RK Gupta, Head, Intellectual Property Management Division Council of Scientific & Industrial Research New Delhi, India [email protected] IP Policies.

RK Gupta, Head,

Intellectual Property Management Division

Council of Scientific & Industrial Research

New Delhi, India

[email protected]

IP Policies and Systems in Public Funded Biotech R&D Sector

WIPO Training of Trainers Program on Intellectual Property Asset Management

by Biotech SMES

Evolution of IP Policy of Evolution of IP Policy of Scientific Research Institutions of Scientific Research Institutions of

IndiaIndia

1995-20101995-2010

Scientific and Industrial Research Scientific and Industrial Research InstitutionsInstitutions

Mandate

Research Teaching Focus on select areas to meet national economic & strategic

requirements

IMPACT of R&D Output IMPACT of R&D Output (Patents/Publications)(Patents/Publications)

Capacity building Alternate process/ products development Development of technology in case of denials Control of price of competing products Employment generation Growth of New businesses Revenue generation Benefit sharing Development of industrial clusters around R&D institutes Technology Transfer/ spill-overs

Initial Objectives of IP Policies of Scientific and Initial Objectives of IP Policies of Scientific and Industrial Research InstitutionsIndustrial Research Institutions

To create massive awareness programs among scientists, students and faculty

To capture IP from ongoing R&D projects To identify new problems To protect R&D output through appropriate IP

protection nationally and internationally

Objectives of IP Policies of Scientific and Objectives of IP Policies of Scientific and Industrial Research InstitutionsIndustrial Research Institutions

CSIR-1996 ICMR-2002 ICAR-2006 To create IPR awareness To work for societal benefit To safeguard public health To facilitate capture and protection of IP at early stages before publication

of research results, where applicable To facilitate recordal of lab data To obtain “Invention Disclosures” form from scientists To form linkages between IP cells of labs and central IP departments To handle IP ownership issues To valorise IP through various mechanisms To facilitate sharing of royalties with scientists

Focus of IP Protection in Scientific Focus of IP Protection in Scientific and Industrial Institutionsand Industrial Institutions

Patents * * * * * Copyrights * * * Plant varieties * * * * Layout design for integrated circuits *

Trademarks * Industrial design * * Geographical indication *

Ownership of IPOwnership of IP

Scientific departments Scientists Funding agencies Sponsors Collaborators (Indian as well as foreign research

institutions/universities) Governmental authorities (like NBA) IP in contracts, PPPs & International Agreements Governmental rights

Valorisation of IPValorisation of IP

Licensing (exclusive, non-exclusive, limited exclusive, royalty free, equity)

Assignment / saleSpin-offs and start upsCo-Development

Benefit sharingBenefit sharing

Scientific DepartmentsResearchersTechnical staffTechnology Transfer Cells

IP Policies of Scientific & Industrial Research IP Policies of Scientific & Industrial Research Institutions-Current StatusInstitutions-Current Status

IP Policy Components Remarks

Vision/Mission stated

Implementing authority centralized/decentralized/hybrid

Ownership of various firms of IP need for a flexible policy

Use of significant resources of the institutions not clear in many cases

Assessment of IP need for improvement

Invention Disclosure and assignment of rights existing

Protection of IP in Foreign Countries need for a dynamic policy

Maintenance of IP rights need for a better understanding

Material Transfer Agreement better understanding needed/application of NBA/BDA Rules

Sharing of Earnings provisions existing, implementation difficult in several cases

Conflict of interest need for better understanding

Publication Policy clear

Setting up of IP cells established/need for further strengthening

IssuesIssues Cost of IP protection Societal concerns Managing IP in sponsored research/collaborations Problems in sharing IP in International collaborations Monitoring and Implementation of IP in agreements Absence of linkages between IP and development policies IP valuation and licensing Formation of Spin-off and Start up companies IP in acquisition and mergers. Biological Material Transfer Issues and National legislations IP enforcement issues Open source initiatives with global partnerships Worldwide technology transfer Centers being unprofitable FTO

IP Management Policy of CSIR IP Management Policy of CSIR & its Implementation – A Case & its Implementation – A Case

StudyStudy

Council of Scientific & Industrial Research, India

CSIRCSIR The largest network of publicly funded Research

Labs in the world 17000 highly qualified Scientists, Engineers,

Auxiliary staff Annual Budget about Rupees 1450 Crores aprox. R&D in Aerospace, Biological Sciences,

Chemicals, Pharmaceuticals, Drugs, Earth Resources, Food, construction, minerals, metals, environment, leather, information products etc.

