Nanodrugs in the Post-Blockbuster World – Critical Patent Issues and FDA Regulatory Challenges

R. Bawa
Bawa Biotech LLC and Rensselaer Polytechnic Institute, US

Keywords: nanodrugs, nanotechnology, FDA, US Patent Office, nanotech regulation, patent law, nanosilver, carbon nanotubes

Summary:

In today’s global economy, pharmaceutical companies are under enormous pressure to maintain profitability in light of numerous challenges ranging from revenue losses due to patent expirations on blockbusters to enhanced regulatory oversight to an ever-increasing challenge from generic manufacturers. As a result, pharmaceutical companies are turning to miniaturization and nanotechnology to enhance or supplement drug target discovery and drug development. On the regulatory front, emerging technologies, like nanomedicine, bring with them concerns and uncertainties about how they should be regulated. The “baby steps” the US FDA has undertaken over the past decade are inadequate and have contributed to regulatory uncertainty. With this backdrop, my presentation will highlight, via pictures and animations: • the definition of nanotechnology and nanomedicine – hype, confusion and trends; • size-driven innovations in nanodrugs (FDA approved nanodrugs, commercial activity in the nanomedicine space, etc.); • critical issues, strategies and challenges relating to patenting nanodrugs – a primer for physicians and scientists; • issues resulting from the current “nanopatent land grab” by “patent prospectors” • regulatory challenges facing the FDA – nanosilver, carbon nanotubes and nanoparticles as test cases.