Hatch-Waxman and IPR Strategy
Inter partes review (IPR) proceedings have become an attractive option for generic drug manufacturers wishing to utilize the PTAB’s streamlined patent validity decision process while also reaping the benefits of the Hatch-Waxman Act. However, many believe that allowing generics to apply both of these strategies disrupts the balance between encouraging pharmaceutical innovation and lowering drug prices that the Hatch-Waxman Act intended to preserve. This debate has escalated since the Hatch-Waxman Integrity Act of 2018, which seeks to force generics to choose between the Hatch-Waxman framework and IPR.
- IPR basics and how they apply to Hatch-Waxman cases
- The “who, when, and where” of IPR filings and the decisions that go into filing
- Recent decisions and arguments impacting Hatch-Waxman and IPR strategy