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ABSTRACT
Section 3(d) of India’s Patents Act forbids patents on pharmaceutical substances that do not demonstrate a significantly enhanced efficacy over and above prior known substances. This article discusses the long and tortuous history of the provision. Only after an extended period of difficulty did India get to grips with World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and interpret it strategically to benefit the nation and its industry. This sophistication reached a near crescendo with the emergence of section 3(d), its crude drafting notwithstanding. India’s efforts to tailor its patent regime to promote the national interest whilst remaining compliant with TRIPS stands in stark contrast to a number of other countries that have simply toed the line of the developed world’s maximalist intellectual property (IP) agenda. As such, it represents a significant milestone and a valuable lesson in the IP and development debates.
Acknowledgements
The author wishes to thank the University of Pennsylvania for hosting him at a conference in 2013 and providing a generous honorarium which made this paper possible. He also wishes to thank Rupali Samuel, Smaran Shetty, and Pankhuri Agarwal for exceptional research assistance; and Susan Sell, Jayashree Watal, and Charles Clift for their insightful suggestions that helped improve the paper. Many thanks to Neeti Wilson for sharing the EMR decisions referred to in this paper; decisions that are not publicly available, and feature for the first time in this published piece.
Notes on contributor
Shamnad Basheer is the Honorary Research Chair Professor of Intellectual Property Law at Nirma University and the founder of SpicyIP.
Notes
1 See generally Laurence R Helfer, ‘Pharmaceutical Patents and the Human Right to Health: The Contested Evolution of the Transnational Legal Order on Access to Medicines’ in Terence C Halliday and Gregory Shaffer (eds), Transnational Legal Orders (Cambridge University Press 2015). See also Kenneth C Shadlen and others (eds), Intellectual Property, Pharmaceuticals and Public Health: Access to Drugs in Developing Countries (Edward Elgar Publishing 2011).
2 AIR 2013 SC 1311.
3 Carlos M Correa, ‘The Novartis Decision by India’s Supreme Court: A Good Outcome for Public Health’ South Bulletin 75 (7 October 2013) <www.southcentre.int/question/the-novartis-decision-by-indias-supreme-court-a-good-outcome-for-public-health> accessed 25 September 2017; R Jai Krishna and Jeanne Whalen, ‘Novartis Loses Glivec Patent Battle in India’ Wall Street Journal (1 April 2013) <www.wsj.com/articles/SB10001424127887323296504578395672582230106> accessed 2 February 2018.
4 ‘PhRMA Statement on India Supreme Court Decision on Glivec’ (1 April 2013) Pharmaceutical Research and Manufacturers of America Press Release <www.phrma.org/press-release/phrma-statement-on-india-supreme-court-decision-on-glivec> accessed 25 September 2017; ‘Supreme Court Denial of Glivec Patent Clarifies Limited Intellectual Property Protection and Discourages Future Innovation in India’ (1 April 2013) Novartis Press Release.
5 Amy Kapczynski, Chan Park and Bhaven Sampat, ‘Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents’ (2012) 7(12) PLoS One.
6 The term ‘evergreening’ does not have a precise definition, but denotes a wide range of inequitable practices involving minor modifications to existing chemical substances to create allegedly new drugs, when such drugs do not confer any significant therapeutic outcome or patient benefit. These minor modifications are then patented, resulting in an unwarranted extension of pharmaceutical patent monopoly. The modern version of evergreening is not necessarily restricted to old drugs that are tweaked ever so slightly, but also applies to old chemical substances that may not have been previously available as a drug, but possessed a functionality similar to the allegedly new version that is made into a drug form—as was the case with Novartis’ Glivec.
7 Shamnad Basheer and T Prashant Reddy, ‘The “Efficacy” of Indian Patent Law: Ironing Out the Creases in Section 3(d)’ (2008) 5 SCRIPTed 232.
8 See Section 8.
9 See Section 10.
10 The Development Agenda attempts to situate IP policy within the larger developmental paradigm and comprises a set of 45 principles that aid developing countries in tailoring their IP regimes to promote national interests and developmental goals. See WIPO, The 45 Adopted Recommendations under the WIPO Development Agenda (2007) <www.wipo.int/ip-development/en/agenda/recommendations.pdf> accessed 25 September 2017.
