Evaluating flexibility in international patent law

Hastings Law Journal

Volumn 65, Issue 1, 2013, Pages 153-211

  Rajec, Sarah R Wasserman ^a  

^a STANFORD LAW SCHOOL   (United States)

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EID: 84892681877     PISSN: 00178322     EISSN: None     Source Type: Journal    
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References (161)

1. MARTIN J. ADELMAN ET AL., GLOBAL ISSUES IN PATENT LAW 3 (2011).
2. Margaret Chon describes the TRIPS agreement as effecting a "tectonic shift in the landscape of intellectual property law." Margaret Chon, Intellectual Property and the Development Divide, 27 CARDOZO L. REV. 2821, 2824 (2005).
3. In addition to existing tailoring mechanisms, legal scholars have suggested numerous other means of tailoring patent laws to particular industries or situations. Some of these suggestions relate to judicial interpretation of current law. See, e.g., DAN L. BURK & MARK A. LEMLEY, THE PATENT CRISIS AND HOW THE COURTS CAN SOLVE IT (2009) [hereinafter THE PATENT CRISIS]
4. Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L. REV. 1575 (2003)
5. Michael W. Carroll, One Size Does Not Fit All: A Framework for Tailoring Intellectual Property Rights, 70 OHIO ST. L.J. 1361 (2009) (proposing a framework to evaluate existent and proposed tailoring measures based on the traditional economic case for intellectual property protection)
6. Anna B. Laakmann, An Explicit Policy Lever for Patent Scope, 19 MICH. TELECOMM. & TECH. L. REV. 43 (2012) (suggesting that the courts use patentable subject matter doctrine as an explicit policy lever for calibrating patent scope)
7. Sarah R. Wasserman Rajec, Tailoring Remedies to Spur Innovation, 61 AM. U. L. REV. 733, 742-48 (2012) (suggesting that courts analyze the public interest in granting incentives to innovate and maintain access in order to determine the appropriateness of a permanent injunction for a company that lacks market share)
8. Other suggestions would require legislative action. See, e.g., Gideon Parchomovsky & Michael Mattioli, Partial Patents, 111 COLUM. L. REV. 207 (2011) (suggesting two new patent forms in addition to the current system to mitigate social costs of traditional patents and increase access by subsequent inventors).
9. Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 MICH. TELECOMM. & TECH. L. REV. 345, 359-64 (2007) (explaining how FDA regulation provides similar protections to patent law, often for purposes that align more closely with patent law than with the health and safety concerns more typically associated with its mission).
10. Graeme B. Dinwoodie & Rochelle C. Dreyfuss, TRIPS and the Dynamics of Intellectual Property Lawmaking, 36 CASE W. RES. J. INT'l L. 95, 98-100 (2004) (discussing how TRIPS does not allow flexibility for future negotiation of similar arrangements, even where all stake-holders are represented in bargaining, and suggesting that because the WTO's dispute settlement body looks at challenged legislation piece-meal, the result is that concessions benefiting the public are more likely to be struck down while measures appealing to patent-holders will be upheld, thus undermining the negotiations).
11. JOHN H. JACKSON ET AL., LEGAL PROBLEMS OF INTERNATIONAL ECONOMIC RELATIONS: CASES, MATERIALS AND TEXT ON THE NATIONAL AND INTERNATIONAL REGULATION OF TRANSNATIONAL ECONOMIC RELATIONS 844-45 (3d ed. 1995).
12. See KEITH E. MASKUS, INTELLECTUAL PROPERTY RIGHTS IN THE GLOBAL ECONOMY 29 (2000) (Intellectual property rights "generate monopoly positions that reduce current consumer welfare in return for providing adequate payoffs to innovation, which then raises future consumer welfare.").
13. Modern American patent law is rooted in the Constitution, which gives Congress the power to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." U.S. CONST. art. I, § 8, cl. 8. See Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. CHI. L. REV. 1017, 1022 (1989)
14. reprinted in MARTIN J. ADELMAN ET AL., CASES AND MATERIALS ON PATENT LAW 33-34 (1998) (explaining how the courts expect the right of exclusion to provide an incentive for individuals to invest in research and to disclose their new inventions, thereby benefiting the general public)
15. see also David S. Olson, Taking the Utilitarian Basis for Patent Law Seriously: The Case for Restricting Patentable Subject Matter, 82 TEMP. L. REV. 181, 195-97 (2009) (analyzing how the patent system offers a solution to the public goods problem by granting inventors exclusive right to control their invention for twenty years).
16. See Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 63 (1998) ("[T]he patent system represents a carefully crafted bargain that encourages both the creation and the public disclosure of new and useful advances in technology, in return for an exclusive monopoly for a limited period of time.")
17. WILLIAM M. LANDES & RICHARD A. POSNER, THE ECONOMIC STRUCTURE OF INTELLECTUAL PROPERTY LAW 12-16 (2003) (utilizing "the tragedy of the commons" to demonstrate the need for individual property rights in order to encourage innovation).
18. Michael Abramowicz and John Duffy suggest direct application of this sort of weighing in The Inducement Standard of Patentability, arguing that a patent application should be denied "if the innovation would be created and disclosed even without patent protection," because "denying a patent on the innovation costs society nothing... and saves society from needlessly suffering the well-known negative consequences of patents." Michael Abramowicz & John F. Duffy, The Inducement Standard of Patentability, 120 YALE L.J. 1590, 1594 (2011).
19. Following Locke's labor theory, the inventor's rights in her invention are derived from the labor with which it is imbued, resulting in property rights over the resulting invention. See, e.g., HOLGER HESTERMEYER, HUMAN RIGHTS AND THE WTO: THE CASE OF PATENTS AND ACCESS TO MEDICINES 29-30 (2007) [hereinafter HESTERMEYER, HUMAN RIGHTS] (explaining-and dismissing-a natural law rationale for patent law)
20. ROBERT P. MERGES, JUSTIFYING INTELLECTUAL PROPERTY 34-67 (2011) (discussing the application of John Locke's ideas to theories justifying intellectual property law). Other justifications for the patent system include the contract theory, the reward theory, and the prospect theory. HESTERMEYER, HUMAN RIGHTS, supra, at 30-33.
