The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach.
The need to simplify admittance to vital medicines for those with lifethreatening or deadly diseases like HIV, tuberculosis, and malaria has caused noteworthy interest. Yet, anforeseeable tension exists between the need for pharmaceutical establishments to profit from their patented inventions and the desire to provide access for disadvantaged persons. Emerging nations have tried to resolve this pressure through the issuance of patent compulsory licenses; sanctions for government approved generic copies. so that those in need of the most significant new treatments can get them at an reasonable price. However, the exercise of compulsory licensing comes with a price: the temporary or permanent withdrawal of some part of a patent owner’s right to dismissinterrupts the investment-backed anticipation of the property right. In the future, pharmaceutical establishments and other industries reliant on upon intellectual property rights may distrust licensing nations’ promises to defend and enforce patent rights, not to mention copyrights, and trademarks. As a result, industries that find the safety of property rights deficient in a given nation may avoid engaging in foreign direct investment with that nation. Because foreign direct investment (“FDI”) is a foremost potential foundation of economic growth for recipient nations, the loss of such speculation resources arising from compulsory licensing practices could force emerging nations to pay a particularly heavy cost for providing wanted medicines for its citizens. This article scrutinizes the interrelationship between the issuance of compulsory licenses for essential medicines and the influx of FDI. Specifically, it discovers the latent for collective action and bargaining on the part of licensing nations to minimize FDI losses while conserving access. This article concludes by bestowing optimal negotiating strategies for nations that impose compulsory licenses which cause influx in foreign direct investment.
The Relationship Between Patent, Compulsory License And Foreign Direct Investment:
Intellectual property rights at their fundamental are investment-inducing machineries. The idea is to trade limited market exclusiveness for the improved production and disclosure of useful goods, research or services. Not surprisingly, strict innovation investment may be convoyed by significant parallel investment in business facilities and personnel, amplifying the effect of the rights on economic development. In developing countries, a significant amount of such investment may come from outside the country, stimulating the growth of local industry beyond that which would be possible through endogenous investment alone. It is this broad impact on a country’s economic wealth that purportedly justifies the global institution of strong intellectual property regimes. Strong rights should lead to greater investment, all things being equal. Yet, there remain great differences in intellectual property rights between countries, suggesting that the investment incentives can be different as well. Moreover, gives inherent in international intellectual property agreements license the relaxation of rights in certain conditions. The imposition of a compulsory license, explicitly endorsed in international law, is one of the most significant reductions in rights, and it has great latent to impact both local and foreign investment practices. Nowhere is this relationship more visible than in the context of the invention and delivery of essential medicines. Features such as the amount of investment at stake, dependence on intellectual property rights, great likelihood of rights lessening, and social importance combine to create a useful agenda for study.
(i) Public Health, Compulsory Licenses and the NoveltyAdvice Loop:
Public health has emerge as a major international political main concern because it has turn into ever clearer that improving the health of a nation’s citizens provides profitable and moral rewards. Such impacts rationalize great expenditures because widespread disease can have self-evident effects on a nation’s health, economic permanence, and national security. significantly, these struggle are no longer country-specific; public health issues reach transversely international borders. In a physical sense, modern air voyage permits diseases to spread more easily than ever, making one country’s crisis a latent concern to all. In an economic sense, the extreme malady burden of a particular country or region removes wealth that could otherwise be used in global trade. And in a social sense, the panorama of profound human suffering compels nominally self concerned parties to care and participate in its alleviation. The international community has therefore searched for solutions through a choice of organizations that target public health issues. In large part, medical science has responded to the need. Recent advancements in pharmaceuticals and biotechnology provide the possibility of tumbling or eliminating a number of the world’s most dread diseases. Millions of lives have likely been saved due to modern medical technology. To encourage the private funding of public health, it is normally acknowledged that intellectual property rights in particular, patents are necessary. By providing a partial right to exclude competitors from qualifying inventions, patents authorize their owners the ability to extract monopoly rents, thus as long as the primary investment incentive. In replace, society obtains admission to goods or services that may not have been invented but for the patent incentive, or at least not extensively disclosed. While some view monopoly rents as a reward for invention, most believe it better uttered as the item for consumption of an ex ante gamble: make an intelligent speculation and, depending on the market, you may win.
