Overview
Timothy “Tim” J. Shea, Jr. is a director in Sterne Kessler’s Biotechnology & Chemical Practice Group where he has practiced for over 25 years and leads the firm’s Biosimilar Initiative. He specializes in advising biopharmaceutical companies and research institutions on complex legal issues relating to the protection, enforcement and transfer of their intellectual property. He practices primarily in the fields of immunology, molecular biology, genetic and medical diagnostics, biotherapeutics, and drug delivery. He has extensive experience advising clients on the creation and management of strategic patent portfolios, freedom-to-operate and patentability issues, complex prosecution strategies, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments. Tim has published and spoken extensively on IP issues related to therapeutic antibodies and biosimilars.
Tim’s biosimilar experience includes advising biosimilar developers on pre-aBLA strategies and tactics, including freedom-to-operate, clearance analyses, label and carve out strategies, exclusivity analyses, and launch timing. He also has represented biosimilar developers in inter partes review proceedings before the Patent Trial and Appeal Board involving patents covering the reference product. Tim was part of the lead counsel team representing Sandoz in its litigation with Genentech related to rituximab (RITUXAN). He has also represented both brand companies and biosimilar companies in connection with due diligences related to the acquisition, or divesting, of biosimilar products.
A significant portion of Tim’s practice involves counseling emerging companies on strategies for creating, protecting and leveraging their IP assets to grow their businesses. He frequently advises clients on all aspects of technology transfer, including the drafting and negotiation of patent and technology license agreements, material transfer agreements, sponsored research agreements, confidentiality and nondisclosure agreements, joint developments agreements, etc. Tim is a past Vice-Chair of the Life Sciences Committee for Licensing Executives Society International, an international network of IP licensing professionals. He also serves as the Executive Editor of the Chicago-Kent Law Review.
Tim is also is a contributing author of Patent Office Litigation, Second Edition, published in 2017, the book provides a fresh and comprehensive exploration of patent office litigation proceedings, including how the proceedings interact with other aspects of patent procurement and enforcement, while delivering practical analysis and advice. This second edition of Patent Office Litigation is the follow up to the first version of the book that was published in 2012 by Thomson Reuters Westlaw that focused on the contested proceedings that were introduced under the America Invents Act that year.
Tim received his B.S. in Biology from Washington and Lee University in 1988 and his J.D. from Chicago-Kent College of Law (with High Honors, Order of the Coif) in 1995. During law school, Tim served as an Executive Editor of the Law Review. He then served as a judicial extern to the Honorable Rebecca Pallmeyer of the U.S. District Court for the Northern District of Illinois. Prior to attending law school, Tim worked for several years in the biotech industry in the areas of genetic diagnostics.
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Education
- J.D., Chicago-Kent College of Law, with high honors, order of the coif
- B.S., Biology, Washington & Lee University
Admissions
- District of Columbia
- U.S. District Court for the Eastern District of Virginia
- United States Patent & Trademark Office
- Virginia