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Abstract
For the past twenty years Indian Ayurvedic medicine has experienced a profound transformation originating in a complex process of industrialization and unequal but significant integration within the world of global pharmacy. The reformulation of classical combinations of medicinal plants described in centuries-old reference texts used by Ayurvedic practitioners lies at the heart of this process. Reformulation means at the same time simplifying and standardizing polyherbal combinations in order to (1) adapt them to mass and mechanized industrial processing, (2) mobilize elements of biomedical experimentation in the laboratory and the clinic to provide evidence of medical value, and (3) link Ayurvedic and biomedical categories to address the health needs of cosmopolitan consumers. Intellectual property rights play a peculiar role in the reformulation strategy since Ayurvedic formulas are viewed both as collective resources that must be protected from private appropriation to ensure further mining and as innovative products deemed protected through trademarks and patents.
This article explores this conundrum, using the Traditional Knowledge Digital Library (TKDL) that the Indian government began to develop in 2000 as a lens into this Indian path to biocapital. The article discusses three dimensions of the TKDL trajectory: (1) its origins in the international controversies about “biopiracy”; (2) the structure and operations of the database and its complex relationship with Ayurvedic knowledge, since its main aim is to translate traditional formulations into a scientific and legal idiom amenable to the work of patent offices worldwide; and (3) the consequences outside of India of its establishment, in particular at the European Patent Office, where TKDL-based information is used to evaluate patent applications for polyherbal drug formulation protection, thus creating a new jurisprudence about the boundaries between the protection and the appropriation of traditional medical knowledge.
Notes
1 Dr. J., Traditional Knowledge Digital Library (CitationTKDL), interview by the author, September 2010, Gazhiabad.
2 For a detailed discussion of the reformulation regime, see CitationPordié and Gaudillière 2013. This framework was developed as basis for the collective project Pharmasud: Savoirs locaux, construction de marches et mondialisation: deux régimes d'innovation pharmaceutique au Sud, sponsored by the French Agence Nationale de la Recherche, under which the research on the CitationTKDL presented in this article was conducted.
3 On the globalization and the industrialization of Ayurvedic medicine, see Banerjee 2009, CitationBode 2008, CitationLeslie 1989, CitationMadhavan 2009, CitationPordié 2011, CitationReddy 2002, CitationSivaramakhrishnan 2006, and CitationZimmermann 1995.
4 See CitationPatwardhan et al. 2008, CitationPatwardhan and Mashelkar 2009, and CitationPatwardhan and Vaidya 2010.
5 EP 90250319, Examination Report, 8 September 1992.
6 EP 90250319, Amended Application, filed 22 February 1993.
7 EP 90250319, reply from W. R. Grace's lawyer, 10 October 1996.
8 EP 90250319, EPO to W. R. Grace's lawyer, 30 September 1997.
9 On the idea that patent systems have been constructed historically on a mechanical ontology that later conflicted with other ontologies focusing on molecular processes rather than machines, see CitationPottage 2007 and 2010. On the use of a chemical ontology in the early days of gene patenting, see CitationCalvert and Joly 2011.
10 EP 90250319, EPO to W. R. Grace's lawyer, transmitted documents, 26 May 1998.
11 EP 90250319, Grounds for final decision, 13 February 2001.
12 The chemical ontology of the patent system emerged in the early twentieth century as a way of defining patentable innovations not only as new machines or processes for making things (including substances) but also as new composition of matter described on a chemical or molecular basis only. On this chemical ontology and the patenting of living entities, see CitationGaudillière and Joly 2013.
13 On the history of intellectual property rights on living organisms, see CitationKevles 2002 and CitationGaudillière, Rheinberger, and Kevles 2009.
14 Ayurveda Drug Controller of Kerala Trivandrum, interview by the author, March 2013.
15 In 2013, TKDL promotion through its website did not refer to a single research agreement aimed at the design of new therapeutic products.