11 Peter Drahos and John Braithwaite, Information Feudalism: Who Owns the Knowledge Ecology? (New Press 2002); Susan K Sell, Private Power, Public Law: The Globalization of Intellectual Property Rights (Cambridge University Press 2003); Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries (Zed Books 2001); Charles Clift, ‘Why IPR Issues Were Brought to GATT: A Historical Perspective on the Origins of TRIPS’ in Carlos M Correa (ed), Research Handbook on the Protection of Intellectual Property under WTO Rules: Intellectual Property in the WTO, vol. I (Edward Elgar 2010) 10–14.
12 WTO Trade Negotiations Committee, Ministerial Declaration on the Uruguay Round (20 September 1986) GATT Document MIN.DEC, 7–8.
13 Under the 301 process, the US President could authorise the withdrawal of trade benefits to a country or impose duties on its goods if its IP regime was found inadequate in protecting US IP exports: Drahos and Braithwaite (n 11) 89.
14 ibid.
15 ibid 136.
16 WTO Trade Negotiations Committee, Mid-Term Review of the Uruguay Round (21 April 1989) GATT Document MTN.TNC/11, 21.
17 WTO Trade Negotiations Committee, Draft Agreement on Trade-Related Aspects of Intellectual Property Rights (29 March 1990) GATT Document MTN.GNG/NG11/W/68.
18 Watal (n 11) 29–30, however, argues that the July 1990 text is the first composite text to have consolidated various proposals presented by countries to the TRIPS negotiating group and ought to be considered the first effective TRIPS negotiating text. See WTO Trade Negotiations Committee, Status of Work in the Negotiating Group: Chairman’s Report to GNG (23 July 1990) GATT Document MTN.GNG/NG11/W/76.
19 Sell (n 11).
20 Watal (n 11) 43.
21 ibid 33–34.
22 ibid; Hiroko Yamane, Interpreting TRIPS: Globalisation of Intellectual Property Rights and Access to Medicines (Hart Publishing 2011).
23 Drahos and Braithwaite (n 11) 141.
24 See James Fraser, A Handy-Book of Patent and Copyright Law (S Low, Son, and Co 1860) 64.
25 Sudip Chaudhuri, ‘TRIPS Agreement and Amendment of Patents Act in India’ (2002) 37 Economic and Political Weekly 3354.
26 Bill 59 of 1953.
27 N Rajagopala Ayyangar, Report on the Revision of the Patents Law (September 1959) 60.
28 ibid 22.
29 ibid 14; see also 1 and Appendix A, Tables 4 and 6.
30 ibid 15.
31 United States Senate Committee on the Judiciary, Administered Prices: Drugs (87th Congress, 1st Session, Report 448 of 1961) <ipmall.law.unh.edu/sites/default/files/BAYHDOLE/4_PREPPED_FILES/1961.05.08_Senate_Report_on_Administered_Prices_Drugs.pdf> accessed 25 September 2017.
32 Act 39 of 1970.
33 Robert L Ostergard, ‘Intellectual Property: A Universal Human Right?’ (1999) 21 Human Rights Quarterly 156.
34 See eg K Anji Reddy, An Unfinished Agenda: My Life in the Pharmaceutical Industry (Penguin 2015).
35 Jean O Lanjouw, ‘The Introduction of Pharmaceutical Product Patents in India: “Heartless Exploitation of the Poor and Suffering”?’ (1998) National Bureau of Economic Research Working Paper 6366 <www.nber.org/papers/w6366.pdf> accessed 25 September 2017.
