The Bill (H.R. 7251) would require companies desiring to launch a generic or biosimilar product to choose between an IPR and the Hatch-Waxman/BPCIA framework.
Members of the US House and Senate, on December 11, 2018, jointly introduced the Hatch-Waxman Integrity Act of 2018. Copies of the House and Senate Bill may be found here and here, respectively. If enacted, the Act would amend the FD&C and PHS Acts to require a generic (505(b)(2) or 505(j)) or biosimilar (351(k)) manufacturer wishing to challenge a brand-name drug patent to choose between: (i) an Inter Partes Review (IPR) before the Patent Trial and Appeal Board (PTAB) or (ii) the Hatch-Waxman (generic drugs) or BPCIA framework (biosimilars). Another portion of the Bill modifies the Securities and Exchange Act to penalize a person who undertakes a short sale of any publicly traded security of the owner of a patent that is the subject of an IPR petition.
Updates on the progress of this legislation will be provided.
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