Bioproperty, Biomedicine and Deliberative Governance

Patents as Discourse on Life

Katerina Sideri

• Publisher: Routledge
• Year: 2016
• ISBN:
  9781317174189
• Edition: 1
• Topic: Diritto
• Subtopic: Etica e responsabilità professionale nel diritto

Biomedical patents have been the subject of heated debate. Regulatory agencies such as the European Patent Office make small decisions with big implications, which escape scrutiny and revision, when they decide who has access to expensive diagnostic tests, whether human embryonic stem cells can be traded in markets, and under what circumstances human health is more important than animal welfare. Moreover, the administration of the Trade Related Aspects of Intellectual Property Rights by the World Trade Organization has raised considerable disquiet as it has arguably created grave health inequities. Those doubting the merits of the one size fits all approach ask whether priority should be given to serving the present needs of populations in dire need of medication or to promoting global innovation. The book looks in detail into the legal issues and ethical debates to ask the following three main questions: First, what are the ideas, goals, and broader ethical visions that underpin questions of governance and the legal reasoning employed by administrative agencies? Second, how can we democratize the decision making process of technocratic institutions such as the European Patent Office? Finally, how can we make the global intellectual property system more equitable? In answering these questions the book seeks to contribute to our understanding of the role and function of regulatory agencies in the regulation of the bioeconomy, explains the process of interpretation of legal norms, and proposes ways to rethink the reform of the patent system through the lens of legitimacy.

Chapter 1
Introduction
Patents as Discourse on Life: The Purposes of Patents in the Field of Biotechnology and Biomedical Innovation

Patents claiming the commercial use of transgenic animals and plants, medicines and diagnostic tests, human cells and tissue present a momentous challenge to policymakers, regulators, lawyers, scientists, philosophers, and the public at large. They raise fundamental questions about rational decision-making in the field of science and technology, and revive familiar debates over democracy and technocracy. Agricultural and animal biotechnology bring the promise of enhanced production conducive to human health, and biomedical science and technology seek to develop novel drugs and exotic therapies with great commercial potential that we never imagined before. The promise of a better quality of life through the rational use of technology has almost religious undertones: Monsanto, one of the leading companies in agricultural technology in the world, marketed its products under the slogan ‘Food, Health, Hope’,¹ and the language of salvation is central in the hype that often surrounds relevant research.²

The language of hope interweaves with the language of markets. Transgenic animals, human stem cells, genetic sequence information, diagnostic tests and medicines become commodities to be traded in markets, as they are protected by patents. The most prominent justification behind state intervention to put in place an intellectual property system granting the patent privilege to inventors is that knowledge is a public good that can be under-produced due to the problem of free riding: inventive technologies can be easily copied, and in this case investment will not be recouped. As a result potential inventors will lack the incentive to engage in research and development in a field of paramount economic importance, as international trade increasingly relies heavily on high technology innovations.³ Hence certain incentives, such as intellectual property, seem important for sustaining the generation of knowledge.

In other words, patents are market tools useful for incentivizing socially beneficial research and development. They present a temporary state monopoly (20 years) to inventors so that they can recoup their investment by means of exploiting commercially their invention, and in return inventors publish the details of how their invention works in public records, making important information accessible to the public, which would have otherwise been kept secret. At the same time, patents are intellectual property (IP) rights and, as a species of property rights, they grant inventors the right to exclude others from using their invention unless they choose to license its use. Robert Merges argues that patents as private rights should join the list of essential liberties, as creative freedom and autonomy are important values; even if they lead to some distributional unfairness (as users have to pay to have access to goods), they should belong to the basic rights to which we are entitled.⁴ Therefore, incentives to invent present an example of desert-based policies and link to opportunities given to creative people to make the most of their own life through their own efforts.⁵

