Takeda v. Mylan: High-Cost Generic Drugs from Baseless Paragraph IV Certifications

In <i>Takeda v. Mylan</i>, the Federal Circuit revisited attorney fees in the context of an ANDA application. In doing so, the court provided additional guidance regarding factual circumstances that may support such awards and addressed several of the unanswered questions from the <i>Yamanouchi v. Danbury</i> opinion.

9 minute read June 29, 2009 at 04:40 PM
By
Gregory M. York
Takeda v. Mylan: High-Cost Generic Drugs from Baseless Paragraph IV Certifications

The Hatch-Waxman Act has established a process by which a drugmaker can obtain FDA approval to market a generic drug prior to expiration of patents directed to the corresponding brand drug.

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