international standards for intellectual property …...cornerstones of the western theory of...

* Graduate Liberal Studies Program, Georgetown University; Villanova University, J.D.; Mr. Brindley is also an employee of the United States Patent and Trademark Office (USPTO) and would like to express that all views or opinions presented within this article are purely his own, made for academic purpose, which do not reflect the opinions, policies or positions of the USPTO and are not made in any official capacity in any way. † Neuroethics Studies Program, Pellegrino Center for Clinical Bioethics; Inter-disciplinary Program in Neurosciences, and Graduate Liberal Studies Program, Georgetown University, Washington, DC, USA; Human Science Center, Ludwig-Maximilians Universität, München, GER.

Published Online July 2014

International Standards for Intellectual Property Protection of Neuroscience and Neurotechnology: Neuroethical Legal

and Social (NELS) Considerations in Light of Globalization

Timothy Brindley* and Dr. James Giordano†

Abstract With an increasingly globalized economy, the past 20 years have evidenced a trend towards global, uniform intellectual property standards through the advent of the World Trade Organization (WTO) and Trade Related Aspects of Intellectual Property (TRIPS). New TRIPS practices and increased levels of IP protection have had a significant effect on developing nations’ access to biomedical science and technologies. Moreover, while these agreements may afford prima facie recognition of the importance of public health, and allow compulsory licensing of implements essential to the public health, developing nations often face – and have externally-imposed – economic pressures that mitigate or prevent using these venues to acquire and employ state-of-the-art bioscientific capability.

As neuroscientific research and neurotechnology enter the forefront of biomedical innovation, they will undoubtedly become subject to these same effects and considerations. Increased global IP protection allows a nation and its major industries the ability to control the use of, and access to, neurotechnology on the world stage. Current advancements in neurotechnology such as brain implants, novel psychotropic drugs, and brain-machine interfaces (BMIs) can be used to treat a host of neuropsychiatric disorders, improve cognitive function, and affect individual and group cognitions and behaviors. The capability to enhance medical care, affect human performance, alter the quality of life, and shape the human condition through the use (or deprived use) of neurotechnology generates questions and concerns related to international and corporate biopolitical relationships, and neuroethical obligations are spawned by the intersection of neuroscience, socio-culture, and law in the crucible of international justice. Guiding neuroethical principles that inform and/or contribute to policies regarding the use of neurotechnology and the level of control entities may wield over advancements that are intimately yoked to the scope and tenor of the human being, human condition and human predicament require NELS scrutiny, as policies within the USA and Europe will inevitably be reflected in the global community through treaties, agreements and laws, such as TRIPS. Our work focuses upon the ways that global IP rights and standards may become more prominent vehicles for applying neuroethical policies. We engage with ongoing efforts devoted to

2014 INTERNATIONAL STANDARDS FOR INTELLECTUAL PROPERTY 34 PROTECTION OF NEUROSCIENCE AND NEUROTECHNOLOGY

discerning the methods required to ensure neuroethically sound implementation of neurotechnology upon an ever more pluralized world stage in the future.

I. INTRODUCTION .................................................................................................................. 34 II. NEUROTECHNOLOGY ASCENDANT ............................................................................. 35 III. FOUNDATIONS OF INTELLECTUAL PROPERTY ....................................................... 37 IV. TRIPS AGREEMENT ......................................................................................................... 38

A. Dispute Settlement Within TRIPS ................................................................................................... 40 V. TRIPS IN PRACTICE ........................................................................................................... 41 VI. ANALYSIS OF TRIPS IN VIEW OF THE PRINCIPLES ................................................. 42 VII. FURTHER ETHICO-LEGAL CONSIDERATIONS ......................................................... 43 VIII. CONCLUSIONS ............................................................................................................... 45

I. INTRODUCTION Through iterative and reciprocal engagement of tools and theoretical expansion, neuroscience and neurotechnology have become a conjoined enterprise that has enabled translation of the outcomes and products of brain research in biomedicine, public life, and national security and defense on a global scale.1 That neurotechnologies are employed to affect the human predicament (of disease, trauma, pain, etc.), human flourishing and even the nature of the human being affords considerable leverage to those nations possessing neurotechnological capabilities.2 Such leverage is manifest in biological, socio-cultural and economic domains.3 To be sure, neurotechnology is not only a potent biological and social force, but is - and will increasingly become - “big business” and therefore necessitates development of explicit guidelines, policies and laws to regulate and govern development and use in international settings.4 Toward these ends, we assert that extant mechanisms for the international regulation of biotechnology may require review and perhaps re-appraisal in light of neuroethical evaluation of the scope and potential power of emerging neurotechnologies, and of the neurotechnology industry at-large. More specifically, we ask if and how neurotechnology – as commercial products – will be employed to evoke viable goods in and between developed and developing nations, how commercial controls, such as intellectual property (IP) constructs and rights will affect such development and use, and whether and in what ways neuroethical considerations and practices can and should be employed to address and/or amend guidelines and governances directing such commercial activities.

Globalized IP rights are primarily regulated by the Trade-Related Aspects of International Property (TRIPS) Agreement, which requires World Trade Organization (WTO) 1 See generally NEUROTECHNOLOGY: PREMISES, POTENTIAL, AND PROBLEMS (James Giordano, ed., 2012). 2 Roland Benedikter & James Giordano, Neurotechnology: New Frontiers for European Policy, 1 EUR. J. OF GOV’T 204, 204-07 (2012). 3 See James Giordano, Neurotechnology as Demiurgical Force: Avoiding Icarus’ Folly, in NEUROTECHNOLOGY, supra note 1, at 2. 4 Misti Ault Anderson, Nicholas Fitz & Daniel Howlader, Neurotechnology Research and the World Stage: Ethics, Biopower and Policy, in NEUROTECHNOLOGY, supra note 1, at 287.

