Managing Intellectual Property Rights Over Clinical Trial Data to Promote Access and Benefit Sharing in Public Health

The nature and scope of intellectual property protection, if any, which clinical trial data should receive in terms of Art. 39 of the TRIPS Agreement have been put back in the spotlight through recent events: First through suggestions by heads of the Dutch, French and UK regulatory authorities as well as the European Medicines Agency that such data should not be considered commercially confidential information. Secondly, courts in countries such as Argentina and Brazil have recently decided cases in which they had to balance rights over clinical trial data with competing public health priorities. Both courts decided that public health interests take priority over claims for exclusive rights over clinical trial data. These events raise pertinent ethical and legal concerns, which warrant considerations of strategies that can be used to manage intellectual property rights over clinical trial data with a view to fostering access and benefit sharing in public health. This paper draws lessons from these events and suggests possible options for strategic management of intellectual property rights over clinical trial data in order to cater to public health needs. The concept of access and benefit sharing, which has so far been debated in the fields of biodiversity and most recently in the human genome context is applied to public health with a view to initiating discussions on how it can inform decision making in the management of intellectual property rights over clinical trial data.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save

• Get 10 units per month
• Download Article/Chapter or eBook
• 1 Unit = 1 Article or 1 Chapter
• Cancel anytime

Buy Now

Price includes VAT (France)

Instant access to the full article PDF.

Rent this article via DeepDyve

Similar content being viewed by others

Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement

Responsible data sharing in a big data-driven translational research platform: lessons learned

Towards a Paradigm Shift in Governing Data Access and Related Intellectual Property Rights in Big Data and Health-Related Research

Explore related subjects

Notes

See, for example, Art. 13 of the EU Council Regulation (EEC) No 1768/92 of 18 June 1992, which provides that the SPC “shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of 5 years.” available at http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1992/R/01992R1768-20070126-en.pdf; see also Moore (1998, p. 137–140); de Pastors (1995, p. 189–192).

I owe this useful observation to Dr Dannie Jost, Senior Research Fellow and Science Advisor, World Trade Institute, University of Bern.

See Pugatch (2006, p. 101–110) for a detailed discussion of these approaches at the domestic and international levels. See also Meitinger (2005, p. 128–130).

Baker (2008, p. 305). See also Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 3550 (2000 & Supp. 2005).

Discussions with Dr Dannie Jost, Senior Research Fellow and Science Advisor, World Trade Institute, University of Bern.

Di Blasi (2009, p. 35). The TRIPS Agreement has been incorporated into the Brazilian law by virtue of Decree number 1355.

Agência Nacional De Vigilância Sanitária – ANVISA v. Lundbeck Brasil Ltda: Suspensão De Liminar E De Sentença No 1.425–DF (2011/0184444-8) (Superior Tribunal de Justiça). See Fischmann (2012, p. 220) for a commentary on this decision.

These are countries that are considered to have “serious IPR deficiencies that warrant increased bilateral attention concerning the problem areas or practices.” See Masterson (2004, p. 20). Argentina, Brazil, Canada, Chile, China, India, Indonesia, Israel, Thailand and Venezuela are currently on this list.

The Article prohibits any acts of competition that “are contrary to honest practices in industrial or commercial matters …”.

Article 31 of the treaty is a customary rule of interpretation of public international law, available at http://untreaty.un.org/ilc/texts/instruments/english/conventions/1_1_1969.pdf.

The European Parliament, in its Resolution on the TRIPS Agreement and access to medicines (12 July 2007) called on the European Council “to restrict the Commission’s mandate so as to prevent it from negotiating pharmaceutical-related TRIPS-plus provisions affecting public health and access to medicines, such as data exclusivity, patent extensions and limitation of grounds of compulsory licences, within the framework of the EPA negotiations with the ACP countries and other future bilateral and regional agreements with developing countries.” Available at http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2007-0353+0+DOC+XML+V0//EN.

Sala III, Camara Nacional de Apelaciones en lo Civil y Comercial Federal (Division III of the Federal Civil and Commercial Court of Appeals in Argentina), Case No. 5.619/05 (decided on 1 February 2011).

Human and Fluss “The World Medical Association’s Declaration of Helsinki: Historical and Contemporary Perspectives”, available at http://www.wma.net/en/20activities/10ethics/10helsinki/draft_historical_contemporary_perspectives.pdf.

Decision of the Tokyo High Court on 16 November 2007; see the translation and report by Fujimoto (2010, p. 616–619).

See DiMasi et al. (2003, p. 151–185). It has been argued that the report is based on proprietary and unverifiable data [see Ho (2011, p. 267)].