The act of compulsory licensing is usually retrospective in nature. Such measures are generally imposed only after considering property that already exists, and then reallocating ownership rights by nationalizing them. Although the incentive to invent with respect to the licensed invention cannot be changed (since invention has already taken place), innovation policy advocates argue that the incentive to create future inventions is decidedly reduced. In other words, it is posited that some inventions that would have been created in view of the full power of the patent rights, will never come to be in the face of compulsory licensing. This may be an acceptable trade off: a compulsory license is predicated the assumption that the beneficial health effects from the limitation will be significant, outweighing the loss of any innovation investment. At least one hundred countries make compulsory licenses available in one form or another. Additionally, there has been support for compulsory licenses in international law since the 19th-century Paris Convention for the Protection of Industrial Property. The most prominent and specific modern treaty to address compulsory licensing is the Trade-Related Aspects of Intellectual Property (“TRIPS”) agreement, which came into effect in 1995 as part of the Uruguay Round of trade discussions , Referring to “use without the authorization of the right holder,” article 31 explicitly permits member states to issue licenses under three circumstances: (1) after efforts to obtain a license from the patent holder on “reasonable commercial terms and conditions” have failed,
(2) in the case of “national emergency or other circumstances of extreme urgency” and
(3) for public non-commercial use. The latter two circumstances are significant in that they do not require prior negotiation with the patent holder (which should theoretically make a compulsory license easier to obtain).
An important limitation to TRIPS article 31 was a provision requiring that licensed rights be practiced domestically, for the benefit of the home market.47 Recently, WTO members agreed to relax the domestic production rule in the context of essential medicines by permitting the manufacture and export of products a non-licensing country to a licensing country.48 In response, several governments amended or proposed to amend their patent laws to permit the manufacture and sale of pharmaceuticals under such circumstances. However, only one country, Rwanda, has notified the WTO of its intent to from use the amended importation provisions.
(ii) Retribution through Foreign Direct Investment Disincentives:
FDI is the flow of people, capital, and technology from a source country to a destination country. FDI frequently takes the form of the acquisition or production of subsidiaries in the host country by a multinational enterprise (“MNE”). FDI usually grants control through management or outright ownership of the enterprise in the host country to the MNE. Passive investment or non-equity investment through instruments such as bonds, debt securities, and notes does not generally constitute FDI activities. MNEs may pursue three types of FDI -- vertical, horizontal, and distribution. Distribution FDI, the least discussed and least invasive of the three, involves establishing sales offices, distribution networks, and services facilities in the target nation. Vertical FDI (“VFDI”) refers to investment of a component of a larger product in different countries. The location of each stage of product production is chosen to minimize production costs. Firms locate facilities to mine mineral resources near the mineral itself. Intensive labour processes exist where labour costs are lowest. Horizontal FDI comprises the manufacture of the entire good in one place. This may include manufacturing, research and development, and distribution of the product. As firms mature they generally move from vertical to horizontal FDI activities. The choice to pursue FDI by an MNE is principally a profit motive, but the factors that impact that decision are more complex. An MNE planning FDI must have some efficiency advantages that can be leveraged by placement of production assets within a foreign country. These efficiency advantages may manifest in three forms ownership, localization, and internalization, known collectively as the “OLI” theory. An ownership advantage usually involves the exportation of an intangible asset such as marketing power, technological expertise, and intellectual property ownership to a foreign country where those assets can be optimally utilized. MNEs export such knowledge-based assets to take advantage of a supportive information infrastructure. Through Multiplan production, MNEs receive economies of scope by producing technical knowledge in one location and applying to plants across different nations. Less commonly, ownership advantages many manifest in tangible forms, such as an exclusive claim to a valuable natural resource. Location advantages provide geographic efficiency benefits to MNE production in target countries. Such advantages include distance to markets, low wage costs, natural resources, and even trade protection from manufacturing “inside” an external trade barrier. MNEs also seek supporting infrastructure, such as transportation in order to bring goods to market, marketing outlets in order to develop brand equity reliably, and a financial network from which to receive loans, grant credit, or pursue local investments. Finally, internalization advantages occur when MNEs exploit advantages in multinational operations by acquiring established enterprises in the region. In essence, this involves buying a subsidiary with the local knowledge and expertise to produce the product for a given national or regional market. An internalization advantage occurs when the profits gained from exploiting the firm’s assets are greater when the assets are kept within the company as compared to licensing the use of those assets to a foreign firm.68 One ameliorating factor to external impacts on the FDI profit motive is the vertical nature of certain industries. High barriers to entry and lower level of competition between countries can make it somewhat less likely that a compulsory license imposed on one product will impact FDI related to other companies or have horizontal effects across other industries. In other words, if an individual nation is willing to accept the possible loss of investment in this segregated industry segment, FDI in other areas may make it less significant.