35 STANFORD JOURNAL OF LAW, SCIENCE & POLICY Vol. VII

Member States to have and adhere to (more) rigorous IP laws.5 In addition, TRIPS is used in conjunction with free trade agreements by developed nations to compel less-developed nations to be regulated by even more stringent IP standards than those required by the WTO.6 Recent attention to the TRIPS and its application to, and influence upon, globally commercialized products has been increasing given recent multi-national trajectories in scientific and technological innovation, and the potential utility of extant intellectual property regulation upon shared and/or distributed resources, outcomes, and products.7 Intellectual property is fundamental to the economy of the western world and is viewed as necessary to the furtherance of technological progress.8 Without it, the traditional argument goes, inventors would have little incentive for innovation, and scientific advancement would likely slow or halt.9 While the cornerstones of the western theory of property rights provide strong support for IP rights’ frameworks that are currently in place in countries of similar economic standards (e.g., the United States and Western Europe), application of these IP frameworks within economically dissimilar countries (e.g., developing countries) prompts inquiry into the reasoning that was fundamental to the formulation – and continued viability – of current IP rights, as well as the ethical and legal issues that arise from the ongoing use on an economic world stage that is increasingly misaligned. The present trend towards more uniform, global IP standards allows a nation and its major industries the ability to control the use of, and access to, scientific outcomes and technologic products. Yet, given the pace and breadth of current neurotechnological development, we query if regnant TRIPS standards are adequate or sufficient to direct and sustain international development, distribution and use of new products of brain science. In this essay, we define and discuss recent and near-future trends in neurotechnology development and growth on the world stage, focus upon those principles that were fundamental to the establishment of IP rights, address present international practices associated with TRIPS and TRIPS-plus agreements, and discuss neuroethical implications related to these practices that are important to consider as neurotechnology enters the realm of international IP and is used to leverage international economic influence.

II. NEUROTECHNOLOGY ASCENDANT

At present, neurotechnology is a $158 billion global industry that is poised to incur continued expansion as a consequence of government funding and commercial support.10 Exemplary of this trend, the United States’ Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative announced in April 2013 is structured to seek $100 million in government funding for neuroscience research and development for the fiscal year 2014, with an additional $100 million provided by key entities in the private sector. Combining 5 Anna Lanoszka, The Global Politics of Intellectual Property Rights and Pharmaceutical Drug Policies in Developing Countries, 24 INT’L POL. SCI. REV. 181, 184 (2003). 6 See infra Part V. 7 See Roger Kampf & Hannu Wagner, The Role of the TRIPS Agreement in the Global Health Policy, 6 STANFORD J. L. SCI. & POL’Y 17 (2011). 8 Robert L. Ostergard, Intellectual Property: A Universal Human Right?, 21 HUM. RTS. Q. 156, 163 (1999). 9 Nevin M. Gewertz & Rivka Amado, Intellectual Property and the Pharmaceutical Industry: A Moral Crossroads Between Health and Property, 55 J. BUS. ETHICS 295, 304-05 (2004). 10 Neurotech Insights, NEUROINSIGHTS (2013), http://www.neuroinsights.com/newsletter/ neurotech2012.html (last visited Nov. 16, 2013).


these targets over four years, it is in total an $800 million effort.11 In addition to U.S. efforts in neurotechnology, other enterprises also propel this global trend. For example, the Switzerland-based Human Brain Project (“HBP”) was awarded $1.3 billion in February 2013 by the European Commission.12 The HBP is a collaboration of more than eighty research institutions in Europe that are dedicating efforts to map the human brain. The project aims to construct a silicon-based computational simulation, with the intent to employ this reverse-engineering to create novel, neurally-modeled information processing systems.13

Currently, over 800 companies are committed to neurotechnology research, development, testing and evaluation (RDTE) worldwide, with an annual growth rate in excess of 9%.14 The neurotechnology market is supplemented by a 200% increase in venture capital financing, reflecting investments of greater than $12 billion in the past decade.15 Such rapid and profound technological and economic growth is not confined to activities in and of the United States or Europe. Large-scale academic center and commercial investments in neuroscience and neurotechnology in China, Japan and Singapore reflect these nations’ focal dedication to the field.16 In fact, it is estimated that by 2020, neurotechnology research, development and market translation in Asia will surpass that of western nations.17 This establishes neurotechnology as an international enterprise and a strong economic force in and upon global markets and world cultures.

As depicted in Figure 1, those neurotechnologies currently in production or under development can be generally classified as either assessment or interventional approaches.18 Further specificity of technology kind and type yields categorizations of: neurodiagnostics (for example, various neuroimaging technologies, neurogenetic and neuroproteomic assessment technologies, and neuroinformatics); neuropharmaceuticals (as primarily used in the treatment of neurological, psychiatric and sensory disorders); neurodevices (such as neuroprosthetics, neuromodulatory technologies including forms of indwelling and transcranial brain stimulation devices; peripheral and cranial nerve stimulators; neurosurgical devices, and neurally-yoked gaming technologies); and neurocellular technologies (such as stem cell and biosynthetic approaches to neurodegenerative conditions).

Moreover, these technologies are increasingly being developed, modified and employed within an inter-disciplinary paradigm known as Advanced Scientific Convergence.19 Under this rubric, new processes, small (but influential) modifications of existing products, and innovative designs may all establish new opportunities for creating commercial “niches” and protecting revenues, and complicate extant standards of patent protection and IP rights. Commodification 11 BRAIN Initiative, http://www.whitehouse.gov/infographics/brain-initiative (last visited Nov. 16, 2013). 12 Elbert Chu, European Researchers Win $1.3 Billion to Simulate the Human Brain, POPULAR SCIENCE (Feb. 18, 2013, 10:00 AM), http://www.popsci.com/science/article/2013-02/how-simulate-human-brain-one-neuron-time-13-billion. 13 Id. 14 NEUROINSIGHTS, THE NEUROTECHNOLOGY INDUSTRY 2012 REPORT 22 (2012). 15 Id. 16 Id. 17 NEUROTECHNOLOGY INDUSTRY ORGANIZATION, NEUROTECH CLUSTERS IN 2010: LEADING REGIONS IN THE GLOBAL NEUROTECHNOLOGY INDUSTRY 2010-2020, at 41 (2009). 18 See infra Figure 1. 19 See James Giordano, Integrative Convergence in Neuroscience: Trajectories, Problems and the Need for a Progressive Neurobioethics, in TECHNOLOGICAL INNOVATION IN SENSING AND DETECTING CHEMICAL, BIOLOGICAL, RADIOLOGICAL, NUCLEAR THREATS AND ECOLOGICAL TERRORISM 115 (Ashok Vaseashta et al. eds., 2012).


