T K D L
TRADITIONAL KNOWLEDGE DIGITAL LIBRARY (TKDL)
Traditional Knowledge Digital Library (TKDL) is a collaborative project
between Council of Scientific and Industrial Research (CSIR), Ministry of Science and
Technology and Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and
Homoeopathy (AYUSH), Ministry of Health and Family Welfare.
TKDL involves documentation of the knowledge available in public domain on
traditional knowledge from the existing literature related to Ayurveda, Unani and Siddha in
digitized format, in five international languages which are English, French, German,
Spanish and Japanese. So far, the TKDL includes about 2.12 lakh medicinal formulations
( Ayurveda: 82,900; Unani: 1,15,300; Siddha: 12,950 ), from 148 books available in public
domain, and the database exists in 34 million A4 size pages. Creation of TKDL – Yoga is
under process and till date about 900 no. of Yoga postures from 14 old yoga books in
public domain have been transcribed, which will also be videographed and added to TKDL
database.
Government of India, on 29
of TKDL database to International Patent Offices, under Non-disclosure Agreement,
between CSIR and respective International Patent Office, according to which -
(i) Access to TKDL by the examiners of an international patent office would only
be utilized for patent search and examination, and
(ii) International Patent Offices and their examiners would not make any third
party disclosure other than what is necessary and essential for the purpose of patent
search and examination.
Access to TKDL has been given to European Patent Office (having 35
member states), German Patent Office, Indian Patent Office and United States Patent and
Trademark Office (the Agreement for which was signed in November 2009, on the sidelines
of the State visit of Hon’ble Prime Minister to United States).
The genesis of the maiden Indian effort dates back to the year 2000, when an
interdisciplinary Task Force of experts was set up by Department of AYUSH and CSIR, to
devise a mechanism on protection of India’s Traditional Knowledge, after the wrong patents
granted on the wound healing properties of turmeric (US patent No. 5,401,504) by USPTO
and on the bio-pesticidal property of Neem (EPO patent No. 436257) by EPO, came to
notice which were later fought and got revoked. Pursuant to this, studies were carried out to
find out the extent of misappropriation of India’s traditional knowledge which show that
there is a continuous rise in misappropriation of traditional medicinal knowledge of India at
the International Patent Offices, as reflected in the table below,
th June 2006, has approved to provide the accessS.No Patent Databases Studied Year of Study No. of patents
taken
1 USPTO 2000 4,896
2 International Patent Offices 2003 15,000
3 ----------do--------------------- 2005 35,567
4 -----------do--------------------- 2008 85000
Number of patents taken on Indian Systems of Medicine at International Patent
Offices each year is approx.2000.
With reference to Yoga, the study conducted by the TKDL team on the
international patent databases in February 2004 found 249 patents taken on Yoga, in May,
2005 found over 2300 patents, 2315 Trademarks at USPTO and nearly 150 copyrights at
USPTO, taken on Yoga
The reason for this misappropriation at International Patent Offices, as
identified, is that the traditional medicinal knowledge exists in local languages, such as
Sanskrit, Urdu, Arabic, Persian and Tamil which is neither available nor can be understood
by patent examiners even in case of availability, at international patent offices since the
information exists in local languages. In other words, there exists a language and format
barrier due to which patents are being taken on the existing traditional knowledge of India.
To break this language and format barrier Traditional Knowledge Digital Library (TKDL) was
created by India, which with the help of Information Technology tools and a novel
classification system i.e., Traditional Knowledge Resource Classification (TKRC), makes
the knowledge available to patent examiners in patent application format and in a language
that can be understood by them.
TKDL has enabled inclusion of approx. 200 subgroups instead of few
subgroups available earlier in the International Patent Classification (IPC). The decision
was taken in 35
the initiative of India. This is likely to have significant impact on the system of search and
examination while granting patents in the area of traditional knowledge whereby the
possibilities of grant of wrong TK patents shall get significantly reduced.
International specifications and standards for setting up of TK databases and
registries have been established based on TKDL specifications, which were adopted by the
Intergovernmental Committee (IGC) of WIPO on Intellectual Property and Genetic
Resources, Traditional Knowledge and Expression of folklore in its fifth session held in
2003.
