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Safe harbour provisions can be relied on but their boundaries are still being defined, explain Jeanna Wacker and Tasha Francis Gerasimow of Kirkland & Ellis.
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.
What is the safe harbour provision?
The safe harbour provision, codified in 35 USC §271(e)(1), was introduced in 1984 as part of the Hatch-Waxman Act. It provides: It shall not be an act of infringement to make, use, offer to sell, or sell within the US or import into the US a patented invention […] solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
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Hatch-Waxman Act, safe harbour, patents