Navigating the Murky Waters of the Hatch-Waxman 'Safe Harbor'
The boundaries surrounding the Hatch-Waxman safe harbor are not always clear. This article explores the statutes and recent case law surrounding the provision to shed some light on its contours.
September 13, 2022 at 12:05 PM
8 minute read
Patent Litigation
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:
"It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States 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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