However, the question of whether property rights are suitable for protecting intangibles has always generated debate, and history has taught us that monopolies can always abuse their economic power.⁶ Pharmaceutical companies argue that the prices of drugs reflect research and development (R&D) costs. When governments have to pay often extravagant prices to buy important cancer drugs for their public health system, pharmaceutical companies are quick to remind them that if they do not refinance R&D through healthy revenues, then innovation in a field of paramount importance (public health) will be stifled. Recently, a publication in Blood challenged this claim: IP rights and the private profits flowing from them are far from deserved, and pharmaceutical companies may misinform governments with regard to R&D costs.⁷ As for the problems created by the use of a species of property rights to protect innovators, many argue against the absolutist conception of property rights that often underpins administrative decision-making and judicial reasoning; the owners of technology control useful innovations to such an extent as to put in disadvantage the users of technology, such as patients, innovators of follow-on technologies, and the public at large.⁸ Extensive property rights in genes have deterred innovation,⁹ and pharmaceutical innovation has declined.¹⁰

More fundamentally, the use of patents, a market tool, to incentivise research and development of biotechnological and biomedical inventions, raise broader ethical concerns. Instances of intense public debate were triggered by various decisions of the European Patent Office in cases concerning transgenic animals, diagnostic tests and inventions involving human embryonic stem cells. The public debate that surrounded the adoption of the Biotechnology Directive¹¹ in Europe and, more recently, a decision of the Court of Justice of the European Union, which interpreted the Biotechnology Directive as prohibiting patents involving human embryonic stem cells, manifested the same tensions. The role of the World Trade Organization in administering the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), and the role of trade agreements adopting TRIPs plus (or TRIPs other)¹² standards have similarly proven controversial.

In all these instances, civil society activism, networks of actors involving universities, research centres and non-governmental organizations, the governments of developing countries and global institutions such as the World Health Organization (WHO) cast a critical eye on the fundamentals of the patent system in two important ways: first, they challenge the idea that law is a neutral instrument to regulate social behaviour. Rather, it is part of and constitutes a powerful (bio)ethical discourse, which understands the connection between well being, health, property and trade in a particular way. Let us pause here to examine this contention in detail. The patent privilege is granted through administrative agencies, such as the European Patent Office (EPO) and the United States Patent and Trademark Office (US PTO), which examine patent applications to see if the technologies disclosed meet a set of criteria laid down in primary legislation, commonly including an examination of requirements (such as the novelty and non-obviousness of the invention claimed by the patentee). The procedure is characterised by techno-scientific expertise; decision-making is delegated by governments (or contracting states in the case of a treaty such as the European Patent Convention) to administrative agencies having the expertise to engage in the practical management of technical affairs. But for many, the problem is that one way of thinking about property rights in knowledge goods and how they link to freedom, will formation, scientific progress and technological innovation has assumed moral force to the point of excluding competing accounts.

It is important to note that the European Patent Convention (EPC) is unique in that it states that an invention can be denied protection if it is contrary to morality or ordre public.¹³ However, the morality provision of the EPC has been given a very narrow interpretation by the EPO, and it would have been even narrower if civil society groups had not used the opposition procedure of the EPO to challenge various decisions. Morality is commonly defined by means of reference to legal sources and materials, but this account of morality is closed and rigid. When the Court of Justice of the Europe Union recently tried to give guidance as to the best way to understand contentious terms in the Biotechnology Directive such as ‘dignity’ and ‘embryo’, its decision manifested the same rigidity. In all these instances, the real reasons behind public anxiety triggered by biotechnology and its uses failed to be filtered into the patent system, as I will explain shortly. In the USA there is no morality exception. At the global level, the question of how private rights for the production of public goods and trade can coexist with other values such as health, development and equity has been the subject of contentious debates concerning the future of the WTO, the interpretation of TRIPs and the problem of economic coercion in the case of various bilateral, regional and multilateral treaties.