21. See Steven Wilf, The Making of the Post-War Paradigm in American Intellectual Property Law, 31 COLUM. J.L. & ARTS 139, 191-92 (2008) (explaining the common, hostile view of patents as monopolies during the post-war years)
22. But see United States v. Dubilier Condenser Corp., 289 U.S. 178, 186 (1933), amended by 289 U.S. 706 (1933) ("Though often so characterized, a patent is not, accurately speaking, a monopoly.... In consideration of [an invention's] disclosure and the consequent benefit to the community, the patent is granted.").
23. David Fagundes & Jonathan S. Masur, Costly Intellectual Property, 65 VAND. L. REV. 677, 696-98 (2012)
24. See Fagundes & Masur, supra note 21, at 689-90 (estimating that between legal costs and Patent Office fees, "an average patentee will spend approximately $22, 000 to successfully prosecute a patent application."). Filing fees for patents start in the hundreds of dollars, but rise with additional claims, drawings, and length of application; issuance of the patent comes with its own fees as well. See Setting and Adjusting Patent Fees, 78 Fed. Reg. 4212 (Jan. 18, 2013) (to be codified at 31 C.F.R. pts. 1, 41, 42); U.S. PATENT & TRADEMARK OFFICE, CURRENT FEE SCHEDULE (Oct. 4, 2013).
25. See David E. Sosnowski, Resolving Patent Disputes via Mediation: The Federal Circuit and the ITC Find Success, MD. B.J., Apr. 2012, at 24, 26 (citing findings on patent litigation costs that averaged $916, 000 when less than $1 million was at risk, $2.8 million when between $1 million and $25 million was at risk, and $6 million when more was at risk).
26. See Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101-508, § 10101, 104 Stat. 1388, 1388-91 (1990); see also Melissa F. Wasserman, The PTO's Asymmetric Incentives: Pressure to Expand Substantive Patent Law, 72 OHIO ST. L.J. 379, 407 (2011) (explaining the costs to the agency of the various stages of examination and grant as compared to the fees charged).
27. Morton Salt Co. v. G.S. Suppiger Co., 314 U.S. 488, 493-94 (1942). The doctrine has been limited somewhat by statute. See 35 U.S.C. § 271(d) (2012).
28. eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006).
29. CHRISTINE MACLEOD, INVENTING THE INDUSTRIAL REVOLUTION: THE ENGLISH PATENT SYSTEM, 1660-1800, at 40 (1988). MacLeod explains how the fifteenth-century Venetian patent system spurred the development of other modern patent systems: "Emigrant Italian craftsmen, seeking protection against local competition and guild restrictions as a condition of imparting their skills, disseminated knowledge of their patent systems around Europe." id. at 11
30. See John F. Duffy, Inventing Invention: A Case Study of Legal Innovation, 86 TEX. L. REV. 1, 21-23 (2007) ("[P]olicy set forth in Venetian statute was quite plainly copied throughout Europe.").
31. See ROBERT P. MERGES & JOHN F. DUFFY, PATENT LAW AND POLICY: CASES AND MATERIALS 7 (5th ed. 2011) (discussing how state patents were granted in the American colonies and how conflicts among the states led to the creation of a national patent system, rooted in the Constitution).
32. MADHAVI SUNDER, FROM GOODS TO A GOOD LIFE: INTELLECTUAL PROPERTY AND GLOBAL JUSTICE 179 (2012).
33. MERGES & DUFFY, supra note 37, at 9 (citing Fritz Machlup & Edith Penrose, The Patent Controversy in the Nineteenth Century, 10 J. ECON. HIST. 1 (1950).
34. "The WTO recognizes as least-developed countries (LDCs) those countries which have been designated as such by the United Nations." Least-developed Countries, WORLD TRADE ORG. [WTO] (last visited Oct. 31, 2013), http://www.wto.org/english/thewto-e/whatis-e/tif-e/org7-e.htm.
35. Least Developed Countries are nations identified as such by the United Nations Economic and Social Council through its Committee for Development Policy and includes countries with "a low per capita income, a low level of human resource development and a high degree of economic vulnerability." Criteria for the Least Developed Countries, WORLD INTELLECTUAL PROP. ORG. [WIPO], http://www.wipo.int/ldcs/en/criteria-ldcs.html (last visited Oct. 31, 2013).
36. id. art. 5(A) (limiting the conditions under which a compulsory license may be granted to at least four years after the filing of the patent or three years after the grant of the patent, stating that a compulsory license must be refused "if the patentee justifies his inaction by legitimate reasons" and requiring that compulsory licenses be non-exclusive). This requirement actually strengthened the rights of the patent holder. Previously, numerous countries had working requirements that called for a forfeiture of patent rights upon the failure of a patent holder to work the patented invention. J.H. Reichman, Beyond the Historical Lines of Demarcation: Competition Law, Intellectual Property Rights, and International Trade after the GATT's Uruguay Round, 20 Brook. J. Int'l L. 75, 100 n. 113 (1993). Thus, by allowing only a compulsory license, the Paris Convention allowed the patent holder to maintain ownership of her patent and receive licensing revenue from the recipient of the compulsory license.
37. Jerome H. Reichman & Catherine Hasenzahl, Non-voluntary Licensing of Patented Inventions: Historical Perspective, Legal Framework Under TRIPS, and an Overview of the Practice of Canada and the USA, UNCTAD-ICTSD Project on IPRs and Sustainable Development, Issue Paper No. 5, at 10, (June 2003), http://ictsd.org/downloads/2008/06/cs-reichman-hasenzahl.pdf.
38. "By the late 1970s, from the standpoint of industrialized country patent holders, the Paris Convention was most notable for what it does not do. The Paris Convention does not define a patent or what criteria are used for granting it. It does not prescribe subject-matter coverage, it does not set a minimum-or maximum-term of a patent, it does not define the rights of patent holders, and it was perceived as having a weak dispute settlement mechanism." FREDERICK M. ABBOTT, Intellectual Property, International Protection, in MAX PLANCK ENCYCLOPEDIA OF PUBLIC INTERNATIONAL LAW ⊥ 21 (2010).
