Is Informed Consent Needed To Use Clinical Trial Data In Patent Applications?

May 2, 2002 Published Work
Presented in Manhattan on May 2, 2002 at the 18th Annual Joint Patent Practice Program - sponsored by the NJIPLA, CTIPLA, NYIPLA & Philadelphia IPLA.

Pharmaceutical companies are discovering new and more effective pharmacologic products for diagnosing, preventing and treating disease on an almost daily basis. The Food and Drug Administration (FDA) requires manufacturers to demonstrate the safety and efficacy of these products through, among other things, the conduct of clinical trials that test the new product in human subjects.1
These clinical trials establishing safety and efficacy of the new product are generally large, lengthy and conducted at multiple sites, because a single site cannot recruit patients in sufficient numbers to show a statistically significant difference between the new product and placebo for efficacy.2 The conduct of clinical trials has now grown into a multi-billion dollar per year industry.