36 Reddy (n 34) 35.
37 Eg Simon Reid-Henry and Hans Lofgren, ‘Pharmaceutical Companies Putting Health of the World’s Poor at Risk’ The Guardian (26 July 2012) <www.theguardian.com/global-development/poverty-matters/2012/jul/26/pharmaceutical-companies-health-worlds-poor-risk> accessed 25 September 2017. India accounts for about 10% of the global pharmaceutical industry in volume terms and 1.4% in value terms. Eighty-seven per cent of the generic drugs on the WHO List of Prequalified Medicines were manufactured in India in 2012, and Indian pharmaceutical firms accounted for 49% of the overall drug master filings in the United States in 2012. See India Brand Equity Foundation, ‘Indian Pharmaceuticals Industry Analysis’ <www.ibef.org/industry/indian-pharmaceuticals-industry-analysis-presentation> accessed 25 September 2017.
38 Bal Krishan Keayla, ‘Brief History of the Working of the National Working Group on Patent Laws’ (unpublished manuscript, nd); Reji K Joseph, ‘India’s Engagement with the World Trade Organization: The Role of Non-State Agents’ in Amitabh Mattoo and Happymon Jacob (eds), Shaping India’s Foreign Policy: People, Politics and Places (Har-Anand Publications 2010).
39 Anitha Ramanna, ‘Interest Groups and Patent Reform in India’ (March 2004) IGIDR Working Paper 2003–006 <www.igidr.ac.in/pdf/publication/WP-2003-006.pdf> accessed 22 December 2014.
40 George K Foster, ‘Opposing Forces in a Revolution in International Patent Protection: The US and India in the Uruguay Round and Its Aftermath’ (1998) 3 UCLA Journal of International Law and Foreign Affairs 283.
41 ibid.
42 SP Shukla, ‘Amendment of Patents Act: Why Parliament Must Defeat It’ (1994) 29 Economic and Political Weekly 3127.
43 ibid.
44 See art 65.4.
45 Sebastian Haunss and Kenneth C Shadlen (eds), Politics of Intellectual Property: Contestation Over the Ownership, Use, and Control of Knowledge and Information (Edward Elgar 2009) 2.
46 Joseph (n 38).
47 See Hoffman-La Roche Ltd v Cipla Ltd (2008) 37 PTC 71 (Delhi High Court), the first pharmaceutical product patent infringement case in post-TRIPS India. The alleged infringer, Cipla, was selling a vital anticancer drug (erlotinib hydrochloride) at one-third of the price charged by Roche, the multinational patentee. Justice Ravindra Bhat of the Delhi High Court refused to restrain an allegedly infringing generic manufacturer on the grounds of public interest. This finding was later upheld by the appellate court in Hoffman La-Roche Ltd v Cipla Ltd (2009) 40 PTC 125 (Delhi High Court).
48 Peter-Tobias Stoll, Jan Busche and Katrin Arend (eds), WTO: Trade-Related Aspects of Intellectual Property Rights (Brill 2008).
49 See TRIPS, art 70.8(b).
50 See Patents Act 1970, § 24B, and TRIPS, art 70.9.
51 Department-Related Parliamentary Standing Committee on Commerce, 35th Report on India and WTO (4 April 1998) <164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Commerce/Report-35.htm> accessed 25 September 2017.
52 While the US complaint in 1996 targeted the non-implementation of the mailbox obligation, the EU action, filed a year later, focused on the lack of an EMR regime in India. See WTO, India: Patent Protection for Pharmaceutical and Agricultural Chemical Products (WT/DS50) [1999] <www.wto.org/english/tratop_e/dispu_e/cases_e/ds50_e.htm> accessed 25 September 2017. See also WTO, India: Patent Protection for Pharmaceutical and Agricultural Chemical Products (WT/DS79) [1999] <www.wto.org/english/tratop_e/dispu_e/cases_e/ds79_e.htm> accessed 25 September 2017.
53 Archa Saran, ‘India: A Changing Regime—India’s Tryst with January 1, 2005’ Mondaq (15 November 2004) <www.mondaq.com/india/x/29573/technology/A+Changing+Regime+Indias+Tryst+with+January+1+2005> accessed 20 February 2018.
