Replies to post #142220 on Biotech Values

[DewDiligence]

Re: ABT’s anti-FoB CP and the Fifth Amendment Takings Clause

I commented on ABT’s Citizen Petition in #msg-75095592. I doubt that ABT’s arguing on the basis of the Takings Clause will work, but I suppose it’s worth trying.

Why won’t the argument work, IMO? Because any ANDA submission necessitates a Fifth Amendment taking insofar as Hatch-Waxman empowers the FDA to take the originator’s data on efficacy and safety of the reference drug and give these data to the ANDA applicant to enable the FDA to approve a generic version of the drug. I fail to see why the 351(k) pathway that governs FoB’s is different from Hatch-Waxman in this regard. Does anyone disagree?