Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 601 F.3d 1359 (Fed. Cir. ), cert. granted, slip op. (U.S. June 27, 2011) (No. 10-844)

Next term, the Supreme Court will consider the complicated Hatch-Waxman Act, which provides a regulatory scheme for balancing the various interests associated with brand and generic pharmaceutical products.  When the FDA approves a drug for multiple diseases or uses, it relies on the approved drug maker’s description of its patent claims coverage in order to determine whether they would cover (and potentially block) generic drugs. The Act allows for some policing of these descriptions through lawsuits (or counterclaims) to seek correction of the information submitted by the patentee regarding the scope of its patent claims.

The Federal Circuit held that the Hatch-Waxman Act only allows for deletion of improperly listed patents. (Read the panel opinion here.) The generic drug maker, Caraco, argues that the Act also allows for correction of misstatements of patent scope. Three generic companies and two associations filed briefs in support of Caraco’s petition for certiorari.

Notably, the Federal Circuit denied Caraco’s petition for panel and en banc rehearing on this issue.

Read the Questions Presented here.