How Inter Partes Review Impacts Hatch-Waxman Exclusivity
- Dennies Varughese & H. Keeto Sabharwal
- IP Law 360
In a recent article published with IP Law360, Dennies Varughese and H. Keeto Sabharwal discuss Hatch-Waxman exclusivity in light of new inter partes review proceedings. There are several areas of uncertainty as to the operation and consequences of inter partes review. One particularly important unanswered question is whether, and to what extent, a successful IPR challenge by a subsequent abbreviated new drug application filer may impact the “failure to market” trigger for forfeiture of 180-day Hatch-Waxman exclusivity held by a first-to-file ANDA applicant.
To read the full article, download the attached PDF.