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Implications of IPD Disclosure for Statutory Innovation Incentives

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Part of the Munich Studies on Innovation and Competition book series (MSIC,volume 16)

Abstract

This chapter examines the intersection between disclosure of non-summary clinical trial data and statutory innovation incentives from a de lege lata perspective. In view of the allegations of the research-based pharmaceutical companies that mandatory disclosure would ‘impede’ their innovation incentives, it is essential to clarify how IPD disclosure might affect the applicable protection afforded under the existing EU framework. In particular, the analysis focuses on the implications of data disclosure for patents and sector-specific exclusivity-based forms of protection. Overall, the analysis shows that the industry’s concerns regarding the offsetting effect on incentives can be justified only to a limited extent.

Keywords

  • Clinical trial data
  • Disclosure
  • Innovation incentives
  • Market exclusivity
  • Orphan drug exclusivity
  • Paediatric indication
  • Patents
  • Returns on investment
  • Supplementary protection certificate
  • Test data exclusivity

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Notes

  1. 1.

    While this overview focuses on the debate in the EU, analogous arguments regarding the impeding effect of clinical trial data disclosure on innovation incentives were raised by pharmaceutical companies during the public consultation conducted by the USFDA on the availability of masked and de-identified non-summary safety and efficacy data. See Availability of anonymized non-summary safety and efficacy data; request for comments (4 Jun 2013) https://www.regulations.gov/document/FDA-2013-N-0271-0001/comment. Accessed 26 Mar 2021.

  2. 2.

    EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/349245/2014, p. 23.

  3. 3.

    ibid p. 74; EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/344107/2014, p. 19.

  4. 4.

    EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/354914/2014, pp. 70–71.

  5. 5.

    EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/342115/2014, p. 12.

  6. 6.

    EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/344107/2014, pp. 27–28.

  7. 7.

    ibid p. 86 (citing the submission of Pfizer); EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/342115/2014, p. 32 (citing the submission of EFPIA).

  8. 8.

    Case C-513/16 P(R) EMA v PTC Therapeutics International [2017] ECLI:EU:C:2017:148, para 55.

  9. 9.

    In that case, access was requested by a university science student in connection with the preparation of a master’s thesis. Case T-44/13R AbbVie v EMA [2013] ECLI:EU:T:2013:221, para 20.

  10. 10.

    ibid para 46.

  11. 11.

    In particular, AbbVie alleged that it would suffer ‘the damage […] of a financial nature [that] in practice […] is impossible to assess […] given the many ways in which the clinical study reports could be used by an indeterminate number of competing undertakings throughout the world, before an indeterminate number of regulatory authorities’. Case C-389/13 EMA v AbbVie [2013] ECLI:EU:C:2013:794, para 31.

  12. 12.

    ibid para 32.

  13. 13.

    ibid.

  14. 14.

    C-390/13 P(R) EMA v InterMune [2013] ECLI:EU:C:2013:795, para 34 (emphasis added).

  15. 15.

    Case T-718/15 R PTC Therapeutics International v EMA [2016] ECLI:EU:T:2016:425, para 92 (emphasis added).

  16. 16.

    Doshi (2014).

  17. 17.

    PhRMA and EFPIA (18 Jul 2013) Principles for responsible clinical trial data sharing. Our commitment to patients and researchers, pp. 1, 4. https://www.efpia.eu/media/25189/principles-for-responsible-clinical-trial-data-sharing.pdf. Accessed 26 Mar 2021.

  18. 18.

    https://www.clinicalstudydatarequest.com. Accessed 26 Mar 2021.

  19. 19.

    Independent review panel charter (2 Mar 2020), p. 2 (emphasis added). https://www.clinicalstudydatarequest.com/Documents/Independent_Review_Panel_Charter.pdf. Accessed 26 Mar 2021.

  20. 20.

    PhRMA and EFPIA (18 Jul 2013) Principles for responsible clinical trial data sharing. Our commitment to patients and researchers, p. 4. https://www.efpia.eu/media/25189/principles-for-responsible-clinical-trial-data-sharing.pdf. Accessed 26 Mar 2021.

  21. 21.

    ibid.

  22. 22.

    ibid (emphasis added).

  23. 23.

    Merck (Nov 2020) Procedure on access to clinical trial data, p. 1. https://www.merckclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf. Accessed 26 Mar 2021.

  24. 24.

    ibid.

  25. 25.

