Showing posts from May, 2021

Orange Book Insights No. 26: Interesting New Patents From FDA''s Orange Book: Vol. 41, Supplement 3

Is a method of preventing certain patients from receiving a drug a “method of using” the drug? Patents directed to computerized methods of preventing a patient from receiving a drug have previously been listed in the Orange Book. Most notable are patents listed by Celgene for their thalidomide product, THALOMID®. Thalidomide can cause significant birth defects if a woman takes the drug while pregnant. The Celgene patents were directed to a computer system meant to prevent a pharmacy from selling THALOMID to a woman who has not had a recent negative pregnancy test. So when I saw that the “What’s New” for Supplement 3 of my Orange Book Companion ® showed that Zogenix had listed a patent with computer system claims for their FINTEPLA® (fenfluramine) product, I thought of one of Yogi Berra’s famous witticisms: “it’s déjà vu all over again”! Why might FINTEPLA have a computer system patent? Fenfluramine was part of an infamous diet drug combo called “fen-phen” in the 1990’s. Fen-phen was bl