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Paul A Calvo

Paul A Calvo

Sterne Kessler Goldstein & Fox, USA

Title: Choosing between patents and trade secrets for protecting biotech products or bio-production processes

Biography

Biography: Paul A Calvo

Abstract

The choice of trade secrets versus patent protection has taken on renewed importance in the biotechnology sector with the advent of biosimilar biologics. From an originator perspective, increasing importance is being placed on secondary patent protection, i.e., patents that cover manufacturing processes, formulations, etc. The goal of these filings is to extend protection of the original composition and method, and use of patents by covering production methods or the commercial formulation. However, there are many originator companies which can bypass filing for patent protection, and the disclosure of their bioprocess that comes with it, in favor of keeping some of their critical processes secret. Factors that weigh in favor of patent or trade secret protection will be outlined in the context of products versus processes.