54 This deletion was effectuated through the Patents (Amendment) Act, 2005 (hereinafter ‘the 2005 Act’), an enactment meant to be India’s last step towards full and final TRIPS compliance. This Act began as the Patents (Amendment Bill), 2003 under the Bharatiya Janata Party government. The Bill lapsed owing to a change in government and the consequent dissolution of the Lok Sabha (India’s lower house of Parliament). The new coalition government, led by the Indian National Congress, endorsed the Bill. However, since they were unsure of whether it would go through Parliament in time to meet the TRIPS deadline of 1 January 2005, it was sought to be passed as a Presidential Ordinance. Owing to pressure from Congress’s coalition partners, changes were made to the Ordinance and cleared by the Parliament in the third week of March as the Patents (Amendment) Bill, 2005. It finally came into force with retrospective effect from 1 January 2005. See Shamnad Basheer, ‘India’s Tryst with TRIPs: The Patents (Amendment) Act, 2005’ (2005) 1 Indian Journal of Law and Technology 15.
55 For a broad overview of these provisions, see Basheer (n 54). See also Janice M Mueller, ‘The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation’ (2007) 68 University of Pittsburgh Law Review 491.
56 See Lawrence M Sung, ‘Strangers in a Strange Land: Specialized Courts Resolving Patent Disputes’ (2008) 17(4) Business Law Today 27, 27 (noting that patent disputes are amongst the most complex and often ‘muddied with esoteric and arcane language, laws, and customs’).
57 See Section 5.
58 This was not a one-way street, however, and NGOs and academics also passed on some of their acquired proficiency to industry. For example, the Indian Pharmaceutical Alliance consulted extensively with Prof Frederick Abbot in the run-up to the 2005 amendments and even commissioned a report from him which they then submitted to the Mashelkar Committee, arguing that legal amendments to restrict the grant of pharmaceutical patents to new chemical entities (NCEs) alone would be compatible with TRIPS.
59 See Ramanna (n 39) (tracking the emergence of NGOs in the initial WTO/TRIPS era).
60 See the earlier discussion on the formation of the NWGPL in Section 5.
61 Ramanna (n 39); Viviana Munoz Tellez, ‘Patent Reform in India: The Campaign to Protect Public Health’ <www.ipngos.org/NGO%20Briefings/Patents%20Act%20amendment.pdf> accessed 22 September 2017.
62 See Statement of Objects and Reasons of the Patents (Amendment) Bill, 2005:
Given the importance of the issues, the Government undertook broad-based and extensive consultations involving different interest groups on aspects critical to the changes which were necessary in the Patents Act, 1970. These included country-wide interactive sessions with various interest groups, including scientists, academicians, economists, representatives of various industry sectors (such as pharmaceutical, biotech, and software), chambers of commerce, private and public sector units, journalists, non-governmental organizations, representatives of State Governments, lawyers and attorneys and other interest groups and extensive inter-Ministerial consultations.
63 Novartis (n 2) [79].
64 Basheer and Reddy (n 7) 234, 249.
65 Prashant Reddy, ‘Pages from History: The Mysterious Legislative History of Section 3(d)’ SpicyIP (9 November 2011) <spicyipindia.blogspot.in/2011/11/pages-from-history-mysterious.html> accessed 22 December 2017; KM Gopakumar, ‘The Need to Curb Patents on Known Substances’ (2013) 48 Economic and Political Weekly 55; Amit Sengupta, ‘Supreme Court Judgment on Novartis Case: Vindication of Left’s Principled Position in 2005’ People’s Democracy (7 April 2013) <archives.peoplesdemocracy.in/2013/0407_pd/04072013_7.html> accessed 22 September 2017; Manoj Mitta, ‘Evergreening Clause: Thank the Left for It’ Times of India (7 April 2013) < timesofindia.indiatimes.com/home/stoi/deep-focus/evergreening-clause-thank-the-left-for-it/articleshow/19422636.cms> accessed 25 September 2017.
66 SR Yechuri, ‘Suggestions for Patents (Third) Amendment Bill to Amend the Indian Patents Act 1970’ SpicyIP (2 December 2004) <www.spicyip.com/docs/CPI1.pdf>; Reddy (n 65); Shamnad Basheer, ‘The Mashelkar Committee Report on Patents: Placing It in Context or Reading the Lines and Not ‘Between’ Them’ SpicyIP (28 January 2007) <spicyipindia.blogspot.in/2007/01/mashelkar-committee-report-on-patents_28.html> accessed 25 September 2017.
