Posts Tagged: "Section 325"

Limiting Section 325(d) Delegation Will Ensure a More Predictable Inter Partes Review Process

Congress created Inter Partes Review (IPR) to weed out clearly invalid patents that would not have been issued had the United States Patent and Trademark Office (USPTO) known about certain prior art. However, USPTO Director Iancu should consider limiting his delegated authority in 35 U.S.C. § 325(d) to prior art that was not presented to the USPTO during examination. As such, all references in the prosecution record would be presumed to have been fully considered by the examiner and could not form any part of a post grant petition. This change would exercise the discretion provided by Congress to its fullest, preserve USPTO resources by not reconsidering the Office’s prior decisions, and restore some predictability to the U.S. patent system.

Russell Slifer

January 13, 2019

Double jeopardy at the PTAB forces Allergan and others to seek sovereign immunity defenses

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review process under the Drug Price Competition and Patent Term Restoration Act, colloquially known as Hatch-Waxman. This law creates a regime by which a generic drugmaker can file an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA). The branded pharmaceutical listed in the Orange Book will be covered by patents but the generic drugmaker can include a Paragraph IV certification in the ANDA, a declaration that the patents covering the Orange Book-listed drug are unenforceable and invalid. When a company like Allergan has to face Hatch-Waxman validity trials in federal district court and serial IPRs at the PTAB, it turns Allergan’s Restasis patents into piñatas taking hit after hit at multiple forums before being finally ripped asunder at some point.

Steve Brachmann

November 2, 2017