Anticompetitive Conduct and Patents Listed in the Orange Book

Branded pharmaceutical manufacturers are required by law to list all patents in the Orange Book that cover an approved drug product. However, over-inclusiveness of such listings can give rise to allegations of anticompetitive conduct. A review of recent rulings shows that courts have taken a statutory interpretation in ex post decisions regarding inappropriate patent listings. Additionally, to avoid determinations that such inappropriate listings constitute anticompetitive conduct, the burden ap