Traditional Knowledge Digital Library. Presentation Adapted from Dr. V K Gupta, CSIR

Transcription

1 Traditional Knowledge Digital Library Presentation Adapted from Dr. V K Gupta, CSIR

2 TRADITIONAL KNOWLEDGE (TK) UNDERSTANDING KNOWLEDGE IS THE FIRST STEP TO MANAGING IT EFFECTIVELY.

3 Why Document? Know the Knowledge Protect ( Defensive) Deal with possible misappropriation

4 Traditional Knowledge and Genetic Resources Associated TK is critical for ABS purposes Rights on knowledge get recognised in the Patent System Traditional Knowledge gets misappropriated in the International Patent System due to lack of access to such knowledge Systems by the Patent Examiners

5 TKDL Objectives & Target Audience Preventing Misappropriation of Indian Traditional Knowledge Break Format & Language barriers Current use by Patent Offices Multilingual (French, German, Japanese, English & Spanish)

6 Protecting of Traditional Knowledge India s difficult experiences Turmeric Basmati Neem

7 Neem Patent Case - EP at European patent Office (EPO) Date of Grant 4 August 1994 Date of Opposition 14 June 1995 Date of Final Rejection 8 March 2005 No. of documents submitted by Applicant 47 during opposition No. of documents submitted 45 by the Opposing Party No. of oral hearings after Opposition 20 Average time between hearings 3 to 4 months No. of Lawyers/ Examiners in each hearing 8

8 Complexities & Context of International Opposition on granted patents (Case Basmati Patent Invalidation & Protection efforts by APEDA) Engagged K&S Partners ( to ) paid towards legal fees Rs crores (Rs. 5.1 crores to foreign law firm)(2.0 million US $) Outcome of efforts Got Cancelled 3 claims of M/S Rice Tech at USPTO Trade mark Registration of Basmati at US & Pakistan Watch on trade mark registration in foreign jurisdiction Initiation for GI registration in India so far not successful In addition to legal cost equal amount likely to be spent in travel and other administrative costs. Therefore cost invalidation of granted patent at International level could be 2-3 million US $

9 IPC and Structure of Classification SECTIONS 8 CLASSES 120 SUB-CLASSES 628 MAIN GROUPS 69,000 SUBGROUPS

10 Stages of Formal Acceptance of Traditional Knowledge Classifications Feb 2001 India submitted a approval on inclusion of Traditional Knowledge at International Patent Classification Union Task Force of five Nations constituted by WIPO Feb 2002 Task Force recommends creation of subclass in A61 linking Traditional Knowledge Recourse Classification developed by India with International patent Classification

11 Stages of Formal Acceptance of Traditional Knowledge Classifications Feb 2003 International Patent Classification Union adopted 200 subgroup for publication by July, 2005 Accords formal recognition and acceptance of Traditional Knowledge as a distinct discipline at International level Oct 2004 Deliberations on IPC-TKRC concordance list of the new main group A61K 36/00

12 Prior Art

13 Status Ayurveda 91,410 Siddha 15,290 Total Million Unani 1,29,170 Yoga 1,305 TKDL ready to safeguard million medicinal formulations like Neem and Turmeric in Ayurveda,Unani and Siddha which are present in 34 million A4 size pages, at International Level

14 Cost/ Effectiveness of TKDL TKDL Route No. of A4 Size page information in 5 international languages Expenditure Incurred 34 Million 3.0 Million US $ Translation Route Skill needed, knowledge of Ayurveda/ Unani/ Siddha/ Sanskrit/ Persian/ Tamil/ German/English/French/Japanese/Spanish/Modern medicine & Science Incase above skill set was available, it would have costed 4.0 billion US $, a team of 5000 and time period of 60 years against the team of 100 and cost of 3.0 million US$ TKDL protects 0.25 million formulations based on Neem cases, cost of such protection would be astronomical(200 billion US$).

15 WIPO has plans to Internationalise TKDL to utilise Indian TKDL as a template for other willing Countries rich in TK and GR World Intellectual Property Organisation, Geneva April-2010

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17 Access to TKDL Users Shall not disclose the content to third party Shall utilize for patent search & examiners, can give printouts to patent applicants for citation purposes No use other than search & examination Will provide non-confidential information received from applicant on usage to provider Will give feedback for enhancing the features of TKDL Provider Shall provide uninterrupted access Training to users (as and when needed) Render assistance in search & examination (as & when needed) Free to utilize for itself & can grant access to others

18 TKDL Access Agreement to International Patent Offices (CCEA has approved access to TKDL for International Patent Offices) Feb 2009 European Patent Office Indian Patent Office July 2009 Oct 2009 German patent Office U S Patent & Trademark Office Nov 2009 Access Agreement with USPTO was signed on the sideline of the state visit of Hon ble Prime Minister to United states Feb 2010 UK Patent & Trademark Office Canadian I P Office Sept 2010 Jan 2011 IP Australia IP Australia Japan Patent Office April 2011

19 Global Watch System Monitor 24 x 7 basis, applications concerning TK/GR at identified Patent Offices Examine claims on Novelty with TKDL Prior art Submit Prior art evidences as per respective National Legislation

20 Submission of TKDL based evidences Preparing the necessary interventions and evidences, for filing at IPOs Screening of Third Party Observations (TPO) Filing of TKDL Evidences

21 No. of Cases of MNCs identified on Bio-Piracy where TKDL Priorart evidences submitted Outcomes realised through (Cancellation/ Withdrawn/ Amendment of Claims) USA UK Germany Italy Japan Australia Others Total For details log on to Total

22 EPO No. of Cases of MNCs identified on Bio-Piracy where TKDL Priorart evidences submitted Outcomes realised through (Cancellation/ Withdrawn/ Amendment of Claims) USPTO IP Australia CIPO UKPTO CGPDTM Total 990 For details log on to Total

23 TKDL AS DETERRENT NO. OF PATENT APPLICATIONS FILED AT EPO ON MEDICINAL PLANTS(A61K 36/00) IN PARTICULAR CONCERNING INDIAN SYSTEM OF MEDICINE Year Period Feb-Sept Oct-Jan After 6 months of conclusion of TKDL Access Agreement with EPO, Percentage Reduction during Oct - Jan ( ) in filing of application=44%

24 TKDL Out-Comes Against Bio-Piracy Successfully safeguarded Bio-piracy attempts to patent Medicinal Plants (usages) Aloe Vera Withania Somnifera Brahmi Ginger Cannabis Mint Melon Terminalia Arjuna Pistacia Vera Andrographis

25 Learning from TKDL TK is a new experience even for International Patent System. Examiners can have different opinion concerning novelty / inventive step with in a Patent Office itself and even across International Patent Offices. Indian Patent Act has a provision under Section 3(P) accordingly knowledge which in effect is a Traditional Knowledge can not be patented. Guidelines to ascertain novelty / inventive step in Traditional Knowledge based patent applications. Inclusion of TKDL in PCT Minimum Documentation.

26 Limitations of TKDL TKDL is a Defensive Technical tool only. Currently it is limited to Indian medicinal plants and those documented knowledge only Access to TKDL is Limited to International Patent Offices only. TKDL is not a substitute for an international legally binding instrument for protection of Traditional Knowledge rather it would compliment such a system as & when it get established. In addition to International legally binding instrument databases such as TKDL, International System need to evolve practical guidelines which can help examiners in ascertaining the novelty & inventive step.

27 The Next Steps Currently the National Biodiversity Authority is developing the concept of TKDL Plus Focus on implementation of Nagoya Protocol at national level

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