Council of Scientific & Industrial Research, India

CSIR Mission CSIR Mission

“To provide scientific industrial R&D that maximizes the economic,

environmental & societal benefits for the people of India”

Serve the Nation

IP Management in CSIR - GenesisIP Management in CSIR - Genesis

Patenting activity in CSIR - instituted since its very inception and looked after by its Patent Cell at CSIR HQ. (few patent filings)

Enactment of Patents Act, 1970 - the Patent Cell upgraded to the Patents Unit. (Sporadic filings)

India joins WTO in 1995 – the Patents Unit upgraded as a Division named Intellectual Property Management Division (IPMD) in 1995

Post -1995 : Boost to patenting of drugs, pharmaceuticals and bio-tech inventions

CSIR’s IP Policy (1996) : Meeting Post-WTO CSIR’s IP Policy (1996) : Meeting Post-WTO ChallengesChallenges

“The maximization of the benefits to CSIR from its intellectual property by stimulating higher levels of innovation through a judicious system of rewards, ensuring timely and effective legal protection for its IP and leveraging and forging strategies alliances for enhancing the value of its IP.”

Statement of the IP Policy

CSIR Targets (Vision 2001)

Portfolio of 500 foreign patents (then 80 in 1996)

Portfolio of 1000 Indian patents (then 436 in 1996)

Meeting post WTO challengesMeeting post WTO challenges

Goals of the IP Policy stimulate and encourage increased creativity and innovation in CSIR

to gain economic advantage; develop skills amongst the scientists to understand, interpret and

analyze the techno-legal and business information contained in patents and other IP documents;

use the information acquired from analysis of IP documents to direct and mount strategic R&D programmes;

establish a globally acceptable system of recording and documentation of experimental results and data;

evolve appropriate systems to capture and assess the intellectual property generated in the CSI R system;

provide the highest level of professional techno-legal services for securing and protecting the IP generated;

manage the portfolio of IP as a business activity; manipu1ate the patent portfolio, defensively / and aggressively, to

forge strategic alliances / international S&T collaborations, to gain business advantage / and ward of competition;

Institutionalization of IP Management Institutionalization of IP Management Structure in CSIRStructure in CSIR

DG, CSIR

CSIR LABS IPMD

IP management

structure in CSIR

SloganSlogan

1996~Patent and publish

1998~Patent, publish and prosper

IP ManagementInformation & DocumentationPatent Search & AnalysisTechno-Legal DraftingPatent LitigationLicensing, Valuation and

negotiating IP licensing deals

Capacity Building (1995-2010)Capacity Building (1995-2010)

Patent Portfolio DevelopmentPatent Portfolio Development

Expansion of Patent Coverage

(Improvement Patents)

Protection of New Uses/Combinations

Creation of Buffer Zone Surrounding Patents

Performance of CSIRPerformance of CSIR

CSIR Patent filingCSIR Patent filingCSIR Patent filingCSIR Patent filing

377409 413 421 405 415 407

170207 183

262

605663

915

669719

921

761

261

404

0

100

200

300

400

500

600

700

800

900

1000

1999-00 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09

India Foreign

CSIR Patents Granted Abroad

6294

191218

300

244

364339

319

0

50

100

150

200

250

300

350

400

2000-01

2001-02

2002-03

2003-04

2004-05

2005-06

2006-07

2007-08

2008-09

CSIR Patents Granted in India

112 117

341

162

276

175

278 281

399

703

0

100

200

300

400

500

600

700

800

1999-00

2000-01

2001-02

2002-03

2003-04

2004-05

2005-06

2006-07

2007-08

2008-09

CSIR Patent Applications filed in foreign countries

262

605663

915

669719

921

761

261

404

0100200300400500600700800900

1000

1999-00

2000-01

2001-02

2002-03

2003-04

2004-05

2005-06

2006-07

2007-08

2008-09

Deliberate intervention to focus on commercially and strategically important inventions

CSIR Patent Applications filed in India

377409 413 421 405 415 407

170207

183

050

100150200

250300350

400450

1999-00

2000-01

2001-02

2002-03

2003-04

2004-05

2005-06

2006-07

2007-08

2008-09

Deliberate intervention to focus on commercially and strategically important inventions

US Patents Granted (till April 6, 2010)

1 CSIR 1103

2 IITs 25

3 IISc 08

4 Other Indian Universities 22

Sources : USPTOSources : USPTO

PCT Applications Published during 2002-2009PCT Applications Published during 2002-2009

Sr. No.

