“Traditional Knowledge Digital Library - ABS Initiative Knowledge and Genetic Resources ... TKDL protects 0.25 million formulations based on Neem cases, cost of such protection would

“Traditional Knowledge Digital Library”

Presentation Adapted from Dr. V K Gupta, CSIR

TRADITIONAL KNOWLEDGE (TK)

UNDERSTANDING KNOWLEDGE IS

THE FIRST STEP TO MANAGING IT

EFFECTIVELY.

Protect ( Defensive)

Deal with possible misappropriation

Know the Knowledge

Why Document ?

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

Preventing Misappropriation of Indian Traditional Knowledge

Break Format & Language barriers

Current use by Patent Offices

Multilingual

(French, German, Japanese, English & Spanish)

Objectives & Target Audience TKDL

Protecting of

“Traditional Knowledge”

India’s difficult

experiences

Turmeric

Basmati

Neem

Neem Patent Case - EP436257 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

Complexities & Context of International

Opposition on granted patents

(Case Basmati Patent – Invalidation & Protection efforts by APEDA)

Engagged K&S Partners (1995 - 96 to 2011-12) paid towards legal fees Rs. 7.62 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 $

IPC and Structure of Classification

SECTIONS

CLASSES

SUB-CLASSES

MAIN GROUPS

SUBGROUPS

8

120

628

69,000

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

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

Prior Art

Status

Ayurveda

91,410

Unani

1,29,170

Siddha

15,290

Yoga

1,305

Total 0.250

Million

TKDL ready to safeguard 0.250 million medicinal formulations like Neem and Turmeric in Ayurveda ,Unani and Siddha which are present in 34 million A4 size pages, at

International Level

Cost/ Effectiveness of TKDL

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$).

TKDL Route

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

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

European Patent

Office Feb

2009

Indian Patent

Office

July

2009

IP Australia

German patent

Office Oct

2009

UK Patent &

Trademark Office Feb

2010

Jan

2011 IP Australia

Nov

2009

U S Patent &

Trademark Office

Canadian

I P Office Sept

2010

Japan Patent

Office April

2011

Access Agreement with USPTO was signed on the

sideline of the state visit of Hon’ble Prime Minister to United states

TKDL Access Agreement to International Patent Offices

(CCEA has approved access to TKDL for International Patent Offices)

Global Watch System

Examine claims on Novelty with TKDL Prior art

Submit Prior art evidences as per respective National Legislation

Monitor 24 x 7 basis, applications concerning TK/GR at identified Patent Offices

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

Outcomes realised through (Cancellation/ Withdrawn/

Amendment of Claims)

USA

UK

105

Total

No. of Cases of MNCs identified on Bio-Piracy where TKDL Prior-art evidences submitted

239 31

26 05

990 Total

Germany 48 07

Italy 45 08

Japan 49 10

Australia 37 05

Others 455 39

For details log on to http://www.tkdl.res.in

Outcomes realised through (Cancellation/ Withdrawn/

Amendment of Claims)

EPO

USPTO

IP Australia

CIPO

UKPTO

105 Total

No. of Cases of MNCs identified on Bio-Piracy where TKDL Prior-art evidences submitted

374 74

50 03

139 19

26 01

241 08

IP Australia

CGPDTM 160 -

990 Total

For details log on to http://www.tkdl.res.in

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

2005 65 26

2006 55 25

2007 30 24

2008 41 25

2009 35 14

After 6 months of conclusion of TKDL Access Agreement with EPO, Percentage Reduction during Oct - Jan (2009-10) in filing of application=44%

Brahmi Ginger

Pistacia

Vera Melon Mint

Terminalia

Arjuna

Withania

Somnifera

TKDL Out-Comes Against Bio-Piracy Successfully safeguarded Bio-piracy attempts to patent Medicinal Plants (usages)

Aloe Vera Cannabis

Andrographis

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.

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.

The Next Steps

Currently the National Biodiversity Authority is

developing the concept of

TKDL Plus

Focus on implementation of Nagoya Protocol at

national level