67 Basheer (n 66).
68 RA Mashelkar and others, Report of the Technical Expert Group on Patent Law Issues (December 2006) <www.ipindia.nic.in/writereaddata/images/pdf/report-of-technical-expert-group.pdf> accessed 25 September 2017.
69 Shamnad Basheer, ‘Deconstructing the Mashelkar Committee Report Controversy: Part I’ SpicyIP (26 February 2007) <spicyip.com/2007/02/deconstructing-mashelkar-committee.html> accessed 25 September 2017; Ravi Sharma and Sara Hiddleston, ‘Mashelkar Committee on Patent Law Withdraws Report; Seeks More Time’ The Hindu (22 February 2007) <www.thehindu.com/todays-paper/tp-national/mashelkar-committee-on-patent-law-withdraws-report-seeks-more-time/article1800679.ece> accessed 22 September 2017.
70 Sharma and Hiddleston (n 69).
71 RA Mashelkar and others, Report of the Technical Expert Group on Patent Law Issues (revised, March 2009) <www.ipindia.nic.in/writereaddata/images/pdf/report-technical-expert-group-on-patent-law-issues.pdf> accessed 25 September 2017.
72 ibid para 4.3. However, the Committee also noted at para 4.5 that ‘[t]he TEG was not mandated to examine the TRIPS compatibility of Section 3(d) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself with these issues’.
73 For discussion on rules versus standards, see Section 10.
74 See Basheer and Reddy (n 7); Basheer (n 54). See also Novartis (n 2) [86] where the apex court notes:
The haste with which the Government was constrained to rush the Bill through Parliament to make the law compatible with the TRIPS Agreement perhaps explains the somewhat unclear drafting of some very important provisions, which called for much greater clarity; the presence of some terms and expressions in the definition section that are nowhere used in the Act; and a few loose ends that could have been properly tied up if more time and attention was given to the drafting.
75 R Capdiville and others, ‘Glivec (STI571, Imatinib), a Rationally Developed, Targeted Anticancer Drug’ (2002) 1(7) Nature Reviews Drug Discovery 493.
76 ‘Crystal Modification of a N-Phenyl-2-Pyrimidineamine Derivative, Processes for its Manufacture and Use’, Application 1602/MAS/98 (17 July 1998).
77 Shamnad Basheer and Prashant Reddy ‘“Ducking” TRIPS in India: A Saga Involving Novartis and the Legality of Section 3(d)’ (2008) 20(2) National Law School of India Review 131.
78 Novartis AG v Union of India (2007) 4 MLJ 1153 (Madras High Court).
79 ibid [8].
80 Novartis (n 2) [15].
81 Novartis AG v Union of India MIPR 2009 (2) 34 (Madras High Court).
82 ibid [19].
83 See generally Basheer and Reddy (n 7).
84 US Patent No 5521184, titled ‘Pyrimidine Derivatives and Processes for the Preparation Thereof’ (filed 28 April 1994; granted 28 May 1996).
85 See n 76.
86 Novartis (n 2) [170].
87 ibid [170].
88 ibid [84].
89 ibid [180].
90 I base this assumption on the fact that none of the other parties to the litigation had countenanced this line of argument. I must note, however, that while Indian courts have a poor history of appropriate attribution (see Ruma Pal, ‘5th VM Tarkunde Memorial Lecture: An Independent Judiciary’ (New Delhi, 10 November 2011) who decries ‘the prolific and often unnecessary use of passages from text-books and decisions of other judges—without acknowledgment in the first case and with acknowledgment in the latter’), the Novartis court did meticulously cite the various texts and other materials on which it relied. The failure to cite to an argument advanced by an intervenor cum amicus appears to be an aberration.
