In the life sciences industry, which encompasses pharmaceuticals and biopharmaceuticals, patent protection and exclusivity rights are of critical importance. For industry innovators, patents and exclusivity rights are essential for companies and academic institutions to protect and recoup the very substantial research and development investments that are made to discover and develop new medicines and biologics that can treat and cure ailments, diseases, and other medical conditions. For generic drug and biosimilar manufacturers, challenging those patents?and the financial incentives to do so?allows them to manufacture and market affordable medicines with relatively small investments. The Federal Courts, U.S. Congress, and U.S. Food and Drug Administration (FDA) have created a body of case law, statutes, and regulations that are tailored to this industry. These laws and regulations provide both incentives to innovators to bring new products to market, and also incentives to those who seek to market generic equivalents or biosimilars of the products before the innovators? patent rights and exclusivities expire. This course will delve into many of the laws and regulations that should be understood by anyone who is interested in patent litigation, prosecution, or licensing in the life sciences industry.
Instructors: Richard Kurz