    Merck Serono. Summary of Merck’s responsible data sharing policy for researchers, p. 1 (emphasis added). https://www.merckgroup.com/content/dam/web/corporate/non-images/research/healthcare/Summary_of_Mercks_Responsible_Data_Sharing_Policy_EN.pdf. Accessed 26 Mar 2021.

  26. 26.

    Roche (1 Jun 2013) Roche global policy on sharing of clinical trials data, p. 1 (emphasis added). https://www.roche.com/dam/jcr:1c46aa73-cea0-4b9b-8eaa-e9a788ed021b/en/roche_global_policy_on_sharing_of_clinical_study_information.pdf. Accessed 26 Mar 2021.

  27. 27.

    Pfizer (2015) A guide to requesting Pfizer patient-level clinical data, p. 2. http://www.pfizer.com/files/research/research_clinical_trials/A_Guide_to_Requesting_Pfizer_Patient-Level_Clinical_Data_April_2015.pdf. Accessed 26 Mar 2021.

  28. 28.

    Amgen. Clinical trial data sharing request. https://www.amgen.com/science/clinical-trials/clinical-data-transparency-practices/clinical-trial-data-sharing-request. Accessed 26 Mar 2021.

  29. 29.

    ibid. See also Independent review panel charter (2 Mar 2020), p. 2 (stating that study sponsors ‘may, in exceptional circumstances, veto a request to access data where they feel there is a potential conflict of interest or an actual or potential competitive risk’). https://www.clinicalstudydatarequest.com/Documents/Independent_Review_Panel_Charter.pdf. Accessed 26 Mar 2021.

  30. 30.

    Metrics. https://www.clinicalstudydatarequest.com/Metrics.aspx. Accessed 9 Jun 2021. In total, 611 research proposals were submitted between 1 Jan 2014 and 30 Apr 2021.

  31. 31.

    Reasons why access cannot be provided (enquiries for Sanofi studies). https://www.clinicalstudydatarequest.com/Metrics/Reasons-Access-Not-Provided-Sanofi.aspx. Accessed 9 Jun 2021.

  32. 32.

    PhRMA and EFPIA (18 Jul 2013) Principles for responsible clinical trial data sharing. Our commitment to patients and researchers, p. 4. https://www.efpia.eu/media/25189/principles-for-responsible-clinical-trial-data-sharing.pdf. Accessed 26 Mar 2021.

  33. 33.

    OECD and Eurostat (2005), p. 91. See also OECD and Eurostat (2018), p. 20 (emphasising that the ‘requirement for implementation differentiates innovation from other concepts such as invention, as an innovation must be implemented, i.e. put into use or made available for others to use’).

  34. 34.

    OECD and Eurostat (2018), p. 87. See also Hall et al. (2010), p. 1035.

  35. 35.

    Nightingale and Mahdi (2006), p. 74.

  36. 36.

    OECD and Eurostat (2005), p. 17 (emphasis added). See also OECD and Eurostat (2018), p. 20 (defining innovation as ‘a new or improved product or process (or combination thereof) that differs significantly from the [the innovator’s] previous products or processes and that has been made available to potential users’).

  37. 37.

    Potential effects of IPD disclosure on competition in the respective markets are discussed in detail in Chap. 8 at Sect. 8.1.4.

  38. 38.

    Breschi and Malerba (2005), p. 135.

  39. 39.

    Levin et al. (1987), p. 983.

  40. 40.

    Breschi and Malerba (2005), p. 135 (emphasis added).

  41. 41.

    Cohen (2010), p. 138.

  42. 42.

    Breschi and Malerba (2005), p. 135 (with further references).

  43. 43.

    ibid.

  44. 44.

    ibid.

  45. 45.

    Knowledge spillovers are discussed in more detail in Chap. 7.

  46. 46.

    Breschi and Malerba (2005), p. 135 (emphasis added).

  47. 47.

    See e.g. den Hertog J (2010) Review of economic theories of regulation. Utrecht School of Economics Discussion Paper Series No 10-18, p. 16. https://ideas.repec.org/p/use/tkiwps/1018.html. Accessed 26 Mar 2021; Stiglitz (1999), pp. 308–309.

  48. 48.

    According to Arrow, indivisibilities, inappropriability and uncertainty are ‘three classical reasons for the possible failure of perfect competition to achieve optimality in resource allocation’ and the ‘discrimination against investment in inventive and research activities’. Arrow (1962), pp. 609, 616.

