Aaron F. Barkoff, Ph.D.
Aaron F. Barkoff is a partner at McDonnell Boehnen Hulbert & Berghoff, specializing in pharmaceutical and biotechnology patent law.
Dr. Barkoff focuses on patent litigation, with a special emphasis on ANDA litigation. He has extensive experience in pre-filing investigations, discovery, dispositive motions, trial and appeals. In addition, Dr. Barkoff counsels pharmaceutical and biotechnology companies regarding freedom to operate, patent validity, and FDA regulatory issues. Dr. Barkoff also prosecutes patent applications in the fields of pharmaceuticals and biotechnology.
Dr. Barkoff is particularly interested in legal issues at the intersection of patent and FDA law, such as those arising in ANDA litigation. In May 2006, he founded Orange Book Blog, a website that reports on new developments in pharmaceutical patent law and FDA law.
education
J.D., University of Chicago Law School
Ph.D., University of Wisconsin-Madison, Biochemistry
B.A., Lawrence University, Biology
bar admissions
Illinois
U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Northern District of Illinois
U.S. Patent & Trademark Office
professional leadership
Speaking Engagements
"Recent Decisions Impacting Paragraph IV Challenges and Motion Practice," presented at ACI Paragraph IV Disputes Conference, April 2010
"Evaluating the IP Implications of Launching a Biosimilar," moderator of panel discussion at IIR Business of Biosimilars Conference, September 2009
"Non-Patent Exclusivity," presented at ACI FDA Boot Camp, September 2009
"Patent & IP Overview: Hatch-Waxman, the Patenting Process and More," presented at ACI FDA Boot Camp, July 2009
"Introduction to Patent Law," presented at Annual Meeting of the RNA Society, May 2009
"Non-Patent Exclusivity," presented at ACI FDA Boot Camp, March 2009.
"Likely Competitive Effects of Follow-on Biologic Regulatory Incentives," panelist at Federal Trade Commission roundtable entitled, "Competition Issues Involving Follow-on Biologic Drugs," November 2008
Demonstrated Cross-Examination at ACI Paragraph IV On Trial Conference, November 2008
"Implications of Recent Developments and Trends in Litigating Paragraph IV Disputes," panelist at CBI Paragraph IV Disputes Conference, October 2008
"Non-Patent Exclusivity," presented at ACI FDA Boot Camp, September 2008
"Understanding the 180-day Exclusivity Forfeiture Provisions of the MMA," presented at IIR Generic Drugs Summit, June 2008
"Innovation and Success Strategies", panelist at iiBIG Drug Delivery 2007 Conference, October 2007
"A New Look at Orange Book Listings, Delistings and Related Challenges," presented at ACI Maximizing Pharmaceutical Patent Life Cycles Conference, October 2007
"Patent & IP Overview: Hatch-Waxman, the Patenting Process and More," presented at ACI FDA Boot Camp, September 2007
"Strategies for Defending Against Generic Drug Patent Challenges," presented as an FDANews Audioconference, March 2007
"Is a Thriving Generic Drug Biotechnology Industry Just Around the Corner?," presented at LSI Biotechnology 2007 Conference, January 2007
Professional Associations
American Bar Association
American Intellectual Property Law Association
- Special Committee on the FDA
Federal Circuit Bar Association
Intellectual Property Owners Association
- Pharmaceutical Issues Committee
publications
Founder and Author of the Orange Book Blog
BNA Pharmaceutical Law & Industry Report
- Editorial Board
KSR International v. Teleflex, U.S. Supreme Court Brief of Amicus Curiae Intellectual Property Owners Association in Support of the Respondents
Barkoff, A.F., Dickson K.S., Gray, N.K., Wickens, M. (2000) "Translational Control of Cyclin B1 mRNA During Meiotic Maturation: Coordinated Repression and Cytoplasmic Polyadenylation," Developmental Biology 220(1):97-109.
Gillian-Daniel, D.L., Gray, N.K., Aström, J., Barkoff, A., Wickens, M. (1998) "Modifications of the 5' Cap of mRNAs during Xenopus Oocyte Maturation: Independence from Changes in Poly(A) Length and Impact on Translation," Molecular and Cellular Biology 18(10):6152-63.
Barkoff, A., Ballantyne, S., Wickens, M. (1998) "Meiotic Maturation in Xenopus Requires Polyadenylation of Multiple mRNAs," The EMBO Journal 17(11):3168-75.