Traditional Medicines And Intellectual Property Rights (Ipr) Issues
Developed from experience gained over the centuries and adapted to the local culture and environment, Traditional Knowledge/Traditional medicinal practices were transmitted orally from generation to generation. It tends to be collectively owned and takes the form of stories, songs, folklore, proverbs etc. attached to cultural values, beliefs, rituals, community laws and local language.
Research in Traditional Medicines shall be encouraged for the better understanding of the mechanism of action of drugs being used, chemical reactions happening during its processing by the body, active principles responsible for the particular action of the drug and the identification of the molecules responsible for toxicity reduction etc. The potential portfolios of research include standardization of various drugs, modifications in the ‘form’ and ‘route’ of drug administration, enhancement of shelf-life of the drug, quality standards of drug production, and innovations in processing, packaging, storage, transport, delivery etc. There is no bar on the researchers to take out a patent on the substantially improved version of Traditional Knowledge or on development of new drugs based on Traditional Medicine principles.
However misappropriation of Traditional Knowledge by private business outfits has become quite rampant nowadays, owing to the vulnerability of it being “passed off” as inventions. Though “Intellectual Property” does not include “knowledge” in the strict sense, plenty of patents have already been taken on Traditional Knowledge (Especially Traditional Medicines). Of course, there are a few sagas of successful revocation of some of those patents, but at the cost of exchequer.
The patent Examiners are not left with any choice other than granting a patent on an "invention" reaching his table "in the form of a document", if it "fits to his logic" that it is an industrial innovation and not in the public domain. Many Corporate establishments pass off "Traditional Knowledge" as if it is an invention made by them and many a times it is easy for them to get through the formalities since such knowledge is not sufficiently codified and made available to the Examiner in a searchable database. In the recent past, CSIR India has been engaged with creating a traditional knowledge digital library (TKDL), a database that will serve as “prior art” against any move to register patents based on Traditional Knowledge. 'Prior art' is meant to encompass everything that has been published, presented or otherwise disclosed to the public on the date of patent (the prior art includes documents in foreign languages disclosed in any format in any country of the world).
India’s Traditional Knowledge Digital Library (TKDL) contains approximately 2.08 lakh formulations based on Ayurveda, Unani, Siddha and Yoga. The formulations have been transcribed in five international languages viz. English, French, German, Spanish and Japanese with the objective of preventing misappropriation of Traditional Medical Knowledge at the International Patent Offices. India has already shared the TKDL with European Patent Office (EPO) and USPTO on an agreement that EPO and USPTO shall utilize the database for search and examination only and shall not make any third party disclosure except for the purpose of giving a copy of the printout to the inventor/applicant as citation. The Access Agreement signed with these patent offices unequivocally mentions that TKDL is a “prior art”. I wonder how 'confidentiality' can be maintained if TKDL is treated as a 'prior art'.
While the codification of Traditional Knowledge in to Digital Libraries and sharing it with patent offices is a viable solution to direct misappropriation, it is feared that such digital libraries may serve as a platter for capitalists looking for private appropriation of improvements on such traditional knowledge that is not accessible otherwise. Of Course, TKDL is the right strategy to prevent the direct misappropriation of Traditional Knowledge already in public domain and known to a large cross-section of people (wound healing property of turmeric for example). However, it is learnt that the concept of TKDL is being extended (in combination with “Prior Informed Consent” and “Access and Benefit Sharing” tools) to enable codification of community-owned Traditional Knowledge also. In the latter case, it is a clear injustice to those communities, if TK of this nature is shared with patent offices.
It is hard for the Patent offices to keep the contents of TKDL secret from third parties, since no patent could be denied without disclosing the coded TK associated with the invention to the claimant. Patent Examiner can limit the scope of a patent claim on TK (or reject it altogether), only if he/she gives the relevant extract from TKDL to the inventor to show that it is a “prior art”. Fraudsters may file patent applications purely on conceptual grounds (which would look like as if they had performed the invention), only to see that they could fetch the authentic information on a TK practice/product.