(and ownership) of neurotechnology will be governed by IP laws, and this protectionism brings to light the potential creation of neurotechnological biopower. We posit that this may be comparable to the pharmaceutical examples provided herein that demonstrate that international ethical, social and political pressures associated with the level and use of biomedical technology will increasingly rely upon: (1) the global IP forum(s) for implementation, and (2) renewed consideration of the capabilities and limitations of current IP regulations to affect the scope and conduct of neurotechnology research, development, use and ownership.

III. FOUNDATIONS OF INTELLECTUAL PROPERTY

Intellectual property rights are justified, in principle, by two main theories: John Locke’s labor theory of property, and the doctrine of utilitarian inference.20 Locke’s labor theory justifies the exclusive ownership of an intangible object because of the inventive efforts and labor that essentially create the value of a new or modified object.21 The admixture of existing resources (i.e., the physical product) and innovation become the property of the individual responsible for its creation (not simply the resource on its own). The crux of this idea is found in the Lockean proviso, which states, “Labour bring the unquestionable Property of the Labourer, no Man but he can have a right to what is once joined to, at least where there is enough and as good left in common for others” (emphasis added).22 Simply put, a person is entitled to that which they newly create, as long as the exclusive right will leave the rest of society with as much opportunity to use the common resource as would otherwise be possible. In this way, Locke stresses that one must give “…due deference to mankind.”23 Robert Nozick, a frequently cited commentator on Locke, interprets the proviso to mean that others who are “. . . no longer free to use the appropriated property, should not be made worse off than before the property was appropriated.”24 According to Nozick, an individual is “worse off” if they “. . . are no longer free to use what they could previously use.”25 The IP rights of an individual are therefore subordinate to the existing rights of others. As such, one cannot use one’s IP rights to infringe on the extant rights of others. It seems plausible that notions of “enough and as good” may intimate that IP rights should not take away from inalienable rights of individuals to things essential to life.26 The idea of an exchange occurring between an inventor and society is founded within utilitarian principles, which set forth that the morally best acts are those that “maximize human welfare,” and/or “create the greatest good for the greatest number”.27 In advocating utilitarianism, John Rawls stated that “the principle for society is to advance as far as possible the welfare of the group, to realize to the greatest extent the comprehensive system of desire arrived at from the desire of its members.”28 Thus the utilitarian stance advances the rights of an individual obtained through equality of the social good. 20 Ostergard, supra note 8, at 156-57. 21 Id. at 156. 22 Wendy J. Gordon, A Property Right in Self-Expression: Equality and Individualism in the Natural Law of Intellectual Property, 102 YALE L.J. 1533, 1562 (1993). 23 Id. 24 Ostergard, supra note 8, at 160. 25 Id. 26 Gordon, supra note 22, at 17. 27 Ostergard, supra note 8, at 163. 28 Id. at 163.


The utilitarian argument for IP rights is premised upon providing incentives (for inventors) to produce new, innovative technologies, which will in turn promote public welfare. The exclusive right of ownership creates motivation for inventors to provide initial investments; this appears to be particularly pertinent for certain neurotechnologies, due to their high cost of research and development.29 It is held that if IP rights are weakened or negated, inventors will lose incentives to innovate and this will consequently impede progress.30 As such, society strikes a bargain with (any and all) inventors, such that in exchange for divulging the merits of newly created technology, society will grant the inventor a short-term monopoly over the creative destination of that innovation.

IV. TRIPS AGREEMENT In 1994, World Trade Organization (“WTO”) became the enforcement body for the Trade-Related Aspects of International Property (“TRIPS”) Agreement.31 TRIPS provides minimum standards for protection of IP rights, and affords rules for enforcement of IP standards in every country holding membership in WTO.32 TRIPS posits a stronger set of rights for patent holders within a particular country.33 Some of these requirements include a minimum of 20 years protection from the filing date of a patent and new patent laws protecting pharmaceuticals in countries where none previously existed.34 In formulating TRIPS, developed countries (e.g., U.S., Western Europe) argued that higher international standards of IP rights would increase foreign investment by providing a more predictable legal system and business environment that would improve the economic climates of developing countries.35 These standards are actually at a level comparable to those of industrialized nations, and have proven costly to developing countries that must often enact substantial changes and provide for an entirely new administrative framework and judicial system in order to support such IP legislation.36 The stringent IP standards in the TRIPS agreement pose additional problems for developing nations. Innovation, particularly with respect to biotechnology and pharmaceuticals, is predominantly generated in and from developed countries, and often it is developed nations’ corporations and individuals that apply for, obtain, and leverage patents for domestic use.37 Under TRIPS, such companies have stronger IP rights, which allow them to control (if not prohibit) importation of biotech products into particular countries, and to prevent generic versions of the product from being developed and sold. In this way, commercial entities may also set any fair market price on their products, regardless of whether or not such products are considered important for public health, or whether such products, once commercialized, will be affordable to those in need.

29 See Gewertz, supra note 9, at 297. 30 Id. 31 See Mirela V. Hristova, Are Intellectual Property Rights Human Rights?, 93 J. PAT. & TRADEMARK OFF. SOC’Y 339, 341 (2012). 32 All members of the WTO are bound by WTO agreements. See Lanoszka, supra note 5, at 184. 33 Id. 34 Id. 35 Id. at 186. 36 Id. at 184. 37 Id. at 190.