91 Emphasis is in the original. See the Summary of Arguments in (2013) 6 SCC 1, 91–92 <spicyip.com/wp-content/uploads/2015/02/2013_6_SCC_1.pdf> accessed 22 September 2017. See also Prashant Reddy, ‘A Successful Academic Intervention before the Supreme Court in Novartis – Glivec Patent Case’ SpicyIP (20 November 2012) <spicyip.com/2012/11/a-successful-academic-intervention.html> accessed 22 September 2017.
92 Novartis (n 2) [172].
93 Summary of Arguments (n 91) 92–96.
94 21 CFR § 316.3(b)(3)(iii) (1999).
95 Novartis (n 2) [186].
96 Swaraj Paul Barooah, ‘Breaking News: Patent Office Ejects Gilead’s Hep C Drug Patent Application’ SpicyIP (15 January 2015) <spicyip.com/2015/01/breaking-news-patent-office-rejects-gileads-hep-c-drug-patent-application.html> accessed 25 September 2017.
97 Summary of Arguments (n 91) 97–98.
98 Basheer and Reddy (n 7) 255–57.
99 Summary of Arguments (n 91).
100 See eg Nick Robinson, ‘A Quantitative Analysis of the Indian Supreme Court’s Workload’ (2013) 10 Journal of Empirical Legal Studies 570.
101 Sheo Nandan Paswan v State of Bihar AIR 1987 SC 877 [163] (Supreme Court of India).
102 See Basheer and Reddy (n 7).
103 I had suggested to the court that on certain technical factual points it should remand the case back to the lower fora for a more thorough determination. See ‘Submissions of Shamnad Basheer’ in Summary of Arguments (n 91).
104 See n 84.
105 See n 76; US Patent No 6894051, titled ‘Crystal modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for its Manufacture and its Use’ (filed 18 January 2000; issued 17 May 2005). The priority date for this patent application is 18 July 1997.
106 See Ted Sichelman, ‘Commercializing Patents’ (2010) 62 Stanford Law Review 341, 356–57.
107 Novartis (n 2) [156].
108 See Shamnad Basheer and Prashant Reddy, ‘The “Experimental Use” Exception through a Developmental Lens’ (2010) 50(4) IDEA: The Intellectual Property Law Review 831.
109 Novartis (n 2) [109].
110 ibid [132].
111 ibid [155].
112 ibid [191].
113 Illustratively, Thambisetty criticises the Supreme Court for having missed the opportunity to assess the patentability of the Novartis invention through the conventional ‘inventive step’ frame: Sivaramjani Thambisetty, ‘Novartis v Union of India and the Person Skilled in the Art: A Missed Opportunity’ (2014) 4(1) Queen Mary Journal of Intellectual Property 79.
114 See eg In re Dillon 919 F2d 688, 692 (US Court of Appeals for the Federal Circuit (Fed Cir) 1990); In re Deuel 51 F3d 1552, 1558 (Fed Cir 1995).
115 In Leo Pharmaceutical Products Ltd v Teresa Stanek Rea, Acting Director, US Patent & Trademark Office No 2012–1520 (Fed Cir 12 August 2013), the greater ‘storage stability’ of the product was held to be an unexpected result. See also Ortho-McNeil Pharm Inc v Mylan 348 F Supp 2d 713, 749 (NDWV 2004), where a ten-fold increase in solubility, among other characteristics, was held to be an unexpected result.
116 See Eisai Co v Dr Reddy’s Laboratories Ltd 533 F3d 1353 (Fed Cir 2008); Takeda v Alphapharm 480 F3d 1348 (Fed Cir 2007). In both these cases however, the US Court of Appeals for the Federal Circuit found against a motivation to either start with the lead compound in question or to modify it in the manner suggested by the patentee. In fact, the prior art ‘taught’ away from using the respective lead compounds in both these cases.
117 Novartis (n 2) [190].
118 ibid [103].
119 See generally Isaac Ehrlich and Richard A Posner, ‘An Economic Analysis of Legal Rulemaking’ (1974) 3 Journal of Legal Studies 257; Louis Kaplow, ‘Rules Versus Standards: An Economic Analysis’ (1992) 42 Duke Law Journal 557.
120 Eg the term ‘significant enhancement’ of efficacy, which calls for a case by case determination, in much the same way as the term ‘reasonable’.