  49. 49.

    See e.g. Orsenigo L, Sterzi V (2010) Comparative study of the use of patents in different industries. Università Commerciale Luigi Bocconi KITeS Knowledge, Internationalization and Tech. Studies Working Paper 33/2010, p. 7 (arguing that ‘the role of patents is likely to be higher […] where imitation is easier, i.e. when the ratio between the costs of imitation to the costs of innovation is lower (e.g. chemicals, pharmaceuticals, machinery)’); Encaoua et al. (2006), p. 1425 (noting that ‘[w]hen imitating is as costly as inventing, or when firms have economic and technical means for protecting their inventions then […] there is no need for further legal protection’); Bessen and Meurer (2005), pp. 26–27 (noting that ‘patent premium is greatest in the pharmaceutical industry’ and that the patent system ‘provides critical incentives for research and development in the pharmaceutical and a few other industries’); Levin et al. (1987), p. 796 (reporting that only in the drug industry product patents were regarded by the majority of respondents ‘as strictly more effective than other means of appropriation’); Mansfield (1986), p. 175. But see Qian (2007), p. 450 (finding ‘no statistically significant relationship between national pharmaceutical patent protection and […] domestic R&D’); US Senate, Subcommittee On Antitrust and Monopoly (1961), p. 119 (reporting an ‘overwhelming’ finding that ‘[d]rugs discovered in foreign countries without product patents outnumber those discovered in countries with such protection in the order of 10 to 1’, while ‘drugs which are among the most widely used in the world were discovered in countries which have never awarded patents on pharmaceutical products’).

  50. 50.

    Hall and Harhoff (2012), p. 548 (emphasis added).

  51. 51.

    Reg 469/2009/EC, rec 4. See also Case C-457/10 P AstraZeneca AB v European Commission [2012] ECLI:EU:C:2012:770, para 8.

  52. 52.

    Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (2 Jul 1992) OJ L 182, repealed by Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (16 Jun 2009) OJ L 152.

  53. 53.

    Reg 469/2009/EC, art 4.

  54. 54.

    Reg 469/2009/EC, art 1(b).

  55. 55.

    Reg 469/2009/EC, art 1(a).

  56. 56.

    Case C-431/04 Massachusetts Institute of Technology [2006] ECLI:EU:C:2006:291, para 19 (recollecting that the proposal for the Regulation introducing SPCs concerned ‘only new medicinal products’ defined as ‘an active substance in the strict sense’, while ‘minor changes’, including a new dose or the use of a different salt or ester, ‘will not lead to the issue of a new [SPC]’). See also Case C-484/12 Georgetown University v Octrooicentrum [2013] ECLI:EU:C:2013:828, para 31.

  57. 57.

    Reg 469/2009/EC, art 1(c).

  58. 58.

    Reg 469/2009/EC, rec 9.

  59. 59.

    Reg 1901/2006/EC, art 36 (specifying the conditions).

  60. 60.

    On the duration, scope and nature of protection, see Chap. 4 at Sect. 4.2.4.

  61. 61.

    Such argument, however, contradicts the inducement theory of patents, according to which patents induce not only an invention but also its development and commercialisation. Mazzoleni and Nelson (1998), p. 276 ff.

  62. 62.

    Dir 2001/83/EC, rec 10.

  63. 63.

    Dir 2001/83/EC, rec 9.

  64. 64.

    As discussed below at Sect. 5.4.1.2.

  65. 65.

    Ragavan (2018); Baird (2013); Correa (2008).

  66. 66.

    Patent protection usually outlasts test data exclusivity. See European Commission (8 Jul 2009) Pharmaceutical sector inquiry final report, p. 73 [hereinafter Pharmaceutical sector inquiry final report]. https://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf. Accessed 26 Mar 2021. According to the report, the test data protection term outlasted the duration of the corresponding patent protection (including SPC protection) in 51 out of the examined 713 cases.

  67. 67.

    IFPMA (2011) Data exclusivity: encouraging development of new medicines, p. 5. https://www.ifpma.org/wp-content/uploads/2016/01/IFPMA_2011_Data_Exclusivity__En_Web.pdf. Accessed 26 Mar 2021.

  68. 68.

