- Keywords > compulsory licences
- Keywords > Intellectual Property Rights (IPR)
- Keywords > parallel importation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > pharmaceutical
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS Agreement
- Keywords > TRIPS flexibilities
(2000; 91 pages)
4.1 Traditional medicinal knowledge & intellectual property rights
The rise of modern information technologies has led to an increasing awareness of the value of traditional knowledge, including in particular traditional medicine. At a time when the wealth of nations lies increasingly in the knowledge which their peoples hold, the use of intellectual property rights related to ‘traditional knowledge’ has become an important issue. While the debate is in its early stages, there is a lot of concern and controversy, but also considerable confusion. This is partly due to the fact that there is no common terminology, and that the concepts and expectations of different stakeholders vary.
So what is meant by the terms ‘traditional’ and ‘indigenous’ knowledge? Although indigenous knowledge is generally considered traditional knowledge, not all traditional knowledge is indigenous knowledge. Indigenous knowledge can be seen as a subset of traditional knowledge (TK). For example, information passed down by traditional means amongst the Gagudju of Australia may be referred to as ‘indigenous knowledge’ or ‘traditional knowledge’; however, the information passed down by early North American colonists through traditional means would be ‘traditional knowledge’ but not ‘indigenous knowledge’. This distinction between ‘indigenous’ and ‘traditional’ knowledge resurfaces in a modified form in the field of traditional medicine, especially in Asian countries.
In the Asian context, the terms ‘indigenous’ and ‘traditional’ are used to differentiate knowledge according to the codification of the tradition, rather than the affiliation of the knowledge holder. A distinction is made, particularly in South Asia and China, between the codified systems of ‘traditional medicine’ and non-codified medicinal know-how, which includes tribal and ‘indigenous medicine’. The codified knowledge systems include the Ayurvedic system of medicine, which is codified in the 54 authoritative books of the Ayurvedic System. As will be discussed below, this distinction may have implications in the intellectual property context for the relation of the subject matter to the public domain.
The following priority areas with regards to traditional medicine and intellectual property can be identified: (i) availability, scope and use of IPRs in traditional medicine; (ii) systematic documentation of traditional medicine for IP purposes; and (iii) regional and inter-regional information exchange on traditional medicine and compilation of databases thereof.
Following consultations with a wide spectrum of stakeholders, including governments, practitioners of traditional medicine, pharmaceutical industry, research institutes, non-governmental organizations (NGOs) as well as indigenous and local communities, a number of issues and concerns have been identified. These focus on patents and trade secrets; some of the issues and concerns related to patents are summarized here.
Practitioners of traditional medicine expressed a wide range of views and needs in relation to the patent system, reflecting diverse points of view and ongoing experimentation with the patent system. These included propositions to use the existing patent system for TK protection, to develop sui generis protection for TK, modeled upon but different from the patent system, to exclude certain systems of traditional medicine from patentability, as well as the assessment that the patent system is entirely inadequate for the protection of traditional medicine.
A common point among these diverging views was that the interactions between traditional medicine and the patent system are growing rapidly. Stakeholders noted that these interactions encompass two developments: first, there is an increasing number of patents filed and granted over TK-based inventions. Hence the informal innovations of TK systems enter the ambit of IPR policy. Secondly, TK holders and policy makers are developing new uses for the patent system as a tool within TK-related frameworks, such as access and benefit sharing frameworks, access to affordable health care, etc.
Availability of patent protection versus disclosure in the case of traditional medicine
The availability of patent protection for traditional healers is hampered on one hand by problems related to the acquisition and exercise of rights, and on the other hand by the disclosure of patentable inventions during the documentation of traditional medicine; the publication of documented traditional medicinal knowledge is a high priority for initiatives which aim at making traditional medicine more widely available as a source of primary health care.
Depending on the knowledge holders’ views regarding the grant of exclusive rights over traditional knowledge, they either seek disclosure or try to avoid it.
• Traditional healers who seek to prevent the grant of any patents over their inventions have adopted systematic disclosure of documented traditional medicinal knowledge as a strategy, because such disclosure destroys the novelty of the innovation and makes it unpatentable. Some organizations are therefore systematically disclosing the innovations compiled in their traditional-knowledge-databases.
• On the other hand, practitioners of traditional medicine who seek to obtain patents for traditional medicine-based inventions have developed documentation strategies which prevent disclosure in a sufficiently clear and complete manner. They have adopted strategies which are intended not to disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
To resolve specific problems related to the unintentional disclosure of traditional knowledge, two modifications or additions to the existing system are proposed:
• an extended grace period could be provided for the patent applications of TK holders. This would exclude premature disclosure of traditional knowledge from prior art, if that disclosure was made within a specified period before the filing of an application. A practitioner or documentation project making such a premature disclosure, e.g. because they were unaware of its IP implications, would be temporarily protected against the consequences of such disclosure.
• a registration mechanism could be developed for informal innovations, similar to certain national petty patent systems, which would give registered TK holders the right of precedence in matters of filing of applications for protection of such registered traditional know-how.
Those practitioners of traditional medicine who are interested in obtaining patents often experience a number of problems, which make the formal IP system inaccessible for them. This system is based on document-intensive, highly codified structures and procedures. It presupposes the existence of written records, a condition which traditional practitioners cannot rely upon in practice, because traditions often lack written records.
