Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavours to question the legitimacy of the evergreening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system – namely the ‘natural law’ or ‘natural rights’ theory, the ‘reward by monopoly’ theory, the ‘monopoly-profit incentive’ theory, the ‘exchange for secrets’ theory or the ‘contract’ theory, and the ‘prospect’ theory – to the practice of evergreening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of evergreening is not consistent with any of these theories and therefore lacks any plausible justification.
CorreaC. Trade related aspects of intellectual property rights: a commentary on the TRIPS agreement. OUP Catalogue. See World Trade Organization. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). Art. 27.
2.
World Health Organization. Public health innovation and intellectual property rights.
Geneva:
World Health Organization, 2006, p. 131.
CookA.How increased competition from generic drugs has affected prices and returns in the pharmaceutical industry.
Washington, D.C.:
US Government Printing Office, 1998.
5.
GhidiniGPeritzRJRicolfiM (eds). TRIPS and developing countries: towards a new IP world order?
UK:
Edward Elgar Publishing, 2014, p.125.
6.
FlintAPayneJ. Intellectual property rights and the potential for universal access to treatment: trips, acta and HIV/AIDS medicine. Third World Quarter2013; 34: 500–515. See also Vondeling GT, Cao Q, Postma MJ, et al. The impact of patent expiry on drug prices: a systematic literature review. Appl Health Econ Health Policy2018; 658: 1–8.
7.
KapczynskiA.Engineered in India – patent law 2.0.N Engl J Med2013;
369: 497–499.
KappeE.Pharmaceutical lifecycle extension strategies. In: Ding M, Eliashberg J and Stremersch S (eds) Innovation and marketing in the pharmaceutical industry, Vol. 6.
Berlin:
Springer, 2014, pp.225–254.
13.
FM't HoenE.Private patents and public health: changing intellectual property rules for access to medicines. Amsterdam: Health Action International, 2016, p. 93.
KapczynskiA.Harmonization and its discontents: a case study of TRIPS implementation in India's pharmaceutical sector.Calif Law Rev2009;
97: 1571–1649.
16.
CorreaCM. Guidelines for the examination of pharmaceutical patents: developing a public health perspective. Int Centre Trade Sustain Develop2007; 26: 1–56
.
17.
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., No. 1:10- cv-01376-TWP-DKL, 2014 WL 1350129 (S.D. Ind. Mar. 31, 2014), aff'd, 567 F.App'x. 967 (Fed. Cir. 2014). See more HoCM.Should all drugs be patentable: a comparative perspective. Vanderbilt J Entertain Technol Law2014;
17: 316.
Russia, USA, New Zealand, Singapore, Canada, Japan, Israel, Indonesia, South Korea, and Mexico are some of the examples of countries having a sympathetic view towards patent protection for new use of known drugs. Some countries like United States, Japan, Israel, Korea, Australia, and the European union member countries provide for patent term extension for pharmaceuticals. See Dwivedi G, Hallihosur S and Rangan L. Evergreening: a deceptive device in patent rights. Technology in Society 2010; 32: 327. See also JA Kemp, Patent Protection For New Uses Of Known Drugs, 1, www.Jakemp.Com/Uploads/Files/Events/New%20Uses%20for%20Known%20Drugs.Pdf (accessed 23 April 2019).
20.
The Organization for Economic Co-operation and Development (OCED). The knowledge-based economy.1996, 3. See more Organization for Economic Co-operation and Development. A new Economy? The changing role of innovation and information technology in growth. Berlin: OECD Publishing, 2000.
21.
PhamN.The impact of innovation and the role of IP rights on US productivity, competitiveness, jobs, wages and exports. NDP Consulting, 2010; 6.
22.