    Palmedo (2013). The study examined whether test data exclusivity protection impacted pharmaceutical investment in 45 countries, including the EU member states and found no statistically significant relationship between data exclusivity protection and the level of investment by the pharmaceutical industry in the examined jurisdictions. Apart from data exclusivity, the variables included gross national income, population and ease of doing business. But see Gaessler and Wagner (2020) (showing that data exclusivity can be an effective policy instrument in cases where a drug cannot be protected under patent rights). See also Shaikh (2016), pp. 30 ff (providing an overview of studies on the impact of test data exclusivity).

  69. 69.

    See Reichman (2009), p. 42 ff. See also Shaikh (2016), p. 25 (pointing out that ‘[a]lternate incentives such as rewards, prizes, public-private partnerships in R&D, purchase commitments for the final output of the pharmaceutical R&D, tax benefits etc are more direct and targeted as compared to test data exclusivity’). The debate features the opposition between protection by exclusive rights vs. the liability rule-based cost-sharing approach. On the cost-sharing approach to pharmaceutical test data protection, see Weissman (2006); Fellmeth (2004). On the normative underpinnings of test data exclusivity, see Reichman (2009), pp. 36 ff; Shaikh (2016), pp. 21 ff; Kim D (forthcoming) Test data exclusivity: an elusive pursuit to strike a balance between affordable drugs and protection of returns on investment. In: Bonadio E, Goold P (eds), The Cambridge handbook of non-creative intellectual property. CUP, Cambridge.

  70. 70.

    Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (22 Jan 2000) OJ L 18. For an overview of incentives implemented to support research, marketing and development of orphan medicinal products at EU and national level, see European Commission (22 Dec 2016) Inventory of Union and member state incentives to support research into, and the development and availability of, orphan medicinal products – state of play. SWD(2015) 13 final. Besides market exclusivity, incentives include tax reduction, direct reimbursement after marketing authorisation, joint procurement, etc.

  71. 71.

    Regulation 1901/2006/EC of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (27 Dec 2006) OJ L 378/1. For an overview of regulatory incentives for R&D for paediatric drugs in the EU, see EMA (9 Sep 2014) Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Pediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation. EMA/24516/2014 Corr.3. https://ec.europa.eu/health/sites/default/files/files/paediatrics/2013_annual-report.pdf. Accessed 26 Mar 2021.

  72. 72.

    EMA (27 Oct 2016) 10-year Report to the European Commission. General report on the experience acquired as a result of the application of the Paediatric Regulation. EMA/231225/2015, p. 66. https://ec.europa.eu/health/sites/default/files/files/paediatrics/2016_pc_report_2017/ema_10_year_report_for_consultation.pdf. Accessed 26 Mar 2021. See also Reg 141/2000/EC, rec 8; Reg 1901/2006/EC, rec 19.

  73. 73.

    Reg 141/2000/EC, art 3(1).

  74. 74.

    Reg 141/2000/EC, art 8(1). During the term of protection, a drug authority ‘shall not […] accept another application for a marketing authorisation, or grant a marketing authorisation […] for the same therapeutic indication, in respect of a similar medicinal product’. A ‘similar medicinal product’ means ‘a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication’. A ‘similar active substance’ refers to ‘an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular features) and which acts via the same mechanism’. Reg 847/2000/EC, art 3(3)(b) and (c), respectively.

  75. 75.

    Reg 141/2000/EC, art 8(3). See also European Commission (23 Sep 2008) Guideline on aspects of the application of article 8(1) and (3) of Regulation (EC) No 141/2000: assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity. OJ C 242.

  76. 76.

    A ‘paediatric population’ refers to the population aged between birth and 18 years. Reg 1901/2006/EC, art 2(1). A ‘paediatric use marketing authorisation’ is defined as

    a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.

    Reg 1901/2006/EC, art 2(4).

  77. 77.

    Reg 1901/2006/EC, art 38.

  78. 78.

    EMA (27 Oct 2016) 10-year Report to the European Commission. General report on the experience acquired as a result of the application of the Paediatric Regulation. EMA/231225/2015, p. 9.

  79. 79.

    Reg 1901/2006/EC, art 36.

  80. 80.

    Reg 1901/2006/EC, art 37.

  81. 81.

    See Reg 141/2000/EC, rec 8 (stating that ‘the strongest incentive for the pharmaceutical industry to invest in the development and marketing of orphan medicinal products is where there is a prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered’).

  82. 82.

    Pharmaceutical sector inquiry final report (n 66), p. 23.

  83. 83.

    EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/349245/2014, p. 18.

