Enablement and Written Description in the Spotlight
Includes a Live Web Event on 12/01/2022 at 2:00 PM (EST)
For the first time since the founding of the Federal Circuit, the Supreme Court will be taking a close look at Section 112. The Supreme Court has granted certiorari in Amgen v. Sanofi on the following question: Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.” And while the Supreme Court denied certiorari in a closely watched written description case, Juno v. Kite, the law of written description could very well be affected by what the Supreme Court does in Amgen. Our panel of distinguished inhouse counsel, Larry Coury, Stephanie Donahue, Henry Hadad, and Stuart Watt, moderated by experienced trial counsel, Paul Berghoff, will guide us through the issues and arguments concerning the current state of enablement and written description law and where the law may be headed.
McDonnell Boehnen Hulbert & Berghoff LLP
Paul Berghoff, founder of McDonnell Boehnen Hulbert Berghoff LLP, has three decades of experience as lead trial counsel in complex patent litigation – both jury and bench trials and PTAB proceedings – concentrating in litigation involving pharmaceuticals, medical devices, biotechnology, electronics, and software. He has successfully tried scores of patent cases and has successfully argued dozens of times before he US Court of Appeals for the Federal Circuit. He services as Chair of the firm’s Litigation & Appeals Practice Group. He is Vice-Chair of IPO’s Amicus Brief Committee.
Vice President, Head of Litigation and Associate General Counsel
Regeneron Pharmaceuticals, Inc.
Larry Coury is Vice President, Head of Litigation and Associate General Counsel at Regeneron Pharmaceuticals, Inc. in Tarrytown, NY. Larry oversees all of Regeneron’s litigation matters, including patent matters, and he is a registered patent attorney. Prior to joining Regeneron, Larry was in private practice at Fish & Neave, Paul Weiss, and Cravath. Larry received his Ph.D. in Biophysics from Harvard University, and his J.D. from Fordham Law School.
Principal Counsel, Global Patent Litigation
Stephanie Donahue is global in-house patent litigation counsel at Sanofi. She is responsible for managing patent infringement litigation brought by and against Sanofi around the world. In that role, among other things, she develops and executes strategic patent infringement litigation action plans, negotiates patent infringement settlements, and communicates case developments and litigation risks to senior management. Prior to joining Sanofi in 2014, Stephanie practiced at various law firms for over 10 years. She was Counsel at Vinson & Elkins LLP and an associate at Fitzpatrick, Cella, Harper & Scinto (now Venable LLP).
Senior Vice President, Innovation Law
Bristol-Meyers Squibb Company
Henry Hadad is Senior Vice President and Deputy General Counsel at Bristol-Myers Squibb in Princeton, NJ, where he is Chief Intellectual Property Counsel, as well as lead counsel to Research & Early Development. He was also Chief IP Counsel at Schering-Plough Corporation, and held prior roles at Johnson & Johnson and in private practice. Henry is a member of numerous IP organizations, and is a past president of Intellectual Property Owners Association. He holds a B.S. in Biology from Haverford College and a J.D., cum laude, from the American University, Washington College of Law.
Vice President, Law & Intellectual Property Officer
Stuart Watt is Vice President of Law and Intellectual Property Officer of Amgen Inc. and leads a group of 45 patent attorneys responsible for patent strategy, filing and prosecution of patent applications in the U.S. and foreign countries, patent litigation, and patent licensing. Mr. Watt has actively represented Amgen in patent litigation in the U.S. and various countries around the world. He joined Amgen in 1992. Prior to that time, he was associated with the patent law firm of Richards, Medlock & Andrews (now Sidley & Austin) in Dallas, Texas. Mr. Watt is a graduate of Brigham Young University (B.S.Ch.E.) and the University of Washington School of Law (J.D.).