Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants (Updated)

On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals.  The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA applicants to certify in their aBLA that, for any patent that could be included in the list of potentially infringed patents to be supplied by the reference product sponsor, the aBLA applicant has not and will not file an IPR or PGR challenging the potentially listed patents. For ANDA applications under 505(b)(2) or 505(j), the applicant would need to certify that it has not and will not file an IPR or PGR, and is not relying, in whole or in part, on any decision issued by the PTAB in an IPR or PGR proceeding.

In his office’s summary of the amendment, Senator Hatch stated that “[e]ven though Congress did not intend to upset its drug/biologic-specific Hatch-Waxman and BPCIA procedures with the enactment of the IPR and PGR processes, generic drug and biosimilars manufacturers have increasingly used the IPR process to circumvent the Hatch-Waxman Act and BPCIA patent challenge processes while nonetheless taking advantage of their abbreviated processes for drug entry.”  According to Senator Hatch, the amendment “would close the loophole unintentionally created by the America Invents Act” and help “restore the careful balance of the Hatch-Waxman Act and the BPCIA, and to prevent the IPR or PGR processes from undercutting them…”

In a press release, Senator Hatch stated that he “strongly support[s] IPR” but does not “support its use in a way that upends or eviscerates Hatch-Waxman.”  Senator Hatch further stated that the amendment “would preserve Hatch-Waxman as the standard path for generic companies to challenge brand patents, while keeping IPR as an option in situations where other interests come into play,” but “would prevent companies from using IPR to put added litigation pressure on innovators above and beyond what Hatch-Waxman already provides.”

UPDATE (December 18, 2018):  On December 11, 2018, Senator Orrin Hatch (R-UT) issued a press release stating that he, along with Senator Thom Tillis (R-NC), and Representative Bill Flores (R-TX), introduced the Hatch-Waxman Integrity Act of 2018 in the Senate and House of Representatives. Senator Hatch previously introduced and withdrew the bill at a Senate Judiciary Committee hearing as an amendment to the CREATES Act.  In its current form, the bill would amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 “to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes.”

Stay tuned for further updates.