Hatch-Waxman amendment: a Hobson’s choice


Janine Carlan

Hatch-Waxman amendment: a Hobson’s choice

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If enacted by Congress, the proposed amendment to the Hatch-Waxman Act would spell trouble for generic pharmaceutical companies seeking to take on brand competitors in patent litigation, says Janine Carlan of Arent Fox.

US Senator Orrin Hatch, co-author of the original Hatch-Waxman Act of 1984, has introduced a new bill seeking to dramatically change the current course of Hatch-Waxman litigation. On June 13, Hatch introduced an amendment, the Hatch-Waxman Integrity Act of 2018, that is designed “to restore the careful balance the Hatch-Waxman Act struck to incentivise generic drug development”.

According to Hatch, the amendment would restore the balance by outlawing the ability to use the inter partes review (IPR) process in the context of a Hatch-Waxman litigation.


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