Ships in the Night: Resolving Administrative Conflict between FDA- and Patent-Related Legislation

Abstract

In 2011, the Leahy-Smith America Invents Act altered U.S. patent administrative law, creating three review procedures whereby third parties have means of challenging the patentability of previously-issued patents. Lawmakers established the administrative framework, and policymakers, judges, and executive employees implemented, revised, and altered their procedures to conform. The marketplace and public adjusted their business and personal expectations accordingly.

Unexpected, though, was the Leahy-Smith America Invents Act's profound impact on the carefully balanced administrative schemes involving the approval of biosimilars and generic drugs. The unintended statutory conflicts among three administrative pathways, the Drug Price and Competition and Patent *1112 Term Restoration Act, the Biologics Price Competition and Innovation Act, and the Leahy-Smith America Invents Act, have increased costs and complexity in unwarranted ways. Senator Orrin Hatch recently sounded a siren of warning as to the conflicts between these dissimilar ships set to crash into one another.

Principles of administrative comity compel accommodation. So does sound and serviceable administration. While a handful of legislative fixes have been proposed, introduced, revised, debated, and abandoned, to date no one in the literature has identified, discussed, and analyzed that conflict, reviewed the full range of potential solutions, and offered a workable, easily-implementable administrative alternative. We do.

In the interests of promoting generic drug competition, reducing needless litigation costs, and restoring the delicate balance Congress struck between the courts and the administrative state with the abbreviated regulatory/litigation pathways for generic and biosimilar medicines, this Article analyzes the Leahy-Smith America Invents Act, the Drug Price and Competition and Patent Term Restoration Act, and the Biologics Price Competition and Innovation Act, and looks to the legislative history and analogous district court practice.

This Article recommends that the United States Patent and Trademark Office adopt guidance and policy directing the Patent Trial and Appeal Board to exercise their statutory discretion to deny institution during parallel statutory Drug Price Competition and Patent Term Restoration Act or Biologics Price Competition and Innovation Act litigation. This is all the more judicious after SAS Institute Inc. v. Iancu, a Supreme Court decision upholding the United States Patent and Trademark Office Director's authority to issue regulations, and it accords with the other provisions and legislative history of the various acts. This Article offers proposed agency guidance and internal policy recommendations that would provide clarity in an area where it is sorely needed; after all, someone must see the ships safely ashore.