The interpretation of patent norms is not a neutral exercise. The patent system fails to talk openly about ethics, but at the same time, it tacitly constitutes a particular way to think about human motivation, human vulnerability and responsibility towards oneself, peers and distant others. Moreover, patents link to the understanding that markets emerge somehow naturally; however, this ignores the role of law (property, contract) in setting the framework within which markets function.¹⁴ In short, public disquiet is the result of the widespread feeling that one particular way to think about technological innovation and the production of knowledge currently feeds into the interpretation of patent norms shaping the relationship between private and public interest. The focus on markets and private property has resulted in different perspectives being viewed as unfeasible in market economies. The ethical priority of private property and trade is presented as beyond contestation, but others argue that the ownership and control of knowledge is a powerful social structure.¹⁵

Administrative agencies have important discretionary powers, engaging in tacit policy-making when filling the gaps of detailed rule-making, which tacitly reproduce background values that escape scrutiny and revision, concerning the importance and meaning of health and technological innovation. Patents eventually regulate things such as who has access to expensive diagnostic tests and essential medicines; they interfere in the relationship between physicians and patients; they crystallize understandings about the responsibility of health by states; responsibility towards oneself and others; whether and under what circumstances human health is more important than animal welfare; whether the health needs of a population should take precedence over private rights; moreover, patents reproduce a particular conception of personhood and ideas about human motivation; they are premised on the assumption that a market incentive (in the form of patents) and the related idea of profit maximization are the best way to bring about social benefit, and satisfy the health needs of individuals and populations. Finally, patents being a species of property rights, they may blur the distinction between life and things,¹⁶ as in the case they claim animals, human genes and tissue. This may happen if they create social norms that make it acceptable and appropriate to talk about living things in terms of their value and use, in other words when a commodified view of life spreads in social spheres beyond the economy. In short, the idea of liberal neutrality is firmly put under the spotlight. Public disquiet can no longer be interpreted as a sign of ignorance. A legal and policy discourse that understood the management of technological innovation as a narrow field of technical expertise and administrative agencies as the apolitical managers of technology is failing.¹⁷

Related to the criticism directed against the ideas of liberal neutrality, technical expertise and efficient markets is the following demand made by those who distrust regulatory decision-making: trade needs to engage in a conversation with ethics. This conversation needs to feed into the interpretation of patent norms. We can translate this claim in theoretical terms in the following way: the patent system ought to serve a variety of individual and collective purposes.¹⁸ Patents allocate to individuals a degree of control over the use of the claimed invention. The degree to which inventors can control the uses of the invention and their obligations and responsibilities towards society should depend on the object claimed and on the social goals that the patent system ought to serve.¹⁹

The question I want to answer here is this: What are the purposes that the patent system currently serves? As a second step I want to ask: How is this account challenged and by whom? Currently, the general goals of intellectual property law in the field of biotechnology/biomedical innovation include the reward of creativity and protection of autonomy; the promotion of technological innovation and production of knowledge through the creation of markets providing the incentive to profit-maximizing agents to engage in socially beneficial behaviour; finally, in the policy discourse associated with patents, the association between property rights, trade and economic growth pervades our current understanding of the proper role and function of the patent system. It is well documented how the poor performance of US and European companies in the 1980s was the starting point to think about global rules enforcing intellectual property rights; it was the concerted efforts of a coalition of business interests mostly from the US that pushed for the adoption of TRIPs.²⁰

In the 1980s the US Supreme Court in Chakrabarty²¹ decided that a genetically modified bacterium was patentable, and the same year the US government adopted the Bayh-Dole Act according to which small businesses, universities and other non-profit organizations funded with public funds by federal agencies could retain title to patented inventions. The Bayh-Dole Act made possible collaborations between the academia and industry. Scientists could license a patented invention to a private entity, which could then be translated into real-world commercial applications. In fact, licensing could be the source of significant revenue for universities, as evidenced in the case of recombinant DNA technologies licensed by the University of Stanford, Columbia and California, which used the money to fund jobs and research.²²

According to the Economist, in a piece titled ‘Innovation’s Golden Goose’, published in 2002, the Bayh-Dole Act ‘together with amendments in 1984 and augmentation in 1986, unlocked all the inventions and discoveries that had been made in laboratories throughout the United States with the help of taxpayers’ money. More than anything, this single policy measure helped to reverse America’s precipitous slide into industrial irrelevance’.²³ However, others argued that the economic effects are difficult to measure, and there seems to be little evidence that the increase in university patenting and licensing boosted economic growth t...