This course examines the special legal and policy issues arising from the use of intellectual property rights in the pharmaceutical and biotechnology fields. The course will cover: (1) U.S. case law impacting intellectual property, patents, trademarks and copyrights in the pharmaceutical and biotechnological arts; (2) the interplay of the regulatory approval process for therapeutic and diagnostic products with intellectual property rights; (3) the Hatch-Waxman Act and its impact on how patent rights for pharmaceuticals are procured and enforced ; and (4) major legislative developments affecting the use of intellectual property rights in the drug, biotechnology and medical device fields, such as the Biologics Price Competition and Innovation Act of 2009 and the America Invents Act of 2011. Other topics may be included depending on current judicial or legislative developments. A background in biologics or pharmaceuticals is not required, although completion of a basic patent law or a food and drug law course is recommended.
Students will have the option of taking this course for either two or three credits. The three credit option will require a paper that satisfies the upperclass legal writing requirement in compliance with Law Center regulations. The two credit option will require completion of several shorter legal writing samples on student-selected or assigned topics.