RK Gupta, HeadIntellectual Property Management DivisionCouncil of Scientific & Industrial ResearchIndiaguptark04@yahoo.comManagement of Intellectual Property (IP) in CSIR LaboratoriesCSIR-WIPO Workshop on Negotiating Technology Licensing Agreements

India Habitat Centre, New Delhi, 4-8 July 2005

CSIR Mission To provide scientific industrial R&D that maximizes the economic, environmental & societal benefits for the people of India

Serve the Nation

IP IN CSIR: CHRONOLOGY 1942: Formation of CSIR:Applied & Industrial R&D-Central Patent Cell-Indian Patents-Individual Initiative-Sporadic Licensing of Technology1970: New Patents Act: Flip To Pharma, Food & Chemical Sectors- Patent Unit- Greater Awareness Creation Laboratory Initiative- No. 1 Position in India-Licensing of Technology including Patents-Sporadic Foreign Filing1995: India joins WTO1998: India joins Paris Convention/PCT 1999: Patent amendment to provide EMR retrospectively from 1/1/95

. Contd2003: 2nd amendment in Patents Act TK not patentable Term of Patent 20 years Deferred Examination 18 months publication Process patents for biotech inventions Patent Tribunal Set up at Chennai EMR granted Patents Amendment Act 2005 effective from 1.1.2005

.. Contd1999 2004:Plant Varieties and Farmers Rights Act PassedDesigns, TM /Copyright Acts updated and at par with developed worldGI Registry Set up at Chennai200, 000 designations for India under PCTModernization of Indian Patent Office and its branchesBoost to patenting of drugs, pharmaceuticals, botanicals and bio-tech inventions in CSIR

IP ManagementDG, CSIRLAB DIRECTORIPMDIPM CELLStaff 28 (Scientists 13, Technical Support:7, Others:8)PolicyPlanningAll Techno-legal matters (Capturing. drafting, Filing, Prosecution, Litigation)Assisting labs in ValorizationAwareness1 Scientist and other staffCapturePatent SearchEvaluation+AssessmentGap FillingInternal preliminary DraftingInfringement MonitoringValorization

Acquisition & ProtectionIP Cell In each Lab

Disclosures and recordalsPublications Scrutinized For IPScrutiny for patentingEarly Spotting of IP and its CaptureAssessment & Filling up of GapsPatent Search and Preliminary DraftingInputs for examination and maintenance

.. ContdIPMDAwareness, training, capture, disclosure and patentability Assessment, drafting, filing, and prosecution of Indian and Foreign Patents, litigation.

Foreign ProtectionWhere to protect, Route Attorneys, Maintenance, Potential, Expenses, Duration

Patent Filing in Different CountriesPotential Commercial OpportunitiesProduct/Process Life TimeAlternative Protective MechanismsCost of PatentingDefensive/Deterrent Position with respect to CompetitorsFeasibility of Policing and EnforcementPotential for Trading the PatentPublicity/Advertisement gainsForce Competitors to invest in getting around the patent

Monitoring StructureGOVERNMENT Overall CSIR TargetsDG, CSIR Labwise and CSIR TargetsIPMD - Labwise and CSIR Targets IPMD - Director/IPMC/Division/Unit/Engg./SCDIRECTOR Division/Unit TargetsIPMC - Division/unit Targets/Engg./SC

Stimulating InnovationIndividualsCareer AdvancementCertification From CEOMonetary Incentives: Sharing Of Monies RealizedLabRequirement for performance appraisalCompetitive pressureCSIRTarget setting publiclyNational expectation

Meeting post WTO challengesTo meet the challenges under new IP regime, CSIR announced its IP Policy in 1996 which envisaged:

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.

CSIR sets up its own targets of developing a portfolio of 1000 Indian and 500 Foreign patents by 2001.

