What are the elements of the statutory definition of a "substantial similarity" between a drug and its chemical structure?
MultiRegion, United States of America
The following excerpt is from United States v. Demott, 906 F.3d 231 (2nd Cir. 2018):
2 Although the wording of the statutory definition in 802(32)(A) is arguably unclear on this point, we assume for purposes of this opinion, as have all the parties, that the requirement of substantial similarity in pharmacological effect is in addition to the requirement of substantial similarity in chemical structure. See United States v. Roberts , 363 F.3d 118, 121 (2d Cir. 2004) (assuming that these elements are conjunctive, rather than disjunctive, requirements).
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