The major exception to these stipulations is offered in Article 8 of TRIPS, which states, “Members may . . . adopt measures necessary to protect public health.”38 This does not allow WTO members to breach the TRIPS agreement for public health reasons, but allows the use of certain mechanisms within TRIPS to take necessary action.39 While such language might suggest the paramount importance of public health,40 TRIPS does not provide a definition of “public health”, nor does it stipulate the primacy of public health concerns over those of IP regulation. Two primary mechanisms for allowing a patented product to be used without authorization by the patent holder within a developing country are “compulsory licensing” and “parallel importation.” The first mechanism, compulsory licensing, as established by Article 31, allows the government of a country to issue a license to another entity within that country to use, manufacture, or import a product without permission from the patent holder.41 There are, however, standards defining when a government may issue a compulsory license. A compulsory license must be “necessary to protect the public health” and requires that the proposed user of the patented product attempt to negotiate with the patent holder for a reasonable period of time, except in situations of national emergency.42 Further, the license must be limited in scope and duration for the purpose(s) that it was authorized, and must be predominantly used within the domestic market of the (WTO) member state.43 The member state receiving the products must also demonstrate insufficient domestic production capabilities to meet the needs for the product in question,44 and the government issuing the compulsory license must provide “adequate compensation” to the patent holder, although there are no strict definitions or regulations determining this value.45 Malaysia, Indonesia, Zambia, Zimbabwe, and Mozambique have recently successfully issued compulsory licenses for antiretroviral medicines.46

Parallel importation is a second mechanism by which a product may be used in a developing country without patent holder authorization or approval. Under this mechanism, a third party who has lawfully acquired the product through the market may sell it to a country for a lower price than the patent holder based upon the rationale that the patent holder has exhausted their right to the product by selling that particular batch.47 The Doha Declaration of 2001 was issued by the WTO in attempt to clarify the relationship between public health and TRIPS as

38 Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations 320 (1999), 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement]. 39 ANDREW LAW, PATENTS AND PUBLIC HEALTH: LEGALISING THE POLICY THOUGHTS IN THE DOHA TRIPS DECLARATION OF 14 NOVEMBER 2001, at 65 (2009). 40 Id. at 66. 41 Lanoszka, supra note 5, at 184. 42 Sara M. Ford, Compulsory Licensing Provisions Under the TRIPS Agreement: Balancing Pills and Patents, 15 AM. U. INT’L L. REV. 941, 959 (2000). 43 TRIPS Agreement, supra note 38, at arts. 319(c) and (f). 44 LAW, supra note 39, at 135. 45 Id. at 135. Compensation for the patent holders damages is more commonly accepted as opposed to remuneration for the licensee’s gains, which is similar to eminent domain cases within the U.S. See id. 46 Lisa Forman, Trade Rules, Intellectual Property and the Right to Health, 21 ETHICS AND INT’L AFF. 337, 341 (2007). 47 Carlos M. Correa, Pro-Competitive Measures Under TRIPS to Promote Technology Diffusion in Developing Countries, in GLOBAL INTELLECTUAL PROPERTY RIGHTS: KNOWLEDGE, ACCESS, AND DEVELOPMENT 40, 54 n.6 (Peter Drahos & Ruth Mayne eds., 2002).


entailed by compulsory licensing.48 Member states notably agreed that each has the sovereign right to determine grounds for compulsory licenses and provide for their use, and claimed that the TRIPS Agreement “does not and should not prevent members from taking measures to protect the public health.”49 Further, TRIPS “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicine for all.”50

A. Dispute Settlement Within TRIPS Prior to the advent of TRIPS, international IP arrangements were governed under the Paris Convention (1883), Berne Conventions (1886), and subsequently the General Agreement on Tariffs and Trade (GATT) from 1948 through 1994 (until it was assimilated into the framework of the WTO).51 These former international IP agreements lay the foundation for the rationale and importance of the present adjudicatory framework of the WTO and TRIPS. The Paris Convention provides that the same procedural treatment for patent and trademark applications must be given to an applicant regardless of whether the applicant is a national of that country.52 The Berne Convention, on the other hand, requires signatory states to recognize the copyright works of those from other signatory states.53 Both conventions identified the International Court of Justice (ICJ) at the dispute settlement body.54 In other international matters, however, the international community has generally been reluctant to accept the ICJ’s jurisdiction.55 No international IP dispute has ever been brought before the ICJ, essentially rendering the Paris and Berne conventions “toothless”.56 Instead, the primary means of international IP dispute resolution the General Agreement on Tariffs and Trade (“GATT”) , the predecessor to the WTO, which conducted panel hearings during the 1980s to consider several different intellectual property disputes through a primarily negotiation-driven process.57

An interest in creating an IP dispute settlement body with more relative force than a negotiation-type outlay compelled the creation of the Dispute Settlement Body (DSB) within the WTO and TRIPS.58 The DSB of the WTO clearly has more of a legal/tribunal framework, with an appellate process that allows for retaliatory action against member states that fail to comply with rulings in a timely manner.59 For example, an appeal is characteristically required when

48 LAW, supra note 39, at 157. 49 Id.; see also Charles T. Collins-Chase, The Case Against Trips-Plus Protection in Developing Countries Facing Aids Epidemic, 29 U. PA. J. INT’L L. 763, 778 (2008). 50 Collins-Chase, supra note 49, at 778. 51 Gail E. Evans, Issues of Legitimacy and the Resolution of Intellectual Property Disputes in the Supercourt of the World Trade Organization, 4(3) INT. TRADE L. & REG. 81, 81 (1998). 52 Summary of the Paris Convention for the Protection of Industrial Property (1883), WORLD INTELLECTUAL PROPERTY ORGANIZATION, http://www.wipo.int/treaties/en/ip/paris/ summary_paris.html (last visited May 19, 2014). 53 Id. 54 Evans, supra note 51, at 83-84. 55 For example, the U.S. declared itself unbound by ICJ rulings after its trial for crimes committed against Nicaragua in the 1980s. See W. Michael Reisman, Has the International Court Exceeded Its Jurisdiction, 80 AM. J. INT’L L. 128, 128 (1986). 56 Evans, supra note 51, at 83-84. 57 Id. 58 Id. at 83. 59 Id. at 85.


