Introduction
As regards to biological resources, India can be considered as one of the mega-diverse countries of the world. Further, the relationship between India’s rich biodiversity and its indigenous people is not only extraordinary but has been prominent through the ages. The prevalence of its rich biodiversity can be directly correlated with Traditional Knowledge (‘TK’), particularly relating to the Ayurveda, Unani and Siddha systems of medicine, which have been passed down from generations. While there is no internationally accepted definition of TK, the World Intellectual Property Organization (WIPO) describes that TK in a specific sense refers to knowledge resulting from ‘intellectual activity’ and defines TK as ‘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’[1]. Recently, the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge was attended by the member states at the diplomatic conference held from 13 May to 24 May 2024, taking a step forward to include provisions specifically for Indigenous Peoples as well as local communities. As per this treaty, if an invention claimed in a patent application is based on genetic resources, each contracting party shall require applicants to disclose the country of origin or source of the genetic resources. And if the claimed invention in a patent application is based on TK associated with genetic resources, each contracting party shall require applicants to disclose the source of the TK associated with genetic resources[2]. While the Treaty acts as an instrument to conform the patent system of member states in relation to genetic resources and TK associated with genetic resources, the cross-link between TK and intellectual property has been long recognized by the Indian Patent Law. Moreover, in view of India’s compliance obligation to the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement), the Indian Laws provide several provisions to ensure conservation and sustainable use of biological diversity and safeguard traditional knowledge and the interests of associated Indigenous people/communities. This article aims to shed light on the current Indian Patent Law associated with safeguarding TK.
Traditional knowledge and Indian Patent Law
Section 2(1)(j) of the Indian Patents Act, 1970 (‘Act’), states that ‘invention means a new product or process involving an inventive step and capable of industrial application’. Hence, anything that falls under the category of ‘TK’, would be construed as ‘previously known’ or ‘part of public domain’ and hence, would not suffice as an ‘invention’ under the meaning of the Act. Further, Section 3(p) of the Act specifically bars the patenting of ‘an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components’. In addition, Sections 3(b), (c), (d), (e), (f), (h), (i), and (j) of the Act may be relied upon during the examination of Patent Applications related to TK.
The Applicability of these provisions while assessing patent applications can also be witnessed in the judgment passed by the High Court of Himachal Pradesh in Dhanpat Seth and Ors. v. Nil Kamal Plastic Crates Ltd., 20 September 2007[3]. The Appellants (plaintiffs) held a patent (Patent No. 195917) in respect of a device used for manufacture of manually hauling the agricultural produce. Previously, a suit seeking a grant of permanent prohibitory injunction restraining the defendant from infringing the Patent was filed. The primary allegation of the defendant was that there was no novelty or invention in the Patent and in fact it is just a centuries-old device popularly known as ‘KILTA’ which was originally made of bamboo and has now been substituted by plastic. The Single Judge had dismissed the application for grant of interim relief on various grounds and one of the grounds was related to traditional knowledge i.e.,
- The patentees (plaintiffs) device is basically an imitation of the traditional Kilta. There is no novelty about the same.
Aggrieved by the order of Single Judge, the plaintiffs filed an appeal in the Himachal Pradesh High Court. The Division Bench while upholding the order passed by the learned Single Judge in Dhanpat Seth & Ors. v. Nil Kamal Plastic Crates Ltd., MANU/HP/0206/2007: AIR 2008 HP 23[4] held that the device developed by the plaintiffs forms a part of TK and, therefore, cannot be said to be an invention and further directed revocation of the plaintiff’s patent under Section 64 of the Act. The Court also concluded that the plaintiffs are, therefore, not entitled to any injunction.
This article intends to highlight the relevant sections of the Act, relied upon by the Court, particularly, Sections 2(1)(j), 2(1)(ja), and 3(p). With respect to Section 2(1)(ja), the Court emphasized that the definition of an ‘invention’ clearly shows that even a process involving an inventive step is an invention within the meaning of the Act. It is, therefore, not necessary that the product developed should be a totally new product. Even if a product is substantially improved by an inventive step, it would be termed to be an Invention. The definition of ‘inventive step’ provides that when technical advances as compared to existing knowledge take place in an existing product or there is improved economic significance in the development of the already existing device and the invention is not obvious to people skilled in the art, it would amount to an inventive step para 11 of 3.
Upon examining the device of the plaintiff as well as the traditional Kiltas, the Court opined that a Kilta is a traditional product which has been used ‘since time immemorial’ for carrying produce including agricultural produce in hill areas especially in the State of Himachal Pradesh and there is virtually no difference in the overall design of the traditional Kilta or the ‘devices’ developed by the plaintiffs and the defendant. At most, the only distinction is that the Kilta is made of bamboo and the plaintiff’s device was made of polypropylene copolymer (PP). The Court further opined that there is nothing new about the process of manufacturing the traditional Kilta made of natural material as compared to that of synthetic material. Hence, contrary to the plaintiff’s contentions, the court declared that the plaintiff’s device was neither novel nor inventive paras 13 and 17 of 3. In light of these facts, the Court prima facie was of the view that ‘the device developed by the plaintiffs is in fact the result of traditional knowledge and aggregation /duplication of known products such as polymers and, therefore, cannot be said to be an invention’. para 27 of 3.
