| 1. India joins hands with the US and UK to help prevent misappropriation of its traditional knowledge at the United States Patent & Trademark Office (USPTO) and United Kingdom Trademark & Patent Office (UKPTO) with the signing of the TKDL (Traditional Knowledge Digital Library) Access Agreement with USPTO in November 2009, on the sidelines of the State visit of Hon’ble Prime Minister of India to the US and with UKPTO in January 2010. This TKDL Agreement with the US is the first-ever agreement signed in the area of science and technology during the visit of an Indian PM to the US.
2. TKDL Access Agreement has in-built safeguards on non-disclosure to protect India’s interest against any possible misuse. Under the agreement, the patent examiners at International Patent Offices can utlise the TKDL for patent search and examinations purposes only and cannot reveal the content to third party unless it is necessary for citation purposes.
3. Earlier, in February 2009, a similar TKDL Access Agreement was signed by India with the European Patent Office (EPO), making TKDL database available to their Patent Examiners (EPO having 34 member states) for establishing prior art, in case of patent applications based on Indian system of medicine.
4. Significant impact has already been realized at EPO during the last one year. Beginning July 2009, TKDL team has identified 36 patent applications at EPO which concern Indian systems of medicine and third party TKDL evidences have been filed at EPO. In two such cases EPO has already set aside its earlier intention to grant patents after it received TKDL evidence. In other eleven cases, applicants themselves decided to withdraw their four-to-five year old applications on being confronted with TKDL evidence. It is expected that in balance 23 cases, either EPO would reject these applications or applicants themselves would with draw their wrong claims/patent applications unless they are able to establish the novelty of their claims/applications.
The details of applications where EPO based on TKDL evidences decided to set aside its earlier intention to grant patents and details of applications filed at EPO where applicants themselves decided to withdraw their claims/patent application after they were confronted with TKDL evidence are attached in Annexure 1.
5. A recent study carried out by TKDL expert team has revealed a sharp decline (44%) on filing of patent applications concerning Indian systems of medicine, in particular, on the generic group on medicinal plants at EPO. Normally, on average, 80 such patent applications are being filed every year at EPO. About 25 get filed during October-December and 15-40 patents get granted yearly during this period. In contrast, during October-December 2009 only 14 applications got filed and no wrong patent was granted.
6. Misappropriation and bio-piracy are the issues of great concern for 130 developing countries and this agenda is being pursued at multilateral forums such as Convention on Biological Diversity, TRIPS Council at World Trade Organization and World Intellectual Property Organization. However, so far there has been no consensus on ensuring protection of traditional knowledge. It is for this reason, Mexico, only after more than 10 years of legal battle, was able to get the patent on Enola bean at USPTO cancelled on 10.7.2009. Similarly, cancellation on Monsonto Soybean patent happened on 6.7.2007 at EPO but after 13 years of legal battle, India is the only country in the world which has set up an institutional mechanism (TKDL) and is able to prevent grant of wrong patents in only few weeks of time through an e-mail and at zero cost, whereas other countries need to fight for 10-12 years and have to spend million of US dollars to meet legal and other expenses even for opposing a single patent.
7. TKDL, a collaborative project between CSIR and Department of AYUSH, Ministry of Health and Family Welfare is a maiden Indian effort to help prevent misappropriation of traditional knowledge belonging to India at International Patent Offices. Its genesis dates back to the Indian effort on revocation of patent on wound healing properties of Turmeric at the USPTO and anti-fungal properties of Neem at EPO. Besides, in 2000, the TKDL expert group estimated that about 2000 wrong patents concerning Indian systems of medicine were being granted every year at international level, mainly due to the fact that India’s traditional medicine knowledge existed in languages such as Sanskrit, Hindi, Arabic, Urdu, Tamil etc. and was neither accessible nor understood by patent examiners at the international patent offices.
8. TKDL has overcome these language and formal barriers by scientifically converting and structuring the available information contents in 30 million A4 size pages of the ancient texts into five international languages, namely, English, Japanese, French, German and Spanish, with the help of information technology tools and a novel classification system – Traditional Knowledge Resource Classification (TKRC). Today, India through TKDL is capable of protecting about two lakh (0.2 million) medical formulations similar to those of neem and turmeric. On an average, it takes five to seven years for opposing a granted patent at international level which may cost Rs. One to three crore (0.2-0.6 million US$) . One could only imagine the cost of protecting two lakh (0.2 million US$) medicinal formulations in the absence of TKDL.
9. TKDL is a proprietary and original database TKDL technology integrates diverse disciplines and languages such as Ayurveda, Unani, Siddha, Sanskrit, Arabic, Persian, Tamil, English, Japanese, Spanish, French, German, modern science & modern medicine. TKDL is based on 148 books of Indian Systems of Medicine, which are available at a cost of Rs. 50,000. These books are the prior art and can be sourced by any individual/organization at national/international level. TKDL acts as a bridge between these books and international patent examiners. It is the TKDL technology which has created a unique mechanism for a Sanskrit sloka to be read in German by an examiner at EPO or any other international Patent Offices on his computer screen.
10. These unique international agreements would have long-term implications on the protection of traditional knowledge and global intellectual property systems in view of the fact that in the past patents have been granted at EPO and USPTO on the use of over 200 medicinal plants due to the lack of access to the documented knowledge in public domain. Also, at any point in time, 40-50 patent applications based on Indian traditional knowledge are awaiting grant of patent. ****
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Annexure I
1. Details of applications where EPO based on TKDL evidences decided to set aside its earlier intention to grant patents are given below:
(i) EPO decided to grant patent to M/s. Data Medica Padova SPA, Italy on 19.2.2009 for use of Pista (Pistacia vera) in an anti-cancer drug. TKDL evidence based on eight Unani books published as early as 10th century and one Siddha book published in 1924 was filed on 09.7.2009. EPO, based on TKDL evidence, set aside its earlier intention to grant patent on 14.7.2009.