ELEMENTS OF IP MANAGEMENT POLICYAwareness, Motivation & PromotionIP Management SkillsMatrices For PerformanceAcquisition & ProtectionAudit & ValuationValorizationIncentives & RewardsMonitoring & Review

Performance of CSIR

Current Status of CSIRs IP

Chart2

12402957

9902152

INFORCE

PENDING

No. of Patents

Patents Inforce and under prosecution/pending for prosecution

Sheet1

CSIR'S FOREIGN PATENTS

IN-FORCE793

PENDING2141

TERM OVER30

LAPSED56

ABANDONED94

PCT537

CSIR'S INDIAN PATENTS

IN-FORCE1054

PENDING2789

TERM OVER1295

LAPSED2181

ABANDONED935

Sheet1

CSIR'S FOREIGN PATENTS

Sheet2

0

0

0

0

0

CSIR'S INDIAN PATENTS

Sheet3

INDIAFOREIGN

INFORCE1240990

PENDING29572152

Sheet3

INFORCE

PENDING

No. of Patents

Patent Inforce and Pending

CSIR Patent filing

Chart1

26494

310112

377199

410452

410580

421728

406506

419469

INDIA

ABROAD

CSIR Patent Applications Filed

Sheet1

FiledINDIAABROAD

1997-199826494

1998-1999310112

1999-2000377199

2000-2001410452

2001-2002410580

2002-2003421728

2003-2004406506

2004-2005419469

GrantedINDIAABROAD

1997-199815524

1998-199913438

1999-200011235

2000-200111756

2001-200234186

2002-2003166189

2003-2004276217

2004-2005175237

Sheet1

INDIA

ABROAD

CSIR Patent Applications Filed

Sheet2

INDIA

ABROAD

CSIR Patents Granted

Sheet3

Top PCT applicants in 2002

RankApplicantCountryNo1Council of Scientific & Industrial ResearchIndia1862Samsung Electronic Co.Rep of Korea1843Biowindow Gene Development IncChina1364LG electronics IncChina1255Huawaei Technologies Co.China846Ranbaxy Laboratories Ltd.India567LG Chem Ltd.Rep of Korea478SAE Magnetics (H.K.) Ltd.China319The National University of SingaporeSingapore2810Philips Electronics Singapore PTE Ltd.Singapore24

*CSIR filed 213 PCT applications in 2003Top PCT applicants in 2003

US patents granted to CSIR

% Share of CSIR in the total US Patents granted to Indians excluding foreign assignees

Chart1

40.4

34.9

40.5

33

45.9

64.3

57.6

61.1

Percentage

% Share of CSIR in the Total US Patents Granted to Indians

GRAPH

Percentage

1997-9840.4

1998-9934.9

1999-0040.5

2000-0133.0

2001-0245.9

2002-0364.3

2003-0457.6

2004-0561.1

INDIANCSIR

1996-976110

1997-988419

1998-9914129

1999-0016034

2000-0118534

2001-0224568

2002-03367146

2003-04467141

2004-05495140

GRAPH

Percentage

% Share of CSIR in the Total US Patents Granted to Indians

DATA SHEET

INDIAN

CSIR

US Patents Granted to Indians & CSIR

YearIndian InventorsCSIRIndian Inventors and not Indian AssigneesIndian Inventors and Assignee name not mentionedCSIR % share in the total US Patents granted to Indians excluding NRIs and foreign assignees

1996-97611044840.0

1997-988419511440.4

1998-9914129721434.9

1999-0016034881240.5

2000-0118534971533.0

2001-02245681141745.9

2002-033671461571764.3

2003-04467141222057.6

2004-05495140266061.1

Expansion of Patent Coverage(Improvement Patents)Protection of New Uses/CombinationsProtection of Plant Varieties/SoftwareCreation of Buffer Zone Surrounding PatentsPatent Portfolio Development

Some key portfolios

Bio-enhancersHerbal Formulations - anti-diabetic - anti-oxidant - Hepatoprotective - Immunomodulation - Weight ReductionStandardization of herbal productsAnti-malarials and anti-cancer compounds and formulationsFood products and processes

Some key portfolios

Biotechnology and bio-informatics ProductsLeather technologyOptical FibreDrugs & PharmaceuticalsNanotechnologyPolymersAerospaceothers

CSIR Patents on Drugs/Pharmaceuticals/Chemicals/Biotechnology during NFYP & TFYP

Chart2

71

257

265

4918

7424

5649

4145

FILED

GRANTED

Drug/Pharmaceutical/Chemical/Biotech Product Patents (Filed/Granted)

Sheet1

Drug/Pharmaceutical Product Patents (Filed/Granted)

