Kelley, Jim

Jim Kelley joined Nielsen IP Law LLC after 22 years with Eli Lilly and Company, last serving as Senior Director, Assistant General Patent Counsel. His years of experience negotiating licenses and determining risks associated with launching complex technologies bring a depth of knowledge and unique insight to counsel firm clients.

Jim’s career in patents includes prosecution, portfolio management, litigation, licensing, opinions, counseling, amicus advocacy, regulatory exclusivity, patent term extension (PTE), trade secret protection, and management. He has deep experience with biological products, peptides, proteins, antibodies, processes, and formulations. He is very familiar with issues and strategies relating to patenting small molecule drugs and to generic and biosimilar competition. For several years, he led a patent quality initiative that included pre-filing review of all patent applications, regardless of the type of active molecule.

Jim led or participated in the writing of four (4) amicus briefs submitted to the Supreme Court and in ten (10) amicus briefs submitted to the Court of Appeals for the Federal Circuit on behalf of Lilly. The subject matters of these briefs included claim scope during patent term extensions, written description, exemption from patent infringement liability during drug discovery and development, utility, obviousness, inequitable conduct, and subject matter eligibility.

As an adjunct professor of Law, Jim created a course titled “Drug Innovation and Competition Law” at Indiana University (McKinney) School of Law, Indianapolis and taught it from 2008 to 2013. Jim has been very active in AIPLA, including serving as Chair and Vice Chair of the Biotechnology Committee, Vice Chair of the amicus Committee, and as an active member of the Subject Matter Eligibility Task Force, and the Legislation, Chemical Practice, and Food and Drug Committees.

Prior to his patent career, Jim worked as a chemical engineer for ten years at Lilly, the Stroh Brewery Company in Detroit, and Molecular Genetics, Inc. in Minnesota, and as a scientist for ten years at the University of Michigan conducting research in enzymology, protein chemistry, and human nutrition.