India: Traditional Knowledge And Scope For Patent Protection

Last Updated: 30 January 2018
Article by Suchi Rai Singh

Most Read Contributor in India, July 2018

Traditional Knowledge

Traditional Knowledge (TK) is the awareness, experience, expertise, knowledge and applications that are established, continued, performed and passed on from generation to generation within a region or community, often forming a part of its cultural, social or spiritual identity. TK can be attributed to in a wide variety of contexts, viz. agricultural, scientific, technical, ecological and medicinal knowledge as well as biodiversity-related knowledge.

TK is mostly undocumented and typically inherited via word of mouth.

Examples are as follows:

  • Use of turmeric (Curcuma longa) for medicinal purposes.
  • Use of ashwagandha (Withania sominifera) to treat heart related ailments.
  • Traditional healing practices such as Yoga.

Defensive protection of TK12

Defensive protection refers to a set of strategies to ensure that third parties do not gain illegitimate or unfounded IP rights over TK. These measures include the amendment of the World Intellectual Property Organization

(WIPO)-administered patent systems (the International Patent Classification system and the Patent Cooperation Treaty (PCT) Minimum Documentation) The PCT minimum documentation is defined by WIPO as the minimum requirement for patent collections used to search for prior art documents for the purpose of assessing novelty and inventiveness. Some countries and communities are also developing TK databases that may be used as evidence of 'prior art' to defeat a claim to a patent on such TK. WIPO has developed a toolkit to provide practical assistance to TK holders on documenting TK.

Positive protection of TK13

Two aspects of positive protection of TK by IP rights are being explored:

  • Preventing unauthorized use of TK, and
  • Active exploitation of TK by the originating community itself.

14Negotiations on an international legal instrument are taking place within the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. In some countries, sui generis legislation has been developed specifically to address the positive protection of TK. In addition, providers and users may also enter into contractual agreements and/or use existing IP systems of protection.

Patentability of Traditional Knowledge:

Indian patent laws do not permit the protection of TK under section 3 (p) of the Indian Patent Act, 1970. An invention which in effect, is traditional knowledge or which is an

aggregation or duplication of known properties of traditionally known component or components is not an invention and cannot be patented.

However, if there is a substantial improvement in the existing TK which enables the invention to fulfill the criteria under the Indian IP law, IP protection can be sought.

The key issue in protecting TK is prior knowledge of the innovation as much of TK is already in public domain being passed on orally or through documentation through generations. This makes most TK ineligible for IP protection as majority of information is already part of "prior art" and therefore there is very little in terms of novelty which can be established for patent protection.

TK is an integral part of strength of local community knowledge. Attempts to exploit TK owned by local communities, for industrial or commercial benefit is a major issue as it is unfair exploitation of knowledge owned by local communities, as IP protection creates monopoly of patent owners. Governments the world-over including India have enacted laws to prevent such unfair exploitation of TK.

15Indian law has adequate provisions for the protection of TK. Traditional knowledge, by its very definition, is in the public domain and hence, any application for patent relating to TK does not qualify as an invention under section 2 (1) (j) of the Patents Act, 1970, which defines that "invention means a new product or process involving an inventive step and capable of industrial application". Further, under section 3(e) of the Patents Act "a substance obtained by a mere admixture resulting only in the

aggregation of the properties of the components thereof or process for producing such substances" is not an invention and hence, not patentable.

Applications for patents based on TK contravening the provisions of law can be refused under section 15 or in pre-grant opposition under clauses (d), (f) and (k) of Section 25 (1) and granted patents can be revoked in post-grant opposition under clauses (d), (f) and (k) of Section 25 (2) of the Patents Act, 1970.

It is required that all patent applications relating to Traditional Knowledge (TK) are correctly identified, screened and classified as "Traditional Knowledge" by RECS Section of Patent Office. The RECS in-charge is required to take due care that no case relating to TK is wrongly screened and classified. Additionally, the person in-charge of screening is required to accord appropriate IPC classification for such TK applications so that these applications can be properly routed for examination to the respective groups such as Chemistry, Pharmaceuticals, Agrochemicals, Biotechnology, Microbiology, Biochemistry, Food, Mechanical, etc. The screening of an application as "Traditional Knowledge" is an administrative process for facilitating the examination and to indicate that the subject-matter of the application is important and has relevance in the context of traditionally known substances, articles or processes for preparing them or their use.