Intellectual Property and Competition Review Committee. Review of intellectual property legislation under the competition principles agreement. IP Australia, Canberra, September, 2000, p.136. Researchers like Petra Moser, who support diffusion of ideas to improve the technology, have exactly opposite view and conclude on the basis of historical evidence that stringent patent protection granted to early generations of inventors tends to discourage innovation. It limits access to essential knowledge and discourages follow-on inventors if the holder of a broad scope patent protection on an essential technology refuses access to them and creates a deadlock. These problems tend to slow down the pace of technological innovation; concepts like ‘patent pooling’ and ‘compulsory licensing’ of patents are used to deal with such situations. See Moser P. Patents and innovation: evidence from economic history. J Econ Perspect 2013; 27: 26; OECD, patents and innovation: trends and policy challenges (OECD Publishing, Paris, 2004) 9., DOI: http://doi.org.ezp01.library.qut.edu.au/10.1787/9789264026728-en.; Ilic B. and Pretnar B. The economic notion of the incentive to invent in the legal perspective of patent protection. Econ Business Rev Central South East Eur 2004; 6: 284, http://search.proquest.com/docview/219429071?accountid=13380.
23.
SchumpeterJA.Capitalism, socialism and democracy.
UK:
Routledge, 2010, pp.81–108
24.
CornishWLlewelynDAplinT.Intellectual property: patents, copyright, trade marks and allied rights.
London:
Sweet & Maxwell, 2003, p. 114.
25.
LockeJ. In: Laslett P (ed.) Two treatises of government. Cambridge University Press, 1988, p. 301.
26.
Revolutionary constitutions of the USA and France drew upon natural law ideas of John Locke. For the same reason, the early French patent law of 1791 applied the natural law or natural rights theory and regarded an industrial invention as the property of its creator. See Machlup F. An economic review of the patent system (No. 15). Washington, D.C: US Government Printing Office, 1958, p.22.
27.
MaughanE.Protecting the rights of inventors: how natural rights theory should influence the injunction analysis in patent infringement cases. Georgetown J Law Public Policy2012; 10: 233–234.
28.
DenicolòVFranzoniLA.The contract theory of patents.Int Rev Law Econ2003;
23: 365.
29.
IlicBPretnarB.The economic notion of the incentive to invent in the legal perspective of patent protection. Econ Business Rev Central South East Eur2004;
6: 286.
30.
McCallC.Trans-Pacific trade pact triggers fears over drug prices.Lancet2015;
385: 2450–2451.
31.
KesanJP.Economic rationales for the patent system in current context. Geo Mason L Rev2014;
22: 897.
32.
LemleyMA.Ex ante versus ex post justifications for intellectual property. Univ Chicago Law Rev2004; 71: 129–149.
33.
MachlupF.An economic review of the patent system (No. 15). US Government Printing Office, 1958, pp.23–24.
34.
United States Constitution Article I, § 8, Clause 8.
35.
Aronson v Quick Point Pencil Co., 440 U.S. (1979).
36.
World Trade Organization. Agreement on trade-related aspects of intellectual property rights (TRIPS Agreement) Article 7.
DamKW.The economic underpinnings of patent law.J Legal Studies1994;
23: 247–271.
39.
LandesWMPosnerRA.The economic structure of intellectual property law.
Cambridge:
Harvard University Press, 2009, pp. 294–295.
40.
ScotchmerS.Standing on the shoulders of giants: cumulative research and the patent law.J Econ Perspect1991;
5: 29–41.
41.
CCOM vJiejing (1994) 122 ALR 417, 433.
42.
Universal Oil Products Co. v. Globe Oil & Refining Co., 322 U.S. 471 (1944).
43.
PaulAD. The evolution of intellectual property institutions and the panda’s thumb. Meet Int Econ Assoc Moscow 1992; 1–26.
44.
KitchEW.The nature and function of the patent system.J Law Econ 1977;20: 265–290.
45.
DuffyJF. Rethinking the prospect theory of patents. Univ Chicago Law Rev 2004; 439–510.
46.
MergesRPNelsonRR. On the complex economics of patent scope. Columbia Law Review1990; 90: 839–916; Lemley MA. Ex ante versus ex post justifications for intellectual property. Univ Chicago Law Rev 2004; 71: 129–149.