compulsory licenses are issued.60 Article 41.4 allows patent holders to seek judicial review within the member state that issues a compulsory license to address all administrative decisions made, and to insure that a member of the DSB of the WTO also be present for the proceedings.61

The DSB is a panel of representatives from the member states that hears grievances (filed by a particular member state against another) regarding potential violations of the agreement.62 The decision of the panel may then be forwarded to the Appellate Body of the WTO, which may affirm or reject the DSB ruling.63 Should a member state be found to be in violation of TRIPS, they have a certain period of time to reform their policies so as to properly align with TRIPS; failure to enact such reforms open the member state to face possible trade sanctions.64 Because member states have representation at the DSB proceedings, patent holder(s) must persuade governments to file an action should they believe that treatment is a violation of TRIPS, and judicial review was ineffective. As of 2009, the DSB or Appellate Body has not had an opportunity, or a case, to rule on either the scope of the term “public health” within TRIPS, or on the suitability of an issued compulsory license.65 In previous disputes, the DSB has accepted the protection of social welfare (in particular “psychological health”) as a valid exception to other WTO agreements.66

V. TRIPS IN PRACTICE

In 1997, South Africa enacted the South African Medicines and Related Substances Control Amendment Act (Medicine Act), which was designed to address the high prices of pharmaceuticals needed to treat a number of emergent public health crises (including HIV/AIDS, tuberculosis and malaria).67 This law used a parallel importation system, which is (like compulsory licensing) expressly allowed under TRIPS.68 At that time, the per capita cost for HIV/AIDS treatments in most African countries was around $12,000 per year.69 Parallel importation of the appropriate drugs greatly reduced public costs within South Africa.70 Although, this is a provision allowed by the TRIPS agreement, a number of corporations claimed that it unfairly curtailed corporate profits, and several complaints were filed in the U.S.71 In response, from 1997-1999, the U.S. began a trade-related coercion program to engage the South African government and its policymakers in a number of ways, most notably through Section 301 of the 1974 Trade Act.72 The 1974 Trade Act was revised in 1988 to include “Special 301” provisions that required the Office of the U.S. Trade Representative (“USTR”) to create a watch list identifying countries that deny adequate and effective protection of IP rights, 60 Id. at 92. 61 TRIPS Agreement, supra note 38, at art. 41.4. 62 Understanding the WTO: Settling Disputes, WORLD TRADE ORGANIZATION, http://www.wto.org/english/thewto_e/whatis_e/tif_e/disp1_e.htm (last visited Apr. 29, 2013). 63 Id. 64 Id. 65 LAW, supra note 39, at 67. 66 LAW, supra note 39, at 67. 67 Willem Pretorius, TRIPS and Developing Countries: How Level is the Playing Field?, in GLOBAL INTELLECTUAL PROPERTY RIGHTS, supra note 47, at 183, 190-91. 68 Id. 69 Id. at 191. 70 Id. at 190. 71 Id. at 191. 72 Id. at 192.


or deny fair and equitable market access from U.S. IP holders.73 This statute has also been employed to compel India and Brazil to sign the TRIPS agreement, because placement on this list revokes a country’s Most Favored Nation status and gives the U.S. reason to increase trade tariffs.74

Use of the Special 301 list as a mechanism for economic leveraging is not subject to limitation within TRIPS, and was used as an economic incentive on South Africa by refusing preferential treatment under the Generalized System of Preferences (GSP) program until sufficient progress was made against their use of parallel importation.75 In 1998, the U.S. exerted further economic pressure on South Africa through passage of an omnibus appropriations law to discontinue aid to South Africa pending a State Department report verifying that progress had been made to repeal relevant sections of the Medicines Act.76 Ultimately, after about two years of economic pressure, international response to the U.S. position regarding South Africa’s public health crisis forced the removal of South Africa from the Special 301 list, with the condition that South Africa acknowledge that the AIDS epidemic was an inherently “special circumstance.”77 Agreements made between countries that require a particular nation to have more stringent IP rights than those required by TRIPS are commonly referred to as “TRIP-plus” rules. The U.S. has engaged a number of trade agreements with developing nations that require TRIPS-plus rules that affect access to more affordable biomedical therapeutics. A recent example of the use of TRIP-plus rules is the US-Jordan Free Trade Agreement (FTA) of 2000, which followed the U.S. requiring Jordan to have certain TRIPS-plus rules in order to enter the WTO earlier that year.78 In this way, Jordan was the first country to enter into a TRIPS-plus type of agreement with the U.S., as part of a larger plan to create a free trade zone across the Middle East and North Africa that remains in effect today.79 Since this agreement, the U.S. has entered into FTAs with Morocco, Oman, and Bahrain with similar TRIPS-plus requirements.80

VI. ANALYSIS OF TRIPS IN VIEW OF THE PRINCIPLES JUSTIFYING INTELLECTUAL PROPERTY

The strongest and most practical justification for the present trends toward globalized standards of IP through TRIPS and TRIPS-Plus agreements is based upon a utilitarian stance. Providing greater international IP rights to inventors promotes incentives for innovation and theoretically increases net social benefit. However, this rationale and its implications are not without potential problems. At present, the greatest benefit(s) gained from higher IP standards