It is debatable whether TKDL stops Bio-piracy or facilitates it.Instead of TKDL, a "Traditional Knowledge Docketing System" (TKDS) [something like Management Information System (MIS)] may be created and maintained by authorities. TKDS shall contain the location at which the Traditional Knowledge is available, the community that possesses the TK,a short description of nature of TK and the PROTOCOLset by the communities/TK holders for providing access to such Traditional Knowledge. TK communities shall be educated about their entitlements on the TK and they shall be empowered to negotiate their due share of monetary benefits in commercializing the TK owned by them. However documentation of the TK in public domain may be done in national interest (In the form of TKDL). This shall be laid open to public.
As the Concepts like “Prior Informed Consent”, “Access and Benefit Sharing” etc. have proven to be the wrong tools to make the Knowledge in the custody of Traditional Practitioners available for further research while upholding their interests. A sui generis legislation for the protection of Traditional Knowledge is the need of the hour.
Suigeneris legislation for “rights” on Traditional Knowledge : Kerala’s IPR Policy Imperative
IPR Policy of Kerala underscores that the Government is very much concerned about protecting its rich traditional wealth comprising of Traditional knowledge practices, Tribal medicines, Ayurveda practices and biodiversity. The Policy released on 27th June 2008, finds that the possible solution could be to acknowledge the deemed rights for the Traditional Knowledge holders and make them aware of their rights. The policy document proposes to commit all traditional knowledge, including traditional medicines, the practice of which sustains livelihoods of many, to the realm of “Knowledge Commons” and not to the “Public Domain”. “Knowledge Commons” refer to the knowledge, which is the collectively produced sphere of ideas and which is left unencumbered for the greater benefit of all.
The ownership is attributable to the State/Crown, given the fact that TK is an accumulated traditional wealth and the long kept preserve of its practitioners, tribal communities and families, wherein all of them act as deemed "trustees" of the State/Crown. Hence, the intention of the proposed legislation is 'not exactly the creation of rights on TK', but assigning some of the rights (not all the rights) owned by the State to those "deemed trustees", in return of their willingness to put the TK to the realm of "Knowledge Commons"
Knowledge in digital form offers unprecedented access to information through the Internet but at the same time is subject to ever-greater restrictions through intellectual property legislation, over-patenting, licensing, overpricing, and lack of preservation. As per the latest reports, many of the Digital Libraries are now on their way to becoming 'Knowledge Commons'. The “Knowledge Commons” will be a vibrant, user-centred learning facility integral to the academic lives of students. The Commons will integrate scholarly resources, information technology, software, expertise, instruction and study space.
While the Policy envisages proprietary rights on traditional knowledge, all the right holders will be deemed to be holding their rights under a “Commons License”, wherein the right holders shall permit others the use of the knowledge in their possession for non-commercial purposes. It is further stipulated that any development made using this knowledge licensed under the above obligation should be put back to the realm of “Knowledge Commons”, say “Traditional Knowledge Commons”, and hence denying the scope of patenting thereof.
The fundamental concept of "Creative Commons" [some rights reserved and not all rights reserved] has been adopted in Kerala IPR Policy to shape the concept of “Commons License”, as it moots utilization of the Knowledge for non-commercial purposes. To quote Lawrence Lessig, founder of Creative Commons, it is "a culture in which creators get to create only with the permission of the powerful, or of creators from the past". “Creative Commons” provide free tools that let authors, scientists, artists, and educators to easily mark their creative work with the freedoms they want it to carry. It permits to copy, distribute and transmit the work or to adapt the work only for non-commercial purposes. If you alter, transform, or build upon this work, you may distribute the resulting work only under the same or similar license to this one. Licensees may distribute derivative works only under a license identical to the license that governs the original work.
Though the concept of “Commons License” envisaged by the Policy is based on the fundamental concept of “Creative Commons” employed by open source advocates, its scope varies significantly from that of “Creative Commons License”. This “Commons License” shall not be confused with the seasoned free software concepts (or open source) and "Creative Commons" licenses like GNU GPL, LATEX etc. which mostly applies to "Expressions" protectable under "Copyright". Specific provisions for such “Traditional Knowledge Commons License” will have to be worked out to ensure free, non-commercial reproduction and codification of the Traditional Knowledge. It has to be a kind of “deemed licence” which immediately applies on the user of TK, the moment he decides to employ it for any purpose. The provisions of the deemed license are to be laid down in the legislation to ensure free, non-commercial reproduction and codification of the Traditional Knowledge.
