Biotech Values

[DewDiligence]

>…it seems to me that the "loophole" was the recognition that an AG was not a generic restricted/governed by Hatch-Waxman but rather a license of the patent holder.<

That’s right. I consider this a loophole in H-W because it’s clear that Congress did not intend to provide for AG’s* when the H-W bill was drafted back in the 1980s.

*If Congress had intended to provide for AG’s, H-W would presumably have mentioned AG’s explicitly and it would not have contained such elaborate provisions for first-filer exclusivity.