Traditional Knowledge Digital Library in India: Impact on

Patent Examination

INTRODUCTION:
An attempt was made by the University of Mississippi Medical Centre to patent
turmeric powder. Though the University was granted a US patent over using
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 Trademarks 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 there exists a need to remove language
barriers, as India’s traditional knowledge (herein after 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 TKDL 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
 Family Welfare of India. 

TKDL is being implemented at the CSIR. The inter-disciplinary 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 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, Traditional Knowledge Resource Classification (TKRC).
TKRC is modeled 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 State 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 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 evidences on 09.07.2009. Based upon these evidences,
the EPO set aside its prior intent to grant the patent on 14.07.2009.

(ii) On 25.02.2010 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 percent) 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. Now that’s a lot of time saved!
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 a 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 has 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 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
whereby 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