Differential Impact Of Foreign Direct Investment Threats:
Nations improve their intellectual property rights for a variety of reasons, not the least of which is to improve the effectiveness of domestic industries in global markets. Intellectual property laws can protect local producers from foreign pirates in the domestic market. Strong intellectual property protections are also a pre-requisite for admission into the WTO. In spite of the significant administrative and enforcement costs that TRIPS requires, developing nations seek admission to the WTO in order to obtain access to markets that the WTO promises to open. The result is that accession to WTO standards may be viewed as the “cost of admission” to the global marketplace. Intellectual property laws are also widely believed to have a signalling effect for the nations that enact them. The passage of such laws indicates to investors that a nation recognizes the rights of foreign firms and a government is willing to let foreign investors make strategic business decisions without undue government interference. Stronger intellectual property rights also signal a nation’s shift toward a more transparent legal system with unbiased application of commercial laws and reduced corruption in government activities. Although the evidence supporting the conclusion that these signals impact MNE behaviour is inconclusive, several poor nations including those with limited technical capabilities have unilaterally improved their intellectual property rights during the 1990s. There is also significant evidence that patents work as signalling devices for the firms that own them. Patents signal to financial markets and customers that a firm holds a strong market position and can potentially achieve dominant status. Patents also act as symbolic markers of progress in research and development and product as product differentiators.
Patents also signal strong firm productivity, innovation, and research and development activity. Patents signal to venture capitalists that a company is well managed and has defined a market niche for itself. If patents can readily convey broad information beyond the mere possession of an intellectual property, presumably when a patent is placed in jeopardy in a particular market it may send a variety of negative signals about the firm. A pharmaceutical enterprise entering a market where its patents are readily vulnerable to a compulsory license may cause firm observers, such as those who recommend or sell the firm’s stock, to question the firm’s projected revenue streams from conducting FDI in that new market. Questions may arise whether the target nation’s economy will be a breeding ground for sales-impeding parallel imports. Just as the sale of a product through a low-status selling channel of a product can signal a diminution in brand status to the consumer, exposure of a patent to an uncertain legal environment can signal that the firm may not consider the patent to be as valuable as others believe. Even the threat of an “anti-patent” such as a compulsory license can impair firm equity, thereby reducing the attractiveness of a country as an investment partner. Any firm calculating its returns from FDI will have to account for the possibility of these signalling-based losses. While the relationship between compulsory licensees and FDI is straightforward in theory, the actual economic mechanism can vary dramatically in practice.78 Most pronounced is the difference between countries at different income and investment attraction levels. Depending on inflow of FDI relative to compulsory licensing savings, the association may or may not be strategically important. Some general observations are possible using the broad categories of “least-developed countries” and “middle-developed countries.”