The TKDL Access Agreements are unique and would have long-term
implications on the protection of traditional knowledge and global intellectual property
systems. The impact of TKDL Access agreement with EPO may be appreciated due to the
fact that generally, a patent opposition process involves an average time of 10-12 years
and expenses running into millions of US dollars. For example, the opposition process in
the cases of Neem Patent (EP436257), Enola beans patent (US Patent No. 5894079) and
Monsanto Soybean patent (EP301749) took 10 years in each of the first two cases and 13
years in the third case, when the final decision on rejection could arrive. On the other hand,
with the help of TKDL, opposition communicated in the form of ‘Third party observation’
against patent applications filed on India’s traditional knowledge at EPO, shows the impact
in few weeks of time without any cost implications. In fact now cancellation happens at
international patent office based on e-mail from TKDL, unit CSIR For example, based on
the examination carried out by the TKDL team on the patent applications filed at the EPO
and the TKDL database, CSIR had submitted ‘Third party observations’ in 36 cases where
patent applications were filed on India’s TK, giving evidences from TKDL for the
misappropriation. In response, EPO has set aside intention to grant patent in two of the
cases, whereas six patent applications have been withdrawn by the applicants on receiving
details of
other patent offices where CSIR has been able to conclude the Access Agreement.
The access to the TKDL for International Patent Offices would also enhance the
negotiating strengths of India and the developing countries at the international fora. In fact,
the international IP community has recognized TKDL as the effective tool for protection of
traditional knowledge. In a recent communication, the Director General, World Intellectual
Property Organization has recognized TKDL as a strong practical tool which has made
unparallel contributions to the international policy context of the patent systems by offering
a template for other countries who seek to protect their own traditional knowledge. EPO
has described TKDL as a unique encyclopedia which is very precise and shall prevent bioprospectors
from digging up ancient medical wisdom and laying claim upon them. EPO has
acknowledged that with TKDL, examiners have improved access to background information
at an early stage of patent examination vis-a-vis a scenario where a patent may have been
granted and the countries had to present evidence against it. USPTO considers TKDL as a
part of the very important work being done internationally with respect to TK databases
Several countries and organizations such as South Africa, African Regional
Industrial Property Organization (ARIPO), Mongolia, Nigeria, Thailand, Malaysia have
shown interest for creating their own TKDL based on TKDL created by India for protecting
their own traditional knowledge.
th IPC Union Meeting of World Intellectual Property Organization (WIPO) onprior art available in TKDL, from EPO. Similar results are expected at USPTO andAnnex.I
Effectiveness and impact of TKDL access agreement with European Patent Office
(Feb 2009)
The TKDL access agreement was concluded with European Patent Office in
February 2009, as a mutually beneficial agreement, since it enhances the quality of
examination for TK based patent applications for EPO and it prevents misappropriation for
India.
So far 35 patent applications based on Indian traditional medicinal knowledge have
been identified, being processed at European Patent Office, wherein in our opinion no
novelty or innovation exists. Third party observations against these patent applications have
been filed, quoting relevant references from TKDL. Since then in two cases EPO has set
aside its intention to grant patent and in other six cases applicant(s) have decided to
withdraw their applications on receiving information about
EPO. Remaining 27 cases are under examination at EPO. Details of the cases are given
below.
prior art existing in TKDL, fromA. Cases where intention to grant has been set aside:
EP1747786
(3 Weeks)Title: Natural product in cream with anti-vitiligo therapeutic properties
Applicant & Country: PERDIX EUROGROUP S L, Spain
Key dates:
Filing: 24-July-2006
Intention to grant: March-2009
TKDL Evidence Sent: 08-July-2009
Setting aside intention to grant: 28-July-2009
*
Description in Annex - AEP1520585
(1 Week)Title: Cancer treatment using natural plant products or essential-oils or components from
some pistacia species
Applicant & Country: DATA MEDICA PADOVA S P A, Italy
Key dates:
Filing: 24-Sept-2004
Intention to grant: 19-Feb-2009
TKDL Evidence Sent: 09-July-2009
Setting aside intention to grant: 14-July-2009
*
Description in Annex - BB. Cases where applicants decided to withdraw their applications
EP1607006
(3 Weeks)Title: Functional berry composition
Applicant & Country: UNILEVER NV, Netherland
Key dates:
Filing: 18-June-2004
TKDL Evidence Sent: 17-July-2009
Unilever withdrew its application: 04-August-2009
*
Description in Annex - CEP1781309
(9 Weeks)Title: nelumbinis semen extract for preventing and treating ischemic heart disease and
pharmaceutical composition and health food containing the same
Applicant & Country: Purimed Co., Ltd. Seoul, Korea
Key dates:
Filing: 09-June-2005