Organizations2002

-2003

2003-

2004

2004-

2005

2005-

2006

2006-

2007

2007-

2008

2008-

2009Total

Average

1 CNRS, France 181 235 278 268 221 260 253 1696 242

2 CSIR, India 73 139 173 158 95 91 49 778 111

3 RIKEN, Japan 32 87 108 78 88 74 55 522 75

4 CSIRO, Australia 68 39 64 47 45 64 55 382 55

5CSIR, South Africa

4 8 3 8 5 11 5 44 6

6Max Planck, Germany

60 62 55 59 55 55 54 400 57

Some key portfoliosSome key portfolios

Bio-enhancers Standardized Herbal Formulations Anti-malarials and anti-cancer

compounds and formulations Anti-diabetic molecules Anti-oxidants Hepatoprotectives Immunomodulators

Chemicals and Polymers Leather Bio-informatics Products Nanotechnology Food products and processes Engineering

Some key portfoliosSome key portfolios

Portfolio Building – An ExamplePortfolio Building – An Example

Extract / Active Betel Leaf Fraction

Antimonocytic Activity

Antileishmanial Activity

Immunomodulator Activity

Anti Leukemia Activity

P

P

P

P

Market Entry

NEW SYNERGISTIC FORMULATION

Compounds Identified

New Use Protected

FORMULATION + COMPOSITION

Antiasthamatic Activity

P

Models for Valorizaion of IPModels for Valorizaion of IP

Creating a Market Share in an established market Licensing and R&D Collaboration Breaking the monopoly of Multinationals Solving Basic Problems of the Poor Strategic and Public health Attracting Contract research Creating new opportunities through Image and

Confidence Building

Major IP Licensing Deal - IMajor IP Licensing Deal - I

IMTECH’s Clot specific Streptokinase Technology Licensed to NOSTRUM Pharmaceuticals nc., USA in July, 2006

More than Rs 28 Crores –milestone payments

Royalties

Success Stories in Licensing - IISuccess Stories in Licensing - II NCL-GE Alliance – originated in 1993. GE supported the R&D at NCL Alliance operating for over 9 years successfully

and emerged as a paradigm in “relationship” management in R&D.

Cash flow to NCL from GE of around USD 8.5 m over the period 1994-1995 to 2003-2004

Exposure to and training of NCL scientists to world class R&D management practices.

Building up of world class facilities and resources in NCL

Success Stories in Licensing - IISuccess Stories in Licensing - II

Attracting and hiring of talented young scientists New contract research opportunities with

multinational companies Diffusion of ideas and generic methods developed

to Indian industries Half a dozen patents assigned to GE CSIR owns several patents based on generic ideas

developed while interacting with GE having relevance to systems other than polycarbonates

Led to Setting up of GE’s R&D Centre at Bangalore

Success Stories in Licensing - IIISuccess Stories in Licensing - III

United States Patent 6,893,479 (CSMCRI)

Integrated method for production of carrageenan and liquid fertilizer from fresh seaweeds

“An integrated method is developed to utilize to a maximum extent the fresh biomass of seaweeds such as Kappaphycus alvarezii that can be crushed to release sap and where the sap is useful as a potent liquid

fertilizer after suitable treatment with additives and dilution while the residue is a superior raw material for extraction of κ-carrageenan, thereby

enhancing the value of the seaweed. Other advantages of the invention include a reduced drying time and drying area to obtain the raw material for κ-carrageenan production in dry and storable form, a reduced cost of

transporting and storing this raw material because of its lesser bulk, easier handling due to its free flowing granular nature, and its direct use for gel

preparation in certain applications”

© Council of Scientific & Industrial Research, India

Success Stories in Licensing - IVSuccess Stories in Licensing - IV

CSIR licenses Sea Weed Technology to Pepsico

A plant growth harmone and regulator is derived from fresh Sea Weed grown along the shoreline.

Liquid Sea Weed Fertilizer increases yields from same seed by 10% for wheat, 30% for peddy, 20-30% for fruits and vegetables to 35% for corn and chana, BT cotton 20%, Banana for 19%.

Patent application fined in India and abroad

© Council of Scientific & Industrial Research, India

Case Study-VCase Study-V

Licensing of IICT’s anti-cancer patent portfolio to a US Biopharmaceutical Co

Returns: Rs. 2.5 Crores (subject to milestones) +royalties

Attracting Multinational Contract Attracting Multinational Contract ResearchResearch

CSIR’s Licensed PatentsCSIR’s Licensed Patents

% Utilization of unique patents in force 8.67

% Utilization of patent applications under prosecution 2.60

Current & Future IP Strategy

To plan and design strategic patent portfolios for short, medium and long term development requirement of national economy

To partner with national and international players to develop strategic IP portfolios for national economic needs

To focus on commercially and strategically important inventions

Valorization of existing IP Portfolios

Formation of a separate entity for licensing / spin-offs etc.

Challenges Challenges

Implementation of Bill on Protection and Utilization of Publicly Funded Research

Need for a harmonized National IP Policy Framework with basic common components

THANKS