Otsuka Pharmaceutical v. Burwell

Alkermes, an innovative drug manufacturer, sought FDA approval to market an injectable drug used for the treatment of schizophrenia. A competitor filed a citizen protest asking FDA to not approve the drug, on the ground that the competitor’s drug had marketing exclusivity that barred approval of the new drug application. The FDA sided with Alkermes and approved the application, so the competitor sued the FDA to block its decision. The Goodwin team intervened in the district court action to represent Alkermes’s interests. The district court granted summary judgment in the FDA and Alkermes’s favor. A decision from the U.S. Court of Appeals for the D.C. Circuit is pending.

Otsuka Pharmaceutical v. Burwell

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