This article is written by Akshatha Shetty, pursuing Certificate Course in Intellectual Property Law and Prosecution from LawSikho. The article has been edited by Aatima Bhatia (Associate, LawSikho) and Ruchika Mohapatra (Associate, LawSikho).

Introduction

An attempt was made by the University of Mississippi Medical Centre to patent turmeric powder. Though the University was granted a patent overusing turmeric powder for curing wounds, the Council of Scientific and Industrial Research (CSIR), India, challenged the same by claiming that the use of turmeric powder was not a new invention and that its medicinal use existed since ages. Later, the United States Patent and Trademark Office (“USPTO”) revoked this patent agreeing to the obvious fact. 

However, the revocation of the turmeric patent at USPTO incurred a lot of time, effort, and money. It also highlighted that there exists a need to remove language barriers, as India’s traditional knowledge (hereinafter referred to as “TK”) was mostly recorded in Sanskrit and other regional languages. All this pushed to create a proactive mechanism for the protection of TK. 

Thus, to prevent exploitation and to provide worldwide protection to Indian traditional knowledge, in 2001, a project named The Traditional Knowledge Digital Library (“TKDL”) was initiated in India. This article’s focus lies on the Traditional Digital Knowledge Library and its impact on patent examination. 

Traditional knowledge digital library

TKDL was formed  in collaboration with:

• CSIR, 
• Ministry of Health,
• Ministry of Science and Technology and the Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha and Homeopathy (AYUSH), and 
• Ministry of Health and Family Welfare of India.  

TKDL is being implemented at the CSIR. The interdisciplinary team which worked in the formation of the TKDL for Indian Systems of Medicine included traditional medicine experts (Ayurveda, Unani, Siddha and Yoga), scientists, patent examiners, IT experts and technical officers.

The TKDL contains digital documentation, in millions of pages, of publicly available traditional knowledge (TK) that relates to Ayurveda, Unani, Siddha, Sowa Rigpa and Yoga.

Once the traditional knowledge is recorded in TKDL, legally, it turns into public domain knowledge. Under the patent law, this means that it is considered to be prior art. This criterion removes its ability from being patentable. Patent examiners can easily check this database and reject any patent application that probably is a mere copy of the traditional knowledge. Thus, TKDL enables in preventing instances of bio-piracy.

Impact on patent examination

To overcome the language and format barrier, TKDL provides information in five international languages: English, French, Japanese, German and Spanish, on TK existing in India. This helps the patent examiners at international patent offices to understand better.

Information on Indian TK has been structured and classified under an innovative classification system called the Traditional Knowledge Resource Classification (TKRC). TKRC is modelled on WIPO’s International Patent Classification (IPC). Furthermore, it has also inspired revisions of the IPC system, which makes it better adapted to incorporate traditional medical knowledge. Thus, the TKRC is not unilaterally shaped by the IPC; the IPC has also been updated and adapted to the TKRC. 

More than 22 lakh medicinal formulations/ practices have been recorded into the TKDL database, along with several thousand sub-groups. This has improved the standard of search and scrutiny of the prior art concerning patent applications filed in the area of traditional knowledge.

By facilitating access to information, which otherwise would not be easily available to patent examiners, TKDL seeks to prevent the granting of patents for products developed utilizing TK where there has been little if any, inventive step. This, in turn, prevents the granting of erroneous patents.

The TKDL enables prompt and almost cost-free cancellation or withdrawal of patent applications relating to India’s traditional knowledge.

At present, access to TKDL is available to 13 patent offices: 

• United States Patent & Trademark Office,
• European Patent Office, 
• Indian Patent Office, 
• Japan Patent Office, 
• Canadian Intellectual Property Office, 
• United Kingdom Patent Office, 
• Intellectual Property Australia, 
• German Patent Office, 
• Intellectual Property Corporation of Malaysia, 
• Chile Patent Office, 
• Rospatent- Intellectual Property Office of Russia, 
• Spanish Patent and Trademark Office and,
• Peru Patent Office under the TKDL Access (Non-disclosure) Agreement. 

As per the preconditions of the Access Agreement, examiners of the patent office can make use of TKDL for research and examination purposes only and cannot disclose the subject matters of TKDL to any third party unless it is required for citation. TKDL Access Agreement is unique and has in-built protection on non-disclosure to safeguard India’s interest against any possible abuse. However, it has attracted some criticism because of its high level of confidentiality.

Did you know that at the time when TKDL was being formed, i.e., in 2001, it was estimated that, every year, around 2,000 patents relating to Indian medicinal systems were being fallaciously granted by patent offices around the world?

More interestingly, even copyright over yoga postures and trademarks on yoga tools were increasing unchecked in the West. The US alone has granted more than 100 yoga-related patents!

