Thomas Clouse, National Cancer Institute; Eldora Ellison, Sterne Kessler Goldstein & Fox PLLC
This course will provide an orientation to legal requirements, as well as practical guidance, for lawyers who are interested in patents and licenses relating to pharmaceutical and biotechnological products. Faculty experts will begin with a brief overview of the patent procurement process and will illustrate patent requirements with specific examples in the pharmaceutical and biotechnology arena. Faculty will also highlight the practical problems and challenges faced in the patent process. Patent issues that relate to the FDA drug approval process will be considered including the Hatch-Waxman Act, patent term extensions, exemption from infringement and the generic drug approval process. Participants will learn why generic drug manufacturers are commonly sued for patent infringement before they have sold a product. Attendees will receive guidance on the basics of licensing of patented therapeutics, diagnostics, and other biomedical or biotech product licensing issues including technology valuation, industry partnering and deal structuring. This class is a good introduction for lawyers who would like to learn the fundamentals of patenting and licensing in the life sciences field and corporate attorneys and venture capitalists with an interest in the biotech and pharmaceutical fields.