Indian civilizations has been enlightening the world since time immemorial, and is one of the continuous civilizations where history is still alive, awake and its lessons are beyond the limitations drawn by time, space and causation, unlike anywhere else where history is only discovered buried underground or in mystically abandoned forms. Therefore, history in India is termed as “itihasa” in Sanskrit and its derivative Indian languages. In innumerable instances, the transmission of knowledge is only through cryptical hymns or “shlokas”, only in verbal or oral form without any written manifestation, as an effort to preserve knowledge beyond the limitations of physicality, although many of which have been written down at later stages not only in Sanskrit, Ancient/ Modern Tamil, but also in Arabic and Urdu. The best written form is available in the form of Susruta Samhita and Charaka Samhita, as materia medica for surgical intervention and plant based medicine respectively. Thus, this form of history lives through tradition, the phrase may be bibliographically defined as “the transmission of customs or beliefs from generation to generation, or the fact of being passed on in this way”. Traditional knowledge is acquired knowledge through traditional means i.e. perpetuated through generations. As per the definition of World Intellectual Property Organization (WIPO), “Traditional knowledge (TK) is knowledge, know-how, skills and practices that are developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity”.
Traditionally, India used to be the frontrunner when it came to technology, innovation, science, engineering, mathematics, arts, literature, medicine, education, philosophy, sports or whatever facets of human activities, closely followed by China, something which is also evident through historical data available for gross domestic product (GDP). India used to be at the apex, followed by China till the sixteenth-seventeenth century prior to the industrial revolution. This openness was however, renounced for a brief period due to foreign invasion of an unprecedented nature, resulting in protectionism. Since the 90s, India started opening up yet again and began merging its capabilities with the rests of the world while being a signatory to several treaties under the auspices of the World Trade Organization (WTO). However, in this process, it also safeguarded its own capacities and resources, considered as imperative especially in the aftermath of the disputes over the alleged patenting of the likes of neem, turmeric and basmati. The grant of a US patent for wound healing properties of turmeric, and the time, effort and money spent allegedly on revocation of the patent, highlighted the need to legislate a mechanism for TK protection.
Thereafter, to prevent misappropriation, India took a pivotal role in the documentation of traditional knowledge and put the impetus to protect the same at the centre stage of the International Intellectual Property System. This had been followed by execution of Traditional Knowledge Digital Library (TKDL) Access (Non-Disclosure) Agreements with several international patent offices including thirteen European Patent Office (EPO), United State Patent & Trademark Office (USPTO), Japan Patent Office (JPO), Intellectual Property Office, United Kingdom (IPO, UK), Canadian Intellectual Property Office (CIPO), German Patent Office, Intellectual Property Australia, Indian Patent Office (IPO), Chile Patent Office, Intellectual Property Corporation of Malaysia, Intellectual Property Office of Russia (Rospatent), Peru Patent Office and Spanish Patent and Trademark Office, leading to rejection/ abandonment/ withdrawal/ outright amendment of many patent applications concerning India's traditional knowledge.
TKDL thus is a pioneering initiative for the sole purpose of protection of TK, considered valuable to the locals yet vulnerable because of the open economy. As per the official website of TKDL (Ref.: http://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng), more than 70% population and livelihood of millions of people in India is dependent on traditional medicine. For documented medicines, TKDL successfully addressed the language and format barrier by systematically and scientifically converting and structuring the available contents of the ancient texts related to all the traditional forms of medicine including Ayurveda, Siddha, Yoga, Sowa Rigpa, Unani into five international languages, namely, English, Japanese, French, German and Spanish, through the intervention of information technology (IT) tools and an innovative classification system i.e. Traditional Knowledge Resource Classification (TKRC), classifying the Indian TK in myriad subgroups. The initiative of setting international specifications and standard for setting up TK databases was adopted by the Committee in the fifth session of the Intergovernmental Committee (IGC) of WIPO on Intellectual Property and Genetic Resources, Traditional Knowledge and Expression of folklore, thus, with the establishment of TKRC, TKDL acts as a bridge between these written source of knowledge and International patent examiners. Thus, by the system set-up, adhering to the terms and conditions (T&Cs), examiners of the patent offices at agreeable terms may utilize TKDL for search and examination, however, may never reveal the contents therein the TKDLs to any third party unless obligatory for citation. Besides oppositions, pre-grant oppositions are filed before various IP offices referring to the TKDL with little or no cost.
A notable case is regarding a patent application on another endemic Indian plant neem, i.e. Azadirachta indica, used traditionally as astringent, disinfectant, against infections, skin disorders, ulcers or the likes, filed by W.R. Grace and the Department of Agriculture, USA before the EPO, claiming a method of controlling fungi on plants comprising of contacting the fungi with a Neem oil formulation. A legal opposition to this patent was lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), in co-operation with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament (MEP), with the evidences found in ancient Indian ayurvedic texts both for use in the case of humans and plants. This also resulted in exclusion of several neem-based emulsions and solutions from US patents of the same domain.
