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.
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.
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Gregory M. YorkThis premium content is locked for The Intellectual Property Strategist subscribers only
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