BioBridge Healthcare Solutions Pvt. Ltd, India
Ganesh Kumraj is a Quality and Operations Management professional with extensive knowledge of International Standards and Regulations and an expert in Project design, Commissioning, Product Development, Scale-up and Commercial scale manufacturing of Final Drug product and Bulk drug substance. He has over 23 years of experience and worked at various senior level positions in the Biotechnology industry. He has been enlisted by WHO, Geneva on their panel of NRA experts besides serving on assignments for conducting cGMP training programs for manufacturers and National Drug Inspectors under GTN (Global Training Network). He is active on the domestic and international Speaker circuit on a variety of issues and topics.
Intellectual property law enables and gives proper direction alongwith the rules that individuals and organizations can use when conducting business and making business plans. Unfortunately, the present state of intellectual property laws around the world has created an environment that imposes timing issues ambiguities that are vexing to decision makers in every industry, including the biomanufacturing industry. In United States, courts have defined a ‘Super’ enablement standard that patent application must meet in order to mature into valid, issued patents.European and Japanese courts appear to be following the lead of the US, by embracing the ‘Super’ enablement standard. The timing of intellectual property protection and public notice frequently acts as an impediment to developing global strategy and in making changes in the strategy. This talk describes basic considerations and intellectual property law during development and scaling up biomanufacturing processes, including barrier imposed by the law. This talk also describes intellectual property law tools and strategy for protecting assets of a biomanufacturer engaged in development and scale-up operations