In the light of these references, all stakeholders of Ayurveda in general and scholars of Ayurveda (read therapeutics and pharmaceutics both) in particular must be acquainted with the basics of IPR, patentand its possible proposition in progress of traditional knowledge of Ayurveda with innovative approach.
(A) Applicability of rules of IPR on traditional Ayurvedic knowledge
What makes knowledge “traditional” is not its antiquity: much TK is not ancient or inert, but is a vital, dynamic part of the contemporary lives of many communities today. It is a form of knowledge which has a traditional link with a certain community: it is knowledge which is developed, sustained and passed on within a traditional community, and is passed between generations, sometimes through specific customary systems of knowledge transmission. A community might see TK as part of their cultural or spiritual identity. So it is the relationship with the community that makes it “traditional”.[6
So, Ayurveda is an integral ingredient as an inheritance of different individual communities of Indian culture since primordial times. It has been created by Lord Brahama
(mythological story) and carried out to planet earth by sagacious scholars – Rishis
and being practiced prominently till date.[7
] This is also factual that at present Ayurvedic practice is being accomplished day by day, and evolves as individuals and communities respond to the challenges posed by their social environment and new ailments. Therefore, it is not only desirable to develop a protection policy that documents and preserves TK created in the past, which may be on the brink of disappearance; it is also important to consider how to respect and sustain the development and dissemination of further TK that arises from continuing use of TK systems. These contemporary aspects of development of Ayurveda demand its legal protection to check its (knowledge of Ayurveda) exploitation from commercial houses or individuals with many other fraudulent objectives.
Rules framed for protection of knowledge of various categories under IPR are quite sufficient to check its obnoxious uses either by inventors or swindlers. IPR rules are clearly differentiating the properties and characters of knowledge which may be used for commercial benefits by inventor directly or through a company. Under these compositions of IPR, Ayurvedic traditional knowledge invites greater attention at present. Previously certain sectors of society and ill-minded individuals tried to vilify this wisdom under rules of IPR ultimately leading to patent but aware public and regulatory authorities checked them successfully in few cases.
After flood of fraudulent claims regarding medicines and procedures of Ayurvedic treatment concern authorities in India may adopt policy for positive protection of Ayurvedic traditional knowledge on under mentioned points of concern.[6
- Recognition of value and promotion of respect for traditional knowledge systems
- Responsiveness to the actual needs of holders of TK
- Repression of misappropriation of TK and other unfair and inequitable uses
- Protection of tradition-based creativity and innovation
- Support of TK systems and empowerment of TK holders
- Promotion of equitable benefit-sharing from use of TK
- Promotion of the use of TK for a bottom-up approach to development
(B) Procedures for patent and Ayurvedic perspicacity
In the later part of the nineteenth century new inventions in the field of art, process, method or manner of manufacture, machinery, apparatuses and other substances, produced by manufactures were on the increase and the inventors became very much interested that the inventions done by them should not be infringed by anyone else by copying them or by adopting the methods used by them. To save the interests of inventors the then British rulers enacted the Indian Patents and Design Act, 1911. Since then many amendments was adopted as and when it was felt and finally The Patent Bill was introduced in the Parliament 1970.[8
] A major amendment was introduced in 2005 defining process and product patent in the context of contemporary international rules.
An invention is the creation of intellect and applied to capital and labor, to produce something new and useful. Such creation becomes the exclusive property of the inventor on grant of patent. The Patentee's exclusive proprietary right over the invention is an intellectual property right. The Patent Law recognizes the exclusive right of a patentee to gain commercial advantage out of his/her invention. This is to encourage the inventors to invest their creative faculties, knowing that their inventions would be protected by law and accordingly no one else would be able to copy their inventions for certain period during which the respective inventor would have exclusive rights.[9
Procedures for obtaining a patent consists of the following steps.
- Submission of application
- Examination of application
- Advertisement of acceptance of complete specification
- Opposition to grant of patent to the applicant
- Hearing of parties
- Grant and sealing of patent.
Ayurvedic knowledge is centuries old in this continent and as per rules of Patent, to get a patent it must be new invention, consisting nobility with commercial industrial application. So, in first sight it seems that it is impossible to get a patent on Ayurvedic knowledge which is in ‘public domain’ and ‘prior act’ as per provisions of patent act which prohibit grant of patent in these set of conditions.