73 Peter Drahos, Negotiating Intellectual Property Rights: Between Coercion and Dialogue, in GLOBAL INTELLECTUAL PROPERTY RIGHTS, supra note 47, at 161, 169. 74 Id. at 170-71; see also Ford, supra note 42, at 948. 75 Pretorius, supra note 67, at 192-93. 76 Id. at 193. 77 Id.; see also Ford, supra note 42, at 956. 78 Rohit Malpani, All Costs, No Benefits: How TRIPS-Plus Intellectual Property Rules in the US-Jordan FTA Affect Access to Medicines, 102 OXFAM BRIEFING PAPER 5 (2007), available at http://policy-practice.oxfam.org.uk/publications/all-costs-no-benefits-how-trips-plus-intellectual-property-rules-in-the-us-jord-114080. 79 Id. at 5. 80 Id. at 6.


can reasonably be assumed to be agents and commercial entities in developed countries because they are able to access and further develop upon patented products, as well as potentially promote the economy within their respective country. Further, the standard of living in the western world may be calculated to increase with each new biotechnology that is available to enhance or lengthen the lives of the society’s populace. In contrast, it is likely that those within developing nations never see such a benefit because of stricter IP rights and higher prices. In fact, the people of developing nations are exactly those who stand to gain the greatest quality of life benefits from this innovation. The greatest utilitarian benefit comes from a system that allows for the development of entire peoples because the “greatest happiness for the greatest number is demographically weighed by the masses of the world’s poor.”81 The utilitarian benefit is significantly greater in these areas through the diffusion of technology, not the protection of private property.82 By allowing developing countries to use the patented technology of the western world more freely, basic necessities may be produced and accessed by more people at a lower cost, resulting in significantly greater relative benefit than if use of this technology is subject to more restrictive intellectual property rights.

Locke’s labor theory justifies an individual’s right to their IP based both on the combination of labor and creative efforts with existing resources to create new technology, and upon a social contract whereby (a) the inventor agrees to provide a creation or product in order to advance progress, and (b) society agrees to concede the right to use this technology for a short-period of time. The purpose of the exchange is to allow a society to build on the invention, which is the basis for their relinquishing their rights to the disclosure. In reality, however, a large part of society often does not acquire demonstrable benefit(s) from this exchange.83

Within developing nations, the distribution of goods and effects of new biotechnology are frequently constrained because of high costs. Developed nations have essentially commandeered the “common property” or existing resources based on the huge technological and economic gaps developing nations have created. Thus, provision of resources deemed “enough and as good” is no longer feasible for many developing nations as a consequence of the rights of more technologically capable nations.

The argument that neurotechnology companies will need higher protection in order to profit from product distribution subsequent to costs incurred by RDTE is reasonable. However, Locke’s theory does not appear to sustain that an individual is exclusively entitled to the “full market value” of their product or intellectual labor.84 Rather, it is intended that an individual receive some compensatory sum, particularly based on the “enough and as good” clause, which clearly takes into account the inherent rights of others. This begs a consideration of how much value a developed country should place upon the rights of the people in developing country from the perspective of international justice.

VII. FURTHER ETHICO-LEGAL CONSIDERATIONS

81 See Paul Steidlmeier, The Moral Legitimacy of Intellectual Property Claims: American Business and Developing Country Perspectives, 12 J. BUS. ETHICS 157, 162 (1993). 82 Malpani, supra note 78, at 16. 83 See David Lea, The Expansion and Restructuring of Intellectual Property and Its Implications for the Developing World, 11 ETHICAL THEORY & MORAL PRAC. 37, 55 (2008). 84 Gewertz, supra, note 9, at 300-304.


Rawls is widely known for advocating an approach to distributive equity proposed in his work A Theory of Justice. This approach calls for the provision of economic profits by the state in order to preserve the basic liberties of its citizens, (e.g., the right to health, which is therein referred to as “the difference principle.”).85 Thus, a Rawlsian contention would be that in a particular nation-state, a person’s right to health has greater moral importance than an individual’s right to IP (which is not viewed by Rawls as a basic liberty), and infringement upon that right would not be justified by enhanced economic advantages.86 However, Rawls did not extend this same view of distributive justice to the international stage in the Law of Peoples.87 Rather, the view is abandoned in international contexts because Rawls argued that the difference principle is only applicable between persons who are relevantly situated within a cooperative nation-state given that principles of a constitutional democracy are present and in force.88 On the international stage, not all states aspire to the traditional liberal tenets of a democracy, so the foundations for distributive justice are not inherently sustainable.89 While Rawls explicitly denounced the viable application of distributive justice in an international context, he still held that minimum principles exist for international interactions between societies.90 One of these minimum principles is that “. . . peoples have a duty to assist other peoples living under unfavorable conditions that prevent their having a just or decent political or social regime,” which is referred to as the “duty of assistance”.91 This places a moral obligation on well-ordered societies to ensure that all societies achieve minimal conditions required for their members to lead “worthwhile lives” with the modest goal of guaranteeing basic justice to meet people’s basic needs.92 As such, Rawls, while expressly disfavoring simple distributive justice at an international level, still opined that a minimum duty of assistance is owed to those in developing countries so as to help their peoples live worthwhile lives and fulfill basic needs. Along these lines, it would appear that a Rawlsian perspective would not disfavor the TRIPS, or TRIPS-plus agreements that would largely benefit the U.S., because a nation-state’s duties are primarily to the welfare of its own people. Although the agreements may not be particularly favorable to developing nations in practice, they were freely entered into by those member states, at least in effect. Based on the Rawlsian duty of assistance, however, it would appear that a line would be drawn against actively preventing compulsory licenses for needed and valuable neurotechnologies in developing countries. The moral duty to help all societies achieve minimal conditions necessary to lead “worthwhile lives” would suggest that attempting to prevent developing nations from receiving or providing more affordable neurotechnology would therefore be contrary to the duty to assist. In his book, One World, Paul Singer presents a different and somewhat more controversial argument regarding globalization and international justice. Singer argues that 85 Id. at 298. 86 Id. 87 See Michael Blake & Patrick T. Smith, International Distributive Justice, STAN. ENCYCLOPEDIA OF PHIL. (Oct. 24, 2013), http://plato.stanford.edu/entries/international-justice/#3. 88 Id. 89 Id. 90 Id. 91 Id.; see also Brian J. Shaw, Rawls, Kant's Doctrine of Right, and Global Distributive Justice, 67 J. POL. 220, 222 (2005). 92 Shaw, supra note 91, at 222-24.


