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Finding Safe Harbor: Protections from Infringement for Using Patented Inventions During the Regulato

Development and testing of new therapeutics can be a costly and difficult undertaking; obtaining FDA approval alone can easily cost millions of dollars. In some instances, obtaining regulatory approval can require use of patented inventions, a serious roadblock if a license cannot be obtained. However, in the context of the regulatory approval process, patented inventions can be used in certain circumstances without a license and without being considered an act of infringement.

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