The high costs of filing patent applications is the second, and biggest obstacle to the acquisition of patents by practitioners of traditional medicine. Possible measures to reduce transaction costs and make the patent system more accessible are:
• collective filing of patent applications by traditional healers’ associations, in order to share transaction costs;
• financial and legal assistance to traditional healers’ organizations for the filing of patent applications;
• an extended grace period for TK holders, as mentioned above, to give practitioners of traditional medicine additional time to raise funds for the fees for patent applications,
• collective management of industrial property rights, based on existing models for the collective management of copyrights.
Patents over TK-based inventions granted to non-TK holders
In recent years, public concerns have focused on patents over traditional medicine-based inventions which were obtained by non-TK holders. Even though in some cases these patents were revoked after evidence of their long standing use in traditional medical systems was produced, this so-called biopiracy has generated wide-spread concerns about the equity of the formal IP systems and the recognition of TK as prior art.
The issuing of such patents could be avoided by taking steps to include traditional medicine documentation in the searchable prior art, such as:
• Inclusion of TK newsletters, databases and registries into existing IP information systems for non-patent literature.
• Inclusion of standardized TK documentation into the regular procedures of patent-issuing authorities.
• Development of standards for the international exchange of traditional medicine documentation within existing international IP information systems for the search of prior art.
• Inclusion into the International Patent Classification of classes, subclasses etc. for traditional medicine, so that traditional medicine-based patents can be systematically searched.
Customary protection of traditional medicinal knowledge
The IP needs of TK holders are shaped by their contact with the formal IP systems as well as by the informal IP regimes that prevail in their societies and communities. Contrary to a commonly held view, exclusive rights and monopoly powers over informal innovations are not uncommon within indigenous and local communities. Many local and indigenous communities have evolved diverse but stable societal structures which regulate the flow of traditional knowledge and innovations. Such customary or ‘informal’ regimes may bear remarkable similarity to formal intellectual property systems, and can be just as effective in protecting the local innovator in his or her local context.
The first type of informal regimes are secrecy regimes. These are independent from government regulations or community support, and depend entirely on the inventor’s ability to prevent disclosure. However, in small, traditional communities it is often difficult to conceal innovations, especially when they consist of modifications of more generally known traditional techniques. Secondly, in the absence of formal protection, healers use rituals as part of their traditional healing methods; these often allow them to monopolize their innovations, despite disclosure of the phytochemical products or techniques used.
The impression exists that in many traditional societies such ritual and magical powers are part of informal regimes which protect traditional medicinal know-how from unauthorized use by third parties. Effectively, ritual can function as a barrier to reverse engineering, that is, a mechanism which prevents the use and development of technologies based on imitation. In the local context and within supportive cultural frameworks, ritual regimes can create monopolies approximating those of modern patents which confer on their owners certain exclusive rights in relation to products and processes, which constitute the subject matter of the patent: “to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, or importing for these purposes that product” or process, respectively.16
16 Articles 28.1(a) and (b), TRIPs Agreement.
Box 15 A healer in Karnataka
An example is the case of a traditional healer in Karnataka, India. Since more than 20 years, he treats 50 to 60 patients per day and has developed a specialization in skin diseases. He uses about 40 medicinal plants for oral and external application and produces each application individually for each patent. He only applies his formulations personally and performs elaborate rituals during the treatment to obtain support from Laxmi, the goddess of wealth. His medicines are effective only in association with the appropriate ritual components. The intangible property consisting of the rituals associated with his practices makes the healer’s personal involvement mandatory, even though the technology is fully disclosed.
Systems of traditional medicine are rich and diverse sources of creativity and innovation. Practitioners of traditional medicine and other stakeholders consider such knowledge systems to be a constantly renewed source of wealth, both as an economic asset and as cultural patrimony. This is the case in both developing and developed countries.
The intellectual property issues related to traditional knowledge cut across the conventional branches of intellectual property law, such as copyright and industrial property, since in many cases practitioners of traditional medicine do not separate ‘artistic’ from ‘useful’ aspects of their know-how and intellectual creations.
Numerous indigenous and local communities have protocols for protection of traditional medicine under customary law. Increasingly, we are witnessing a convergence between the formal intellectual property system, on the one hand, and ‘informal’ systems for protection of traditional knowledge, on the other. These systems have been integral and effective within their spheres and have, until recently, existed in virtual independence of each other. Their convergence results from two consequences of current globalization processes, namely, the growing relevance of intellectual property to an increasing number of countries and users, and the expanding recognition that traditional medicinal know how is a valuable economic and cultural asset within the global information society.
However, many legal and practical problems remain yet to be fully understood and addressed: the collective ownership/custodianship of traditional medicine; the problem of ownership and exercise of rights in traditional medicinal knowledge which exists across different countries in a region; practical means for the exercise and management of rights; mechanisms for application of customary law to protect traditional medicine; and the need for comprehensive documentation, and documentation standards, for traditional medicine.
In order to achieve better understanding and wider consensus on these issues it is necessary to address basic conceptual problems and test practical solutions to the protection of traditional medicine.