publicly funded research have fallen.

This view of who creates agricultural innovations and how they should be motivated also effects the way in which research is evaluated. To take one example, in the amici brief put forward in support of Monsanto by various US soybean growers' associations, it was claimed that the USDA's free seed program actually stifled innovation in the seed industry in 19C America. The US Government, on this view, acted as an incumbent in the seed market, dissuading investment in research by private seed companies. The evidence brought forward for this claim is a putative drop of five bushels per acre in the soybean crop yield from 1866-1930. What this statistic hides is the massive expansion of the area under agriculture (often into less agriculturally favourable areas) that occurred during this period. On one tally the soybean crop went from less than 50,000 acres in 1907 to around 5.5 million in 1935. Much of this expansion (even in the years after the end of free seeds in 1924) was the result of varietal tinkering, initially facilitated by free seed programs and later by research at the land grant universities. By using yield as a way to evaluate a program which aimed to increase acreage the Soybean Associations are demonstrating exactly how far current day research has moved from the sorts of aims championed by large scale government development programs. What is more, this view of historical research delineates the possibilities for future research by narrowing the range of legitimate aims to which it can be put.

The second point I'd like to make very briefly concerns 'making'. At several places in the case the court refers to making as constituted by the acts of planting and harvesting. In far less instances, the application of glyphosate is mentioned as part of this process. This slippage is important; if planting and harvesting constitute making, given the amount of GMO pollen allegedly drifting in the wild, infringement would become a lot harder to avoid. Although Monsanto have promised not to sue in such cases, I would argue that focusing on Bowman's application of glyphosate, as the essential step of making, would raise the infringement bar high enough to exclude unintentional infringements. It was, after all, only after the application of glyphosate as a selective pressure that Bowman had actually reconstituted a roundup ready resistant population.

Robert Cook-Deegan (Duke), The Myriad Case: So many messages, so little time

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Association for Molecular Pathology v Myriad Genetics made it to The Daily Show. Who says Supreme Court decisions cannot be funny? This epic case was deliberately constructed by public interest lawyers to change patent jurisprudence. It was a rare public interest patent case that initially seemed quixotic but morphed into conventional wisdom and high theatre. The difference was change of frame from the cloistered world of patent law to the real world of women facing cancer, and legal generalists confronting patent exclusivity that blocked access to information about one's self without permission from a private corporation. The Supreme Court decision itself devoted little attention to considerations beyond innovation policy, but the cultural narrative that surrounded the case pitted IP rights against access to care, control of medical standards of care, and rights to informational self-determination. Does this represent a new direction in IP law, or is it just an unusual outlier case occasioned by a biotech startup with a particular knack for alienating its customers and natural allies while galvanizing opposition from well organized disease constituencies?

Robin Wolfe Scheffler (Yale University), From Chakrabarty to Myriad: Shifts in the Moral and Political Economy of Patenting Life

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In Diamond v. Chakrabarty (1980), the United States Supreme Court affirmed a patent for genetically modified bacteria on a close 5-4 decision. Almost every amicus curiae brief filed by interested parties, including academic bodies such as the American Society of Biological Chemists, Association of American Medical Colleges, and the Reagents of the University of California, supported this ruling. Only the "fringe" Peoples Business Commission filed a dissenting brief. Just recently, in Association for Molecular Pathology v. Myriad, the Court ruled 9-0 that the identification of human genes linked to particular illnesses, in this case the BRCA-1 & 2 genes with certain kinds of cancer, does not constitute a patentable innovation. Others have written about the different interpretations of genes which underlie this ruling, I focus on how this case provides us with an occasion to contemplate how the political and moral economy of gene patents has shifted in recent decades, a fact which is worth stressing given the low odds of success ascribed to the original BRCA patent challenge when it was filed in 2009.

In light of the pattern of interests expressed in Chakrabarty, it is especially striking that numerous scientific and medical organizations opposed Myriad's case. Attending to the broader shifts in the political and moral economy of biomedical and biotechnological research sheds light on this change. In Chakrabarty, the amicus curiae focused on the American competitiveness in global economy citing biotechnological innovation as a key area for growth. The briefs also contended that scientific discoveries would best be translated into effective therapies through commercial intervention. Affirming Chakrabarty's patent seemed to represent a promising way of resolving all of these challenges. Chakrabarty was widely considered to have ushered in a new era of biotechnological collaboration between academic biologists and industry anchored by the security of intellectual property.

In 2013, a different context can be discerned among the dozens of amicus briefs that were filed in Myriad. In particular, a substantial number of individuals and organizations sought to support the (re)creation of a genetic commons for commercial innovation and scientific inquiry. I suggest that this may reflect a set of significant changes since Chakrabarty including: (1) the ethos of open-access embraced by large sectors of the biomedical research community during the Human Genome Project (2) the rise of pharmacogenomics and other genetic technologies dependent on the ready supply of genetic information (3) the ethical status of BRCA and other disease genes as diagnostic tools rather than as therapeutic agents. In shaping the broader biomedical discourse around gene patents, these developments filtered into the Court's dramatic ruling.

