ANDA

In May 2015, Mylan Pharmaceuticals appealed to the Third Circuit after the lower court dismissed its case against Warner Chilcott, which was predicated on a practice called product-hopping. While we await the ruling which is due to come later this year, here is some background information on the developing area ...

In Teva v. Eisai, the Federal Circuit held that a subsequent Paragraph IV filer has standing when a patent listed in the Orange Book causes a delay in the triggering of a first filer’s exclusivity period and prevents the subsequent filer from bringing a generic drug to market. The Hatch-Waxman ...