Collective Action As An Equalizing Mechanism:
Certain individual nations may face significant economic drawbacks to imposing compulsory licenses in the absence of additional negotiating leverage. Unfortunately, often the countries most in need of increased access to essential medicines have the least leverage. The overall economic welfare of a country’s citizens may prevent the maximization of health care interests through the utilization of the flexibility inherent in the TRIPS agreement. On the other hand, countries having no emergent need for compulsory license powers may yield to incentives and employ them for less than socially optimal reasons. Some kind of middle ground would be useful, but it is hard to identify it in the context of individual action. The solution may be to expand the analysis by considering coordinated action among countries. Through the use of a collective action mechanism, it may be possible for a country with a certain level of immunity to share the protection with one or several countries more susceptible to FDI economic retribution. The use of coordinated behaviour may bring about a more equitable result, so long as one is aware of the legal limits of such mechanisms and the anti-coordination strategies that may be employed by opponents of the system.
The Power of Collective Action In International Relations:
In many respects, we tend to view nation-to-nation coordination in terms of great international organizations such at the United Nations, the World Trade Organization and the World Health Organization, among others. The principle of multilateral treatment and most favoured nation guarantees suggests that international interaction must be on a local scale, or global. However, there is also a place for regional coordination within the international framework. Referred to by WTO Director-General Pascal Lamy as the “pepper” in the “multilateral curry,” regional coordination offers distinct advantages in the form of harmonizing investment, competition, technical standards, labour standards or environment rules, when international consensus cannot be achieved. Most important in the context of FDI-retribution, it may offer a mechanism for countering the power of developed countries. The importance of coordinating regions to achieve political or economic benefits greater than that which would be achievable by the respective individual countries is well-understood. Moreover, various legal mechanisms to achieve such coordination are already in place across the globe. Perhaps the most prominent example is the European Union (“EU”), which provides its members with coordinated trading power, regulation and market integration, among other advantages.
There is little doubt that developing countries who issue compulsory licenses also face additional risks in attracting global capital. Particularly for MDCs, a compulsory license can trigger the loss of significant FDI. Thus, each nation has to weigh the benefits as well as the disadvantages of issuing such a license for the benefit of its citizens. Developing nations, however, may attempt to use their compulsory licenses strategically by acting collectively with countries that have similar interests. Through the use of a collective action mechanism, it may be possible for a country with a certain level of immunity from FDI to share that immunity with other countries more susceptible to FDI economic retribution. The use of coordinated behaviour may bring about a more equitable result for developing nations and equalize bargaining power between MNCs and developing nations. The ideas presented in this manuscript present a robust opportunity for further researchers to explore how collective action by nations can foster more favourable results when compared to acting alone. Bargaining based upon collective action may also help promote an agreement that both MNCs and developing nations can find satisfactory. Perhaps most importantly, collective action by nations will help individuals who most need critical drugs have access to them and improve their quality of life.
# The term “compulsory license” can refer to any compelled relaxation of an intellectual property owner’s right to exclude in exchange for a licensee’s payment. Generally, it is used in the context of an unexpected, ex post deprivation of property rights in response to some emergent need.The term could also be used to refer to a remedial measure in antitrust law (United States v. Besser Mfg. Co., 343 U.S. 444, 447 (1952) (compulsory licensing is “a well-recognized remedy where patent abuses are proved in antitrust actions and it is required for effective relief.”
# Foreign direct investment can be defined as a firm’s transfer of assets from one country to another in order to generate wealth for the owner of the assets.
# Suzanne scotchmer; INNOVATION AND INCENTIVES 43-39 (2004) (explaining the rationale for intellectual property rights in terms of providing a mechanism for recouping investment that would otherwise be lost to free riders).
# Bronwyn H. Hall, The Private and Social Returns to Research and Development, in TECHNOLOGY, R&D, AND THE ECONOMY 140, 140-41 (Bruce L.R. Smith & Claude E. Barfield eds., 1996)
# Margaret Chon, Intellectual Property and the Development Divide, 27 CARDOZO L. REV. 2821, 2863 (2006) (“Foreign direct investment is thought to be an optimal way for developing countries to increase their knowledge capacity, technical innovation and ultimately their economic growth.”).
`Convincing countries of this benefit has taken some effort on the part of developed countries’. See Peter Yu, TRIPS and Its Discontents.
# Keith Maskus, Intellectual Property Challenges for Developing Countries: An Economic Perspective, 2001 U. ILL. L. REV. 457, 464-66 (2001).
