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25 August 2022FeaturesPharmaJeanna Wacker and Tasha Francis Gerasimow
Navigating the murky waters of the Hatch-Waxman ‘safe harbour’
The Hatch-Waxman “safe harbour” is a valuable tool for companies looking to develop FDA-regulated products based on existing patented inventions. But the boundaries surrounding the safe harbour 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.
