About This Course
The market for generic pharmaceuticals has grown tremendously over the years and this growth is one that brand name companies are not happy about. In the 2013 Federal Trade Commission v. Actavis, Inc., 570 U.S. , 133 S. Ct. 2,rns (2013), the US Supreme Court determined that a “pay for delay” or “reverse payment” agreement between a brand name and generic pharmaceutical company, effectively delaying generic entry, may be in violation of anti-trust laws and identified a number of factors that lower courts should consider related to these agreements. This CLE course, designed for non-antitrust/patent lawyers to provide an easy and straightforward approach to relevant regulatory and antitrust laws, will provide a thorough explanation of antitrust laws before diving into the Hatch-Waxman Act which offers the framework in which generic drugs are efficiently brought to market. The course will primarily focus on “brand maturation strategies” which pharmaceutical companies employ to delay said entry. The Actavis decision as well as a more thorough understanding of delaying tactics and antitrust litigation on behalf of wholesalers, retailers, prescription drug insurers and consumers against these tactics will be presented.