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James Joseph Kelley

James Joseph Kelley

Senior Counsel

 

Jim Kelley joined Nielsen IP Law LLC after retiring from Eli Lilly and Company as Senior Director – Assistant General Patent Counsel. Jim’s career in patents at Lilly spanned 22 years and included prosecution, portfolio management, litigation, licensing, opinions, counselling, 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.


Admissions
Not licensed to practice in the State of Texas
Licensed to practice in the State of Indiana
U.S. Supreme Court
U.S. Courts of Appeals for the Federal and 7th Circuits
U.S. District Court for the Southern District of Indiana
U.S. Patent and Trademark Office
Indiana Supreme Court


Education
Juris Doctor, Indiana University (McKinney) School of Law, Indianapolis, Summa Cum Laude
Master of Science, Chemical Engineering, The University of Michigan
Master of Public Health, Human Nutrition, The University of Michigan
Bachelor of Science, Cell Biology, The University of Michigan, With Distinction

 

RECOGNITIONS

AIPLA Committee of the Year 2013, Biotechnology Committee Chair
Corporate IP Star 2015-17, Managing Intellectual Property

 

LEGAL PUBLICATIONS

Paula K. Davis, James J. Kelley, Steven P. Caltrider, and Stephen J. Heinig, ESTs Stumble at the Utility Threshold: A divided Federal Circuit upholds the Patent Office’s Utility Guidelines and finds that ESTs provide too little real-world utility to be patented. 23 NAT. BIOTECHNOLOGY 1227 (2005).

James J. Kelley and Gregory A. Cox, The Anti-Written Description Requirement: Antibodies, Example 16, the Guidelines and Noelle v. Lederman, 87 J. PAT. & TRADEMARK OFF. SOC'Y (Sep. 2005).

Steven P. Caltrider, Gregory A. Cox, and James J. Kelley, The Impact of the Written Description Requirement on the Biotechnology and Pharmaceutical Industry: How the Federal Circuit Saved the Industry from Self Destruction, prepared for delivery to the American Bar Association 2005 Summer Intellectual Property Law Conference, Jun. 24, 2005, San Francisco, CA.

James J. Kelley, Are There Two or Three Requirements in 35 U.S.C. § 112, para. 1? THERE ARE THREE, INTELL. PROP. TODAY, Jan. 2004, at 34.

Steven P. Caltrider and James J. Kelley, The “Lilly Doctrine” Is Viable and Critical. 21 NAT. BIOTECHNOLOGY 1131 (2003).

 

 

 

Industries Served...

  • Analytical Instruments
  • Biotechnology
  • Chemical
  • Diagnostic
  • Life Sciences
  • Medical Devices
  • Oil & Gas
  • Pharmaceutical

 

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