According to the policy document, the custodians/preservers of the TK (viz. tribal community, family etc) will be acknowledged as the right holders, but they are obliged to subject the TK possessed by them for the non-commercial purposes of all. Hence the knowledge is revealed for documentation, and enabling further research thereof. However these right holders can license the TK under their possession to others for commercial purposes on negotiated terms and conditions in accordance with the provisions of “Commons Licence”. In respect of such TK, where it is the livelihood of numerous practitioners strewn across Kerala, the State will be deemed to have rights over such Traditional Knowledge. Even though State holds the ownership on such TK, all the actual practitioners of this TK will have an autonomous license for right of commercial use from the State. But these Licensees are not empowered to sub-license this right of commercial use to anybody else, and right for transferring licenses will solely be enjoyed by the State.
Creation of rights and obligations necessitates a Governing Mechanism for acknowledging the right holders, enforcing the rights and recommending legal action against the violators of the rights and "Common License". Therefore the Policy advises to constitute a body called Kerala Traditional Knowledge Authority (KTKA), with which the right holders will have to be registered. KTKA will give general notice to the public, regarding all applications being made to it by practitioners in order to invite Public for bringing to the attention of KTKA, any disputations of applicant's claims or challenges to claims of uniqueness, prevalence of similar practice in more than one location or community etc. After scrutinizing all such cases of disputes and after resolving the issue of ownership/possession, that KTKA would finally register a community/group/individual as "Knowledge Custodian" of such unique set of TK practices.
It is also important that the stake holders be made aware of protecting the rights conferred to them from potential usurpation. Therefore all such stake holders would be advised to join together and form "Knowledge Societies". 'Traditional Knowledge Users' Co-operatives" also will be encouraged in the legislation
Though the Policy envisages putting the developments made on TK back to the realm of “Knowledge Commons”, path breaking inventions like development of a new drug molecule or the process thereof which involves substantial developmental cost need not form part of the “Knowledge Commons” in the strict sense even if TK may form the basis of its origin. The ultimate aim of the legislation is not to protect the financial interests of the TK holders, but the benefit of the Society at large, as in the case of the fundamental concept of PATENTS. Patents bestow monetary reward for revealing technological innovation along with accolades for the inventor. Grant of patent for inventions attracts investment because the commercial exploitation of the invention is possible to its fullest extent during the term of patent. The policy does not support extending "trade secret" protection to TK and the State is totally against creation of monopoly over knowledge. Hence Kerala IPR Policy envisages the ways and means for revealing TK for the greater benefit of Society.
Constitutional sanctity of the proposed legislation
While there is no bar on Kerala State in having a policy on Intellectual Property Rights (IPR) to proclaim its stand with respect to its culture, geography, people, Biodiversity etc., constitutional sanctity of a legislation based on the Policy is debatable as IPR is a union subject. However it is imperative that we have to find ways and means to get around this constitutional law bottle neck and to push this legislation through. I have the following arguments regarding the constitutional sanctity of the proposed legislation
1) The words like "Traditional Knowledge", "Intellectual Property", "Biodiversity" etc. did not find specific mention anywhere under Union list, and the Entry 49 is limited to: "Patents, inventions and designs; copyright; trade-marks and merchandise marks" [The application of ‘pith and marrow’ rule may limit this scope].
2) The ownership of TK may be attributed to the State/Crown, given the fact that TK is an accumulated traditional wealth and the long kept preserve of its practitioners, tribal communities and families, wherein all of them act as deemed "trustees" of the State/Crown. So Traditional Knowledge is very well a "treasure trove" (Item No. 44 of State list), where the State has power to legislate.
3) Item No. 26 of State List can be used to regulate Trading of "Knowledge". Item No. 64 provides for enforcement of punitive mechanisms.
4) Item No. 7 (Contracts) of Concurrent list and Item No. 6 (Transfer of Property) also is relevant.
5) Article 300A covers intellectual property also. Article 304(b) and Article 19(6) gives added advantage to treat TK as a Property and hence regulate its Trading
6) The proposed legislation does not intend to touch the patent Act at all, it being a Union Subject. But a few provisions in Biodiversity Act (made using the residual powers of Central Government) needs to be supplemented with additional provisions, but employing the provisions of Articles 258A and 258 (2).