16 The debate on TKDL access conditions has left few public traces (a hint of it can be found in the Times of India, 30 June 2006), but its existence has been confirmed to us by AYUSH officials. One of the effects of reinforced control was the 2010 reorganization of the TKDL website, which now displays only a limited set of formulations (a few hundred).
17 The TKDL access agreement form (2012 version) states that the responsibility of a user is to “not disclose any information of TKDL contents to a third party unless it is necessary for patent search and examination. The user undertakes the obligations to preserve the secrecy and/or confidentiality of the information(s). The user whenever required may give printouts from TKDL contents to the applicant of patents only for the purpose of citations. The user shall use TKDL information only for patent search and examination and for no other purpose.… Survival of obligations to maintaining the secrecy and confidentiality of TKDL shall remain even after the termination of this agreement.”
18 For an example of this kind of reformulation at the Himalaya drug company, see CitationPordié, Zimmermann, and Gaudillière (unpublished manuscript 2014).
19 This statement is used as a preliminary in all third-party oppositions filed by TKDL.
20 EP 57799434, International Publication Number WO 2006/030426, filed 13 September 2005.
21 EPO to Amcod's lawyer, International Preliminary Report on Patentability, 13 July 2007.
22 EP 57799434, Vosnius and Partner to EPO Munich, 29 January 2008.
23 EPO to Vosnius, 10 November 2008.
24 This was all the more remarkable as the TKDL formulations included dozens of ingredients (one even had 147 and another 182), thus clearly opening a space for an argument about the specificity and novelty of a powerful combination of only three plants.
25 See www.venusremedies.com/home.
26 For the financial information, see CitationVenus 2012; for the patents on herbal formulations, see the Indian Patent Office database, ipindiaonline.gov.in/patientsearch/search/index.aspx.
27 The complete formulation was Azadirachta indica, Curcuma longa, Glycyrrhiza glabra, Jasminum officinale, Pongamia pinnata, Terminalia chebula, Trichosanthes dioica, Capsicum abbreviata, Stellata wild, Symplocos racemosa, Ichnocarpus frutescens, Rubia cordifolia, Berberis aristata, Picrorhiza kurroa, Saussurea lappa, beeswax, and copper sulfate.
28 EP 2112929, International Preliminary Report on Patentability, 16 June 2009.
29 EP 2112929, Annexure 3, “Phase III Clinical Trial Report Sponsored by Venus Remedies Ltd.,” Annexure 2 on tests in rat burn model, and Annexure 1, “Antibacterial and Antifungal Activity of Ampucare by Accugen Labs Inc.,” filed 24 February 2010.
30 Azadirachta indica, Curcuma longa, Glycyrrhiza glabra, Jasminum officinale, Pongamia pinnata, Trichosanthes dioica, Rubia cordifolia, Berberis aristata.
31 The eleven effects claimed are antibacterial and antifungal, anti-inflammatory, analgesic, antioxidant, improving the blood flow, increasing angiogenesis, increasing granulation, immunomodulation, moisturizing, tissue nutrition, and collagen formation. EP2112929, Response to Third-Party Opposition, 19 October 2010.
32 On the international dimension of traditional knowledge registries and the Indian pre-TKDL experience, see CitationAnuradha, Taneja, and Kothari 2001; CitationCullet and Raja 2004; CitationCIPR 2002; and CitationDutfield 1999.
33 See, e.g., Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, Geneva: Third Session, 13–21 June 2002, Document WIPO/GRTKF/IC/3/17, §§132 and 139 (India) and §178 (Brazil); Fourth Session, 9–17 December 2002, WIPO/GRTKF/IC/4/15, §103.
Additional information
Notes on contributors
Jean-Paul Gaudillière
Jean-Paul Gaudillière is a research professor at the Institut national de la santé et de la recherche médicale and director of the Center for Research on Medicine, Sciences, Health, Mental Health, and Society (CERMES3) in Paris. A historian of science and medicine, he has studied extensively the changing relationship between the life sciences, medicine, and the pharmaceutical industry during the twentieth century.