(C) Provisions of patent for pharmaceutical products
India's patent act of 1970 granted patents on chemical processes but did not permit patents on drugs. This allowed Indian drug companies to reverse engineer molecules to produce generic versions of patented drugs. Health activists say the amendments would make it easier for companies to acquire patents on new uses of old drugs and on new combinations of old drugs. Under the new legislation, compulsory licensing that allows local companies to produce generic products would become difficult.
The Patent Amendment Act 2005 passed by the Parliament in its budget session of 2005 brings the Indian Patent Act in full conformity with the intellectual property system in all respects. This replaced an ordinance promulgated on December 2004 to meet WTO obligations. Some of the major amendments have been introduced in Sections 2 and 3 which are as follows: section 2 of the Patent Act is the definition clause: According to section 2(j) invention means a new product or process involving an inventive step and capable of industrial applications.
Inventive step means a feature of an invention that involves technical advance as compared to existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in art.
Thus an invention in order to be patentable, should
- Involve an inventive step capable of industrial application;
- Which should involve technical advances as compared to the existing knowledge or having economicsignificance or both; and
- Be not obvious to a person skilled in art.
Section 3 outlines various situations where an invention (properly so called) can yet be not patentable. Section 3(d) of the Patents Act 1970 has been amended under the new Act to prescribe a class of discovery which cannot be subject matter of patent; it reads as follows:
(d) Mere discovery of a new form of known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least employs one new reactant.
Product patents have been extended to fields of technology such as drugs, food and chemicals but granting of patents are subject to restrictions as mentioned above (Section 3(d)). This section prevents frivolous inventions from being patented. The amendments introduced in the Patents Act exhibit the essence of patentability in the pharmaceuticals and chemicals is inventive ingenuity, novelty andexistence of industrial application or economic significance of the new product or process. Patents work differently in different industries. However, in the pharmaceutical, chemical and biotechnology industries the patent normally equals the product, and protects the extensive investment in research and clinical testing required before placing it on the market.[4
How far all these measures of Patent Act will be beneficial to Ayurvedic medicines of different categories notified in Drugs and Cosmetics Act,1940 to get a patent or to check patent for commercial exploitation is a debatable affair among all stakeholders of Ayurveda eyeing global business with Ayurvedic medicines of different licensing groups.[10
(D) Commercial correlation of patent and Ayurvedic medicines
Patent provides an opportunity of prosperity to patentee. Thus people of diverse surroundings are trying to create wealth through Ayurvedic traditional knowledge by claiming numerous patents on subject matters which are in domain of Ayurveda. Since market of Ayurvedic medicines have boomed all across the globe especially in American, European countries, organizations as well as individuals are not leaving any stone unturned to have some patents related to medicinal plants of Ayurveda to exploit multiple million benefits from these patents. With the upsurge in acceptance of traditional medicine among global public there is unprecedented abundances in applications to grant patent on many aspects of medicinal plants detailed in Ayurveda varying from process to product categories.
(E) The problem of plenty proficiency in Ayurveda
Ayurveda has one million verses in its origin, describing every problem and solution of life, holistically since the dawn of civilization in this continent. And onwards, hundreds of classical texts dealing with different disciplines of medicines were created by visionary scholars of Ayurveda, sharpening, widening and accommodating advancement of knowledge of successive periods. Result of this continuous enlightenment in realm of Ayurveda is anthology of assorted enormous wisdom to serve human of any race, color, caste and creed across the world, transversely. Unfortunately, this immense treasure of Ayurveda is generating a challenging situation for attorney and officials of Patent offices as they do not have assess of this comprehensive knowledge. American and European offices of patent were unable to cross check the claim of new inventions due to several problems such aslack of digitalization, difference in language, unavailability of classical or folk text books of Ayurveda and many more. Taking advantage of these unforeseen conditions some traitors got patent on medical ethics of Ayurveda, on the basis of forged documents.
