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Hatch-Waxman does not provide statutory basis to require amendment of FDA use code
- McDermott Will & Emery
- -
- USA
- -
- May 31 2010
The U.S. Court of Appeals for the Federal Circuit recently reversed and vacated a decision from the U.S. District Court for the Eastern District of Michigan granting summary judgment and ordering a mandatory injunction requiring a pioneer drug manufacturer to amend its “use code” with the U.S. Food and Drug Administration (FDA
Federal Circuit denies Caraco’s petition for rehearing en banc
- McDermott Will & Emery
- -
- USA
- -
- August 27 2010
In a closely watched case, the U.S. Court of Appeals for the Federal Circuit denied Caraco’s petition to rehear en banc its dispute with Novo Nordisk over the statutory construction of the “counterclaim provision” of the Hatch-Waxman Act (HWA
Subsequent ANDA filers have legally cognizable interest in when first-filer’s exclusivity period begins
- McDermott Will & Emery
- -
- USA
- -
- November 30 2010
The U.S. Court of Appeals for the Federal Circuit reversed and remanded a district court’s ruling that generic pharmaceutical company had not sufficiently plead an Article III controversy, thus allowing a declaratory judgment action over four Orange Book listed patents to proceed
FDA labels and method claims must be in sync, or ANDA infringement is sunk
- McDermott Will & Emery
- -
- USA
- -
- May 30 2012
The U.S. Court of Appeals for the Federal Circuit recently held that filing a Paragraph IV certification for an Orange Book listed method-of-use patent was not an act of infringement when an NDA holder’s FDA-approved labeling did not include an indication for every use limitation in the asserted Orange Book patent
Current Search
- Workarea - Litigation
- Workarea - Healthcare
- Firm Name - McDermott Will & Emery
- Author - Clifford R. Lamar, II