increasing globalization is changing how nation-states are perceived, and that ethics should begin to reflect these changes.93 Specifically, he asserts that Rawls’ disapproval of the application of distributive justice to the international stage reflects an outdated perception of the nation-state in today’s global society.94 This new, more global society has arisen, at least in part, due to an increase in technology and the enhanced power of global organizations, such as the WTO.95 As such, Singer offers that “ . . . a global ethic should not stop at, or give great significance to, national boundaries.” The use of TRIPS and TRIPS-plus agreements are clear examples of this push toward more globalized IP standards. Singer is critical of the WTO, asserting that it is a mechanism for “accelerating and extending the transfer of peoples’ sovereignty from nation states to global corporations.”96 And, while he cautions that the foundations for some of his criticisms are as yet unproven, he tenders four accusations against the WTO: (1) The WTO places economic considerations ahead of concerns for human rights; (2) The WTO erodes national sovereignty; (3) The WTO is undemocratic; and (4) The WTO fosters inequality and inequity on a global scale.97

Singer’s globalization views support a far more internationally sensitive framework of distributive justice. It seems that the type of economic activities Singer describes, whereby the power and rights of people and their sovereignty are ceded to corporations – as they appear to be when countries are compelled into TRIPS or TRIPS-plus agreements – would not be supported by such a new global ethic because of the potentially detrimental impact on public health. Singer claims, “In the present situation we have duties to foreigners that override duties to our fellow citizens. For even if inequality is often relative, the state of absolute poverty that has already been described is a state of poverty that is not relative to someone else’s wealth.”98 While some of the views can be regarded as radical, he provides a strong argument that the U.S. has responsibility for the public health of developing nations, which TRIPS-plus agreements do not inherently protect.

VIII. CONCLUSIONS The TRIPS Agreement and TRIPS-plus types of agreements between the U.S. and developing countries are controversial. While TRIPS appears to establish prima facie ethical frameworks for introducing more stringent IP rights in developing countries with greater enforcement capacity than the previous frameworks, in practice it does not seem to have lead to largely desirable effects for these nations. This attempt at worldwide IP standards could thus be regarded as running afoul of fundamental tenets defining the right and good use of IP, and, as such, is focal to the critical international ethical theories as provided by John Rawls and Paul Singer. Within this schema, utilitarian justification for allowing IP rights is violated because developing countries do not receive the explicit benefits afforded by social contract. In light of this, the ethics of actions taken by the U.S. in relation to TRIPS and TRIPS-plus agreements are debatable. Given its purported and widely acknowledged status as a global superpower (based, in large part, on its scientific and technologic capabilities), it could be argued

93 PETER SINGER, ONE WORLD: THE ETHICS OF GLOBALIZATION 8 (rev. ed. 2008). 94 Id. at 8. 95 Id. at 9-10. 96 Id. at 5. 97 Id. at 55. 98 Id. at 175.


that the U.S. owes a moral duty to help the people of developing countries obtain basic necessities; or at least should not be contributing to maintaining a state where they lack availability and access to neurotechnologies that have shown important, if not yet essential, benefit. Rawls’s duty of assistance can be seen to set a lower end of the ethical threshold for international relations. On the other end lies Paul Singer’s theory of global justice, which positions strongly against the United States’ use of TRIPS and its requirement of TRIPS-plus rules in developing countries. To wit, Singer voices opposition to undemocratic WTO practices which heavily favor economic considerations of developed nations, and argues that as the world becomes increasingly globalized, developed countries – such as the U.S. – become ever more responsible for a more micro-economically sensitive and responsive stance. If we assume the aforementioned lower and upper limits, it would be reasonable to assert that an ethically justifiable position exists at a midpoint, which would disallow continued economic pressure from developed nations upon developing nations as a form of biopolitics. As neurotechnology continues to advance in the near future, so too will the potential to leverage these developments as instruments of biopower. The capability to enhance medical care, affect human performance, alter the quality of life, and shape the human condition through the use (or deprivation) of neurotechnology generates neuroethico-legal concerns similar to those raised above. Any sufficiently granular attempt to address and analyze the ethico-legal issues arising from international guidance and regulation of neuroscientific and neurotechnolgical IP rights will raise questions regarding if and how such legal parameters reflect or conform to the core philosophical precepts underlying the law. Although a complete discussion of such foundations and their premises are beyond the scope of the present paper, we feel it is noteworthy to focus upon four main points that we maintain to be fundamental to such discussion and that have the potential to resolve some of the problems mentioned herein.

First, most perceptions (if not working definitions and the actions predicated thereupon) regard "the law" as systematic formulations and constructs for rules of conformity. From this, follows the second point – an ethical question – posed here by paraphrasing MacIntyre: what good, whose justice, which rationality?99 That is, while local laws can be viewed as reflecting communitarian value(s) and some measure of consensus, the extent and uniformity of consensus is diffused in direct relation to the size and diversity of communities affected. Third, and apropos MacIntyre's query in relation to international laws regulating IP right, we believe that a critical view of law is warranted. To wit, such critique should be directed upon the "is-ought" dichotomy as applied to law; namely, the ideal versus actual utilitarian value of such laws, and the influence of regnant sovereignties upon how such utilitarian values are established and enforced.100 To re-iterate: what good, whose justice, which rationality? Fourth and finally, in accordance with Austin's stance against regarding law as a fixed, restricted system (i.e. what is sometimes referred to as a Begriffshimmel),101 it becomes important to recognize that in actuality, laws arise in and from and are reflective of the realities and circumstances of the polis to be affected. Given this, if we acknowledge the reality of a

99 ALASDAIR MACINTYRE, WHOSE JUSTICE? WHICH RATIONALITY? 340 (1988). 100 See JEREMY BENTHAM, AN INTRODUCTION TO THE PRINCIPLES OF MORALS AND LEGISLATION 4 (Clarendon Press 1907) (rev. ed. 1823). 101 JOHN AUSTIN, THE PROVINCE OF JURISPRUDENCE DETERMINED xii-xiv (Cambridge Univ. Press 1995) (1832).