  84. 84.

    ibid p. 46.

  85. 85.

    Case C-390/13 P(R) EMA v InterMune UK [2013] ECLI:EU:C:2013:795, para 34 (emphasis added).

  86. 86.

    EMA (30 Apr 2013) Advice to the European Medicines Agency from the Clinical Trial Advisory Group on Legal Aspects (CTAG5) – final advice, lines 311–321 (emphasis added). https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-final-advice_en.pdf. Accessed 26 Mar 2021.

  87. 87.

    Exploratory endpoints refer to the variables, such as biomarkers, tested in the hypothesis-generating studies that do not support the label claim of an investigational product.

  88. 88.

    EMA publication policy 0070, p. 19.

  89. 89.

    Price and Minssen (2015), p. 686.

  90. 90.

    The terms ‘primary’ and ‘secondary’ patents correspond to the distinction between ‘basic’ and ‘follow-on’ inventions. ‘Primary’ (‘basic’) patents claim an active ingredient (the lead compound), while ‘secondary’ patents claim modifications and derivatives of an active ingredient (e.g. salts, esters, ethers, polymorphs, metabolites and isomers), combinations with other molecules and new methods for the production of the known active ingredients. See Pharmaceutical sector inquiry final report (n 66), p. 100. Such inventions improve the basic active ingredient and can offer therapeutic benefits, such as improved potency and enhanced absorption. ibid p. 187. On the typology of pharmaceutical inventions and patents, see Ahn (2014), p. 34 ff.

  91. 91.

    Pharmaceutical sector inquiry final report (n 66), p. 51; Ahn (2014), p. 56.

  92. 92.

    Applications for basic patents are often filed during the lead identification and optimisation process, i.e. before clinical trials begin. Pharmaceutical sector inquiry final report (n 66), p. 381.

  93. 93.

    The review presented in this section covers the following cases: T 2506/12 Pegylated Liposomal Doxorubincin/Pharma Mar S.A. (4 Oct 2016) ECLI:EP:BA:2016:T250612.20161004; T 1859/08 Anti-ErbB2 antibodies/GENENTECH, Inc. (5 Jun 2012) ECLI:EP:BA:2012:T185908.20120605; T 158/96 Obsessive-compulsive-disorder/PFIZER (28 Oct 1998) ECLI:EP:BA:1998:T015896.19981028; T 0652/12 Treatment for systemic onset juvenile idiopathic arthritis/CHUGAI (8 Dec 2016) ECLI:EP:BA:2016:T065212.20161208; T 1031/00 Amlodipine/SEPRACOR (23 May 2002) ECLI:EP:BA:2002:T103100.20020523; T 0385/07 Aplidine/PHARMA MAR (5 Oct 2007) ECLI:EP:BA:2007:T038507.20071005; T 1493/09 Human papillomavirus vaccines/GSK) (1 Oct 2014) ECLI:EP:BA:2014:T149309.20141001; T 128/82 Pyrrolidin-Derivate/Hoffmann-La Roche (12 Jan 1984) ECLI:EP:BA:1984:T012882.19840112; T 0715/03 Use of ziprasidone for treating Tourette’s syndrome/PFIZER (16 Jan 2006) ECLI:EP:BA:2006:T071503.20060116; T 1745/12 Temozolomide/JIANGSU (4 Jun 2018) ECLI:EP:BA:2018:T174512.20180604.

  94. 94.

    Separate prior art items cannot be combined when assessing novelty, in contrast to inventive step. EPO (Mar 2021) Guidelines for examination in the European Patent Office, pt G, VI-1. https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vi_1.htm. Accessed 26 Mar 2021.

  95. 95.

    ibid VI-2 (emphasis added). https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vi_2.htm. Accessed 26 Mar 2021.

  96. 96.

    Established case law of the EPO Boards of Appeal. EPO (2016), p. 104.

  97. 97.

    Case T 158/96 Obsessive-compulsive-disorder/PFIZER (28 Oct 1998) ECLI:EP:BA:1998:T015896.19981028.

  98. 98.

    ibid para 3.6.2 (emphasis added).

  99. 99.

    ibid.

  100. 100.

    Case T 1859/08 Anti-ErbB2 antibodies/GENENTECH, Inc. (5 Jun 2012) ECLI:EP:BA:2012:T185908.20120605, para 21.

  101. 101.

    ibid para 20.

  102. 102.

