Saturday, September 5, 2015
As the conference draws to a close, there was a roundtable discussion looking to the future of life-patenting:
Martin Gouldstone, Head of Lifesciences Advisory for BDO, reflected on industry concerns over gene patenting. Government funding of medical research has declined in many countries, and regulatory obstacles to approval have increased (for understandable reasons). Estimates of the average cost of bringing a drug to market range from $800M to $1.4B and chances of any particular drug making it to market are very small. Industry is under enormous pressure to replace lost revenue as some big-revenue drugs are going off patent. Companies are beginning to pool resources on research and development and are doing swap deals where companies trade inventories to leverage strengths. Genomics revolution is also driving innovation, and it's just beginning. Challenge is keeping up with speed of technological advances. There is also real danger with the innovation --presented with a future in which 3D printing permits individuals to download and create the bubonic plague, for example, the need for strong regulation is obvious.
Dr. Thana Campos, Van Hugel Institute Research Associate, discussed the phenomenon of universities securing patents for the fruit of its research. She explored the tension between the university mission of disseminating/extending knowledge and the premises of the patent regime. University patents boost university revenue, facilitate more transfer of technology from universities to business partners, and support further innovation and economic development. However, knowledge sharing and spillover are key paths of intellectual development in a university; this is hindered by patents.
Dr. Calum MacKellar, Director of Research at the Scottish Council on Human Bioethics, served as facilitator, and he prompted discussion by asking whether Dr. Frankenstein should have been permitted to patent his creation. Paul Heald pointed out that a patent doesn't give him the right to make the monster or let the monster run amok; it only empowers Dr. Frankenstein to prevent others from making his monster. The problem is not patentability.
A former patent judge asked why churches don't participate in the patent process itself, raising moral concerns as part of the process. A bioethicist speculated that the issues are sufficiently murky morally and technically complicated that churches don't feel comfortable jumping into the process in any particular case. A bishop in the audience observed that, at least in the U.K., people will listen to lay experts more than they will listen to bishops. Another representative of the Church pointed out that the Church is heavily engaged at the level of principle, and he was met with a response that engagement at that level is not sufficient.
Bishop John Sherrington recognized the need for the Church to translate its usual concepts (e.g., common good) into terms that resonate more broadly in these debates. He also reminded participants of Pope Francis's admonition to recognize the real persons before us as the starting point in addressing social issues.
The conversation was robust and relevant. As MoJ's Tom Berg observed in his closing remarks, the Church's rich history of reflection on the meaning of property and economic life, its interest in rigorous and empirical argument, and its global dimension make the Church an essential partner in these conversations.
The Patents on Life conference continues:
Ingrid Schneider, professor of political science at the University of Hamburg, discussed patent governance, ethics and democracy. She sees a legitimacy crisis because of an overexpansion in terms of size and an overreaching of traditional boundaries of patent protection. The patent system is governed by insiders -- a specialized epistemic community with too little responsiveness to the political process and civil society. Blurred boundaries: 1) boundary between discovery and invention (i.e., reflecting a judgment that technology should be accessible to all); and 2) the ordre public and public policy clause (i.e., reflecting a judgment that no one should have access to the technology in question). The ordre public exclusion is designed to function as an ex ante control of the social desirability of an invention. There is a concern that the patent community (applicants, attorneys, examiners, specialist judges) exerts more influence on patent law than the legislature does. Do patent offices view applicants as customers, and if so, what does that mean for the public policies underlying our patent system? She explored the patentability of human embryonic research techniques as an example of these dynamics.
Stephen Colecchi, director of the Office of International Justice and Peace at the United States Conference of Catholic Bishops, spoke about lessons from Catholic social teaching pertaining to life patents. What is the impact of life patents on persons who live at the margins? The Church has expressed concern that technological development has not been accompanied by development of human responsibility. He discussed resources that the American bishops bring to the debate: 1) Catholic social teaching; 2) relationships with the Church in the developing world; 3) experience on the ground working to address challenges in the developing world. He identified four principles to guide the debate: 1) respect for rights of indigenous people; 2) careful balance of property rights and social welfare; 3) concern that commercial interests are favored over common good; and 4) need for transparency. Nevertheless, multinational corporations exert much more influence on IP than Church or other civil society organizations do. It will be critical that the Church continues to engage in a manner that compensates for the power imbalance between richer and poorer nations, and between civil society and the corporate sphere.