This judgment affirms that while analyzing a patent application for inventions based on TK, the analysis under Sections 3(p), 2(1)(j), and 2(1)(j)(a) should not be aligned and rather performed gradatim.
The Added layer of protection
As a subsequent regulatory check, the Indian Patent Office (‘IPO’) issued guidelines for processing patent applications relating to traditional knowledge and biological material on 8 November 2012[5], to prevent the granting of patents relating to the Ayurveda, Unani, and Siddha systems of medicine, etc. The guidelines provide an examination method to the Examiners dealing with patent applications for assessment of novelty and inventive step in the form of six guiding principles. These principles insinuate the Indian Patent Office’s understanding with respect to what is considered as a part of TK and aims to provide a guided path to both the examiner as well as the Applicant to assess the patentability of an invention in a patent application.
These guidelines further mandate that for all patent applications relating to TK, the Examiner must search anticipation in the Traditional Knowledge Digital Library (‘TKDL’) or other relevant databases. TKDL is an initiative of the Govt. of India to provide a unified database for traditional knowledge existing in India in numerous languages and formats. Further, if any citation is made from TKDL database during the prosecution of the patent Application, the Examiner must provide a copy of the citation (English translated) along with the examination report, giving the Applicant a fair opportunity of rebuttal.
The Indian Patent Office provides several checkpoints for screening, and subsequently disallowing applications for patents based on TK. For instance, during examination (under Section 15) or in pre-grant oppositions, under clauses (d), (f), and (k) of Section 25(1) of the Act. In addition, upon grant, patents can be opposed under Section 25(2) of the Act or revoked under Section 64 of the Act. But what is remarkable is the presence of clauses (d), (f), and (k) in Section 25(2) of the Act, acting as rectifying tools for inadvertently granted patents relating to TK. Hence, ‘anticipation having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India’, forms a ground for both pre- and post-grant opposition. In addition, Section 66 of the Patents Act empowers the Central Government to act as a tertiary check and revoke patents in the public interest.
Where are we now?
The Indian Patent law indeed lays the groundwork for safeguarding TK. This is also apparent from the fact that till date, 283 patent applications have been either refused, amended, or withdrawn/abandoned, due to TKDL based examination[6]. Further, the TKDL database is being shared with other patent offices like USPTO, and EPO for subjecting the examination of the patent applications filed in those jurisdictions.
While the ‘end in view’, for IPO, is preventing or overriding grants of Patent Applications relating to traditional knowledge, the interpretation of Section 3(p) of the Act remains a backdrop. An elementary example of this is that the term ‘traditional knowledge’ has not been defined by the Indian Patent law. Even if one were to consider the definition provided by WIPO, the timeline required for such knowledge to be called traditional knowledge cannot be deciphered. Further, the phrase ‘an aggregation or duplication of known properties of traditionally known component or components’ has not been elaborated in the guidelines or the Act. It is not however clear whether ‘an aggregation of unknown properties of traditionally known components’ would fall outside the purview of Section 3(p). Although the language of Section 3(p) is quite similar to the language of Section 3(e) of the Act, yet unlike Section 3(e), no judicial backing is available to establish that ‘synergy’ is a component for consideration in respect of ‘an aggregation of unknown properties of traditionally known components’, for an invention to fall outside the purview of Section 3(p).
The Guiding Principle 3 of the guidelines does specify that, ‘in case an ingredient is already known for the treatment of a disease, then it creates a presumption of obviousness that a combination product comprising this known active ingredient would be effective for the treatment of same disease’. Further, the analysis of said principle provides a feeble indication that such a combination may not be obvious in view of the TKDL-prior art as long as such a composition results in a surprising (superior) effect vis-à-vis the already traditionally known components. However, judicial precedents confirming the same is still absent.
Keeping in view the recent time-honoured recognition given to traditional knowledge by the WIPO treaty, a statutory definition of the term ‘traditional knowledge’ as well as judicial interpretation of Section 3(p) can help both the Examiners as well as the Applicants to further streamline the examination process in India. With such clarity, an Applicant can decide whether or not to file/prosecute a patent application if the subject matter falls within the boundaries of Section 3(p), thereby saving both resources and time.
[The authors are Senior Patent Analyst and Executive Director, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys, New Delhi]
[1] https://www.wipo.int/tk/en/tk/
[2] https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf
[3] Dhanpat Seth and Ors. v. Nil Kamal Plastic Crates Ltd., 20 September 2007
[4] Dhanpat Seth & Ors. v. Nil Kamal Plastic Crates Ltd., MANU/HP/0206/2007: AIR 2008 HP 23
[5] Guidelines for processing of Patent Applications relating to Traditional Knowledge and Biological Material