39. ADELMAN, supra note 1, at 4 (explaining how the PCT allows for centrally filing a patent application and noting the countries in which the applicant would like to apply for patent protection); see also Sisule F. Musungu & Graham Dutfield, Multilateral Agreements and a TRIPS-Plus World: The World Intellectual Property Organisation (WIPO), TRIPS Issues Papers No. 3, at 4, (2003) (discussing the history of WIPO, its creation under the Stockholm Convention, and subsequent status as a specialized agency of the United Nations).
40. Frederick M. Abbott, Protecting First World Assets in the Third World: Intellectual Property Negotiations in the GATT Multilateral Framework, 22 VAND. J. TRANSNAT'l L. 689, 696 (1989).
41. CHARAN DEVEREAUX ET AL., 1 CASE STUDIES IN US TRADE NEGOTIATION 2 (Inst. for Int'l Econs. ed., 2006).
42. Hanns Ullrich, Expansionist Intellectual Property Protection and Reductionist Competition Rules: A TRIPS Perspective, 7 J. INT'l ECON. L. 401, 404 (2004).
43. See Abbott, supra note 55, at 692 (explaining how the United States resolved to protect intellectual property rights, whether unilaterally or multilaterally); see also Devereaux et al., supra note 56, at 1; Susan K. Sell, Post-TRIPS Developments: The Tension Between Commercial and Social Agendas in the Context of Intellectual Property, 14 FLA. J. INT'l L. 193, 194 (2002) (explaining that the lobbying Intellectual Property Committee, "which consists of chief executive officers from a handful of well-connected and economically powerful American-based multinational corporations" played a significant role in drafting and pushing for adoption of TRIPs).
44. see generally DEMETRIOS MARANTIS, OFFICE OF THE U.S. TRADE REPRESENTATIVE, 2013 SPECIAL 301 REPORT.
45. See HESTERMEYER, HUMAN RIGHTS, supra note 17, at 39-40; see also Clyde H. Farnsworth, Washington's Hard Line on Trade, N.Y. TIMES, June 25, 1989, http://www.nytimes.com/1989/06/25/business/washington-s-hard-line-on-trade.html (reporting that during an interview, then-Deputy United States Trade Representative S. Linn Williams defended the U.S. threat to use trade sanctions against Brazil for its lack of sufficient protection of patent rights for pharmaceuticals).
46. See Amy Kapczynski, Harmonization and Its Discontents: A Case Study of TRIPS Implementation in India's Pharmaceutical Sector, 97 CALIF. L. REV. 1571, 1574 (2009).
47. see id. arts. 65-66; see also World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/2, 41 I.L.M. 746 (2002) [hereinafter Doha Declaration] (extending the transition period for least developed country members with respect to pharmaceutical products); see also TRIPS, supra note 54, art. 70.8-9 (requiring countries to make certain provisions for pharmaceutical patents to be filed even if those countries did not yet recognize eligibility for pharmaceutical patents).
48. GRAEME B. DINWOODIE & ROCHELLE C. DREYFUSS, A NEOFEDERALIST VISION OF TRIPS: THE RESILIENCE OF THE INTERNATIONAL INTELLECTUAL PROPERTY REGIME 32 (2012) [hereinafter NEOFEDERALIST VISION] (casting the TRIPS agreement as an intellectual property "tax" developing countries accepted as the cost of doing business in other sectors).
49. Indeed, companies that have focused on production of generic drugs in India, for example, have begun investing in research and development for innovative drugs. See, e.g., Kiran Somvanshi, Innovation Will Be Key to Survival, Says Glen Saldanha, Chairman & MD, Glenmark Pharma, ECON. TIMES, Dec. 21, 2011, http://articles.economictimes.indiatimes.com/2011-12-20/news/ 30534740-1-indian-pharma-generics-glenmark-pharma.
50. In comparison to much of the rest of international public law, the compulsory dispute settlement system and the inability of countries to "pick and choose" among WTO obligations may be seen as "elevat[ing] the importance of public international law generally." James Cameron & Kevin R. Gray, Principles of International Law in the WTO Dispute Settlement Body, 50 INT'l & COMP. L.Q. 248, 249 (2001)
51. However, these characteristics also remove WTO obligations from the reach of flexibility analysis theorized in that field. See, e.g., LAURENCE R. HELFER, Flexibility in International Agreements, in INTERNATIONAL LAW AND INTERNATIONAL RELATIONS: TAKING STOCK 175-96 (Jeffrey Dunoff & Mark A. Pollack eds., 2012) (analyzing non-substantive methods of exercising flexibilities in international law in formal manners-such as the use of reservations, escape clauses, and withdrawal provisions- and informal practices-such as "auto-interpretation," nonparticipation, and noncompliance).
52. See Raymundo Valdés & Runyowa Tavengwa, Intellectual Property Provisions in Regional Trade Agreements 7 (WTO, Working Paper No. ERSD-2012-21, 2012).
53. Requirements are contained in GATT 1994. See General Council Decision, Transparency Mechanism for Regional Trade Agreements, WT/L/671 (Dec. 18, 2006).
54. See Valdés & Tavengwa, supra note 78, at 7 (finding 351 regional and bilateral trade agreements in force in 2012 when goods and services notifications were counted separately; examining agreements reported before 2010 in detail); see also WTO, Regional Trade Agreements, http://www.wto.org/ english/tratop-e/region-e/region-e.htm (last visited Oct. 31, 2013) (suggesting a lower number of 319 regional and bilateral agreements in force).
55. United States-Morocco Free Trade Agreement, U.S.-Morocco, art. 15.9(4), June 15, 2004; NEOFEDERALIST VISION, supra note 68, at 149 (discussing TRIPS plus measures). The Court of Appeals for the Federal Circuit has considered exhaustion of patent rights to occur "when a patented device has been lawfully sold in the United States." See Jazz Photo Corp. v. Int'l Trade Comm'n, 264 F. 3d 1094, 1105 (Fed. Cir. 2001). Under this rule, an article patented in the United States but sold elsewhere under a license would be considered infringing when imported
56. This interpretation was reiterated in Ninestar Technology Co. v. International Trade Commission, 667 F. 3d 1373 (Fed. Cir. 2012), cert. denied, 133 S. Ct. 1656 (2013)
57. The Supreme Court recently ruled that there is international exhaustion in the copyright context. Kirtsaeng v. John Wiley & Sons, Inc., 133 S. Ct. 1351, 1371 (2013). That case need not affect the common law rule in patent law because it involved statutory interpretation instead of the Copyright Act. see id. at 1363-64.