In every case related to TK, the Examiner is required to carry out a thorough search for anticipation in TKDL and/or other databases.

If any citation is made from TKDL database, then copy of the citation (English translated) is required to be sent along with the examination report.

When the subject-matter of claims relate to extracts of plant materials containing undefined active ingredients, such claims cannot be said to be novel if the use of such plants or plant materials is pre-known as a part of teaching of TK. However, if the claims relate to alkaloids and/or active principles obtained from the plant materials and structures of the said alkaloids and/or active principles are characterized, which do not form the part of the prior art, such claims cannot be said to involve an inventive step, since the use of said plant materials and their therapeutic effects are known from the teaching of TK. Thus, the prior art motivates the person skilled in the art to isolate the individual ingredients such as alkaloids, flavonoids, phytosteroids, etc.

TKDL:16

Traditional Knowledge Digital Library is a collaborative project of the Government of India through the Council of Scientific and Industrial Research (CSIR) and the Ministry of AYUSH, to collect information on traditional knowledge existing in India, in various languages and format as a single repository. TKDL serves as a reference of prior arts for patent examiners at International Patent Offices (IPOs).

Features of TKDL:

The two main features of TKDL are Accessibility and Availability. TKDL provides accessibility in terms of Language, Format and Classification. The traditional Indian knowledge exists in local languages such as Sanskrit, Urdu, Arabic, Persian, Tamil, etc. TKDL translates such traditional knowledge into the native languages of the patent examiners, and in five global languages - English, French, Spanish, German and Japanese. The format of TKDL is also unique and is similar to the format of the patent application, making it easily understandable for the patent examiners. The full listing for each TK entity contains a bibliography of traditional Indian documents, which in turn contains links to scanned images of these documents in the original language. TKDL has created a new classification system for the traditional knowledge, known as the Traditional Knowledge Resource Classification (TKRC), which is based on the structure of International Patent Classification (IPC). Each listing in the TKDL includes both TKRC codes and IPC codes. Another main feature is the availability of TKDL. TKDL in complete form is available only at certain national patent offices for use by patent examiners. However, a representative version of the database is available at the TKDL website. This database has 1,200 representative listings.

TKRC:

Traditional Knowledge Resource Classification (TKRC) is an innovative classification system of TKDL. TKRC has structured and classified the Indian Traditional Medicine System in approximately 25,000 subgroups for Ayurveda, Unani, Siddha and Yoga. TKRC has enabled incorporation of

about 200 sub-groups under A61K 36/00 as defined in the International Patent Classification instead of few sub-groups earlier available on medicinal plants under A61K 35/00; thus, enhancing the quality of search and examination of prior-art with respect to patent applications in the area of traditional knowledge.

In 2011, an International Conference was organized by World Intellectual Property Organization (WIPO) in collaboration with CSIR on 'Utilization of Traditional Knowledge Digital Library as a Model for Protection of Traditional Knowledge', at New Delhi. Pursuant to this, WIPO in collaboration with CSIR and DIPP (Ministry of Commerce and Industry), organized an 'International Study Visit to TKDL' for 19 countries interested in replication of TKDL.

TKDL has proved to be a strong tool in protecting the unlawful rights over existing knowledge of TK and having exclusive IP rights over such TK. It also demonstrates the proactive action to protect such knowledge for the current and upcoming generations for years. The idea is not to restrict the use of traditional knowledge, rather to ensure that wrong Patent Rights are not granted due to lack of access to prior art for patent examiners.

Footnotes

12 http://www.wipo.int/tk/en/tk/

13 http://www.wipo.int/tk/en/tk/

14 http://www.wipo.int/tk/en/tk/  

15 http://www.ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_39_1_5-tk-guidelines.pdf  

16 http://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng  

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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