TKDL Evidence Sent: 17-July-2009
Applicant withdrew the application : 18-Sept-2009
*
Description in Annex – DEP2044850
(9 Weeks)Title: Method for altering the metabolism characteristic of food products
Applicant & Country: Clara's ApS, Denmark
Key dates:
Filing: 19-Sept-2007
TKDL Evidence Sent: 25-Aug-2009
Applicant withdrew the application : 30-Oct-2009
*
Description in Annex – EEP1889638
(23 Weeks)Title: Medicaments and food for treatment or prevention of obesity and/or diabetes
containing Cicer arietinum extract
Applicant & Country: Jumpsun Bio-Medicine (Shanghai) Co., Ltd, China
Key dates:
Filing: 06-March-2006
TKDL Evidence Sent: 11-June-2009
Applicant withdrew the application : 20-Nov-2009
*
Description in Annex – FEP1807098
(21 Weeks)Title: herbal compositions for treatment of diabetes
Applicant & Country: Amcod Limited, Mombasa, Kenya
Key dates:
Filing: 13-Sept-2005
TKDL Evidence Sent: 01-July-2009
Applicant withdrew the application : 24-Nov-2009
*
Description in Annex – GEP1967197
(19 Weeks)Title: Use of preparations, purifications and extracts of aloe
Applicant & Country: Cognis IP Management GmbH, Germany
Key dates:
Filing: 09-March-2007
TKDL Evidence Sent: 20-July-2009
Applicant withdrew the application : 27-Nov-2009
*
Description in Annex – HC. Normal opposition cases without support of TKDL
Neem (10 years)
EPO Patent No: EP436257
Applicant & Country: Thermo Trilogy Corporation, 9145 Guilford Road Columbia,
Maryland 21046-1883, USA
Key Dates:
Date of Grant: 4
Date of opposition: 14
Date of Revocation: 8
th August 1994th September 1995th March 2005Monsonto Soybean (13 years)
EPO Patent No: EP301749
Applicant & Country: Monsonto Company, 800 North Lindbergh Boulevard, St. Louis,
Missouri 63167, USA.
Key Dates:
Date of Grant: 2
Date of Opposition: 6
Date of Rejection: 6
nd March 1994th October 1994th July 2007Enola bean (10 years)
US Patent No: 5894079
Applicant & Country: Larry M Proctor, Delta Co., USA
Key Dates:
Date of Grant: 13
Date of Opposition: 20
Date of Rejection: 10
th April 1999th Dec 2000th July 2009D. Time and Cost Effectiveness of TKDL
Generally a patent opposition takes an average time of 10-12 years and involves
expenses running into millions of US dollars. On the other hand, TKDL access agreement
with EPO has created an institutional mechanism whereby either applicants withdraw their
application or EPO sets aside its intention to grant patent within 2/3 weeks of getting TKDL
prior art evidence. Furthermore, this does not have any cost implications to India and/or
European Patent Office.
E. Cases which are under examination and are likely to be cancelled or applicants
may withdraw applications:
USA
•
Asthma/allergy therapy using Nigella sativa•
Method of treatment or management of stress•
Hydroxylated Polymethoxyflavone Compositions•
Agents for sequestering serum aging factors and uses therefore•
Cosmetic herbal compositions•
wounds and ulcerations
Composition and method for facilitating the healing of non-healing and slow-healing•
Compositions for diabetes treatment and prophylaxis•
use
Bioactive compositions from theacea plants and processes for their production and•
Compositions of bakuchiol and methods of making the same•
Methods of Treating EpiphoraJapan
•
Anti-Inflammatory Agent•
Skin aging-preventing or improving agent•
Sleep-Improving Composition•
Composition for treating hepatitis c•
Senescence InhibitorGreat Britain
•
Treatment of inflammatory bowel disease•
Polyphenol Extraction Process•
cancer, HIV, AIDS and autoimmune diseases
Method and system for producing medicinal alcohol as a prophylatic or remedy forItaly
•
A process for the preparation of ferutinine from ferula genus plants•
some pistacia species
Cancer treatment using natural plant products or essential oils or components from•
Methods and composition for treating sore throat ApplicantGermany
•
Use of preparations, purifications and extracts of aloe•
Skin treatment compositionIndia
•
Biotherapeutics for mitigation of health disorders from terminalia arjuna•
tetrahydrotetrahydroxy-curcumin from the extracts of curcuma longa
Process for producing enriched fractions of tetrahydroxycurcumin andAustralia
•
Cysteine protease from ginger (zingiber) as a food improver and anti-inflammatoryChina
•
cicer arietinum extract
Medicaments and food for treatment or prevention of obesity and/or diabetes containingCyprus
•
Treatment and prevention of inflammationKenya
•
Herbal compositions for treatment of diabetesSpain
•
Natural product in cream with anti-vitiligo therapeutic propertiesSouth korea
•
pharmaceutical composition and health food containing the same
Nelumbinis semen extract for preventing and treating ischemic heart disease andBulgaria
•
calendula officinalis and hypericum perforatum
Therapeutical composition for the treatment of dermatosis comprising an extract ofNetherlands
•
Functional berry compositionNew Zealand
•
A CompositionDenmark
•
Method for altering the metabolism characteristic of food productsAnnex - A
Description of Invention: Natural product based on vegetable ingredients with anti-vitiligo
therapeutic properties to be employed in the white patches of depigmentation present in the
skin with vitiligo and to regenerate the melanocyte, which is dysfunctional during the
disease. It shows the following composition:
Watery extract of Pimiemta racemosa 1:1
Watery extract of Cucumis melo 1:2 100 ml.