58. 2 HERBERT HOVENKAMP ET AL., IP AND ANTITRUST: AN ANALYSIS OF ANTITRUST PRINCIPLES APPLIED TO INTELLECTUAL PROPERTY LAW § 45.2 (2009).
59. In Germany, for example, infringement claims are brought and litigated in court as private law issues, while challenges to patent validity are considered public law questions and are initially decided by the German Federal Patent Court. See M.A. Smith et al., Arbitration of Patent Infringement and Validity Issues Worldwide, 19 HARV. J.L. & TECH. 299, 334 (2006).
60. Press Release, European Parliament, Parliament Approves EU Unitary Patent Rules (Dec. 11, 2012).
61. Proposal for a Regulation of the European Parliament and of the Council Implementing Enhanced Coooperation in the Area of the Creation of Unitary Patent Protection, Explanatory Memorandum, COM (2011) 215 final (Apr. 13, 2011).
62. Such divergence occurs within countries, too. In the United States, for example, there is the possibility of different validity decisions from the U.S. PTO and district courts or different decisions from district courts and the U.S. International Trade Commission (the "ITC"). Although federal court decisions are binding on the ITC, the converse is not true. See Sapna Kumar, The Other Patent Agency: Congressional Regulation of the ITC, 61 FLA. L. REV. 529, 538-39 (2009).
63. See HESTERMEYER, HUMAN RIGHTS, supra note 17, at 62-64; see also Panel Report, Canada-Patent Protection of Pharmaceutical Products, WT/DS114/R (Mar. 17, 2000). The WTO found Canada's similar provision consistent with TRIPS, but held that a further provision allowing generic companies to produce "stockpiles" of drugs in anticipation of the patent expiration was inconsistent. id.
64. In addition to extending the term of exclusivities granted to patent holders, the protections offered by the Hatch-Waxman Act also provide pseudo-patent protection on drugs that otherwise do not meet the patentability criteria, because unpatented drugs may sometimes receive market exclusivity. Gregory Dolin, Exclusivity Without Patents: the New Frontier of FDA Regulation for Genetic Materials, 98 Iowa L. Rev. 1399, 1450-51 (2013) (explaining that drugs receiving FDA approval as "new chemical entities" block FDA review of Abbreviated New Drug Applications attempting to piggyback on the pioneer drug's data the subsequent five years, even if the pioneer drug is unpatented or off-patent).
65. Ellen J. Flannery & Peter Barton Hutt, Balancing Competition and Patent Protection in the Drug Industry: The Drug Price Competition and Patent Term Restoration Act of 1984, 40 FOOD DRUG COSM. L.J. 269, 273 (1985) (detailing the 1962 FDA requirements for approval of all new drugs based on a showing of safety and efficacy).
66. H.R. REP. 98-857, pt. 2, at 4 (1984), reprinted in 1984 U.S.C.C.A.N. 2686. See Brief for Knowledge Ecology Int'l as Amicus Curiae Supporting Petitioner, at 2-3, FTC v. Watson Pharms., Inc., 133 S. Ct. 787 (2013) (No. 12-416)
67. sub nom FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013) (discussing the purposes of the Hatch-Waxman Act).
68. See Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j) (2006); see also Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990) (explaining the abbreviated approval process and interpreting the act to exclude from infringement medical devices made and used for the purposes of obtaining FDA approval).
69. See, e.g., Elizabeth Powell-Bullock, Gaming the Hatch-Waxman System: How Pioneer Drug Makers Exploit the Law to Maintain Monopoly Power in the Prescription Drug Market, 29 J. LEGIS. 21 (2002) (arguing that legal and marketing strategies by pioneer pharmaceutical companies have thwarted the goals of the legislation)
70. Natalie M. Derzko, The Impact of Recent Reforms of the Hatch-Waxman Scheme on Orange Book Strategic Behavior and Pharmaceutical Innovation, 45 IDEA 165, 185, 195 (2005) (describing how pharmaceutical companies strategically listed numerous patents for each approved drug to garner longer terms of market exclusivity and how generic companies accepted anti-competitive settlement agreements to stay off the market, and discussing the extent to which reforms solved these problems).
71. According to the World Health Organization's Country Cooperation Strategy brief on India, India accounts for twenty-one percent of the world's global burden of disease. WORLD HEALTH ORG., COUNTRY COOPERATION STRATEGY AT A GLANCE: INDIA (2012). The total expenditure on health per capita in India in 2010 constituted four percent of GDP that year, the majority of which was out of pocket. id.
72. CYNTHIA M. HO, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS 91 (2011)
73. Although India's patent laws under British rule allowed for pharmaceutical patents, India subsequently prohibited patents on pharmaceutical compounds, from 1970 until it was required to under TRIPS in 2005. See V.K. Unni, Symposium, Indian Patent Law and TRIPS: Redrawing the Flexibility Framework in the Context of Public Policy and Health, 25 PAC. MCGEORGE GLOBAL BUS. & DEV. L.J. 323, 327-28, 333 (2012) (explaining that under the 1970 law, India allowed short patent terms for processes of making pharmaceutical products; processes which are trivial to design around). Although India was not required by TRIPS to grant patents on pharmaceutical products until 2005, it was required to accept applications earlier for later processing and granting of exclusive marketing rights under some circumstances, followed by a grant of the remaining patent term. This transitional provision of TRIPS is known as "the Mailbox Rule," and its precise requirements spurred WTO litigation by the United TRIPS, supra note 54, art. 70.8(a)
74. see also Appellate Body Report, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (Dec. 19, 1997) (holding that the required means of filing applications must include allocation of filing and priority dates in addition to preserving novelty and priority as of those dates).
