The Hatch-Waxman “safe harbor” is a valuable tool for companies looking to develop FDA-regulated products based on existing patented inventions. But the boundaries surrounding the safe harbor are not always so clear. Here, we’ll dive into the statutes and recent case law surrounding the provision to shed some light on its contours.
What is the safe harbor provision?
The safe harbor provision, codified in 35 U.S.C. §271(e)(1), was introduced in 1984 as part of the Hatch-Waxman Act. It provides:
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