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CARACO PHARMACEUTICAL LABS v. NOVO NORDISK

No. 10-844.

132 S.Ct. 1670 (2012)

182 L.Ed.2d 678

CARACO PHARMACEUTICAL LABORATORIES, LTD., et al., Petitioners v. NOVO NORDISK A/S et al.

Supreme Court of United States.

Decided April 17, 2012.

Attorney(s) appearing for the Case

James F. Hurst, Chicago, IL, for Petitioners.

Benjamin J. Horwich, for the United States, as amicus curiae, supporting the Petitioners.

Mark A. Perry, Washington, DC, for Respondents.

James F. Hurst, Counsel of Record, William P. Ferranti, Winston & Strawn LLP, Chicago, IL, David S. Bloch, Winston & Strawn LLP, San Francisco, CA, Charles B. Klein, Steffen N. Johnson, Andrew C. Nichols, Christopher M. Bruno, Winston & Strawn LLP, Washington, DC, for Petitioners.

Josh A. Krevitt, Gibson, Dunn & Crutcher LLP, New York, NY, Wayne Barsky, Gibson, Dunn & Crutcher LLP, Los Angeles, CA, Mark A. Perry, Counsel of Record, Scott P. Martin, Gibson, Dunn & Crutcher LLP, Washington, DC, Michael A. Sitzman, Gibson, Dunn & Crutcher LLP, San Francisco, CA, for Respondents.

Justice KAGAN delivered the opinion of the Court.

When the Food and Drug Administration (FDA) evaluates an application to market a generic drug, it considers whether the proposed drug would infringe a patent held by the manufacturer of the brand-name version. To assess that matter, the FDA requires brand manufacturers to submit descriptions of the scope of their patents, known as use codes. The FDA does not attempt to determine if that information is accurate. Rather...

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