Invoking a Patent Challenge: Paragraph IV Certifications and Beyond

4th National Maximizing Pharmaceutical Patent Life Cycles Conference
January 27, 2004

Robert L. Baechtold spoke at the 4th National Maximizing Pharmaceutical Patent Life Cycles Conference held January 27, 2004 at the Le Parker Meridien Hotel in New York City. Mr. Baechtold’s presentation, “Invoking a Patent Challenge: Paragraph IV Certifications and Beyond,” discussed what happens when a paragraph IV certification cannot be made. His presentation also explored the availability of declaratory judgment practice actions and counterclaims, the timing of a paragraph IV certification, FDA rules for determining first-to-file a paragraph IV certification, Paragraph IV certifications vs. method-of-use statements, and inducing or contributing to infringement of a patent claiming an unapproved indication.