The Hatch-Waxman Act, established in 1984, provided a significant reform to the regulatory framework surrounding pharmaceutical patents in the United States. A key element of this reform was the introduction of the ‘safe harbor’ provision, known formally as 35 U.S.C. § 271(e)(1). This provision shields certain activities related to the development and submission of information … Continue reading The Impact of Revenue from a Collaboration Agreement on the 271(e)(1) Defense in Patent Infringement Cases