75. See 35 U.S.C. § 100(b) (2011) ("'[P]rocess' means... a new use of a known... composition of matter, or material."). However, the Indian law may be providing a model for other developing countries, as Thailand and Argentina are considering similar provisions. See Shan Kohli, Section 3(d) Equivalent in the Offing for Thailand..., SPICY IP BLOG (Nov. 02, 2011, 4:21 AM), http://spicyipindia.blogspot.in/2011/11/section-3d-equivalent-in-offing- for.html (noting that Thailand is considering a similar provision)
76. Shouvik Kumar Guha, Argentina goes the 3(d) Way: Creases of Worry for the Pharmaceutical Patent Applicants?, SPICY IP BLOG (May 23, 2012, 10:25 PM), http://spicyipindia.blogspot.com/2012/05/argentina-goes-3d-way-creases-of-worry. html (stating that Argentina is considering a similar provision). It appears that developed countries are fighting back by including provisions requiring that new forms of known substances be considered patentable regardless of efficacy in regional trade agreements, such as the Trans-Pacific partnership
77. See, e.g., DOCTORS WITHOUT BORDERS, HOW THE TRANS-PACIFIC PARTNERSHIP AGREEMENT THREATENS ACCESS TO MEDICINES: TPP ISSUE BRIEF 3 (Sept. 2011).
78. See, e.g., Schering Corp. v. Geneva Pharms., Inc. 339 F. 3d 1373 (Fed. Cir. 2003) (invalidating a patent under the theory of inherent anticipation).
79. See HO, supra note 116, at 93-94 (discussing the Novartis case and criticizing the law for requiring the patent office to make efficacy determinations when the data to prove it will likely not yet exist and because patent examiners do not have the type of resources or expertise that agencies, such as food and drug agencies, that typically make such determinations have). The lack of evidence may not have been an issue in the Novartis case because that application was filed in 1997 and held by the patent office under the mailbox rule; it was rejected during a pre-grant opposition during the examination which only started in 2005. see generally Novartis AG v. Union of India, (2007) 4 M.L.J. 1153 (India).
80. id. The appellate court upheld the decision, holding that section 3(d) was not unconstitutional for being vague, arbitrary, and conferring uncontrolled discretion on the Patent Controller. See Novartis AG v. Union of India, 2013 S.C.R. at para 5(c) (No. 2706-2716) (Apr. 1, 2013) (India), available at http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212.
81. The Patents Act, 1970, No. 39, section 84. The Office of the United States Trade Representative responded to the move in Special 301 Report. See AMBASSADOR RONALD KIRK, OFFICE OF THE U.S. TRADE REPRESENTATIVE, 2012 SPECIAL 301 REPORT (2012).
82. Vikas Bajaj & Andrew Pollack, India Orders Bayer to License a Patented Drug, N.Y. TIMES, Mar. 13, 2012, at B
83. Shamnad Basheer, Breaking News: India's First Compulsory License Granted!, SPICY IP BLOG (Mar. 12, 2012, 1:27 PM), http://spicyipindia.blogspot. in/2012/03/breaking-news-indias-first-compulsory.html. Note that any of these three conditions would be sufficient to support a compulsory licensing decision.
84. Rumman Ahmed, India Appeals Body Rejects Bayer's Plea on Nexavar, WALL ST. J. ONLINE (Mar. 4, 2013) http://online.wsj.com/article/ SB10001424127887324178904578340013954624212.html. In its decision, the Appellate Board quoted the Iyengar Committee Report to emphasize that patent rights are in the interest of the national economy as opposed to the inventor and are therefore subject to the public interest
85. See Sai Vinod, Guest Post: Eye Witness Account of India's First Compulsory License Appeal Before the IPAB [Part I], SPICY IP BLOG (Mar. 8, 2013, 4:15 PM), http://spicyipindia.blogspot.com/2013/03/guest-post-eye-witness- account-of.html.
86. See G. Pramod Kumar, India's Cancer Burden: Why the Govt's CL Ruling Is so Important, FIRSTPOST.INDIA, Jan. 15, 2013, http://www.firstpost.com/india/ indias-cancer-burden-why-the-govts-cl-ruling-is-so-important-589051.html (lauding government plans to issue compulsory licenses for trastuzumab-the patent for which is due to expire in 2014-dasatinib, and ixabepilone)
87. Kevin Grogan, India to Issue Compulsory Licenses on Roche, B-MS Drugs, PHARMATIMES, Jan. 15, 2013, http://www.pharmatimes.com/Article/13-01-15/India- to-issue-compulsory-licences-on-Roche-B-MS-drugs.aspx
88. Divya Rajagopal, Compulsory Licence Likely for Three Cancer Drugs, ECON. TIMES, Jan. 14, 2013, http://articles.economictimes.indiatimes.com/2013-01-14/ news/36331897-1-compulsory-licence-indian-patent-act-patent-controller.
89. See Prashant Reddy, The Political Economy of the Current Round of Compulsory Licensing in India, SPICY IP BLOG (Jan. 16, 2013, 1:19 AM), http://spicyipindia.blogspot.com/2013/01/the-political-economy-of-current-round. html ("The present round of compulsory licencing... is widely seen as the fruits of a sustained lobbying effort by the generic pharmaceutical lobby.").
90. Craig Allen Nard, Legal Forms and the Common Law of Patents, 90 B.U. L. REV. 51, 53 (2010) ("[T]he common law has been the dominant legal force in the development of U.S. patent law for over two hundred years.")
91. see also Arti K. Rai, Patent Validity Across the Executive Branch: Ex Ante Foundations for Policy Development, 61 DUKE L.J. 1237, 1265 (2012).
92. see e.g., Dan L. Burk & Mark A. Lemley, Is Patent Law Technology-Specific?, 17 BERKELEY TECH L.J. 1155 (2003) (arguing that courts apply a lower standard of nonobviousness to biotechnology patents while imposing stricter enablement and written description requirements, while, in contrast, loosening enablement and best mode requirements for software patents); Burk & Lemley, supra note 3 (arguing that technology-specific tailoring through the courts is desirable); THE PATENT CRISIS, supra note 3.
93. The Supreme Court moved to an obviousness standard based on the skills and knowledge of a person having ordinary skill in the art in 2007. KSR Int'l Corp. v. Teleflex Corp., 550 U.S. 398, 419 (2007).
94. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (upholding Chakrabarty's patent on a bacterium genetically modified to break down the components of crude oil)
95. See John M. Golden, Biotechnology, Technology Policy, and Patentability: Natural Products and Invention in the American System, 50 EMORY L.J. 101, 106-07 (2001).
96. Chakrabarty, 447 U.S. at 309 (citing Parker v. Flook, 437 U.S. 584 (1978)
97. Gottschalk v. Benson, 409 U.S. 63, 67 (1972)
98. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)
99. O'Reilly v. Morse, 56 U.S. 62 (1854)
100. Le Roy v. Tatham, 55 U.S. 156 (1853)
101. 2, or the law of gravity, understanding these as "'manifestations of... nature, free to all men and reserved exclusively to none.'" id. (quoting Funk Bros., 333 U.S. at 441). The Supreme Court has shown a recent interest in cases relating to patent-eligibility in these areas. In Bilski v. Kappos, the Court affirmed that business methods are eligible for patents, but suggested that they may still be suspect for vagueness. 130 S. Ct. 3218, 3228-29 (2010)
102. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)
103. the Court invalidated a claim under the "law of nature" exclusion. The Court recently addressed the exclusion of living organisms in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)
104. In addition to these cases, the Court of Appeals for the Federal Circuit recently issued an en banc decision discussing the appropriate test to determine whether "a computer-implemented invention is a patent ineligible 'abstract idea.'" CLS Bank Int'l v. Alice Corp. Pty. Ltd., 768 F. Supp. 2d 221 (D.D.C. 2011), rev'd, 685 F. 3d 1341 (Fed. Cir. 2012), reh'g granted, opinion vacated, 484 Fed. App'x 559 (Fed. Cir. 2012) (en banc)
105. In a plurality opinion, the court invalidated the claims before it and drew from Supreme Court precedent to suggest "guideposts" for a framework that "turns primarily on the practical likelihood of a claim preempting a fundamental concept" and might apply to technologies beyond the "computer-implemented inventions presented in this case." CLS Bank Int'l v. Alice Corp. Pty. Ltd., 717 F. 3d 1269, 1277 (Fed. Cir. 2013).
106. id. at 1292 (quoting Gottschalk, 409 U.S. at 67). The Court continues, explaining that "there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to 'apply the natural law.'" id. at 1301-02 (citing Mark A. Lemley et al., Life After Bilski, 63 STAN. L. REV. 1315 (2011).
107. see generally Brief for the United States as Amicus Curiae Supporting Neither Party, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (No. 10-1150) (arguing that the subject matter was sufficiently applied to be patent-eligible, but that the patents were likely invalid under the novelty and nonobviousness requirements of the patent act and further arguing that the claims would not preempt other practical applications of the correlation described).
108. Memorandum from Andrew H. Hirshfeld, Deputy Comm'r for Patent Examination Policy, to Patent Examining Corps, 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature 3 (July 3, 2012) available at http://www.uspto.gov/patents/law/exam/2012-interim-guidance.pdf (laying out a test of process claims involving natural principles to see whether "additional elements or steps [are included that] relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application.").
109. Ass'n for Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 2107, 2116-17 (2013).
110. See Jacob S. Sherkow & Henry T. Greely, The Future of Gene Patents and the Implications for Medicine, 173 JAMA INTERNAL MEDICINE 1569, 1570 (2013) (suggesting that in the short run, the Myriad decision means "more competitive markets for diagnostic genetic testing," for the genes at issue in that case, but that "in the long term, probably [it doesn't mean] very much").
111. See Mark A. Lemley & Carl Shapiro, Patent Holdup and Royalty Stacking, 85 TEX. L. REV. 1991, 2015 (2007) (explaining that holdup risk is high for complex inventions, particularly when there is no reciprocal risk of litigation and that NPEs bring a significant portion of infringement suits in industries subject to royalty stacking)
112. see also id. at 2164 (emphasizing that "holdup is recognized as a form of market failure that leads to inefficiency, primarily by discouraging what would otherwise be socially desirable investments"); Carol M. Nielsen & Michael R. Samardzija, Compulsory Patent Licensing: Is It a Viable Solution in the United States?, 13 MICH. TELECOMM. & TECH. L. REV. 509, 510-11 (2007) (describing new technologies as particularly susceptible to holdup due to "patent thicket," where hundreds of patents are needed for a single product, yet they all overlap and block one another).
113. MercExchange, L.L.C. v. eBay Inc., 401 F. 3d 1323, 1338-39 (Fed. Cir. 2005), vacated, 547 U.S. 388 (2006).
114. eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391, 395-97 (2006) (noting that issuance of overbroad patents may affect how courts approach the four-factor test).
115. Id. at 395 (Roberts, C.J., concurring) (quoting Martin v. Franklin Capital Corp., 546 U.S. 132, 139 (2005).
116. Although the reasoning was not based on a rule that patent holders who do not practice their inventions should not be entitled to injunctions, the "market share rule" emerging in the district courts following the eBay decision accomplishes much the same as such a rule would, albeit with some logical contortions. See MercExchange, L.L.C. v. eBay Inc., 500 F. Supp. 2d 556, 591-92 (E.D. Va. 2007), remanded by 547 U.S. 388 (2006).
117. See, e.g., Rajec, supra note 3, at 751-58 (suggesting that following eBay, courts are using a "market share rule" to determine whether a permanent injunction is warranted); see also Andrew Beckerman-Rodau, The Aftermath of eBay v. MercExchange, 126 S. Ct. 1837 (2006)
118. A Review of Subsequent Judicial Decisions, 89 J. PAT. & TRADEMARK OFF. SOC'Y 631, 654 (2007) ("[D]irect competition... appears to be the most significant predictor of whether a permanent injunction will be granted.")
119. Bernard H. Chao, After eBay, Inc. v. MercExchange: The Changing Landscape for Patent Remedies, 9 MINN. J.L. SCI. & TECH. 543, 549-55 (2008) (suggesting courts use direct competition as a means for determining the appropriateness of an injunction)
120. Benjamin Petersen, Injunctive Relief in the Post-eBay World, 23 BERKELEY TECH. L.J. 193, 196-98 (2008) (suggesting that courts "place a heavy emphasis" on whether the parties are in "direct competition").
