Recently, Laila Impex’s application pertaining to an herbal composition (IN201641013908) was opposed by CSIR’s TKDL unit. However, in a surprising turn of events, the unit did not attend the hearing, and the representation given also did not emphasize any of the specific grounds of opposition. 

Initiated in 2001, the TKDL aims to serve as a vital link between traditional knowledge books and patent examiners, safeguarding Indian traditional medicinal knowledge and thwarting its misappropriation at international patent offices.  The question of the credibility of these assertions along with the justification (or lack thereof) for investment in this initiative has been extensively discussed previously on the blog. This recent instance raises concerns about the effectiveness of the TKDL and questions whether it fulfills the objectives of preventing the misappropriation of India’s traditional knowledge, for which it was established. This post seeks to analyze and answer these dilemmas.

Is TKDL Failing Us?

It won’t be wrong to say that TKDL’s representation in substance and overall has been a letdown in the present instance. TKDL’s case of abandoning opposition does not help its case, especially in light of some questionable self-proclaimed “milestones” (discussed here, here, here, and here). TKDL, more than once, has claimed to have thwarted European companies from securing a European patent for ancient Indian remedies, but these have been questioned, for instance, by the blogger who goes by the pseudonym, Tufty the Cat (a qualified U.K. and European patent attorney who maintains a blog by the same name), in this SpicyIP Guest post from 2012 shows that a closer examination of TKDL’s contribution as a third-party observation at the EPO suggests its impact in preventing patents for traditional knowledge to be overstated. In another post in 2015, Tufty’s analysis suggested that, 15 out of the 23 claims that had been examined, are false. He has claimed that despite claims of thousands of wrongfully granted applications due to a lack of traditional knowledge information, TKDL struggles to provide compelling examples of applications being rejected based on TKDL references.

However, TKDL is equally seen to have bagged certain genuine wins for itself as well (discussed here, here, and here). Similar observations were made by an anonymous commenter on Tufty’s post as well.

Furthermore, the debate over whether the Indian Government’s investment in the TKDL is worthwhile for taxpayers has been ongoing. The TKDL is primarily envisioned to prevent the patenting of traditional knowledge so as to uphold the ‘nation’s honor’ and protect its advanced traditional knowledge from misuse by scientists from the West, a premise not only weak but also one that often goes a bit out of hand (for instance, claiming European patent claims over yoga postures, as discussed here and most recently reiterated here). Even the observations of the Parliamentary Standing Committee Report on Review of the IPR Regime in India regarding TK begin with complaining about how TK and grassroots innovations frequently fall outside the bounds of patentability criteria, leaving these valuable contributions inadequately protected due to the absence of a robust statutory framework. The report has highlighted issues of TK misappropriation, citing the lack of an effective documentation mechanism and duly acknowledging the shortcomings in the TKDL for TK protection. However, as discussed here, the report recommends database strengthening without specifying the identified shortcomings or corrective measures.

TKDL has also been critiqued, such as by Prashant here and on NPR here, that it is a substantial expenditure for a mere notion of national pride without tangible benefits. The government allocates significant resources (totalling over 2742.078 crores in the five-year duration from 2017 to 2022 as released by the Rajya Sabha) to actively monitor patent applications globally and contest (often frivolous than not) patents through oppositions. 

Many of these funds are solely directed towards opposing patents with a small probability of ever getting worked in the market for commercial gains, leading to the wastage of such funds, as these patents are merely pieces of paper and nothing more. For any patent having commercial value, opposition against improperly granted patents will come up naturally in the market by competitors, and the government’s role in this is contended as being superfluous by Prashant. 

For some time now, a major area of concern has also revolved around the purportedly confidential nature of the TKDL database, accessible only to patent officers and restricted from the general public. It has been discussed several times in this blog, (here, here, here, here, here, here, and here) why this database is not opened up to accredited Indian universities and researchers for actual utilization. Fortunately, there has been some discussion on this front, and in December 2022, the Cabinet approved widening the  access of the TKDL database to users, besides patent offices. The TKDL now envisions serving a broader user base including businesses, research institutions, educational institutions, and researchers, as well as others like ISM practitioners, knowledge holders, patentees and their legal representatives, and government entities, among several others. 

The access to the TKDL database, however, is planned to be facilitated through a paid subscription model, with a phase-wise opening to both national and international users. Furthermore, this initiative has only reached a halfway point in the level of thoroughness required for its implementation. Firstly, the commercial monetization aspect of the TKDL platform still demands better transparency regarding how the collected funds will be utilized. Secondly, creating a ‘Traditional Knowledge Development Fund’ for commercializing TKDL is a definite requirement in this case. Surprisingly, this suggestion, outlined in the National Knowledge Commission’s “Report to the Nation: 2006-2009” (pdf), has not yet been explicitly contemplated by the government.

Analysing the Abandonment

In the instant case, TKDL raised an objection, claiming that the invention, relating to an herbal composition, lacks an inventive step, arguing that the disclosed information in the applicant’s exhibits makes the invention obvious to a person skilled in the art. However, the applicant countered this objection by asserting that the formulation involved a specific ratio of extracts from Mangifera indica and other plant (Acacia nilotica, Cassia auriculata, Sphaeranthus indicus, or mixtures thereof). The applicant emphasizes that the prior art documents do not disclose this specific ratio and, therefore, do not render the invention obvious.

The patent office concluded on the opponent’s representations and the applicant’s arguments that the cited prior art documents did not, in fact, disclose the specific features of the claimed composition, specifically the 4:1 to 1:4 ratio of the first and second mixture. As a result, the patent office acknowledged the invention to involve an inventive step, meeting the criteria for patentability. Though the TKDL raised issues regarding novelty and inventive steps based on the substantive Guiding Principles 1, 2, 3, and 6 under para 14 of the relevant Guidelines of the CGPDTM, TKDL’s absence at the hearing left the opposition feeble. This was also recorded in the order where the concerned officer observed that the opponent “failed to establish this ground of opposition.”

The TKDL’s decision to abandon this opposition is puzzling, considering that its very objective is assimilating extensive information and collaborating with other patent offices.  Also, looking at the ease with which the Patent Office dismissed the opposition, could this be because the TKDL itself knew the grounds of opposition were weak? And if so, why was it filed in the first then? Despite its active opposition to TK patent applications abroad, the TKDL continues to show ineffective scrutiny of Indian patents, as done for several years before. The website reveals no information about the frequency or current oppositions filed by the TKDL. While it mentions a total of 324 outcomes against bio-piracy, the details remain undisclosed. Even CSIR’s annual reports are silent on the specific opposition filed. Given that the TKDL’s primary purpose is defensive protection against patents, it is imperative that this information be made readily available. It is high time that the TKDL reevaluates its approach.

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• Source: https://spicyip.com/2024/01/a-spotlight-on-tkdl-once-more-oppose-only-to-abandon.html