# World Intellectual Property Organization (“WIPO”), Advice on Flexibilities Under the TRIPS Agreement, http://www.wipo.int/ipdevelopment/en/legislative_assistance/advice_trips.html (last visited march 2017-03-21)
# Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 31, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization.
# Michael A. Santoro, Human Rights and Human Needs: Diverse Moral Principles Justifying Third World Access to Affordable HIV/AIDS Drugs, 31 N.C. J. INT’L L. & COM. REG. 923, 932-33 (2006) (discussing the moral benefits to human betterment).
# D. Sachs, The Economic Burden of Malaria, 64 AM. J. TROPICAL MED. HYG. 85, 91 (2001) (“Countries with severe malaria in 1965 had much lower economic growth, amounting to 1.3% lower growth per year, even after other factors such as initial income level, overall health and tropical location are taken into account.”).
# WHO, WORLD HEALTH REPORT 2003 79-80 (2003) (describing the significance of air travel in the spread of SARS, and the need to impose travel restrictions in the case of future epidemics), available at http://www.who.int/whr/2003/en/whr03_en.pdf. (last visited on march 2017-03-21)
# Nancy Gibbs, Persons of the Year, TIME, Dec. 26, 2005, at 38 (naming Bono, Bill Gates and Melinda Gates Time Magazine’s Persons of the Year for their efforts to alleviate global poverty and disease).
# Diseases that once appeared unshakable scourges to humanity like polio, smallpox and leprosy have now been eliminated or controlled to the level that few people give them a second thought. See, e.g., WHO, WORLD HEALTH REPORT 2004 85, ann. tbl. 2 (2004) (hereinafter, “WHO HEALTH REPORT”) (describing the polio eradication programs in the context of collaborative efforts to address the AIDS crisis, and showing in tabular form that polio and leprosy account for an almost immeasurable percentage of the world’s disease burden, with smallpox not evident at all), available at http://www.who.int/entity/whr/2004/en/report04_en.pdf. (last visited on march 2017-03-21)
# This an extension of the general argument for intellectual property rights. See Keith E. Maskus & Jerome H. Reichman, The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods, in KEITH E. MASKUS & JEROME H. REICHMAN, INTERNATIONAL PUBLIC GOODS AND TRANSFER OF TECHNOLOGY 8 (2005) (explaining that the underproduction of public good results without some public/government intervention).
# WILLIAM D. NORDHAUS, INVENTION, GROWTH, AND WELFARE: A THEORETICAL TREATMENT OF TECHNOLOGICAL CHANGE 70 (1969) (stating patents create incentives by conferring monopoly power for a limited period of time).
# This concept was extraordinarily well articulated by the United States Supreme Court in the context of delimiting the proper role of federal patents and state trade secret rights. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151 (1989) (“In consideration of its disclosure and the consequent benefit to the community, the patent is granted.”).
# Edmund W. Kitch, The Nature and Function of the Patent System, 20 J.L. & ECON. 265, 266 (1977) (restating the basic notion historically agreed upon by economists: “The patent is a reward that enables the inventor to capture the returns from his investment in the invention, returns that would otherwise (absent secrecy) be subject to appropriation by others.”)
# Mark A. Lemley, Ex Ante versus Ex Post Justifications for Intellectual Property, 71 U. CHI. L. REV. 129, 148-49 (2004) (arguing that many economic theorists improperly focus on patent rules as a means of controlling already-created innovation, rather than on incentives to produce the innovation).
# this ex post approach is not a requirement. In other intellectual property contexts, there are compulsory licenses that apply to all property rights of a certain type, without regard to individual value or the predilections of the owner.
# Kevin Outterson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 YALE J. HEALTH POL’Y, L. & ETHICS 193, 230 (2005) (arguing that if patent rents are “supra optimal,” compulsory licensing at marginal costs will not reduce innovation).
# Amir Attaran & Lee GillespieWhite, Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?, 286 J. AM. MED. ASSN. 1886, 1891 (Oct. 2001) (concluding that “the extreme dearth of international aid finance, rather than patents, is most to blame for the lack of antiretroviral treatment in Africa.”).