121. It is worth noting that minimum requirements will not necessarily result in uniformity of laws. In practice, however, countries have not extended protection beyond the levels required by TRIPS, except for the regional trade agreements that include "TRIPS plus" measures. See, e.g., PEDRO ROFFE, QUAKER INT'l AFFAIRS PROGRAMME, BILATERAL AGREEMENTS AND A TRIPS-PLUS WORLD: THE CHILEUSA FREE TRADE AGREEMENT 2004. These measures are generally attempts to harmonize, not attempts to implement longer patent terms.
122. The discussion of property versus liability rules in patent law shows that the difficulty in valuation of patent rights argues in favor of property rules. See, e.g., Michael A. Carrier, Cabining Intellectual Property Through a Property Paradigm, 54 DUKE L.J. 1, 1, 52-54 (2004) (noting increasing propertization of intellectual property law but hailing the limits that the property framework can impose); see also THE PATENT CRISIS, supra note 3, at 140; Carroll, supra note 3, at 1396 (summarizing but not endorsing the argument that property rules provide lower administrative costs while still allowing for private contracting).
123. S. REP. NO. 82-1979, at 5 (1952); H.R. REP. NO. 82-1923 (1952); Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
124. See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)
125. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 689 F. 3d 1303 (2012). Originally, the court of appeals for Myriad held that the claimed method was eligible for patent protection, using the "machine-or- transformation" test. id. at 1334. Certiorari was sought and the Court granted, vacated, and remanded the case with instructions to reconsider the case in light of its holding in Mayo. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2114 (2013). The Federal Circuit issued another opinion upholding the patent. Id.
126. But see Mark A. Lemley & Carl Shapiro, Probabilistic Patents, 19 J. ECON. PERSPS. 75 (2005) (describing that even after a patent grant, uncertainty remains about the validity and scope of the patent until it has been litigated).
127. Christopher A. Cotropia, The Folly of Early Filing in Patent Law, 61 HASTINGS L.J. 65, 70 (2009).
128. See, e.g., Comments of anonymous business leader at GW Law School Round Table on implications of Mayo v. Prometheus (May 16, 2012) (suggesting that if a company were considering investing in that field of technology following the Supreme Court decision, it would likely reconsider).
129. Frederick M. Abbott, The Enduring Enigma of TRIPS: A Challenge for the World Economic System, 1 J. INT'l ECON. L. 497, 499 (1998).
130. JAGDISH BHAGWATI, IN DEFENSE OF GLOBALIZATION 183 (2004) (suggesting that the idea that poor countries will benefit from "having to pay for patents they had been accessing freely" was "as implausible as the Mafia telling its victims that the protection money would keep them safe from arson").
131. John F. Duffy, Harmony and Diversity in Global Patent Law, 17 BERKELEY TECH. L.J. 685, 695 (2002).
132. Of course, this varies among industries. The possibility of reverse-engineering is often brought up as particularly easy in the field of pharmaceutical development, which is also characterized by cheap production costs relative to research and development of new chemical entities. Clarisa Long, Our Uniform Patent System, 55 Fed. Law. 44, 45 (2008) (" Pharmaceutical research is a high-cost, highly uncertain process, with a final product that is cheap to reverse engineer, copy, and mass produce.").
133. JOSEPH A. SCHUMPETER, CAPITALISM, SOCIALISM, AND DEMOCRACY 84 (1950) (touting the importance of "competition from the... new technology... which strikes not at the margins of the profits and the outputs of the existing firms but at their foundations and their very lives").
134. It could be argued that the cost of filing for and obtaining a patent serves a certain gate-keeping role. See, e.g., Michael W. Carroll, One For All: The Problem of Uniformity Cost in Intellectual Property Law, 55 AM. U. L. REV. 845, 880-81 (2006) (suggesting that patent law deploys call options by noting that the "potential patentee must assess the option value or strike price of patent protection and compare that to the costs of exercising the option through patent prosecution" and noting that the potential patentee will weigh this against keeping trade secret protection or defensively publishing). However, it is hard to support a costly process simply for its sorting value, particularly where the same result could be obtained by charging higher fees for a streamlined, multi-jurisdictional process.
135. Gerald J. Mossinghoff & Vivian S. Ku, World Patent System Circa 20XX, A.D., 38 IDEA 529, 530 (1998).
136. Both the PTO and the European Patent Office maintain free, user-friendly, online search engines. See U.S. PATENT & TRADEMARK OFFICE, DEP't OF COMMERCE, http://www.uspto.gov/patents/process/search (last visited Oct. 31, 2013)
137. EUROPEAN PATENT OFFICE, http://www.epo.org/searching.html (last visited Oct. 31, 2013)
138. Google also has a patent search tool that creates a search bar specifically for patents. GOOGLE, http://www.google.com/?tbm=pts (last visited Oct. 31, 2013).
139. Matt Rainey, Director: Innovation Division, World Intellectual Prop. Org., Address at the World Intellectual Property Organization's 6th Advanced Research Forum on Intellectual Property Rights: Networked Innovation: Solutions for Local and Regional Needs (July 12, 2012) (describing how the creation of research and development networks and intellectual property hubs in Colombia, various Western African countries, and the middle east can focus on problems like neglected diseases or development of an innovation industry-goals that would be near impossible for any one of the governments to accomplish on their own). Non-governmental organizations, such as the Pan-American Health Organization, also create some of these pharmaceutical collaborations. See PAN AM. HEALTH ORG., http://new.paho.org/hq/index.php?lang=en (last visited Oct. 31, 2013) (search for "Pharmaceutical Collaborations").
140. see generally Michael Abramowicz, Perfecting Patent Prizes, 56 VAND. L. REV. 115 (2003) (discussing prizes as incentives)
141. James Love & Tim Hubbard, The Big Idea: Prizes to Stimulate R&D for New Medicines, 82 CHI.-KENT L. REV. 1519 (2007).
142. KAL RAUSTIALA & CHRISTOPHER SPRIGMAN, THE KNOCKOFF ECONOMY: HOW IMITATION SPARKS INNOVATION (2012) (examining innovative industries that thrive without formal intellectual property protection).
