Gasper LaRosa

A central feature of the Hatch Waxman Act is the "30-month stay," a carefully crafted compromise between the interests of innovator pharmaceutical companies and generics. The innovator is required to list in the FDA's "Orange Book" all patents covering its drug product or an approved method of use. Then, if a generic applicant challenges any of those listed patents as invalid or not infringed, the innovator has 45 days to sue for patent infringement.

A central feature of the Hatch Waxman Act is the "30-month stay," a carefully crafted compromise between the interests of innovator pharmaceutical companies and generics. The innovator is required to list in the FDA's "Orange Book" all patents covering its drug product or an approved method of use. Then, if a generic applicant challenges any of those listed patents as invalid or not infringed, the innovator has 45 days to sue for patent infringement.

In Short The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to avoid findings of infringement in standard Hatch-Waxman cases, but in post-marketing situations, the generic's "skinny label," coupled with its public statements, can be evidence of induced infringement even as to the carved out, patented uses.