121 Jonathan Haidt and others, ‘Group Report: What Is the Role of Heuristics in Making Law?’ in Gerd Gigerenzer and Christoph Engel (eds), Heuristics and the Law (MIT Press 2006) 240–41.
122 Thomas F Cotter, ‘Patent Damages Heuristics’ (2016) Minnesota Legal Studies Research Paper 16–21 <papers.ssrn.com/abstract_id=2809917> accessed 6 October 2017:
Common examples of legal heuristics include … bright-line rules that narrow the scope of a liability determination in comparison with an open-ended, totality-of-the-circumstances standard … . In principle, legal heuristics such as presumptions can serve a variety of purposes—among them to economize on the cost of adjudication, to allocate the burden of producing evidence to the party who probably has better access to it, or to facilitate desired substantive ends—though if left unchecked legal heuristics (like cognitive and other heuristics) also can generate a variety of errors.
123 Jeanne C Fromer, ‘The Layers of Obviousness in Patent Law’ (2008) 22 Harvard Journal of Law and Technology 75 (arguing that courts ought to consider a layered approach to obviousness, giving differential weightage to both conception and the constructive reduction to practice, depending on the technology sector in question).
124 John F Witherspoon (ed), Nonobviousness: The Ultimate Condition of Patentability (Bureau of National Affairs 1980).
125 Gregory Mandel, ‘The Non-Obvious Problem: How the Indeterminate Nonobviousness Standard Produces Excessive Patent Grants’ (2008) 42 UC Davis Law Review 57, 59–60. See also Kelly C Mullally, ‘Legal (Un)certainty, Legal Process, and Patent Law’ (2010) 43 Loyola of Los Angeles Law Review 1109.
126 Jessica Lai, ‘Validity of Obviousness in the Patent Process: A Case Study of Aktiebolaget (LOSEC)’ (2007) 38 Victoria University of Wellington Law Review 603, 608.
127 Inventive step is an ‘imaginary mental state’: Paul M Janicke, ‘On the Causes of Unpredictability of Federal Circuit Decisions in Patent Cases’ (2005) 3 Northwestern Journal of Technology and Intellectual Property 93, para 6. However, some courts have attempted to infuse a modicum of creativity into the skilled person construct. See KSR International Co v Teleflex Inc 127 S Ct 1727 (US Supreme Court) which states that ‘a person of ordinary skill is also a person of ordinary creativity, not an automaton’.
128 Harries v Air King Prods Co 183 F2d 158, 162 (US Court of Appeals for the Second Circuit (2d Cir) 1950) (Hand CJ).
129 Fromer (n 123).
130 But cf Thambisetty (n 113), who argues to the contrary. For other critiques of the Supreme Court decision, see Darren Smyth, ‘The IPKat in despair—What is to be done when senior courts don’t understand novelty?’ The IPKat (9 May 2013) <ipkitten.blogspot.in/2013/05/the-ipkat-in-despair-what-is-to-be-done.html> accessed 22 September 2017.
131 Basheer and Reddy (n 7).
132 See eg Susan Fyan, ‘Pharmaceutical Patent Protection and Section 3(d): A Comparative Look at India and the US’ (2010) 15 Virginia Journal of Law and Technology 198, 224.
133 Basheer and Reddy (n 77) 147–48; Amy Kapczynski, ‘Harmonization and Its Discontents: A Case Study of TRIPS Implementation in India’s Pharmaceutical Sector’ (2009) 97 California Law Review 1571; Carlos M Correa, ‘Is Section 3(d) Consistent with TRIPS?’ (2013) 48 Economic and Political Weekly 49.
134 Christoph Ann, ‘Patents on Human Gene Sequences in Germany: On Bad Lawmaking and Ways to Deal With It’ (2006) 7(3) German Law Journal 279; Dan L Burk and Mark A Lemley, ‘Is Patent Law Technology-Specific?’ (2002) 17 Berkeley Technology Law Journal 1155.
135 ‘Maran Moves Patents (Second Amendment) Bill in Rajya Sabha’ (Department of Commerce press release, 9 May 2002).