7) There is support of State directives under Article 38, 39 (b) and 39(c)
8) Above all, the proposed legislation is 'not exactly for creating rights on TK', but for assigning those rights to those "deemed trustees", in return of their willingness to put the TK to the realm of "Knowledge Commons"
Research in Traditional Medicines shall be encouraged for the better understanding of the mechanism of action of drugs being used, chemical reactions happening during its processing by the body, active principles responsible for the particular action of the drug and the identification of the molecules responsible for toxicity reduction etc. The potential portfolios of research include standardization of various drugs, modifications in the ‘form’ and ‘route’ of drug administration, enhancement of shelf-life of the drug, quality standards of drug production, and innovations in processing, packaging, storage, transport, delivery etc. There is no bar on the researchers to take out a patent on the substantially improved version of Traditional Knowledge or on development of new drugs based on Traditional Medicine principles.
However misappropriation of Traditional Knowledge by private business outfits has become quite rampant nowadays, owing to the vulnerability of it being “passed off” as inventions. Though “Intellectual Property” does not include “knowledge” in the strict sense, plenty of patents have already been taken on Traditional Knowledge (Especially Traditional Medicines). Of course, there are a few sagas of successful revocation of some of those patents, but at the cost of exchequer.
The patent Examiners are not left with any choice other than granting a patent on an "invention" reaching his table "in the form of a document", if it "fits to his logic" that it is an industrial innovation and not in the public domain. Many Corporate establishments pass off "Traditional Knowledge" as if it is an invention made by them and many a times it is easy for them to get through the formalities since such knowledge is not sufficiently codified and made available to the Examiner in a searchable database. In the recent past, CSIR India has been engaged with creating a traditional knowledge digital library (TKDL), a database that will serve as “prior art” against any move to register patents based on Traditional Knowledge. 'Prior art' is meant to encompass everything that has been published, presented or otherwise disclosed to the public on the date of patent (the prior art includes documents in foreign languages disclosed in any format in any country of the world).
India’s Traditional Knowledge Digital Library (TKDL) contains approximately 2.08 lakh formulations based on Ayurveda, Unani, Siddha and Yoga. The formulations have been transcribed in five international languages viz. English, French, German, Spanish and Japanese with the objective of preventing misappropriation of Traditional Medical Knowledge at the International Patent Offices. India has already shared the TKDL with European Patent Office (EPO) and USPTO on an agreement that EPO and USPTO shall utilize the database for search and examination only and shall not make any third party disclosure except for the purpose of giving a copy of the printout to the inventor/applicant as citation. The Access Agreement signed with these patent offices unequivocally mentions that TKDL is a “prior art”. I wonder how 'confidentiality' can be maintained if TKDL is treated as a 'prior art'.
While the codification of Traditional Knowledge in to Digital Libraries and sharing it with patent offices is a viable solution to direct misappropriation, it is feared that such digital libraries may serve as a platter for capitalists looking for private appropriation of improvements on such traditional knowledge that is not accessible otherwise. Of Course, TKDL is the right strategy to prevent the direct misappropriation of Traditional Knowledge already in public domain and known to a large cross-section of people (wound healing property of turmeric for example). However, it is learnt that the concept of TKDL is being extended (in combination with “Prior Informed Consent” and “Access and Benefit Sharing” tools) to enable codification of community-owned Traditional Knowledge also. In the latter case, it is a clear injustice to those communities, if TK of this nature is shared with patent offices.
It is hard for the Patent offices to keep the contents of TKDL secret from third parties, since no patent could be denied without disclosing the coded TK associated with the invention to the claimant. Patent Examiner can limit the scope of a patent claim on TK (or reject it altogether), only if he/she gives the relevant extract from TKDL to the inventor to show that it is a “prior art”. Fraudsters may file patent applications purely on conceptual grounds (which would look like as if they had performed the invention), only to see that they could fetch the authentic information on a TK practice/product.
It is debatable whether TKDL stops Bio-piracy or facilitates it.Instead of TKDL, a "Traditional Knowledge Docketing System" (TKDS) [something like Management Information System (MIS)] may be created and maintained by authorities. TKDS shall contain the location at which the Traditional Knowledge is available, the community that possesses the TK,a short description of nature of TK and the PROTOCOLset by the communities/TK holders for providing access to such Traditional Knowledge. TK communities shall be educated about their entitlements on the TK and they shall be empowered to negotiate their due share of monetary benefits in commercializing the TK owned by them. However documentation of the TK in public domain may be done in national interest (In the form of TKDL). This shall be laid open to public.
