How Unlawful FDA Regulations Created Drug Patent Thickets—And What To Do Now Alfred B. Engelberg September 23, 2026

https://www.healthaffairs.org/content/forefront/unlawful-fda-regulations-created-drug-patent-thickets-and-do-now?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz-842eEELiE_kVbh0ksuh9Qm2KUrESj0wxovOFnzhRP_flnzOXQes05--uJxFf92esbgjOegE8gHNAo0GZoEO74in99_7Q&_hsmi=441023134&utm_source=hasu Eight years after Hatch–Waxman, the Food and Drug Administration issued regulations that turned the law’s aims on their head. The legal and political environment has now aligned to make revocation of these regulations possible.