Justin Turner, barrister and former member of the Gene Therapy Advisory Committee, discussed the treatment of embryonic stem cells before the European Patent Office. To draw a conclusion about the morality of a patent claim, an examiner must draw on the constitutional traditions of the country as well as international treaties. One must take a broad view. Is terminating an embryo generally contrary to morality? No -- there is no unitary principle that terminating embryonic life is immoral; we have the morning-after pill, embryos are necessarily terminated in the course of IVF, etc. Embryos do not have a right to life for purposes of patent law's morality exemption. Patent claims have been rejected but tribunals have not directly answered question of whether it is contrary to morality. He believes that religious politics are playing an important role in the patent system's treatment of the issue; his concern is that the religious objections are not vented properly in the decisions. The legal tribunals should squarely address whether these patents would be contrary to morality.
More from the Patents on Life conference:
Dr. Julian Cockbain, a European patent lawyer and bioethics expert, compared European and American law on the patenting of human body materials. European patent law has taken a wrong turn by claiming that a discovery is not a discovery as such if it has a "technical effect" when in use -- e.g., a gene producing a protein, adrenaline producing an effect on the heart. Also, elements isolated from the human body are patent-eligible even if they are identical to elements occurring naturally in the human body. This renders the exclusion of discoveries toothless. American courts have been much more reasonable on this front. Dr. Cockbain sees a potential way out for European courts because Article 52 of the EPC requires an inventive step, and discoveries do not entail an inventive step.
Dr. Katerina Sideri, an IP advisor at the Agricultural University of Athens, discussed germ line interventions as an example of patents and the moral limits of markets. Patent law's morality exclusion should address not just access and delivery, but problem of commodification. Our understanding of morality must go beyond individual rights and autonomy. Can we find alternative ways to incentivize the development of technology? Especially in biotech, patent offices should be science/technology offices that link to broader political processes.
Day 2 of the Patents on Life conference has begun.
Christopher Rennie-Smith, former chair of the Biotech Board of Appeal and former member of the Board of Appeal at the European Patent Office, spoke on life-form patents before the European Patent Office. There is no overall provision re patenting life forms in the European Patent Convention (EPC), and general exclusions do not include any life form, so life forms that are novel, inventive and industrially applicable are patentable. Article 53 excludes when contrary to "ordre public" or morality; and excludes plant or animal varieties or essentially biological processes for the production of plants or animals. "Morality" has been defined in case law as the belief that some behavior is right and other behavior is wrong founded on the totality of accepted norms rooted in the culture inherent in European society. There is no definition of "animal variety" or "essentially biological process." He discussed the case of the Harvard oncomouse, which presented the question whether Article 53 would function as a bar given the suffering of the genetically manipulated animals and possible risks to the environment posed by the release of manipulated animals. In the end, claims limited to a transgenic mouse (but not a transgenic rodent) succeeded. The method of producing the transgenic mouse was deemed not "an essentially biological process."
Friday, September 4, 2015
University of Minnesota law professor Ruth Okediji presented on the protection of genetic resources and its Judeo-Christian justifications: dominion, stewardship, and reward. Other theories of IP have strengths but also shortcomings: utilitarianism (tends to ignore obligation to steward creative gifts), natural law/continental approaches (tend to ignore the source of creativity), user rights (tend to ignore accountability), and human rights (tend to marginalize command to exercise dominion and can de-value moral basis of reward). She believes that patent system is consistent with biblical precepts, but patent system is not a God-given institution; patents are a tool. Sovereign countries have the mandate and obligation to regulate, use, and steward natural resources.
An international legal framework to regulate access to and use of genetic resources is morally and ethically required. Historically, genetic resources were not patentable because they didn't involve human ingenuity and owe their source to no human. (But isn't this true of all innovation? At what level of abstraction do we draw the line between what is of man and what is of God?) The phenomenon of biopiracy -- i.e., patenting inventions derived from genetic resources and/or traditional knowledge without compensation to the country that is home to those resources/knowledge -- is creating additional pressure to protect these resources. We don't yet have answers given the multiplicity of stakeholders and interests. Given the stalemate on the international front, we may need to consider relying more on national law and encourage less developed countries to invest more in IP systems and institutions. We may need to reconsider the role of international institutions as the appropriate fora for the debate.
University of Virginia law professor Margo Bagley presented biblical insights on misappropriation in life science patenting. She discussed the passage from Leviticus that instructs landowners not to reap to the edges of the field, leaving some food for the poor. Any lessons for our law today? Our legal prohibition on "stealing" self-replicating inventions (e.g. landowners sued by patent-holder after neighbor's GMO plant seeds drift onto their land) can seem unjust because there is no de minimis exception. Stealing pharmaceutical products is also thorny -- Thailand exercised TRIPs rights and issued compulsory licenses on several drugs. Abbot responded that Thailand would not receive new drugs. Many countries didn't grant pharmaceutical products until relatively recently. Margo offered data on pharmaceutical companies' expenditures on research/development and sales/marketing --the latter being higher -- and profit margins (higher than other major industries). Question today is: who's stealing from whom?
