February 12, 2019

In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies.

Hatch-Waxman Integrity Act of 2019

On January 30, 2019, Sen. Thom Tillis (R-NC) and Rep. Bill Flores (R-TX) introduced the Hatch-Waxman Integrity Act of 2019 (H.R.990 and S.344, respectively) with the goal of foreclosing ANDA, 505(b)(2) and biosimilar applicants from petitioning for inter partes review or post-grant review of patents covering the reference listed drug or biologic drug. 

The Act would amend the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2)) by requiring a 505(b)(2) or ANDA applicant to certify that it will not institute IPR or PGR as to any Orange Book-listed patent, and that it will not “rely[] in whole or in part” on any PTAB IPR or PGR decision. Similarly, the bill requires biosimilar applicants to certify that the applicant will not petition to institute IPR or PGR with respect to a patent that covers a reference product or a method of its use and that has been so identified by way of marking or other public notice.

 View the full alert here.