FILEDGRANTED

1997-9871

1998-99257

1999-00265

2000-014918

2001-027424

2002-035649

2003-044145

2004-05741

Sheet1

00

00

00

00

00

00

00

FILED

GRANTED

Drug/Pharmaceutical/Chemical Product Patents (Filed/Granted)

Sheet2

Sheet3

An integrated approach

Traditional MedicineModern MedicineModern Science

The Golden Triangle - Dr. Mashelkars Concept

Current PrioritiesValorization of IP

Clustering Filling Gaps Bubble PatentsPortfolio formationValuationForging Strategic AllianceLicensing/Bartering/SaleCSIR Lab AgentsPublic-Private PartnershipRegulating AccessStrengthening Linkages with IndustryAdopting new models for valorization of IPEnforcement - Action against Infringement

Valorization of IP

Reaching the Current Stage How ?Training of IPMD ScientistsTraining of CSIR IP Coordinators and scientists by leading US and European patent attorney firms, and, consultants; WIPO, Patent Office Experts from USPTO, EPO and Japan.Experts from Multinationals (Pfizer)Training of scientists in patent search, initial assessment of disclosure, preparation of provisional patents and internal evaluationTraining of scientists in patent examinationTraining of scientists in valorization, licensing, arbitration and litigation.

Reaching the Current StageModel for other publicly funded organisationsModel for industrySupport System for Universities through formal and informal channelsRole in impacting national IP PoliciesRole in formulating Universities IP Policies

IP Licensing: Ownership of IP

CSIR

CSIR/Joint

IP Licensing: Approvals for Licensing of IP

Director/Management Council

DG, CSIR

Licensing of IP

Direct Licensing by the Laboratory

Licensing of IP through TTAs/Business consultants/NRDC

Licensing IP: Pricing of IPCost of developmentCost of securing the IPCost of maintaining the IPIntellectual FeeService Tax

Sharing of Premia/Royalty received from Licensing of IP/Knowledgebase

CSIR60%

INVESTIGATORS40%

Distribution of Monies RealisedInnovators & Principal ContributorsS&T and other staff who contribute direct inputs to the specific development/activityRemaining Staff of the laboratoryCSIR Welfare fund (maintained at HQ)

IP Licensing

Success Stories

Streptokinase -Success Stories in Licensing - IIncreasing No. of people suffering from heart diseases worldwide and specially in IndiaCause of death development of a blood clot causing vascular blockagePrevention by timely intravenous administration of a thrombolytic agentProblem-Non availability of affordable thrombolytic agent within six hours of the onset of heart attackDrugs commonly used are tissue plasminogen activator, urokinase and streptokinaseMarket demand for thrombolytics Rs. 1 bnStreptokinase - 80% of the demandGrowth in demand - 20% annualy

Success Stories in Licensing - IIMTECH developed first indigenous clot buster drug STPase and it was launched in market in 2000 through Cadila PharmaIMPACT crash down of the price from Rs. 3,500 to Rs. 2,000 per doseMilestone payments based on the demonstration of the technology i.e 98% purity at 20/100 L scalesRoyalties started from the date of commercial production

Success Stories in Licensing - IFurther R&D work by the lab for the production of recombinant natural type SK at a level nearly 10 times of natural SKThe product is licensed and regulatory testing for rDNA based theraupatics has been completed and this drug is likely to be available at most affordable cost.Licensing model - milestone payments/royaltiesLicensing possible because of IP protection in India, USA & Europe

Success Stories in Licensing - IINCL-GE Alliance originated in 1993.GE supported the R&D at NCLAlliance operated 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 2003-2004Exposure to and training of NCL scientists to world class R&D management practices.

Success Stories in Licensing - IIBuilding up of world class facilities and resources in NCLAttracting and hiring of talented young scientistsNew contract research opportunities with multinational companiesDiffusion of ideas and generic methods developed to Indian industriesHalf a dozen patents assigned to GECSIR owns several patents based on generic ideas developed while interacting with GE having relevance to systems other than polycarbonates

Success Stories in Licensing - IIUshering into NCL the understanding, importance and culture of IPR.Spin off: THPE [1,1,1-Tris(4-hydroxyphenyl) ethane] is a branching agent used in the synthesis of high grade polycarbonates with properties of high transparency, good mechanical and high parison strength.Hoechst Celanese USA, was the only supplier of THPE to the global market. In 1994, NCL initiated a program, funded by GE aimed at developing a proprietary process for THPE.