(ii) EPO decided to grant patent to M/s. Perdix Eurogroup SL. Spain on 02.04.2009 for use of watery extract of kharbooza/melon (Cucumis melo) as an anti-vitilgo cream. TKDL evidence based on Unani book, Muheet Azam (time of origin 19th century) published in 1899 A.D., was filed in 08.07.2009. EPO based on TKDL evidence set aside its earlier intention to grant patent on 28.7.2009.
2. Details of applications filed at EPO where applicants themselves decided to withdraw their claims/patent applications after they were confronted with TKDL evidence are given below:-
(i) M/s. Purimed Co Ltd, Korea filed a patent application on 09-06-2005 for treatment of heart diseases using Indian lotus (Nelumbo nucifera) TKDL evidences based on Sushruta Samhita (time of origin 1000 B.C. – 5th century) and other Ayurveda books were submitted on 17-07-2009. On 04-08-2009 applicant decided to withdraw its claims/patent application.
(ii) M/s. Jumpsun Bio-Medicine (Shanghai) Co. Ltd. China filed a patent application on 06-03-2006 for treatment of obesity and/or diabetes using Bengal gram/Chana (Cicer arietinum) TKDL evidences based on Ashtanga Samgraha (time of origin 5th – 10th century) and other Ayurveda & Siddha books were submitted on 11-06-2009. On 20-11-2009 applicant decided to withdraw its claims/patent application.
(iii) M/s. Amcod Limited, Mombasa, Kenya filed a patent application on 13-09-2005 for treatment of diabetes using Neema, Gheekawaar and Daal Chini (Azadirachta indica, Aloe Vera and Cinnamomum Zeylanicum respectively). TKDL evidences based on Brhat Nighantu Ratnakara (time of origin 1000 B.C. – 20th century) and other Ayurveda, Unani & Siddha books were submitted on 01-07-2009. On 24-11-2009 applicant decided to withdraw its claims/patent application.
(iv) M/s. Clara’s APS. Denmark filed a patent application on 19-09-2007 using Haldi/turmeric, Zeera, Adrak/Ginger and Pyaaz/Onion (Curcuma longa, Cuminum cyminum, Zingiber officinale and Allium cepa respectively) as a slimming agent. TKDL evidences based on Ashtanga Samgraha (time of origin 5th – 10th century) and other Ayurveda books were submitted on 25-08-2009. On 30-10-2009 applicant decided to withdraw its claims/patent application.
(v) M/s. Cognis IP Management Gmbh, Germany, filed a patent application on 09-03-2007 for the treatment of obesity using Gheekawaar (Aloe vera). TKDL evidences based on Rasendrachintamanih (time of origin 16th century) and other Ayurveda & Siddha books were submitted on 20-07-2009. On 27-11-2009 applicant decided to withdraw its claims/patent application.
(vi) M/s. Evonik Goldscmidt Gmbh, Germany, filed a patent application on 30-11-2007 using Arjuna (Terminalia arjuna) as an Anti-ageing/anti wrinkle agent. TKDL evidences based on Siddha book, Therayar Sekarappa (time of origin 10-15th century) and other Ayurveda books were submitted on 07-09-2009. On 27-10-2010 applicant decided to withdraw its claims/patent application.
(vii) M/s. Unilever Nv, Netherlands, filed a patent application on 18-06-2004 using Grape juice and/or Apple juice (Vitis vinifera and Malus pumila respectively) as a cardio tonic. TKDL evidences based on Ayurveda book, Vrindamadhava (time of origin 9th century) and other Ayurveda and Siddha books were submitted on 17-07-2009. On 04-08-2009 applicant decided to withdraw its claims/patent application.
(viii) M/s. Kapur MBBS, B., Dr. Great Britain filed a patent application on 13.06.2007 using Opium, Spinach and Saunf/Fenugreek (Papaver somniferum, Spinacia oleracea and Trigonella foenum-graecum respectively) as immune-modulator agents. TKDL evidences based on Unani book, Kitab-al-Haawi (time of origin 9th century) and other Ayurveda and Siddha books were submitted on 16-02-2010. On 18-02-2010 applicant decided to withdraw its claims/patent application.
(ix) M/s. Natreon Inc, United States of America, filed a patent application on 27-07-2006 using Ashwagandha (Withania somnifera) for the treatment of stress, sleeplessness and anxiety. TKDL evidences based on Ayurveda book, Vangasena (time of origin 12th century) and other Ayurveda, Unani and Siddha books were submitted on 06-07-2009. On 25-03-2010 applicant decided to withdraw its claims/patent application.
(x) M/s. Jan Marini Skin Research Inc, United States of America, filed a patent application on 22-02-2007 using Brahmi, Tea leaves, Ashwagandha, Turmeric (Bacopa monnieri, Camellia sinensis, Curcuma Longa and Withania somnifera respectively) as anti-ageing and anti-inflammatory agents. TKDL evidences based on Ubnani book and anti inflammatory agents. TKDL evidences based on Unani book, Al-Qanoon Fil Tibb (time of origin 11th century and other Ayurveda and Unani books were submitted on 02-07-2009. On 08-04-2010 applicant decided to withdraw its claims/patent application.
(xi) M/s. Avesthagen Limited, India, filed a patent application on 15-08-2003 using arjuna (Terminalia arjuna) as cardio tonic and for the treatment of obesity and diabetes. TKDL evidences based on Ayurveda book, Vrndamadhava (time of origin 15th century) and other Ayurveda, Unani and Siddha books were submitted on 08-07-2009. On 06-04-2010 applicant decided to withdraw its claims/patent application.
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