(F) Tit-for-tat through traditional knowledge digital library
For any sector to exist and grow, the foundation is knowledge base. There are various phases right from discovery of knowledge to deployment of knowledge. It can be used not only for traditional medicinal sector but any sector in capturing knowledge, integrating it properly, organizing and managing it effectively and finally deploying it and developing applications and tools for the end users to make effective use of their domain knowledge.[11
] Perceiving need of digitalization of traditional knowledge of India to protect it from patent biopiracy especially in field of medicine a multiparty as well as multicentric project was launched. It is on record that the Council of Scientific and Industrial Research (CSIR) successfully revoked patents filed on turmeric, Neem
in USA. This success set the tarmac from which the new initiative called the ‘Traditional Knowledge Digital Library (TKDL)’ was perceived and followed. The first phase of TKDL on Ayurveda is marked for completion in October, 2010. This is notable that for bringing out a TKDL on Ayurveda, a Memorandum of Understanding was signed on 6 June 2001 between the National Institute of Science Communication (NISCOM, presently NISCAIR), New Delhi, and the Department of Indian Systems of Medicine and Homeopathy (ISM & H) later renamed as Department of AYUSH (in 2003), Ministry of Health and Family Welfare which is running successfully at present.[12
Further, humble purpose of establishing TKDL is to assimilate the scattered and non-documented literature on TK and bring it into a format which can be easily accessed, understood and retrieved by International Patent Examiners. In the Trade-Related Aspects of Intellectual Property Rights (TRIPS)agreement of WIPO, the classification system in International Patent Classification (IPC) for the documentation of TK, had only one single subgroup related to medicinal plants. Therefore, a modern classification system was evolved which was in line with IPC. Agencies like Indian National Institute of Science Communication and Information Resources (NISCAIR-CSIR) and Dept. of AYUSH, Govt. of India prepared a classification system especially for Ayurveda, in the first instance, and named it as Traditional Knowledge Resource Classification (TKRC).
This will have significant impact on the system of search and examination while granting patents in the area of TK whereby the possibilities of granting of wrong TK patents will be significantly reduced. TKDL targets Indian Systems of Medicine i.e., Ayurveda, Unani, Siddha, Yoga and Naturopathy available in public domain. The related information was documented from the existing literature available in Sanskrit, Urdu, Arabic, Persian and Tamil languages. This was translated into five international languages (English, German, French, Spanish and Japanese) which could be understood by international patent examiners. TKRC is an innovative structured classification system for the purpose of arrangement, dissemination and retrieval of TK. As per the IPC rules, the information is classified under sections, subclass, subgroups which makes it easy for patent examiners to access.
In fact, TKDL is basically a software and with its classification system converts text in local languages into multiple international languages. This software does not transliterate, but it does a knowledge-based conversion where the abstract is converted into several languages using Unicode, metadata methodology. This software also converts traditional terminology into modern terminology e.g., Turmeric to Curcuma longa
to Azadirachta indica
A. Juss; Basmati rice to Oryza sativa
to fever; Kumari
to Aloe vera
to small pox. TKDL includes search interface which provide full text search and retrieval of TK information on IPC and keywords in multiple languages. The search features includes single or multiple word search, Boolean expression search, field search, phrase search etc. Searches are also available on IPC and TKRC codes.[5
TKDL is an effective tool for protection of TK against misuse or misappropriation which raises deep policy questions and practical challenges alike. The changing social environment, and the sense of historical dislocation, that currently affect many communities may actually strengthen resolve to safeguard TK for the benefit of future generations. Just as the technological value of TK is increasingly recognized and its potential realized, the challenge is to ensure that the intellectual and cultural contribution of traditional communities (read Indians)is appropriately recognized. It also provides a potential avenue for developing countries, to benefit from the knowledge economy.[6
Knowledge of Ayurveda, if utilized properly without the bar of patent universally, it may change the economic scenario of country, India. This has been substantiated by The “Report of the Sub Group on Research and Industry” of the Steering Committee on AYUSH for the Eleventh Five –Year Plan (2007-2012), in its proposed export –oriented schemes “Schemes for Development of new Formulations, Technologies, Tools and Practices with Validation of Existing Products and Procedures”, states that one of the measurable outputs for this scheme in the 11th
Plan would be a rise in exports of products put up for retail sales from the AYUSH sector to Rs 3000 Crore by 2012 from Rs 120 Crore in 2005.[13