Merck v. Integra: Transcript of Oral Arguments
On April 20, 2005, the Supreme Court heard oral arguments in the case of Merck KGaA v. Integra (Statutory safe harbor for drug development activity). A transcript of the oral arguments is attached.
Based on the briefs and the oral arguments, I expect that the CAFC decision narrowly interpreting 35 USC 271(e)(1) will be reversed. Respondent Integra’s strongest argument is a technicality — that the question on appeal is not based on any case or controversy remaining between the parties.
In many eyes, the question is not whether Merck’s actions are protected by the statutory safe harbor. Rather, the point of speculation is: How far will the Supreme Court extend the safe harbor?
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