Since gaining access to TKDL in February 2009, the European Patent Office has identified around 215 patents that make use of Indian TK.  In some cases, the EPO has set aside its intention to grant the patent, while in others, applicants have either modified or withdrawn their applications. 

For example: 

(i) On 19.2.2009, the EPO decided to grant a patent to Italy’s M/s. Data Medica, Padova SPA, for the usage of Pista as an anti-cancer drug. The TKDL Department of CSIR of India produced evidence on 09.07.2009. Based upon this evidence, the EPO set aside its prior intent to grant the patent on 14.07.2009.

(ii) On 25.02.2010, the EPO decided to grant a patent to M/s. Livzon Pharmaceutical Group Inc., China, to use Kalamegha and Mint to treat avian influenza. India, through its TKDL Department of CSIR, produced evidence on 20.05.2010, based upon which the EPO set aside its prior intention to grant a patent on 10.6.2010. Due to this, M/s. Livzon Pharmaceutical Group Inc. altered its claims on 05.07.2010 in the independent usage of Kalamegha and Mint to treat avian influenza.

(iii) On 09-06-2005 M/s Purimed Co. LTD., Korea filed a patent application to treat heart diseases using Indian lotus. The TKDL Department of CSIR, India, produced the evidence. The applicant decided to withdraw its claims/patent application on 04-08-2009.

According to WIPO, in just under two years, in Europe alone, India has succeeded in bringing about the cancellation or withdrawal of 36 applications to patent traditionally known medicinal formulations. Not to forget, TKDL has played a crucial role in this success. Similar results are expected from other patent offices too.  According to the CSIR, this could help prevent legally complex and expensive opposition processes.

A study by a TKDL expert team at the EPO shows a sharp decline (44 per cent) in the number of patent applications filed concerning Indian medicinal systems, particularly concerning medicinal plants. The TKDL is proving to be an effective deterrent against bio-piracy. 

According to a report of WIPO, with the help of TKDL, India has successfully managed to protect around 0.226 million medicinal formulations, that too at zero direct cost!

It is also a worthy point to note that, while the post-grant opposition is highly expensive and requires legal assistance, the pre-grant objection, which is supported by the TKDL database, is economical and does not require legal support because the prior art evidence is available from the KTDL.

Another major point is that it takes around four to thirteen years for the matter to be concluded under the post-grant opposition, whereas, it roughly takes around three to twenty weeks in the case of the pre-grant objection with the aid of the TKDL database.  

The TKDL has an integrated global biopiracy watch system that allows the monitoring of patent applications related to Indian medicinal systems. It enables effective detection of attempts to misappropriate this knowledge by third parties filing applications with patent offices around the world. It means that immediate corrective action can be taken, and at zero direct cost, to prevent bio-piracy. Till date, India is the only country to have put such a system in place.

Also, the willingness to adapt the IPC to the TKRC standards, with the common conception of international intellectual property rights regulations, acts as a tool against the neocolonial ‘information feudalism’ or a ‘Western knowledge dominance’, where intellectual property regimes are unilaterally imposed on the developing world by developed countries and multinational corporations. Seen in the context of global information feudalism, it seems remarkable that India’s TKRC has had a direct influence on the standards of patent classification globally. 

Conclusion

The awareness and interest in the utilization of traditional medicine have been steadily renewed worldwide. This has also resulted in enlarging its vulnerability to exploitation. This poses a threat to indigenous and local communities of India, to whom the TK is an asset and on which their livelihood depends. This also curbs the freedom of Indian producers to operate in foreign markets. All these lead to facing the risk of an economic crisis. 

These ‘wrongful patents’ not just affect our community and economy, but also questions our identity. Through traditional knowledge, we conserve and protect the biodiversity and the secrets passed down to us by our ancestors.

The documentation of traditional knowledge prevents the chances of bio-piracy thereby protecting it from misuse and misappropriation by third parties. TKDL is the first of its kind prior-art database of traditional knowledge globally and has proven to be a powerful restraint against bio-piracy. While being recognized internationally as a unique effort, TKDL has set a benchmark in TK protection around the world.

References

• https://link.springer.com/article/10.1007/s10978-021-09299-7
• https://www.bananaip.com/ip-news-center/patentability-of-yoga-analysis/
• https://www.wipo.int/meetings/en/2011/wipo_tkdl_del_11/epo_examples.html
• https://www.wipo.int/wipo_magazine/en/2011/03/article_0002.html
• http://www.tkdl.res.in/tkdl/LangDefault/Common/Abouttkdl.asp?GL=Eng

---

Students of Lawsikho courses regularly produce writing assignments and work on practical exercises as a part of their coursework and develop themselves in real-life practical skills.

LawSikho has created a telegram group for exchanging legal knowledge, referrals, and various opportunities. You can click on this link and join:

https://t.me/joinchat/L9vr7LmS9pJjYTQ9

Follow us on Instagram and subscribe to our YouTube channel for more amazing legal content.