Lemmens and Telfer (2012, p. 82). The authors do however acknowledge the importance of a system of transparency of data “for the promotion of evidence-informed medicine and the protection of public health.” See p. 89.

House of Commons Health Committee. The influence of the pharmaceutical industry. Fourth Report of Session 2004 available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf.

Weissman (2006, p. 167). This is already practised in Chile, Colombia as well as a number of countries in Eastern Europe and Asia.

Personal discussion with Ms Aleksandra Goes and Dr Daniel Gisi, contract manager and technology transfer manager respectively at Unitectra’s Bern office on 24 November 2011.

Swiss Technology Transfer Organisation Unitectra wins the 2011 European BIOTECHNICA Award, Biotechnica 2011 (11–13 October), pp. 1–3. The BIOTECHNICA award recognized Unitectra’s exceptional contribution to the initiation and promotion of cooperation between the publicly funded research community and business.

See Gøtzsche (2011, p. 249), Appendix 1 for a detailed report on the most recent international calls for data sharing.

References

• Abbott FM (2006) The cycle of action and reaction: developments and trends in intellectual property and health. In: Roffe P, Tansey G, Vivas-Eugui D (eds) Negotiating health: intellectual property and access to medicines. Earthscan, London. p 27–40.
• Ad Carvalho ECA, Batilana AP, Simkins J, Martins H, Shah J et al. (2010) Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets. PLoS ONE 5(2):e9314. doi:10.1371/journal.pone.0009314 (2010).
• Andanda P, Schroeder D, Chaturvedi S, Mengesha EH, Hodges TJ (2013) Legal frameworks for benefit sharing: from biodiversity to human genomics. In: Schroeder D, Cook-Lucas J(eds) Benefit sharing: a short handbook for users of biological resources. Springer, Netherlands.
• Arkinstall J, Childs M, Menghaney L, Ford N, von Schoen-Angerer T (2011) The reality behind the rhetoric: how European policies risk harming access to generic medicines in developing countries. Journal of Generic Medicines 8:14–22. Google Scholar
• Baker BK (2008) Ending drug registration apartheid: taming data exclusivity and patent/registration linkage. American Journal of Law & Medicine 34:303–344. Google Scholar
• Banisar D (2006) Freedom of information around the world 2006: a global survey of access to government information laws. Privacy International 38.
• Barra ACG, Albuquerque ID (2011) A decade of generic pharmaceutical policies in Brazil. Journal of Generic Medicines 2(8):72–75. Google Scholar
• Biotechnology Industry Organisation (2012) 2012 special 301 submission to the Office of the United States Trade Representative. Docket No. USTR-2011-0021. available at http://www.bio.org/sites/default/files/2012%20BIO%20Submission.pdf.
• Brownlie I (2003) Principles of public international law. Oxford University Press, New York.
• Caplan AL, Curry DR (2007) Leveraging genetic resources or moral blackmail? Indonesia and Avian Flu Virus sample sharing. The American Journal of Bioethics 7(11):1–2. Google Scholar
• Chalmers I, Glasziou P (2009) Avoidable waste in the production and reporting of research evidence. The Lancet 374(9692):86–89. Google Scholar
• Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG (2004) Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 291:2457–2465. Google Scholar
• Chokshi DA, Parker M, Kwiatkowskia DP (2006) Data sharing and intellectual property in a genomic epidemiology network: policies for large-scale research collaboration. Bulletin of the World Health Organization 84:382–387. Google Scholar
• Correa CM (2002) Protection of data submitted for the registration of pharmaceuticals: implementing the standards of the TRIPS agreement. South Centre, Geneva.
• Correa CM (2006) Protecting test data for pharmaceutical and agrochemical products under free trade agreements. In: Roffe P, Tansey G, Vivas-Eugui D (eds) Negotiating health: intellectual property and access to medicines. Earthscan, London. p 81–96.
• Cottier T, Meitinger I (2000) The protection of test data submitted to governmental authorities: the impact of the TRIPS agreement on EC law. In: Meng W, Stein T (eds) Marketing authorization for pharmaceutical products and the protection of submitted data. p 53–72.
• de Pastors A (1995) Supplementary protection certificates: situation after two years of operation of the EC1768/92 SPC Regulation. World Patent Information 17(3):189–192.
• Di Blasi G (2009) Data exclusivity protection in Brazil. World Intellectual Property Review, November/December 32–35.
• DiMasi JA, Hansen RW, Grabowski HG (2003) The price of innovation: new estimates of drug development costs. Journal of Health Economics 22:151–185. Google Scholar
• Doshi P, Jefferson T, Del Mar C (2012) The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med 9(4):e1001201. doi:10.1371/journal.pmed.1001201.
