This article was first published by IAM on June 2, 2023 in its Special Report 2023 Q2: New Frontiers of Pharma and Biotech IP Strategy.
Daralyn Durie, Janet Xiao and Katherine McNutt of Morrison Foerster explore strategies to reduce the threat of infringement liability in the complex environment of gene therapy development.
The Hatch-Waxman Act created a statutory safe harbor, codified in Section 271(e)(1), Chapter 35 of the US Code, which immunizes drug developers from patent infringement liability for certain activities related to developing and submitting information to regulators. For example, the safe harbor immunizes a generic drug manufacturer from patent infringement liability for using a branded company’s patented drug product to develop and submit information to the FDA as part of the approval process for that generic drug.
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