Watery extract of Citrus aurantifolia 100 mg
Coenzyme Q-10 100 mg Pyridoxine Chlorhydrate
TKDL Evidences: TKDL evidence established the use of
vitiligo/leucoderma since centuries.
Decision of EPO: EPO has set aside its intention to grant patent due to following reasons:
“The application claims the usefuless of the combination of five constituents for the
treatment of vitiligo, one of these constituents being a 1:2 watery extract of
Cucumis melo in the treatment ofCucumis melocontainig catalase and superoxide dismutase. However,
its anti vitiligo property through local application in the Indian Systems of Medicine, since
long, as is evident e.g. from Exhibits 1-5 (TKDL abstracts) as cited in the third party
observation.
Hence, if one ingredient, here
vitiligo, then it had to be expected necessarily in an obvious manner that also a combination
product comprising this known active ingredient must be effective for treating vitiligo.
Thus, as long as no surprising (superior) effect of the claimed combination product vis-àvis
the already known products comprising
and in D2, are shown by the applicant, inventive merits cannot be acknowledged.”
Cucumis melo has been known forCucumis melo, was already known for the treatment ofCucumis melo, as described in the exhibits 1-5Annex - B
Description of Invention: Use of a product obtained from a plant of
manufacturing a medicament for treating or preventing cancer.
TKDL Evidences: TKDL evidence established the use of Pistacia species in the treatment
of cancer since centuries.
Decision of EPO: EPO has set aside its intention to grant due to following:
“A third party observation has been filed on 24 June 2009 together with nine exhibits of
TKDL abstracts. These exhibits seem to disclose the use of
vera
novelty and inventive step of the claims. The applicant is requested to take position. ”
Pistacia genus forPistacia lentiscus and Pistaciafor the treatment of Cancer. The exhibits, in particular exhibit 7, appear pertinent toAnnex - C
Description of Invention: Food composition being a mixture of grape juice and/or apple
juice and berry juice, for use as a medicament for reducing the cardiovascular risk.
TKDL Evidences: TKDL evidence established the use of
the treatment of cardio vascular diseases since centuries.
Current status: Applicant M/s Unilever NV, Netherlands after 5 years of filing its application
has decided to withdraw its claims and application due to TKDL evidence.
Vitis vinifera and Malus pumila forAnnex - D
Description of Invention: Applicant claimed the usefulness of
preventing and treating ischemic heart disease.
TKDL Evidences: TKDL evidence established the use of
preventing and treating ischemic heart disease since centuries.
Decision of EPO: The applicant decided to withdraw his application.
Nelumbinis semen extract forNelumbinis semen extract for theAnnex - E
Description of Invention: Applicant claimed the usefulness of an herbal composition
comprising
Allium cepa (Onion), Zingiber officinale, Cuminum cyminum and Curcuma longaas a slimming agent.
TKDL Evidences: TKDL evidence established the use of
officinale, Cuminum cyminum and Curcuma longa
slimming agent/fat destroyer since centuries.
Decision of EPO: The applicant decided to withdraw his application.
Allium cepa (Onion), Zingiberfor improving digestion process and as aAnnex - F
Description of Invention: Applicant claimed the usefulness of an herbal composition
comprising
diabetes.
TKDL Evidences: TKDL evidence established the use of
of obesity and diabetes since centuries.
Decision of EPO: The applicant decided to withdraw his application.
Cicer arietinum Linn for treatment of obesity and non-insulin dependentCicer arietinum Linn for treatmentAnnex - G
Description of Invention: Applicant claimed the usefulness of a plant extract from
Azadirachta indica, Aloe vera
and its associated complications.
TKDL Evidences: TKDL evidence established the use of
and Cinnamon for the treatment of type II diabetes mellitusAzadirachta indica, Aloe vera andCinnamon
diabetic furuncles since centuries.
Decision of EPO: The applicant decided to withdraw his application.
for the treatment of type II diabetes mellitus and its associated complications likeAnnex – H
Description of Invention: Applicant claimed the usefulness of extract of
Mill
TKDL Evidences: TKDL evidence established the use of
treatment of obesity since centuries.
Decision of EPO: The applicant decided to withdraw his application.Aloe barbadensisfor preventing and treating obesity.Aloe barbadensis Mill for the
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