"New Global Shift"102 and the resultant change in the architectonics of the world-stage of the 21st century – and its attendant diversity in needs, values and reliance upon science and technologies for sating these socio-economic, cultural, if not political needs and demands – then prior or extant legal parameters of communitarian utility may be inapt. This prompts questions of if and how such revision of internationally-tendered laws governing the development, distribution and use of neurotechnology (or any products of science and technology for that matter) could and should be formulated and enacted so as to be realistically grounded, ethically sensible, and economically responsive.103 But while theoretically plausible, these directions can incur problems through potential for (1) misinterpretation of political ideals and aims, (2) miscommunication/misunderstanding and resulting (continued) misalignment of the science and technology with socio-cultural needs and economic realities.104 Yet, such possibilities do not refute the need for a broader discourse, if not dialectic, that entails groups that are representative of both particular and more generalized communities' (i.e.- groups', populations', regions', and/or nations') needs and values' desiderata. In this way, human ecologies, their bio-psychosocial influences and effects, and economics could be incorporated into any attempt at addressing, analyzing and devising the rules and regulations that govern such activities.105 Legal scholar Ani Satz has proposed a system of microeconomically sensitive and macroeconomically enactable development and allocation of high-tech resources and assets, based predominantly upon the work of Amartya Sen.106 Taken together, these approaches seem to be both reasonable and feasible. Still, an underlying question as to which ethical views, systems and constructs will be useful to intuit the issues and resolution-trajectories that ground legislation to contexts of definable "good" and the rationalization of how neurotechnologic research and its outcomes and products should be obtained in and across international parameters. Toward this goal, we have posited the need for a cosmopolitan (i.e. not exclusively Western) neuroethics.107 However, we recognize that this too is not without difficulty in establishment and implementation, and requirements for multi-national, multi-disciplinary participation necessitate respect for various standpoints. Therefore, extant ethical principles may require revision, and other ethical principles may need to be developed anew so as to avoid

102 See Roland Benedikter & James Giordano, The Outer and Inner Transformation of the Global Sphere Through Technology: The State of Two Fields in Transition, 5 NEW GLOBAL STUD. 1, 12-13 (2011). 103 See Anderson, Fitz & Howlader, supra note 4, at 294-96. 104 See Benedikter & Giordano, supra note 2, at 204-07; see also James Giordano & Roland Benedikter, Neurotechnology, Culture, and the Need for a Cosmopolitan Neuroethics, in NEUROTECHNOLOGY, supra note 1, at 233, 233-34. 105 See generally Alejandro Caňadas & James Giordano, A Philosophically-Based Bio-Psychosocial Model of Economics: Evolutionary Perspectives of Human Resource Utilization and the Need for an Integrative, Multi-Disciplinary Approach to Economics, 5 INT’L J. INTERDISCIPLINARY. SOC. SCI. 53 (2010). 106 Ani Satz, Toward Solving the Health Care Crisis: The Paradoxical Case for Universal Access to High Technology, 8 YALE J. OF HEALTH POL’Y L. & ETHICS 92 (2008). 107 See James Giordano, Neuroethics: Traditions, Tasks and Values, 1 HUMAN PROSPECT 2, 2-8 (2011); see also Benedikter & Giordano, supra note 2, at 204-07; James Giordano & Roland Benedikter, An Early - and Necessary - Flight of the Owl of Minerva: Neuroscience, Neurotechnology, Human Socio-Cultural Boundaries, and the Importance of Neuroethics, 22 J. EVOLUTION & TECH 14 (2012); James Giordano & James Olds, On the Interfluence of Neuroscience, Neuroethics and Legal and Social Issues: The Need for (N)ELSI, 2 AJOB NEUROSCIENCE 12, 13-15 (2010).


ethical relativism and ethical imperialism.108 We remain committed to this task, and to ongoing work to assess, inform and improve the ways that neuroscience and neurotechnology is guided, governed and applied in global contexts. To be sure, this work, and its requirement for international collaboration, remains a work-in-progress.

108 See generally John Shook & James Giordano, A Principled, Cosmopolitan Neuroethics: Considerations for International Relevance, 9(1) PHIL., ETHICS, AND HUMAN. IN MED. 1 (2014), available at http://www.peh-med.com/content/9/1/1.


Figures

Classification and Categorizations of Neurotechnologies Assessment Neurotechnologies. Neurodiagnostics Neuroimaging Computed tomography (CT) Positron emission tomography (PET) Single photon emission computed tomography (SPECT) Magnetic resonance imaging (MRI) Functional magnetic resonance imaging (fMRI) Functional near-infrared spectroscopy (fNIRS) Physiological Recording Electroencephalography (EEG) Quantitative electroencephalography (qEEG) Magneto-encephalography (MEG) Genomics and Genetics Chemical Biomarker Analyses Neuroinformatics Computational statistical/analytic hard and software Computational databases Interventional Neurotechnologies. Neuropharmaceutics Neurologic agents Psychiatric agents Sensory-motor agents Neurodevices Neuroprosthetics Cochlear implants Retinal Implants Neuromotor prostheses (e.g.- limbs) Brain-computer interfaces (BCI) Neuromodulatory technologies Deep brain stimulation (DBS) Transcranial magnetic stimulation (TMS) Transcranial and direct cortical electrical stimulation Vagal nerve stimulation Peripheral nerve stimulation In-dwelling micro- and macro-infusion pumps Neurosurgical technologies Radiosurgical devices Neurosurgical navigation technologies Figure 1.

international standards for intellectual property …...cornerstones of the western theory of...

Documents