As the Concepts like “Prior Informed Consent”, “Access and Benefit Sharing” etc. have proven to be the wrong tools to make the Knowledge in the custody of Traditional Practitioners available for further research while upholding their interests. A sui generis legislation for the protection of Traditional Knowledge is the need of the hour.
Suigeneris legislation for “rights” on Traditional Knowledge : Kerala’s IPR Policy Imperative
IPR Policy of Kerala underscores that the Government is very much concerned about protecting its rich traditional wealth comprising of Traditional knowledge practices, Tribal medicines, Ayurveda practices and biodiversity. The Policy released on 27th June 2008, finds that the possible solution could be to acknowledge the deemed rights for the Traditional Knowledge holders and make them aware of their rights. The policy document proposes to commit all traditional knowledge, including traditional medicines, the practice of which sustains livelihoods of many, to the realm of “Knowledge Commons” and not to the “Public Domain”. “Knowledge Commons” refer to the knowledge, which is the collectively produced sphere of ideas and which is left unencumbered for the greater benefit of all.
The ownership is attributable to the State/Crown, given the fact that TK is an accumulated traditional wealth and the long kept preserve of its practitioners, tribal communities and families, wherein all of them act as deemed "trustees" of the State/Crown. Hence, the intention of the proposed legislation is 'not exactly the creation of rights on TK', but assigning some of the rights (not all the rights) owned by the State to those "deemed trustees", in return of their willingness to put the TK to the realm of "Knowledge Commons"
Knowledge in digital form offers unprecedented access to information through the Internet but at the same time is subject to ever-greater restrictions through intellectual property legislation, over-patenting, licensing, overpricing, and lack of preservation. As per the latest reports, many of the Digital Libraries are now on their way to becoming 'Knowledge Commons'. The “Knowledge Commons” will be a vibrant, user-centred learning facility integral to the academic lives of students. The Commons will integrate scholarly resources, information technology, software, expertise, instruction and study space.
While the Policy envisages proprietary rights on traditional knowledge, all the right holders will be deemed to be holding their rights under a “Commons License”, wherein the right holders shall permit others the use of the knowledge in their possession for non-commercial purposes. It is further stipulated that any development made using this knowledge licensed under the above obligation should be put back to the realm of “Knowledge Commons”, say “Traditional Knowledge Commons”, and hence denying the scope of patenting thereof.
The fundamental concept of "Creative Commons" [some rights reserved and not all rights reserved] has been adopted in Kerala IPR Policy to shape the concept of “Commons License”, as it moots utilization of the Knowledge for non-commercial purposes. To quote Lawrence Lessig, founder of Creative Commons, it is "a culture in which creators get to create only with the permission of the powerful, or of creators from the past". “Creative Commons” provide free tools that let authors, scientists, artists, and educators to easily mark their creative work with the freedoms they want it to carry. It permits to copy, distribute and transmit the work or to adapt the work only for non-commercial purposes. If you alter, transform, or build upon this work, you may distribute the resulting work only under the same or similar license to this one. Licensees may distribute derivative works only under a license identical to the license that governs the original work.
Though the concept of “Commons License” envisaged by the Policy is based on the fundamental concept of “Creative Commons” employed by open source advocates, its scope varies significantly from that of “Creative Commons License”. This “Commons License” shall not be confused with the seasoned free software concepts (or open source) and "Creative Commons" licenses like GNU GPL, LATEX etc. which mostly applies to "Expressions" protectable under "Copyright". Specific provisions for such “Traditional Knowledge Commons License” will have to be worked out to ensure free, non-commercial reproduction and codification of the Traditional Knowledge. It has to be a kind of “deemed licence” which immediately applies on the user of TK, the moment he decides to employ it for any purpose. The provisions of the deemed license are to be laid down in the legislation to ensure free, non-commercial reproduction and codification of the Traditional Knowledge.