    Case T 2506/12 Pegylated Liposomal Doxorubincin/Pharma Mar S.A. (4 Oct 2016) ECLI:EP:BA:2016:T250612.20161004.

  103. 103.

    ibid para 2.11 (further holding that ‘[t]he possibility that each drug might cancel out the other’s pharmacological activity is remote and would not have been considered a realistic outcome without actual experimental evidence’).

  104. 104.

    ibid para 2.12.

  105. 105.

    Case T 1031/00 Amlodipine/SEPRACOR (23 May 2002) ECLI:EP:BA:2002:T103100.20020523.

  106. 106.

    ibid para 2.1.1.

  107. 107.

    Case T 158/96 Obsessive-compulsive-disorder/PFIZER (28 Oct 1998) ECLI:EP:BA:1998:T015896.19981028, para 3.5.2 (emphasis added).

  108. 108.

    Inferential reproducibility is defined as the reproducibility of the primary analysis results through independent confirmatory analysis. Chow and Liu (2004), p. 82.

  109. 109.

    Unforeseen effects can be beneficial, neutral or adverse.

  110. 110.

    On exploratory endpoints, see Chap. 3 at Sect. 3.2.2.3.

  111. 111.

    EPO (Mar 2021) Guidelines for examination in the European Patent Office, pt G, VII-5. https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vii_5.htm. Accessed 26 Mar 2021.

  112. 112.

    ibid VII-5.3. https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vii_5_3.htm. Accessed 26 Mar 2021.

  113. 113.

    EPO (2016), p. 185.

  114. 114.

    ibid p. 186.

  115. 115.

    Case T 1745/12 Temozolomide/JIANGSU (4 June 2018) ECLI:EP:BA:2018:T174512.20180604.

  116. 116.

    ibid para 3.5.3.

  117. 117.

    ibid para 3.5.4.

  118. 118.

    T 1493/09 Human papillomavirus vaccines/GSK) (1 October 2014) ECLI:EP:BA:2014:T149309.20141001.

  119. 119.

    ibid para 10.

  120. 120.

    ibid para 19.

  121. 121.

    Case T 0652/12 Treatment for systemic onset juvenile idiopathic arthritis/CHUGAI (8 Dec 2016) ECLI:EP:BA:2016:T065212.20161208.

  122. 122.

    ibid para 19.

  123. 123.

    Case T 2506/12 Pegylated Liposomal Doxorubincin/Pharma Mar S.A. (4 Oct 2016) ECLI:EP:BA:2016:T250612.20161004.

  124. 124.

    ibid para 3.14.

  125. 125.

    ibid.

  126. 126.

    ibid.

  127. 127.

    ibid para 3.15 (emphasis added).

  128. 128.

    ibid.

  129. 129.

    Case T 0385/07 Aplidine/PHARMA MAR (5 Oct 2007) ECLI:EP:BA:2007:T038507.20071005.

  130. 130.

    ibid para 17.

  131. 131.

    Aetiology is a discipline that studies the causes that set a disease process ‘in motion’. Porth (2011), p. xix.

  132. 132.

    Case T 0385/07 Aplidine/PHARMA MAR (5 Oct 2007) ECLI:EP:BA:2007:T038507.20071005, para 16.

  133. 133.

    ibid.

  134. 134.

    Case T 0715/03 Use of ziprasidone for treating Tourette’s syndrome/PFIZER (16 Jan 2006) ECLI:EP:BA:2006:T071503.20060116.

  135. 135.

    ibid para 2.4.3.

  136. 136.

    In contrast to novelty, the assessment of inventive step considers separate prior art references in combination, whereby ‘[e]ven an implicit prompting or implicitly recognisable incentive [could be] sufficient to show that the skilled person would have combined the elements from the prior art’. EPO (Mar 2021) Guidelines for examination in the European Patent Office, pt G, VII-5.3. https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vii_5_3.htm. Accessed 26 Mar 2021.

  137. 137.

    See above (n 108) and the accompanying text.

  138. 138.

    EPO (2016), p. 185. To prejudice novelty, the claimed therapeutic effect would need to be ‘derivable directly and unambiguously’. See above (nn 95–96) and the accompanying text.

  139. 139.

    While the ‘hope to succeed’ implies ‘merely the expression of a wish’, a reasonable expectation of success means a ‘scientific appraisal of available facts’. EPO (2016), p. 186.

  140. 140.