Bronwyn Parry (King's College London), Craft and the art of making patentable biological property

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The success of the Association for Molecular Pathology in overturning Myriad's patents of BRCA I and BCRA 2 gene sequences is characterised as an affirmation that the historical precept established by Judge Burger in the Diamond Vs Chakrabarty case that patent rights ought be made available to any new and useful process, machine, manufacture, or composition of matter, including, in an expensive interpretation "anything under the sun that is made by man" was fundamentally unsustainable. The judgement, for me, provided a rather different affirmation: that the concept of invention, and of what constitutes an invention, remains ontologically insecure. The practice of 'making', I would argue, proves central to the success or failure of such claims. Bilski's's bold prosecution of their case for patent recognition of their 'business method' for hedging risks in energy trading pushed conceptions of what constituted patent-eligible subject matter to the very limit. In my view, craft, and the craft tradition of specialised manufacture or craftsmanship again underpinned the ultimate rejection of their claim: The USPTO rejected it on the grounds that:

[T]he invention is not implemented on a specific apparatus and merely manipulates [an] abstract idea and solves a purely mathematical problem without any limitation to a practical application, therefore, the invention is not directed to the technological arts.

In other words, nothing was here made, the method remained an idea, an abstraction, it was neither "tied to a particular machine or apparatus", nor did it "transform a particular article into a different state or thing."

The question of what kind of labour is really involved in isolating gene sequences such as the BCRA 1 and 2 sits at the heart of such debates. Bently and Sherman have argued that whist the patenting of processes to isolate natural substances is relatively uncontroversial, the same cannot be said for the patenting of the sequences derived from those processes. Serious questions have been raised about how it would be possible for anyone to 'find' or reveal the existence of such sequences embedded with a living organism without first isolating them from their surroundings. Although such patents have been granted on the basis that the material has been transmuted through the act of isolation from a 'naturally' to a 'non-naturally' occurring phenomenon there is nothing to suggest as Sterrckx argues that isolating the element from the body by technical means, or purifying that element changes it's 'naturalness' in any way. So why were isolated gene sequences ever considered patentable? I would argue that historically (in the late 20th century) the work of gene sequencing required some degree of genuine craftsmanship to perform, which, given the manufacturing tradition of patent protection prompted and sustained arguments for their protection as crafted artefacts - as made objects. However, with the rise of computerised high throughput sequencing this craft tradition is lost. They become mass produced consumables viewed by both the patent system and the general public alike with much the same distain as 'knock off' Cartier watches.

Monsanto's claim to its Round-up ready seeds has been sustained in the Bowman Vs Monsanto case conversely, precisely because Monsanto was able to develop a cogent argument that something had indeed here been 'made' germplasm that clearly, and decisively, had no 'natural' counterpart. Yet in this case, perhaps this making was given too much credence, too much, vitality. In rejecting Bowman's claim the Judges were completely dismissive of his argument that Monsanto's patent should not extend to its seed's progeny and that their patent would therefore become 'exhausted' after the second generation. However, it seems that the right to benefit from the craft invested in the production of the artefact of Roundup Ready seeds is, in this case, unlike many others, extended intergenerationally by virtue only of the inherent biological vitality and replicability of the object (biological material) itself. In thinking through the limits of patent some useful comparisons can here be made with other forms of self replicating biological materials such as the HeLA cell line which, although not itself patented, went on to create sustained economic value for its authors.

Graham Dutfield (University of Leeds)

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Alex McKeown (University of Bristol)

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Consideration of the issues raised by the two cases through the lens of (hypothetical) future developments in transgenic human enhancement raises a novel point that I want to address today. Many of the same genes are found in humans and other animal species, but these genes are expressed differently to produce different outcomes. One useful example of this is the PAX6 gene which is essential for the development of eyes and other light sensitive tissues. There is evidence that the gene has been present for at least 540 million years, and consequently it is found across the animal kingdom from humans to flies. Although at a higher taxonomic level it may be simple enough to make inter-species distinctions, given that certain genes are shared, it is not obvious at a lower level what the correct threshold should be for identifying genetic material as definitively 'human'. Consequently, decisions (including moral ones) about the inherent patentability, or not, of human genetic material are based on an ambiguity that would become increasingly unstable with the appearance of interventions which integrate 'animal DNA' into human beings in ways that would enhance health and / or functioning.

Both Myriad and Monsanto stand accused of attempting to enforce unfairly monopolistic protection over objects deemed to be in some way 'natural'. Would the IP and business strategies of either company have created the same level of controversy if the protection sought was over, say, an analogous but functional sequence of porcine DNA, in Myriad's case, or a whole genome sequence of a new and productive soil bacteria, in Monsanto's case? Moreover, transgenic enhancement of human beings is for the time largely a hypothetical issue and consequently (although transgenic human enhancement would undoubtedly generate controversy) we can ask would interventions of this kind raise new and distinct difficulties which do not pertain to the present Myriad and Monsanto cases, or would they simply entail the restatement of existing objections and challenges? To what extent, for example, should interventions such as these be considered as 'natural' or 'unnatural'?

Taking these uncertainties into account alongside the initial difficulty concerning taxonomic classification, the lens of transgenic human research adds weight to the claim that what 'is' uniquely human - as distinct from being something else - is both ambiguous and malleable. Consequently, the extent to which patenting 'human' life is or is not possible in principle remains unclear.

Amanda Odell-West (University of Manchester)

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These presentations were followed by an open discussion with the audience, including questions from Gregory Radick, Soraya de Chadarevian and Giuseppe Testa.

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