# JAY DRATLER, JR., LICENSING OF INTELLECTUAL PROPERTY § 3.03 (2001) (“Many foreign countries have provisions for compulsory licensing in their patent and copyright laws, which are designed to insure that innovation is not neglected or suppressed by private forces within or without their borders.”)
# The Uruguay Round was also significant for creating the World Trade Organization (“WTO”), which as the cooverseer of TRIPS with the World Intellectual Property Organization (“WIPO”), provided significant enforcement powers.
# TRIPS, art. 31. Additionally, Article 30 allows members to create exceptions to patent rights if such exceptions do not “unreasonably conflict with a normal exploitation of the patent” or “unreasonably prejudice the legitimate interests of the patent owner.”
# TRIPS,art. 31 (“[The negotiation] requirement may be waived by a member in the case of a national emergency or other circumstances of extreme emergency or in cases of public non-commercial use”).
# Regulations Amending the Patent Regulations (in Accordance with the Decision of the WTO General Council of 30 August 2003, Paragraphs 1(b) and 2(a)) (June 1, 2004) (Norway), available at http://www.regjeringen.no/nb/dep/ud/dok/rapporter_planer/rapporter/2004/Regulationsamending-the-Patent-Regulations-in-accordance-with-the-decision-of-the-WTO-GeneralCouncil
# Council for Trade-Related Aspects of Intellectual Property Rights, Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.
# Todd S. Shenkin, Trade Related Investment Measures in Bilateral Investment Treaties and the GATT: Moving Toward a Multilateral Investment Treaty, 55 U. PITT. L. REV. 541, 567 (1994)
# Keith E. Maskus, The Role of Intellectual Property Rights in Encouraging Foreign Direct Investment and Technology Transfer, 9 DUKE J. COMP. & INT’L L. 109, 111 (1998).
# Richard J. Hunter et al., Legal Considerations in Foreign Direct Investment, 28 OKLA. CITY U. L. REV. 851, 853 (2003).
# Kevin C. Kennedy, A WTO Agreement on Investment: A Solution in Search of a Problem?, 24 U. PA. J. INT’L ECON. L. 77, 79 n.5 (2003).
# ROY LEVY, THE PHARMACEUTICAL INDUSTRY: A DISCUSSION OF COMPETITIVE AND ANTITRUST ISSUES IN AN ENVIRONMENT OF CHANGE 7-8 (1999) (Federal Trade Commission Bureau of Economics Staff Report), available at http://www.ftc.gov/reports/pharmaceutical/drugrep.pdf. (last visited on march 2017-03-29)
# Paul J. Heald, Mowing the Playing Field: Addressing Information Distortion and Asymmetry in the TRIPS Game, 88 MINN. L. REV. 249, 250 (2003).
# THOMAS L. FRIEDMAN, THE LEXUS AND THE OLIVE TREE (2000) (describing the tension between the forces of globalization and ancient practices of culture, tradition, and community).
# Keith E. Maskus, Implications of Regional and Multilateral Agreements for Intellectual Property Rights, 20 WORLD ECON. 681, 682 (1997)
# Mark A. Lemley, Reconceiving Patents in the Age of Venture Capital, 4 J. SMALL & EMERGING BUS. L. 137, 143-44 (2000).
# Clarissa Long, Patent Signals, 69 U. CHI. L. REV. 625, 651-53 (2002).
# Pascal Lamy, Dir.-Gen., WTO, Regional Agreements: The “Pepper” in the Multilateral “Curry,” Speech Before the Confederation of Indian Industries http://www.wto.org/english/news_e/sppl_e/sppl53_e.htm (last visited on march 2017-03-29)
# Kenneth W. Abbott & Duncan Snidal, Why States Act Through Formal International Organizations, 42 J. CONFLICT RESOL. 3 (1998).
# European Union, Europe in 12 Lessons: 1. Why the European Union?, http://europa.eu/abc/12lessons/lesson_1/index_en.htm (last visited on march 2017-03-29)