    Pharmaceutical sector inquiry final report (n 66), p. 51; Turner (2007), p. 6 ff.

  141. 141.

    Reg 469/2009/EC, art 13. For a definition of a ‘basic patent’, see above (n 57).

  142. 142.

    Patent invalidation proceedings can be based on the prior art already considered during the examination or opposition proceedings and the newly introduced prior art. See Hess et al. (2014) (finding that the newly introduced prior art frequently leads to patent invalidation).

  143. 143.

    On the grounds of SPC invalidation, see Reg 469/2009/EC, art 15.

  144. 144.

    Reg 469/2009/EC, art 14(d).

  145. 145.

    EMA publication policy 0070, annex 1, para 3; annex 2, para 3.

  146. 146.

    EMA (30 Apr 2013) Advice to the European Medicines Agency from the Clinical Trial Advisory Group on Legal Aspects (CTAG5) – final advice, lines 231–237 (emphasis added). https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-final-advice_en.pdf. Accessed 26 Mar 2021. See also EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/344107/2014, p. 85 (citing the argument by Pfizer that competitors ‘may circumvent Regulatory Data Protection rules or take advantage of their non-existence, especially outside the EU, when detailed, non-public domain data are disclosed in the EU’). See also Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 84.

  147. 147.

    That is, according to the requirements under Article 8(3) of Directive 2001/83/EC.

  148. 148.

    It is well-known that the costs of conducting full-scale clinical trials are prohibitive for generic companies. See e.g. Pharmaceutical sector inquiry final report (n 66), p. 35. See also Gaessler and Wagner (2020), p. 10 (reporting that ‘interviews with executives from pharmaceutical companies did not reveal any cases where firms duplicated clinical trials’).

  149. 149.

    E-mail of 26 Sep 2017, inquiry number ASK-32704 (on file with the author) (emphasis added).

  150. 150.

    See e.g. de Carvalho (2018), p. 286 (arguing that the term ‘market protection’ applies only to protection of the products ‘whose marketing has been obtained with the support of protected test data [but not] to bio-equivalent products whose registration has been eventually obtained by a generics manufacturer using its own data’)); Shaikh (2016), p. 9 (noting that test data exclusivity ‘does not necessarily result in monopoly prices in the relevant market’, and that other drug producers, ‘both originators and generics, may target the same market and may get their product approved by generating their own test data’).

  151. 151.

    EMA publication policy 0070, annex 1, para 3; annex 2, para 3. Clinical trial data released by the EMA bears the watermark that states that the use of the documents for commercial purposes is prohibited. ibid p. 6.

  152. 152.

    As noted by the CJEU in PTC Therapeutics International v EMA, even if competitors could gain access to CSRs under the EMA transparency policies, they ‘would still have to carry out its own relevant studies and trials’. Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 91. Thus, the Court held that ‘the claim that the report at issue must be considered confidential in its entirety on the ground that its disclosure might enable competitors to apply for [marketing authorisation] is unfounded in law’. ibid.

  153. 153.

    See above (nn 12, 146) and the accompanying text. During the public consultation conducted by the USFDA concerning the availability of masked and de-identified non-summary safety and efficacy data, the PhRMA submitted that, ‘to the extent that competitors could unmask the data, they could obtain approval of competing products with little effort or investment’. PhRMA (24 Jul 2013) Comments to Docket No. FDA-2013-N-0271: availability of masked and de-identified non-summary safety and efficacy data. Request for comments, p. 4. https://www.regulations.gov/comment/FDA-2013-N-0271-0003. Accessed 26 Mar 2021. See also Institute of Medicine of the National Academies (2015), p. 143 (pointing out the risk that disclosed clinical trial data ‘may be used for “unfair commercial purposes”, such as wholesale copying of originator data sets for purposes of receiving regulatory approval in jurisdictions with limited regulatory data protection laws’).

  154. 154.

    For an overview of data exclusivity regimes, see IFPMA (2011) Data exclusivity: encouraging development of new medicines. https://www.ifpma.org/wp-content/uploads/2016/01/IFPMA_2011_Data_Exclusivity__En_Web.pdf. Accessed 26 Mar 2021.

  155. 155.

    Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Decree of the State Council of the People’s Republic of China No. 360 of 4 August 2002. See also WTO (1 Oct 2001) Report of the Working party on the accession of China. WT/ACC/CHN/49 (01-4679), para 284 (reporting the confirmation from the representative of China that

    China would, in compliance with Article 39.3 of the TRIPS Agreement, provide effective protection against unfair commercial use of undisclosed test or other data submitted to authorities in China as required in support of applications. During this period, any second applicant for market authorization would only be granted market authorization if he submits his own data (emphasis added).

  156. 156.

    Federal Law of the Russian Federation No 61-FZ of April 4, 2010 ‘On Marketing of Medicinal Products’, art 18. See also WTO (17 Nov 2011) Report of the Working party on the accession of the Russian Federation to the World Trade Organization’ WT/ACC/RUS/70, WT/MIN(11)/2, para 1295 (reporting that the representative of the Russian Federation confirmed that Russia had enacted legislation to comply with the requirement under Article 39(3) of the TRIPS Agreement and that, accordingly, during the six-year protection term, ‘any subsequent application for marketing approval or registration would not be granted, unless the subsequent applicant submitted his own data’).

  157. 157.

    An NDA refers to a new drug application, a complete set of documents filed under section 505(b)(1) of the US Federal Food, Drug, and Cosmetic Act.

  158. 158.

    Sections 505(c)(3)(E) and 505(j)(5)(F) of the US Federal Food, Drug, and Cosmetic Act.

  159. 159.

    USFDA (2 Nov 2016) Frequently asked questions for new drug product exclusivity. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm. Accessed 26 Mar 2021.

  160. 160.

    For instance, according to the industry association EuropaBio, competitors might take advantage of data disclosed by the EMA to obtain marketing authorisation for generic products, in particular, ‘in regions where the originator company does not have a marketing authorisation, or where no stewardship or adequate protection for [test data] exists’. EMA (2 Oct 2014) Overview of comments received on ‘Publication and access to clinical-trial data’ (EMA/240810/2013). EMA/344107/2014, p. 27.

  161. 161.

    EMA (30 Apr 2013) Advice to the European Medicines Agency from the Clinical Trial Advisory Group on Legal Aspects (CTAG5) – final advice, lines 93–98 (emphasis added). https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-final-advice_en.pdf. Accessed 26 Mar 2021.

  162. 162.

    For instance, in India, drugs are authorised predominantly based on their earlier approval in other jurisdictions, such as Australia, Canada, the European Union, Japan, the UK and the US. Irrespective of whether the originator drug has been authorised for marketing in India, a generic company is only required to ‘prove that the drug has been approved and marketed in another country and submit confirmatory test and other data from clinical studies on a very few (in some cases as few as 16) Indian patients’. Institute of Medicine of the National Academies (2015), p. 262 (with further references).

  163. 163.

    ibid p. 261 (noting that, in the jurisdictions where ‘competitors can rely for their marketing applications on approval of the molecule by the FDA or the EMA, data release may confer little marginal advantage to the competitor’).

  164. 164.

    The CJEU held that the allegation concerning the potential misuse of CSRs is ‘vague’ and no specific argument was put forward ‘to show that the alleged danger in certain third countries is real’. Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 84.

  165. 165.

    For a definition, see above (n 74).

  166. 166.

    See above (n 75) and the accompanying text.

  167. 167.

    Case T-718/15R Therapeutics International v EMA [2016] ECLI:EU:T:2016:425, para 92 (emphasis added).

  168. 168.

    ibid paras 12, 38.

  169. 169.

    According to the Community register of orphan medicinal products, the orphan market exclusivity for Translarna is expected to expire on 5 Aug 2024. https://ec.europa.eu/health/documents/community-register/html/h902.htm. Accessed 15 Jun 2021.

  170. 170.

    An application for an orphan designation can be filed at any stage of developing a medicinal product before applying for marketing authorisation of that product. Reg 141/2000/EC, art 5(1).

  171. 171.

    European Commission. Community register of orphan medicinal products. https://ec.europa.eu/health/documents/community-register/html/reg_od_act.htm?sort=a. Accessed 15 Jun 2021. In the Community register of orphan medicinal products, an ‘active’ application corresponds to a granted valid application for the orphan designation, while a ‘non-active’ application means that it was withdrawn, refused or expired.

  172. 172.

    Above (n 171).

  173. 173.

    Above (n 167).

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Kim, D. (2021). Implications of IPD Disclosure for Statutory Innovation Incentives. In: Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law. Munich Studies on Innovation and Competition, vol 16. Springer, Cham. https://doi.org/10.1007/978-3-030-86778-2_5

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