Title: What's Fresh? And What Could It Possibly Have To Do With the Orphan Drug Act? (1994 Third Year Paper)
Author(s): Johannes D. Urso
Subject & Subject keywords: Food and Drug Law "Genentech" "human growth hormone" "hGH" "protropin" "humatrope"
Abstract:This is going to be a somewhat unconventional paper. I would like to talk about two seemingly unrelated topics that fascinated me: the first is our classroom discussion on the question of "What is fresh?" The second is an unassigned case in the text, Genentech v. Bowen. Originally, I was going to right a piece on the Orphan Drug Act and simply attach a discussion of "What is fresh" for your interest because I had some thoughts I wanted to share with you. But I soon realized that the two topics are actually quite related. The intrigue in determining "What is fresh?" is quite similar to the problem facing the Bowen court, namely "What is the "same" drug?"

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