IPR mediated opportunities in the pharma industry

Speaker Profile

Prof Prabuddha Ganguli CEO, VISION-IPR

Spanning a professional career of over two decades with Hindustan Lever Ltd in diverse management positions including research, technology transfer, business planning, factory management and head of information services and patents, he is the CEO of the IPR consulting firm VISION-IPR offering services in IPR management, information security and knowledge management. He is Adjunct Professor at the Indian Institute of Technology Bombay, Visiting Professor at the National Law School University at Jodhpur in India and an elected fellow of the Maharashtra Academy of Sciences.

He has been an Alexander von Humboldt Fellow, Germany and a National Science Talent Scholar. He participates in several international activities of WIPO as an IPR Consultant to conduct IPR Awareness and Capacity Building Programmes. He is also the International Consultant coordinating WIPO’s Capacity Building Project and SAARC CD-ROM project. He has been engaged as a Honourary Scientific Consultant to the Office of the Principal Scientific Advisor, government of India for Innovation and IPR Matters.

Synopsis

Post TRIPs years have been a watershed period in India’s Intellectual Property Rights (IPR) history. There have been several changes in quick succession making India TRIPs compliant in most areas of IPR.

India’s undisputed competence in R&D, proven skilled manpower, cost effective manufacturing and entrepreneurial skills has continually driven its chemical and pharmaceutical industry towards positive growth. An enabling IPR framework should now synergise with its existing strengths to build up a lead position in the global pharmaceutical industry. Team India Pharma (TIP) now needs to strategise and galvanise the distinctive role of each of its players that includes the government, industry, private and public R&D centres, educational institutions and industry associations, to perform their roles in tandem and focused manner to deliver innovative cost effective products and services that are unmatched by its global competitors.

With India now largely TRIPs compliant, the strengths gained over several decades have now to be exploited to the maximum so that the TIP can prove its worth and convert India to a major outsourcing hub in the pharmaceutical products and services. With collaborative working being the way forward the TIP will have to develop competence in:

• Importing relevant expertise/technologies and/or export their expertise/technologies;
• Drafting of licensing, confidentiality agreements, royalty, benefit sharing arrangements, market access conditions, etc in situations of mergers, acquisitions, joint ventures;
• Patent drafting, prosecution, and management of IPR.
• Enforcement of IPRs in India;
• Litigations through trained IPR lawyers, trained judiciary to deliver justice and enforcement agencies involving the police, customs excise, taxation officials etc.
• Valuation of intellectual assets and taxation laws in relation to their creation and transfer either inter-organisationally or intra - organisationally.

A key concern has been the weakness in protection of test data submitted to authorities for regulatory clearances. The government will have to ensure appropriate means and legislation in place in India that complies with article 39.3 of TRIPs.

The presentation will elaborate on the imperatives for TIP in the decade to come.