Apart from these and many more extrinsic efforts to deter patent applications in foreign jurisdictions, there are intrinsic efforts to deter the same in own jurisdiction. India signed the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement under the WTO (World Trade Organization) for the transfer of technologies from the signatory developed nations after duly addressing the standards, enforcement and dispute settlement in order to create a sound technological niche. As a minimum standards agreement, TRIPS allows Members to provide more extensive protection of IP (Intellectual Property) as desired, as well as liberty to determine appropriate method of implementing the provisions of the Agreement within the legal system and practice of its member countries, resolving trade disputes over IP, and in assuring WTO members the latitude to achieve its members’ domestic policy objectives. Thus was created the Protection of Plant Varieties and Farmers’ Rights Act (PPV&FRA) giving IP (intellectual property) protection for seed companies for the seeds developed by them, as well as ensuring the rights to farmers for their traditionally conserved varieties; with its corresponding non-patentability under Section 3 of the Indian Patent Act as amended. Any act of patenting of any traditional knowledge was also barred through Section 3(p) saying no patent would be granted for “an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components”.
Several patent applications, more specifically several claims in several patent applications have since been rejected by the Indian Patent Office (IPO) U/S 3(p), possibly along with corresponding lack of Novelty and/ or Inventive Step as any categorical disclosure in TKDL may also tantamount to a lack of Novelty and/ or Inventive Step because of that prior disclosure. In one such case, a Patent (IN 195917) was granted to an individual Mr. Dhanpat Sheth, for a “device used for manually hauling agricultural produce”, offering a solution for persons of variable heights and weights. Validity of this patent was challenged by Nil Kamal Plastic Crates Ltd. before the Himachal Pradesh High Court (HP HC) on the basis of its alleged similarities to a traditional handicraft called “Kilta”, an-all-purpose bamboo basket for carrying any type of load(s), supported by a rope while tied to the forehead.
Hon’ble HP HC, despite a delay of about 13 years from the filing of suit to the decision, while examining the validity of said patent, found that the product protected by the patent is nothing but a “mere duplication of traditionally known device” called “Kilta”, wherein the traditional raw material of the hardware i.e. bamboo had been replaced by plastic. Correspondingly, the patent was revoked in 2018 U/S 3(p) and corresponding Inventive Step U/S 2(1)(ja), as well as U/S 3(d) for mere replacement of bamboo by synthetic plastic.
Regarding this, it is to be noted that TKDL is not an open source information, and only available through special access and/ or subscription. Therefore, it may happen that an inventor may accidentally infringe any TK of any country. However, irrespective of restricted access, the matters are still considered “public”.
Given all this information, coming to the effort of patenting a valuable subject matter involving any biological material(s) procured from India, certain points must be considered. As most of the patent applications objected U/S 3(p) are from pharmaceutical/ biotechnological domain, first of all, it is unlikely that a country like India with its vibrant tradition has left any stone unturned when it comes to the effort of finding a remedy to any problem countered, therefore, an inventor should not work only upon whole plant or plant parts or direct plant derivatives or the like. As micro and nanotechnology are new areas of investigation, the effort may be centred using micro and/ or nano-formulation of plant or plant parts rather than pure extracts including water extracts and alcohol extracts or plant parts per se. Having said so, it may be noted that this suggestion is not full-proof as an application may still be objected U/S 2(1)(ja) as the plant or the part(s) thereof may be known, so are the method of preparing a nano-formulation or the likes, however, the scope U/S 3(p) may be made null and void as such effort of creating micro or nano-formulation may never be anticipated by any TKDL. Secondly, the method of preparation of certain composition/ formulation may be patentable with optimization in process parameters leading to standardization of the protocol. Last but not the least, for any device, if modern technological interphase could be manifested, then there would be little room for an objection U/S 3(p).
In case any objection U/S 3(p) is not rebutted to the satisfaction of the examining authority i.e. the concerned Controller of the IPO, consequences may be faced in the form of pre- and post-grant opposition as well as revocation of the patent, if granted. Following paragraphs discusses the matter in detail in tandem with other related provisions of the act and potential objections and consequences thereof.
It may be noted that Section 3(p) is about existing traditional knowledge, said traditional knowledge is often related to biological material, and the biological material must be mentioned with the details of its source and geographical origin and/ or the deposition details whichever applicable, therefore, the corresponding to Section 10(4)(d)(A)(B)(C)(D) of the Act comes into play and consequences of not satisfying the provisions of these may result in pre-grant opposition U/S 25(1)(j) for non-disclosure or wrong disclosure of the source, U/S 25(1)(f) for non-patentability, and U/S 25(1)(k) specifically for existing knowledge of the invention, oral or otherwise, available within any local or indigenous community in India or elsewhere. In addition, as the existing traditional knowledge also destroys the Novelty as well as the Inventive Step of the subject matter of any invention, pre-grant opposition U/S 25(1)(a) for wrongfully obtaining the invention, U/S 25(1)(d) for pre-existing public knowledge, and U/S 25(1)(e) due to obviousness. Likewise, for a granted patent with such lacunae, an interested party may oppose U/S 25(2)(j), U/S 25(2)(f), U/S 25(2)(k), U/S 25(2)(a), U/S 25(2)(d) or U/S 25(2)(e).
Further, a granted patent may be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court U/S 64 of the Act. U/S 64(1)(q) corresponding to the Section 64(1)(e) or 64(1)(f), a patent may be revoked if found to be anticipated by any TKDL or the like. The non-disclosure of wrongful-disclosure of source and geographical origin makes a granted patent vulnerable U/S 64(1)(p) of the Act.
In sum, given the plethora of traditional wisdom Indians inherit, there may never be a “one size fits all” solution, and care must be taken on a case to case basis rather on a general basis in order to get a patent granted before the IPO.