According to the policy document, the custodians/preservers of the TK (viz. tribal community, family etc) will be acknowledged as the right holders, but they are obliged to subject the TK possessed by them for the non-commercial purposes of all. Hence the knowledge is revealed for documentation, and enabling further research thereof. However these right holders can license the TK under their possession to others for commercial purposes on negotiated terms and conditions in accordance with the provisions of “Commons Licence”. In respect of such TK, where it is the livelihood of numerous practitioners strewn across Kerala, the State will be deemed to have rights over such Traditional Knowledge. Even though State holds the ownership on such TK, all the actual practitioners of this TK will have an autonomous license for right of commercial use from the State. But these Licensees are not empowered to sub-license this right of commercial use to anybody else, and right for transferring licenses will solely be enjoyed by the State.
Creation of rights and obligations necessitates a Governing Mechanism for acknowledging the right holders, enforcing the rights and recommending legal action against the violators of the rights and "Common License". Therefore the Policy advises to constitute a body called Kerala Traditional Knowledge Authority (KTKA), with which the right holders will have to be registered. KTKA will give general notice to the public, regarding all applications being made to it by practitioners in order to invite Public for bringing to the attention of KTKA, any disputations of applicant's claims or challenges to claims of uniqueness, prevalence of similar practice in more than one location or community etc. After scrutinizing all such cases of disputes and after resolving the issue of ownership/possession, that KTKA would finally register a community/group/individual as "Knowledge Custodian" of such unique set of TK practices.
It is also important that the stake holders be made aware of protecting the rights conferred to them from potential usurpation. Therefore all such stake holders would be advised to join together and form "Knowledge Societies". 'Traditional Knowledge Users' Co-operatives" also will be encouraged in the legislation
Though the Policy envisages putting the developments made on TK back to the realm of “Knowledge Commons”, path breaking inventions like development of a new drug molecule or the process thereof which involves substantial developmental cost need not form part of the “Knowledge Commons” in the strict sense even if TK may form the basis of its origin. The ultimate aim of the legislation is not to protect the financial interests of the TK holders, but the benefit of the Society at large, as in the case of the fundamental concept of PATENTS. Patents bestow monetary reward for revealing technological innovation along with accolades for the inventor. Grant of patent for inventions attracts investment because the commercial exploitation of the invention is possible to its fullest extent during the term of patent. The policy does not support extending "trade secret" protection to TK and the State is totally against creation of monopoly over knowledge. Hence Kerala IPR Policy envisages the ways and means for revealing TK for the greater benefit of Society.
Constitutional sanctity of the proposed legislation
While there is no bar on Kerala State in having a policy on Intellectual Property Rights (IPR) to proclaim its stand with respect to its culture, geography, people, Biodiversity etc., constitutional sanctity of a legislation based on the Policy is debatable as IPR is a union subject. However it is imperative that we have to find ways and means to get around this constitutional law bottle neck and to push this legislation through. I have the following arguments regarding the constitutional sanctity of the proposed legislation
1) The words like "Traditional Knowledge", "Intellectual Property", "Biodiversity" etc. did not find specific mention anywhere under Union list, and the Entry 49 is limited to: "Patents, inventions and designs; copyright; trade-marks and merchandise marks" [The application of ‘pith and marrow’ rule may limit this scope].
2) The ownership of TK may be attributed to the State/Crown, given the fact that TK is an accumulated traditional wealth and the long kept preserve of its practitioners, tribal communities and families, wherein all of them act as deemed "trustees" of the State/Crown. So Traditional Knowledge is very well a "treasure trove" (Item No. 44 of State list), where the State has power to legislate.
3) Item No. 26 of State List can be used to regulate Trading of "Knowledge". Item No. 64 provides for enforcement of punitive mechanisms.
4) Item No. 7 (Contracts) of Concurrent list and Item No. 6 (Transfer of Property) also is relevant.
5) Article 300A covers intellectual property also. Article 304(b) and Article 19(6) gives added advantage to treat TK as a Property and hence regulate its Trading
6) The proposed legislation does not intend to touch the patent Act at all, it being a Union Subject. But a few provisions in Biodiversity Act (made using the residual powers of Central Government) needs to be supplemented with additional provisions, but employing the provisions of Articles 258A and 258 (2).
7) There is support of State directives under Article 38, 39 (b) and 39(c)
8) Above all, the proposed legislation is 'not exactly for creating rights on TK', but for assigning those rights to those "deemed trustees", in return of their willingness to put the TK to the realm of "Knowledge Commons"
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