Document Type

Response or Comment

Publication Date

7-27-2023

Abstract

We are pleased to offer written comments to this workshop focused on “… making federally funded inventions more accessible to the public… .” These comments are informed by recent research from the Center for Integration of Science and Industry at Bentley University that has:

  • Quantified the scope of NIH funding for basic or applied research, clinical development, or patents associated with drugs approved by the FDA 2010-2019. This work identified $187 billion in NIH-funded research directly related to these drugs (applied research – 17%) or their biological targets (basic research – 83%), representing a (discounted) investment comparable to reported levels of investment by industry, thus reducing the investment required by industry by approximately half. These studies further show that less than 3.5% of this funding contributing to phased clinical trials and <1% resulted in patents cited as providing market exclusivity and subject to the public interest protections of Bayh-Dole.
  • Compared the financial returns of biotechnology license from academic institutions with those between commercial firms. This work demonstrated that the effective royalty rates and other payments associated with licenses of academic technologies under Bayh-Dole were less than half of those between commercial firms independent of the development stage of products anticipated under these Agreements or other intrinsic terms of the Agreements.
  • A novel approach to quantify the “health value” or direct health benefit realized by individuals taking specific pharmaceutical products independent of impacts on economic activity or indirect, econometric inferences.

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