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Analysis

Judge Lourie's Dissent Revives Debate Over FDA Safe Harbor

By Dani Kass ( April 5, 2024, 8:55 PM EDT) -- U.S. Circuit Judge Alan Lourie has urged the Federal Circuit to reconsider its precedent over a safe harbor that allows infringement when companies are developing products regulated by the U.S. Food and Drug Administration, and many attorneys agreed with him that the appeals court has been improperly expanding the safe harbor for decades....

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