Issues in chemical commercialization

Author

Erin Sommers, erin.sommers@finnegan.com
Krista E. Bianco, krista.bianco@finnegan.com
Irene Hantman, ihantman@verdantlaw.com
Greg Sower, GSower@ramboll.com

Presentation

255th ACS National Meeting - New Orleans
"Issues in Chemical Commercialization"

Abstract

This program will address issues in chemical commercialization from regulatory compliance to Intellectual Property (IP) and contractual considerations. Participants will learn about the regulatory burden the Toxic Substance Control Act (TSCA) imposes on introducing chemicals into commerce from R&D to commercialization. Panelists will discuss protecting intellectual property through patents and EPA’s TSCA notification process. In addition, panelists will discuss contract provisions important to protecting inventors’ rights. Regulatory hurdles will be discussed as well. These include developing testing data for new chemicals and protecting confidential business information (CBI). TSCA does not require testing for new chemicals, however, failure to provide adequate toxicity testing can slow the EPA review process dramatically resulting in delayed access to market and unforeseen testing costs – testing can be designed to provide information for EPA review as well as REACH and GHS classifications. The Lautenberg amendments to TSCA have significantly restricted CBI claims in the US. Additionally, chemicals pursuing GRAS status for food uses will have to make safety information publicly available.