143. THE PATENT CRISIS, supra note 3, at 99-100 (2009) (explaining that industry-specific legislation is more vulnerable than general legislation to lobbying); See Robert Patrick Merges & Glenn Harlan Reynolds, The Proper Scope of the Copyright and Patent Power, 37 HARV. J. ON LEGIS. 45, 50-56 (2000) (discussing how rent-seeking, backward-looking behavior can undermine the forward-looking purposes of the patent system).
144. Jeffery Atik & Hans Henrik Lidgard, Embracing Price Discrimination: TRIPS and the Suppression of Parallel Trade in Pharmaceuticals, 27 U. PA. J. INT'l ECON. L. 1043, 1047 (2006) (describing India and Brazil as having "vibrant generic drugs sectors").
145. See, e.g., JAMES BESSEN & MICHAEL J. MEURER, PATENT FAILURE: HOW JUDGES, BUREAUCRATS, AND LAWYERS PUT INNOVATORS AT RISK 132 (2008)
146. see also FRANK EMMERT, Trade and Intellectual Property, in INTERNATIONAL TRADE LAW 4 (Henry Wang ed., 2012)
147. Brian J. Love, An Empirical Study of Patent Litigation Timing: Could a Patent Term Reduction Decimate Trolls Without Harming Innovators?, 161 U. PENN. L. REV. (forthcoming 2013) (finding that the length of the patent term is exploited by non-practicing entities who primarily sue for infringement during the last years of the patent term, primarily in high tech industries).
148. Carroll, supra note 212 (identifying and exploring the nature of uniformity costs associated with different types of intellectual property and
149. See supra Part III (discussing the permanent injunctions following eBay v. MercExchange).
150. See, e.g., Stuart Minor Benjamin & Arti K. Rai, Fixing Innovation Policy: A Structural Perspective, 77 GEO. WASH. L. REV. 1, 8 (2008) (suggesting that technological innovation can suit the goal of increasing welfare "[b]y mitigating disease and hunger [and].... foster[ing] educational, political, and social development").
151. Understanding the WTO: Developing Countries, WTO, www.wto.org/english/ thewto-e/tif-e/dev1-e.htm (last visited Oct. 31, 2013) (listing various provisions of special treatment for developing countries).
152. See, e.g., T.N. Srinivasen, The TRIPS Agreement: A Comment Inspired by Frederick Abbott's Presentation 3 (Nov. 29, 2000) (unpublished comment), available at http://www.econ.yale.edu/~srinivas/TRIPS.pdf.
153. B. Zorina Khan, Does Copyright Piracy Pay? The Effects of U.S. International Copyright Laws on the Market for Books, 1790-1920 (Nat'l Bureau of Econ. Research, Working Paper No. 10271, 2004)
154. This relationship between industrial development and lax legal protections was also famously made in the context of tort law. MORTON J. HORWITZ, THE TRANSFORMATION OF AMERICAN LAW 1780-1860 (1977)
155. But see Gary T. Schwartz, Tort Law and the Economy in Nineteenth-Century America: A Reinterpretation, 90 YALE L.J. 1717, 1735 (1981) (challenging Horwitz's interpretation of early American tort law).
156. Anupam Chander, How Law Made Silicon Valley, EMORY L.J. (forthcoming 2013), available at http://papers.ssrn.com/sol3/papers.cfm?abstract-id=2340197 (arguing that comparatively less rigid privacy laws and a robust right to free speech in the United States made it far more attractive to Internet-related innovation than other countries).
157. See JAYASHREE WATAL, INTELLECTUAL PROPERTY RIGHTS IN THE WTO AND DEVELOPING COUNTRIES 12 (2001) (noting that in India, there is a strong industry that produces "credible equivalents of products protected by IP elsewhere").
158. A separate line of argument relating to both the level of industrial development in developing countries and the access concerns of the public suggests that the traditional patent regime, rewarding an individual inventor with rights impinging on public access, does not fit with the model of discovery and innovation in certain developing countries. Thus, for countries rich in "traditional knowledge," valuable subject matter and knowledge is possessed collectively and benefited from by all. At the same time, for various reasons, such knowledge would not be patentable. These reasons include that the subject matter may be considered unpatentable laws of nature or that the knowledge is old enough not to be considered novel. Nonetheless, companies from developed countries may exploit the knowledge for free while protecting the results with patents. Imagine, for example, a plant that is known by indigenous peoples to have curative powers. While the plant and its use in medicinal applications is likely unpatentable, an isolated chemical derived from the plant might result in high profits to the company that learns of its use and appropriates that knowledge without paying a premium. This possibility has led to calls for protection of indigenous rights in traditional knowledge. For example, WIPO established the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in September 2000, and in 2009 tasked it with drafting a recommendation or treaty on this topic. For an overview of their progress, see Intergovernmental Committee, WIPO, http://www.wipo.int/tk/en/igc/index.html (last visited Oct. 31, 2013).
159. See, e.g., Jerome H. Reichman & Rochelle Cooper Dreyfuss, Harmonization Without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty, 57 DUKE L.J. 85, 94-99, 103-08 (2007).
160. Srinivasen, supra note 232 (suggesting that the "theoretical justification for, and even more importantly, the empirical evidence" in support of arguments that TRIPS-level protection is necessary to encourage innovation and that foreign enterprises strongly weigh the strength of IPR before investing "is not at all strong"); See Marci A. Hamilton, The TRIPS Agreement: Imperialistic, Outdated, and Overprotective, 29 VAND. J. TRANSNAT'l L. 613, 614 (1996) (stating that the successful implementation of TRIPS will be "one of the most successful vehicles of Western imperialism in this story").
161. In particular, agency personnel are often not politically accountable to the extent that elected officials are. At the same time, they are more likely to have ties to the industry that they regulate and may see that industry as their funding source, either for the institution or for future employment. See, e.g., DANIEL A. FARBER & PHILIP P. FRICKEY, LAW AND PUBLIC CHOICE: A CRITICAL INTRODUCTION 1-37 (1991); Merges & Reynolds, supra note 219.