Michael Kock, Global Head of IP at Syngenta, discussed the ethical use of patents in plant innovations. He noted that the world must produce more food in the next fifty years than it has in the last 10,000 years. Every second, the world loses on football field of farmland due to urbanization and erosion. Climate change is also affecting agricultural production in some regions. He pointed out that carrots are orange only because breeders created an orange carrot in the nineteenth century. Other than some mushrooms and berries, all crops have been changed by humans -- none are "natural." So how much genetic interference is acceptable? Plant variety protection through conventional breeding is generally accepted but plant variety protection does not protect specific attribute, just entire plant variety. We have an increasing need for innovation and increasing need for investment given technical complexity compared to traditional breeding. Can we minimize the problematic effects of a patent on life without losing the benefits? New international licensing platform shows promise -- "free access but not access for free." The platform is based on fair pricing, MFN principle, transparency, "pull-in effect" (if you want access, you have to grant access to your inventions). Voluntary efforts such as the licensing platform, though, may not be sufficient.
University of Illinois law professor Paul Heald presented a sociological history of religious objections to patenting life, asking: why is there no significant religious objection to patenting life in the U.S.? One major reason is the rise of Christian libertarianism and Christian materialism. Business interests succeeded in convincing Americans that business interests and Christian interests overlap. Because patent rights are property rights, criticizing patent rights is akin to criticizing property rights. There have been a few statements made, but they failed to gain traction. There are high information costs in developing an educated position, and this is a relatively low-priority issue for American Christians compared to abortion, the death penalty, etc. Even within the world of corporate agricultural practices, this may not be the most pressing issue; what's more of a problem: seed patents or the seed company's corruption of lending practices in developing countries (forcing local farmers to buy expensive patented seeds by persuading banks not to lend to farmers unless they use the advanced seed technology)?
Dr. Kathleen Liddell, director of the Centre for Law, Medicine and Life Sciences at Cambridge University, addressed the exclusion of "immoral" inventions from patent law. In addition to discussing potential levers for improving current law, she raised questions that must be resolved. When we're proposing morality-based exclusions, are we focusing on the morality of performing the technology itself (e.g. letter bombs), the morality of granting patent rights (e.g. life-saving drugs), the morality of patenting an invention based on unethical research (e.g. embryo-based technologies), or all three? And is morality determined by a harm-benefit calculation, the fact that granting of the patent would be universally regarded as outrageous, or more modestly, that granting a patent would be contrary to a particular country's norms?
She asked theologians to develop a more nuanced understanding of IP law and realistic opportunities and constraints for ethical/religious touchstones within IP law, and she encouraged IP lawyers to develop a better understanding of epistemologies other than law.
St. Thomas Law School's Murphy Institute, directed by MoJ's Lisa Schiltz, and the Von Hugel Institute are co-sponsoring a two-day conference at Cambridge University exploring "Patents on Life: Through the Lenses of Law, Religious Faith and Social Justice." The opening panel featured several insightful exchanges. Archbishop Silvano Tomasi, Apostolic Nuncio and Permanent Observer of the Holy See to the United Nations in Geneva and the World Trade Organization, presented an overview of the Church's social teaching as it pertains to intellectual property, including the idea of a social mortgage on all private property and the need to balance incentives for innovation and the sharing of benefits that result from innovation. When asked whether this emphasis simply reflects the state of the current public debate or contributes a distinctly Catholic insight, he rejected the suggestion that the Church must contribute a unique perspective. What is important, he explained, is that there is a convergence of wills to do what is necessary to achieve a prudent balance between innovation incentives and benefit sharing. His directness in answering the question is a helpful reminder that, as scholars and advocates mining the Catholic intellectual tradition, we need to be careful not to be distracted by a perceived need to articulate (or create) unique insights rather than support and facilitate "a convergence of wills," including wills forged by different traditions and worldviews.
Friday, May 1, 2015
Today I had the privilege of participating in a conference, Reconsidering Access to Justice, hosted by Texas A&M Law School. My role was to offer comments on a great new paper presented by David Luban. In his paper, David explores the “discourse of optimism,” which he uses to refer to the view that "new technologies are revolutionizing the delivery of legal services to such a degree that we might foresee a technical fix to many of access to justice problems." He is hesitant to embrace this optimism fully, noting that a human legal adviser has several qualities that even the most sophisticated machine cannot replicate, including emotional intelligence, moral give-and-take, and creativity. He then discusses the relationship between legal justice and social justice in ways that are insightful and productive, as his longtime readers will expect.
