Intellectual Property Rights & Technology Management at the Indian Council of Medical Research

1. Intellectual Property Rights & Technology Management at the Indian Council of Medical Research Dr Sadhana Srivastava Scientist IPR UnitDivision of Innovation & Translation Research Indian Council of Medical Research New Delhi 110029 wwwicmr.nic.in

2. The agenda • About the Indian Council of Medical Research, Department of Health Research, Ministry of Health & Family Welfare, Govt of India • Intellectual Property and Technology transfer activities • Some technologies developed • Training undergone as Khorana scholar at WARF/UW-M Indian Council of Medical Research, Department of Health Research

3. Indian Council of Medical Research • Established in 1911 as Indian Research Fund Association - world’s second oldest medical body after MRC, UK • Mandate of ICMR is - planning, promoting, co-ordinating and conducting biomedical research • Undertake and support basic, epidemiological, applied and operational research. • Carries out its 33 permanent Institutes/Centers, extramural research projects and with active international collaboration and industry participation Better health through research is the thrust and focus of ICMR Intellectual Property Rights Unit, Indian Council of Medical Research

4. ICMR has a strong national presence • 33 permanent Institutes and Regional Medical Research Centres • Dozens of Field Stations and other laboratories in Medical Colleges all over India

5. Intellectual property and technology transfer

6. Why IPR activities initiated at ICMR? • ICMR scientists not oriented towards creation and protection of IP • Philosophy - new knowledge generated disseminated through publication • WTO/GATT- globalization – put pressure on the generic-driven public health care system of India • New policy – promote innovative, outcome-oriented R&D, return on investments etc. • New thinking on create new IP/products while attempting to solve national health problems

7. Establishment of IPR Unit • Set up in 1999 on the recommendations of the Governing Body of the Council • The IPR Unit is expected to help and assist the ICMR in the areas of intellectual property rights protection and technology transfer and commercialization of all ICMR supported research • Also expected to help create a climate for innovation-driven research • IPR Unit became part of Innovation & Translation Division in 2015

8. What do we do? • Promote innovative, product-directed research for indigenous health products for affordable health care for Indian people • Identification of new inventions and assess their potential for IP protection • Process these new inventions for IP protection after due diligence – both internal and external support • Manage IPR (patent) portfolio of the Council • Commercialization of ICMR IP through the other Tech transfer agencies and own efforts. • Support collaborative R&D through NDAs, MTAs, MoUs etc. • Disseminate the IP and technologies generated by the Council for potential industry partners

9. What do we do? Contd. • Offer training/sensitization workshops on IPR to both ICMR scientists; host internships to trainees under the DST Women Scientist Scheme • Policy support to Govt. on IPR and access to health issues to the WHO, WTO etc. • Showcase ICMR technologies at workshops, conferences, exhibitions and industry meets to seek potential users • To assess market potential of existing technologies of the Council Single window support – from new IP to product development

10. How are new inventions reported? • All new inventions of the Council reported to IPR Unit through a structured New Invention Disclosure Form • Once the new invention is found patentable through due diligence search, techno-legal support provided • ICMR has an empanelled IP attorney firm • Filing and maintenance of patents done centrally at the IPR Unit • All costs for filing, maintenance and prosecution borne by the IPR Unit • Only ICMR supported IP handled Intellectual Property Rights Unit, Indian Council of Medical Research

11. What is technology transfer? • The exchange of information, materials or intellectual property rights • Between (and among) government and academic laboratories or the industry • To facilitate further research and commercialization for public good • Intramural/extramural research

12. Technology Transfer Mechanisms • This general model holds for the majority of inventions, details of the process may vary significantly from invention to invention. • Scientific publications (Information) • Informal scientific collaborations (Information) • Material transfer agreement (Material) • Patent licenses (IP rights, Material) • Non-patent licenses (Material)

13. Policy support for technology transfer and commercializtion

14. IP Policy (2013; 2015) • Ensure rapid and efficient availability of new products/technologies developed with ICMR support through prompt IP protection within and outside India • Ensure that the basic mission of R&D not hindered by IP protection • Provide techno-legal support to all ICMR inventors • Licensing policy to ensure maximal public health impact • There are also policies for patent filing, collaboration with industry, tech transfer, commercialization etc. Intellectual Property Rights Unit, Indian Council of Medical Research

15. Licensing Policy and procedures • Licensing policy laid down in the document Collaborative R&D guidelines (2007) • Scientists encouraged to engage industry for addressing critical national health problems • Tech transfer and licensing terms decided on a case-to-case basis • For industry-sponsored research, MOU drawn up before the project is initiated • Licensing negotiations done centrally • Licensing policy aims to promote access Indian Council of Medical Research, Department of Health Research

16. Patent filings • About 150 New Invention Reports filed from ICMR supported research - intra and extramural scientists. • After due diligence search about 110 patent applications filed in India • About 40 patents filed abroad • Patent filing abroad decided through strong scrutiny • A total of 70 patents granted mostly intramural inventions.

17. IP tool kit It has been ensured that for all collaborations, ICMR scientists put in place the following: • Non-disclosure/confidentiality agreement • Material Transfer Agreement • Data sharing agreement • MOUs/Agreements for collaborative research Intellectual Property Rights Unit, Indian Council of Medical Research

18. Highlights of training obtained as Khorana scholar • Deep understanding of the process of innovation and IP protection • Systems for invention reporting and hand-holding of inventors to bring out products • Exposure to the process of technology transfer • Critical issues to be considered for licensing of technologies • Success stories from the WARF/UW-M system • The exposure at WARF/UW-M has benefited my functioning as a tech transfer manager Indian Council of Medical Research, Department of Health Research

19. Some recent technologies developed

20. Diagnostic Tests developed

21. Some technologies developed by the ICMR

22. Other technologies developed • Device for visualizing cancerous lesions (cervical cancer) transferred to M/s Smart Scientifics, Ambala • Reverse dot blot kit for diagnosis of Thalasseamia to M/s Imgenex, Bhubneswar under contract manufacturing • Fertility assessment kits to M/s HLL Lifecare Ltd. Thiruvanthapuram • Bti based larvicide for antimalaria to various companies. • Monoclonal antibody detection kit for Chlamydia trachomatis to M/s Accurex India

23. Thank you