Effective patent life in pharmaceuticals

Effective patent life is lost in pharmaceuticals because of the lengthy tim e periods required for clinical trials and regulatory approval. A 1984 US l aw restores some of this lost patent time, while also facilitating generic competition when patents expire. This paper examines this law and the effec ts of other policy developments on market exclusivity times in pharmaceutic als. It also performs simulation analyses on how proposed legislative refor ms would impact on future new drug introductions.