• Editorial (2012) Shining a light on trial data. Nature Biotechnology 30(5).
• Eichler HG, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open clinical trial data for all? A view from regulators. PLoS Med 9(4):e1001202. doi:10.1371/journal.pmed.1001202
• Fellmeth AX (2004) Secrecy, monopoly, and access to pharmaceuticals in international trade law: protection of marketing approval data under the TRIPs agreement. Harvard International Law Journal 2(45):443–502.
• Fidler DP (2001) ‘Geographical Morality’ revisited: international relations, international law and the controversy over placebo controlled HIV clinical trials in developing countries. Harvard International Law Journal 42(2):299–354.
• Fidler DP (2008) Influenza virus samples, international law, and global health diplomacy. Emerging Infectious Diseases 14(1):88–94. Google Scholar
• Fischmann F (2012) ANVISA v Lundbeck Brasil Ltda. IIC 43:217–221. Google Scholar
• Fisher (2006) Clinical trials results databases: unanswered questions. Science 311:180–181.
• Fujimoto A (2010) Tokyo High Court, 16 November 2007: JAPAN - Yakugai Ombudsperson Kaigi v. Ministry of Health, Labour and Welfare of Japan, “Iressa”. IIC 41:616–619. Google Scholar
• Gervais D (2008) The TRIPS Agreement: drafting history and analysis. 3rd edn. Sweet and Maxwell, London.
• Gibson J (2009) Intellectual property, medicine and health: current debates. Ashgate Publishing Company, Surrey.
• Godlee F (2012) Clinical trial data for all drugs in current use must be made available for independent scrutiny. British Medical Journal 345. doi: 10.1136/bmj.e7304.
• Gøtzsche PC (2011) Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 12(1):249. available at http://www.trialsjournal.com/content/12/1/249.
• Hayden C (2007) Taking as giving: bioscience, exchange, and the politics of benefit-sharing. Social Studies of Science 37(5):729–758. Google Scholar
• Health Canada (2005) Draft issue identification paper: registration and disclosure of clinical trial information. available at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/draftiipctrd_june_ddeebaucheedec_juin_2005-eng.pdf.
• Ho C (2011) Access to medicines in the global economy: international agreements in patents and related rights. Oxford University Press, Oxford.
• Human D, Fluss SS (2001) The World Medical Association’s Declaration of Helsinki: historical and contemporary perspectives. available at http://www.wma.net/en/20activities/10ethics/10helsinki/draft_historical_contemporary_perspectives.pdf.
• Kent DM, Hayward RA, Griffith JL, Vijan S, Beshansky JR, Califf RM, Selker HP (2002) An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase. Am J Med 113(2):104–111. Google Scholar
• Leibowitz K, Sheckler V (2006) Negotiating clinical trial agreements. The Regulatory Affairs Journal (RAJ) Devices Sept/Oct 289–292:289.
• Lemmens T, Telfer C (2012) Access to information and the right to health: the human rights case for clinical trials transparency. American Journal of Law and Medicine 38(1):63–112. Google Scholar
• Light DW, Lexchin J (2005) Foreign free riders and the high price of US medicines. British Medical Journal 331:958–960. Google Scholar
• Lipkus NB, Mackie JE, Singer PA (2010) Guidance for reconciling patent rights and disclosure of findings at scientific meetings. Health Research Policy and Systems 8:15. available at http://www.health-policy-systems.com/content/8/1/15.
• Masterson JT (2004) Enforcement of trademarks and copyright under the WTO agreement on trade-related aspects of intellectual property rights. In: Masterson JT (ed) International trademarks and copyright enforcement and management. American Bar Association Publishing, Chicago. p 1–26.
• Meitinger I (2005) Implementation of test data protection according to Article 39.3 TRIPS: the search for a fair interpretation of the term ‘unfair commercial use’. Journal of World Intellectual Property 8(2):128–130. Google Scholar
• Moore JW (1998) Patent term restoration for pharmaceutical products in Europe: the supplementary protection certificate. Canadian Intellectual Property Review 14:137–140.
• Organisation for Economic Co-operation and Development (OECD) (2009) The bioeconomy to 2030: designing a policy agenda. OECD Publishing.
• Otamendi J (2011) Confidential data in the approval of a ‘similar’ pharmaceutical product. International Association for the Protection of Intellectual Property e-News 19.
• Pott A (2011) Opening up data at the EMA: EMA’s response to articles. British Medical Journal 342:d3838. doi: 10.1136/bmj.d3838.
• Pugatch MP (2006) Intellectual property, data exclusivity, innovation and market access. In: Roffe P, Tansey G, Vivas-Eugui D (eds) Negotiating health: intellectual property and access to medicines. Earthscan, London. p 97–132.