Success Stories in Licensing - IIPatents were filed in India and abroadExcel has exported THPE valued at around Rs. 30 Crore over the three year period 2001-03NCL has received US $ 50,000 as license fee and royalty payment of around US $ 1,00,000.NCLs endeavour has led to an Indian firm challenging and breaking global monopoly of a single supplier.

Success Stories in Licensing - IIIUnited 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 -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 -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

Success Stories in Licensing - IIICSIR licenses Sea Weed Technology to PepsicoA 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 applications fined in India, US and other countries

Success Stories in Licensing - IIITrials in Punjab, Andhra Pradesh and Gujarat.Realizing the employment generation potential of aqua-agriculture, DBT, ICAR other government deptts. are now pushing sea weed cultivation as a promising money spinner for rural populationSocial Impact: Hundreds of women along the shoreline can look forward to earning more than Rs. 12,000 a month as pepsi suppliers.

Success Stories in Licensing - IVMint oil is used mainly for producing menthol and the by-product dementholised oil (DMO) which finds uses in pharmaceutical and cosmetic industry.Menthol has a cooling, refreshing aroma and antiseptic properties.The current world-wide consumption of natural and synthetic l-menthol in the cosmeticeutical and cigarette industries is estimated at about 15,000 and 3,000 metric tons, respectively.

Success Stories in Licensing - IVAbout 15 years ago bulk of l-menthol rich essential oil of M. arvensis for international use came from Brazil and China. Later China and India became the main exporters. In the last few years India has come to occupy 1st position in the trade of M. arvensis essential oil and its products.

Success Stories in Licensing - IVSocial Impact:Estimated area and production of menthol mint during 1994-2002# Employment Generation# Enhancement in rural earning

YearArea (ha)Production of oil (t)199445000500019961200009000199813300012000200015000014000200215000014000

Success Stories in Licensing - IVA new and distinct variety "Himalaya" of Mentha arvensis, (US Patent No. PP10,935) has been developed by CIMAPcharacterized by its higher yield of oil which is rich in menthol; improved regeneration potential; tolerance to rust, alternaria leaf blight, corynespora leaf spot, and powdery mildew; vigorous growth; deep green broad thick leaves; and pinkish white flowers.

Success Stories in Licensing - IVCIMAP developed another novel mint plant "Kosi" (US Patent No. PP12,426) Characterized by its high biomass and high oil yield with synchronous branching giving globular shape to the canopy for equal distribution of sunlight to the lower leaves

Success Stories in Licensing - IVAnother novel high menthol producing plant "Saksham" (US Patent No. PP13,279) developed by CMIAP obtained through metabolic engineering, a unique method of screening of the somaclones in poison agar medium containing toxic level of menthol. Tolerant to high concentration of menthol in cultures and hence possesses property of accumulating more menthol per unit leaf mass

Success Stories in Licensing - IVA new and distinct interspecific mint hybrid "Neerkalka" (US Patent No. 12,030) developed by CIMAP through sexual crossing between improved Mother plant Mentha arvensis (cv Kalka) and pollen plant Mentha spicata (cv Neera).The hybrid is propagated vegetatively by suckers or stem cuttings and is stable for commercial cultivation.

Success Stories in Licensing - VUnited States Patent 6,858,141 (NCL)Process for the preparation of ultrafiltration membranes of polyacrylonitrile, using malic acid as an additive A process for the preparation of ultrafiltration membranes from polyacrylonitrile using malic acid as additives, with said membrane of molecular weight ranging between 80 to 180K, showing high purification and water permeating ability.

# Cost of water purification (Bacteria + Virus free) few paise per litre as compared to Rs. 10 per litre of mineral water# Licensed to the industry recently; Social Impact- Very high

Other Success Stories from CSIREach lab created several such success stories in recent yearsLicensing was possible because of IP protectionValue realization is a long term processSeveral proposals for IP licensing in the pipeline all because of IP protection nationally and internationally.

Doing Business with IP Challenges

Public-Private PartnershipRegulating AccessStrengthening Linkages with IndustryVenture CapitalCompeting at a fast paceWorking towards Technology oriented systems of InnovationAdopting new models for valorization of IPFocusing on Socially relevant technologiesAdopting best practices in IP Licensing

THANKS