In my response, I focused on the promise of technology in the quest to address access to justice problems. I'll post just a brief excerpt that captures my main point:
I am not confident that the market is effective in distinguishing legal needs that do or do not require the assistance of a lawyer; even in the corporate sector, I think we’re likely to see costs – both to the client and the broader society – from a reduced reliance on lawyers in the pursuit of perceived greater efficiencies. And if corporations don’t always make the call that is in their long-term best interests because of short-term financial considerations, why do we think the poor will fare better? Especially when the broader society is eager to latch on to cheaper technological short-cuts that allow us to avoid adequate funding of legal services?
Of course, our alarm over these trends is a function of our assessment of the value proposition presented by lawyers. Whether it’s representing the marginalized individual or the powerful corporation, if we presume that lawyers bring nothing else to the table beyond legal information or scalable technique, clients have no reason to expect something more, and there’s no reason for alarm when the “something more” fades from view. And as Richard Susskind reminds us, the strictly technical tasks can be disaggregated and divided among the lowest bidders, short-circuiting any role that would require coherent – much less comprehensive – knowledge of the client and her overarching needs and interests, thereby making the “something more” even more elusive. It’s a cycle that feeds on itself.
I write “potentially” because lawyers still have something to say about their future, even if it proves to be only on the margins. But to speak into the future, we need to answer a more fundamental question about who we are in the present, who we are as professionals. As law schools, can we train trusted counselors who, as David Luban puts it, exhibit emotional intelligence, moral give-and-take, and creativity? The public we serve – poor and rich alike – should care very much that we can and do.
Sunday, April 12, 2015
In yesterday's NYT, Adam Liptak notes that no major law firm will touch the SSM cases before the Supreme Court. The explanations offered in the article by firm leaders and industry observers fall into three categories: 1) the issue is so controversial that taking on the representation will impact a firm's attorney recruiting, client retention, and staff morale; 2) firms recognize that there are no meritorious arguments against SSM; and 3) as Michael McConnell puts it, there is a powerful desire to "crush dissent" on the issue of SSM.
Explanation #2 appears to me to be a non-starter. Whether or not SSM is wise as a matter of policy or morally compelled as a matter of justice, I have a hard time believing that the issues surrounding its constitutional status are so one-sided that a firm would see no good-faith basis for litigation. There is, I believe, something to be said for explanations #1 and #3.
I'm reluctant to condemn categorically what's happened here, as we can easily fall into the trap of disclaiming any moral accountability for the cases and causes to which lawyers lend their efforts. I believe that, at least in civil cases, lawyers bear some responsibility for the choices they make in client selection. (I have explored these ideas more deeply here and here.)
Indeed, those who applaud the unwillingness of law firms to step up to defend prohibitions on SSM might look to an earlier era of professional ethics as a guide. David Hoffman’s Resolutions, considered by some to be the nation’s first legal ethics code, included the bold statement: “I am resolved to make my own, and not the conscience of others, my sole guide. What is morally wrong cannot be professionally right.” George Sharswood’s Ethics considered it “an immoral act to afford that assistance, when [the attorney’s] conscience told him that the client was aiming to perpetrate a wrong through the means of some advantage the law may have afforded him.” According to the 1908 Canons of Professional Ethics, the lawyer “advances the honor of his profession and the best interests of his client when he renders service or gives advice tending to impress upon the client and his undertaking the exact compliance with the strictest principles of moral law.”
The inconsistency, of course, is that law firms are not routinely declining other controversial causes, even those that conflict with emerging social norms, nor are they giving even lip service to the existence of accountability to extralegal norms, much less to "the strictest principles of moral law." I'm not suggesting that we should return to the rhetoric of the 1908 Canons (which, I suspect, was empty rhetoric more often than not), just that there is precedent for the notion that lawyers should be morally accountable for the decisions that they, and their clients, make. Will the SSM cases mark the beginning of an era in which firms, perhaps echoing themes from the Corporate Social Responsibility movement, make client selection decisions that are shaped by moral commitments?
If our "Hobby Lobby" moment of morally engaged business organizations is going to extend to large law firms and the choices they make regarding the clients they'll serve, this could be a healthy development for the profession and broader society. If, as I suspect, this is more about firms' unwillingness to court controversy on a rapidly strengthening social norm even when there are important constitutional issues to be resolved, this could be an ominous development for our profession's long tradition of providing a voice for unpopular causes.