GE-520: Fundamentals of Intellectual Property (IP) and Technology Management (1 credit)
1.Intellectual property: Concepts and fundamentals; Concepts regarding intellectual property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); Economic importance, mechanisms for protection of intellectual property-patents, copyrights, trademark; Factors effecting choice of IP protection; Penalities for violation; Role of IP in pharmaceutical industry; Global ramifications and financial implications.
2.Trade related aspects of intellectual property rights: Intellectual property and international trade; Concept behind WTO (World Trade Organisation), WIPO (World Intellectual Property Organisation) GATT (General Agreement on Tariff and Trade), TRIPs (Trade Related Intellectual Property Rights), TRIMS (Trade Related Investment Measures) and GATS (General Agreement on Trade in Services); Protection of plant and animal gentic resources; Biological materials; Gene patenting; Biotechnology / drug related IPR issues; Status in India and other developing countries; Case studies and examples; TRIPS issues on herbal drugs.
3.Nuts and bolts of patenting, copyright and trademark protection criteria for patentability, types of patents; Indian Patent Act, 1970; WTO and modifications under TRIPS: Filing of a patent application; Precautions before patenting-disclosures / non-disclosures, publication-article / thesis; Prior art search-published patents, internet search patent sites, specialized services-search requests, costs; Patent application-forms and guidelines, fee structure, time frames, jurisdiction aspects; Types of patent applications- provisional, non provisional, PCT and convention patent applications; International patenting-requirement procedures and costs; Financial assistance for patenting- introduction to schemes by NRDC and TIFAC; Publication of patents-gazette of India, status in Europe and US; Patent annuity; Patent attomeys technical aspects, criteria for selection, addresses, fee, rights and responsibilities of a patentee; Practical aspects regarding maintaining of a PATENT FILE; Patent infrigment- meaning, scope, litigation, case studies and examples; Patenting by research students, lecturers and scientists- University / organisational rules in India and abroad; Thesis research paper publication, credit sharing by workers, financial incentives; Useful information sources for patents related information-internet sites, brouchers, periodicals, CD roms; Significance of copyright protection for researchers; Indian Copyright Law and digital technologies-Beme convention, WIPO copyright treaty (WCT), WIPO performance and Phonogram Treaty (WPPT); Protection for computer data bases, multi media works; Trade marks legislation and registration system in India-an introduction, meaning of trademark criteria for eligibility; filling application for trademark registration; Trade secrets-scope modalities and protection; Case studies-drug related patents infringments.
4.Technology development / transfer / commercialisation related aspects: Technology development-meaning; Drug related technology development; Toxicological studies, bioequivalence (BU), clinical trials-phase-I, phase-II and phase-III; Approved bodies and agencies; Scale-up, semi-commercialisation and commercialisation-practical aspects and problems; Significance of transfer of technology (TOT), bottlenecks; Managing technology transfer-guidelines for research students, scientists and related personnal; TOT agencies in India-APCTD, NRDC, TIFAC, BCIL, TBSE/SIDBI; TOT related documentation-confidentiality agreements, licensing, MOUs, legal issues; Compulsary licensing excess to medicine issues; DOHA declaration, POST WTO product patent regime from 2005; Challenges for Indian pharmaceutical industry in the context of globalisation of IP; Drug registration and licensing issues-national and global; Drug master file submissions, SOPS; Related registration and marketing issues; Case studies- antiretroviral drugs and others.
5.Funding sources for commercialization of technology: Preparation of a project report, financial appraisal, business models; GOI schemes and incentives; NRDC, TePP, HGT, TDB schemes. PATSER; Venture capitalists, banks. Incubator concept-Case studies with respect to IIT, CCMB, IMTECH, NIPER. Documentation and related aspects.
6.Ethics and values in IP: IP and ethics-positive and negative aspects of IPP; Societal responsibility; Avoiding unethical practices; Echo-responsibility-economic, social and environmental benifits of modern biotechnology; Voluntary adoption of pollution control strategies.