The article delves into the Hatch-Waxman safe harbor as outlined in 35 U.S.C. § 271(e)(1), highlighting its complex legal interpretation and recent court cases. It discusses UCB, Inc. v. Catalent Pharma Solutions, where the court evaluated whether Catalent's actions were sufficiently related to an FDA submission to qualify for safe harbor protections. Emphasizing a flexible interpretation of legal standards, the article illustrates the difficulties in clearly defining the safe harbor boundaries amidst complex factual scenarios that impact legal outcomes.
As these recent cases indicate, the threshold showing to enter the safe harbor, particularly at the pleading stage, is high, as dismissal is only appropriate where the allegations in the complaint clearly and unequivocally establish safe harbor protection.
The courts have recognized that '[a]s far as the text [of the Safe Harbor] is concerned, . . . [it] is not plainly comprehensible on anyone's view.' Just so.
The court adopted a broad and flexible interpretation of the standard, focusing on whether Catalent's actions were 'reasonably related' to FDA submission.
Navigating the Common Law Research Exemption and Hatch-Waxman Safe Harbor is complex and highly fact-intensive, illustrating the challenges faced in this legal landscape.
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