Non-regulated Inventions Do Not Have Safe Harbor From Infringement Under Hatch-Waxman

After years of uncertainty, a Federal appeals court has ruled that the Hatch- Waxman safe harbor exemption from patent infringement does not apply to certain types of patented inventions. The Hatch-Waxman Act provides a safe harbor that immunizes competitors from infringement of patented inventions used solely for uses reasonably related to the development and submission of information needed for Federal regulatory approval. For a number of years, court decisions have determined the scope of this exemption, with a clear trend to extending the safe harbor to more activities and more types of inventions. Based on this trend, a belief developed that the use of any patented invention, including research tools, for research related to the development of data for regulatory submission is covered by the Hatch-Waxman safe harbor.


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