• Reichman JH (2006) The international legal status of undisclosed clinical trial data: from private public goods? In: Roffe P, Tansey G, Vivas-Eugui D (eds) Negotiating health: intellectual property and access to medicines. Earthscan, London. p 133–150.
• Reichman JH (2009) Rethinking the role of clinical trial data in international intellectual property law: the case for a public goods approach. Marquette Intellectual Property Law Review 13(1):1–68.
• Schroeder D (2007) Benefit sharing – high time for a definition. Journal of Medical Ethics 33:205–209. Google Scholar
• Sedyaningsih ER, Isfandari S, Soendoro T, Supari SF (2008) Towards mutual trust, transparency and equity in virus sharing mechanism: the avian influenza case of Indonesia. Annals Academy of Medicine 37(6):482–488. Google Scholar
• Selker HP, Ruthazer R, Terrin N, Griffith JL, Concannon T, Kent DM (2011) Random treatment assignment using mathematical equipoise for comparative effectiveness trials. Clin Transl Sci 4(1):10–16. Google Scholar
• Simm K (2007) Benefit-sharing: a look at the history of an ethics concern. Nature 8:496. Google Scholar
• Tansey G (2006) Introduction: legal fictions and public health. In: Roffe P, Tansey G, Vivas-Eugui D (eds) Negotiating health: intellectual property and access to medicines. Earthscan, London, p 1–7.
• Taubman A (2008a) The international patent system and biomedical research: reconciling aspiration, policy and practice. The American Association of Pharmaceutical Scientists Journal 10(4):526–536.
• Taubman A (2008b) Unfair competition and the financing of public-knowledge goods: the problem of test data protection. Journal of Intellectual Property Law & Practice 3(9):591–606. Google Scholar
• Taubman A (2011) A practical guide to working with TRIPS. Oxford University Press, New York.
• The European Science Foundation (2009) Forward look – investigator-driven clinical trials. available at http://www.esf.org/fileadmin/links/EMRC/FL_IDCT.pdf.
• The National Health Surveillance Agency (ANVISA) and Lundbeck case (2011). World Intellectual Property Review, November/December 29.
• Thomas K (2012) Medical journal to require more details on drug trials. The New York Times. available at http://www.nytimes.com/2012/11/01/business/british-medical-journal-to-require-detailed-clinical-trial-data.html?_r=0.
• Timmermans K (2007) Monopolizing clinical trial data: implications and trends. PLoS Med 4(2): e2. doi:10.1371/journal.pmed.0040002 at 0206.
• Walsh B (2007) Indonesia’s bird flu showdown. Time Health, May 10, 2007, available at http://www.time.com/time/health/article/0,8599,1619229,00.html.
• Weissman R (2006) Data protection: options for implementation. In: Roffe P, Tansey G, Vivas-Eugui D (eds) Negotiating health: intellectual property and access to medicines. Earthscan, London. p 151–178.
• World Health Assembly (2007) Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits. WHA60.28.
• World Health Organization (2006a) Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO Technical Report Series 937. available at http://apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex7_eng.pdf.
• World Health Organization (2006b) Public health, innovation and intellectual property rights, report of the commission on intellectual property rights, innovation and public health. Geneva.
• World Medical Association (2000) Declaration of Helsinki: ethical principles for medical research involving human subjects.
• World Medical Association (2004) Declaration of Helsinki: ethical principles for medical research involving human subjects.
• World Medical Association (2008) Declaration of Helsinki: ethical principles for medical research involving human subjects. available at http://www.wma.net/en/30publications/10policies/b3/.
• Zarin DA, Tse T (2008) Moving toward transparency of clinical trials. Science 319:1340–1342. Google Scholar

Acknowledgments

I would like to thank Professor Thomas Cottier and Dr Dannie Jost, both of the World Trade Institute, Bern (WTI) for their insightful comments during the preparation of the initial versions of this paper. Additional comments, by members of the work package 3 at the WTI, on earlier drafts of the paper are gratefully acknowledged. I am equally grateful for the scholarship from Switzerland’s State Secretariat for Economic Affairs (SECO)-funded cooperation project and the Anderson Capelli research grant which enabled me to prepare this paper while visiting as a research fellow at the WTI. The anonymous IIC reviewers’ helpful comments, which further improved the quality of this paper, are also gratefully acknowledged.

Author information

Authors and Affiliations

1. School of Law, University of the Witwatersrand, Private Bag 3, WITS 2050, Johannesburg, South Africa Pamela Andanda ( Associate Professor )

1. Pamela Andanda