McAndrews, Held & Malloy

Aaron F. Barkoff, Ph.D.
Partner

Email. abarkoff@mcandrews-ip.com
Tel. (312) 775-8096

Practice Areas
Patent Litigation; Pharmaceutical and Biotechnology Patent Law; FDA Regulatory Law

Education
Lawrence University, B.A., Biology
University of Wisconsin-Madison, Ph.D., Biochemistry
University of Chicago Law School, J.D.

Bar Admissions
Illinois
U.S. District Court for the Northern District of Illinois
U.S. District Court for the District of Columbia
U.S. District Court for the Western District of Wisconsin
U.S. Court of Appeals for the Federal Circuit
Registered to practice before the U.S. Patent and Trademark Office

Professional Experience
Aaron Barkoff focuses on pharmaceutical and biotechnology patent law. He has extensive experience in ANDA litigation, from pre-filing investigations and strategy to dispositive motions, trials and appeals. In addition, he provides FDA regulatory advice relating to pharmaceuticals, including advice concerning patent term extensions under Section 156 and Orange Book patent listings. He is the author of Orange Book Blog, a weblog reporting on legal developments at the intersection of patent and FDA law, and is a regular speaker at pharmaceutical patent law conferences.

Representative Matters

AstraZeneca Pharms. et al. v. Biovail Labs. et al., No. 3:09-cv-00128-JAP-TJB (D.N.J.), involving SEROQUEL XR
Sanofi-Aventis Deutschland v. Genentech et al., No. C 08-4909 SI (N.D. Cal.), involving RITUXAN and AVASTIN
Aventis Pharms. v. Barr Labs., No. 1:06-cv-00286-GMS (D. Del.), involving NASACORT AQ
Purdue Pharma Products et al. v. Par Pharma. et al., No. 1:07-cv-00255-KAJ (D. Del.), involving ULTRAM ER
Aventis Pharms. et al. v. Barr Labs. et al., No. 2:04-cv-01064-JAG-MCA (D.N.J.), involving ALLEGRA and ALLEGRA-D
Impax Labs. v. Aventis Pharms., No. 1:02-cv-00581-JJF (D. Del.), involving RILUTEK

Recent Speaking Engagements

"Hatch-Waxman Act: 1984-present," presented at CPhI "Pharma IPR India 2012" conference, February 2012
"The Start of the Paragraph IV Law Suit - Pleadings and Considerations," presented at ACI "Paragraph IV Disputes" conference, December 2011
“Inducement Actions: How Method of Use Claims Controversies Are Influencing Orange Book Listings,” presented at ACI “Maximizing Pharmaceutical Patent Life Cycles” conference, October 2011
"Forfeiture of Exclusivity Dilemmas Relative to Paragraph IV Litigation," presented at ACI "Paragraph IV Disputes" conference, April 2011
“Ariad v. Lilly: The Reaffirmation of Written Description and Enablement and Their Collective Role in Patent Life Cycle Management,” presented at ACI “Maximizing Pharmaceutical Patent Life Cycles” conference, October 2010
“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
“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
Demonstration of cross-examination of an expert witness 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

Professional Associations

American Bar Association
- Section of Intellectual Property Law
American Intellectual Property Law Association
Federal Circuit Bar Association
Intellectual Property Owners Association
- Pharmaceutical and Biotechnology Issues Committee
Intellectual Property Law Association of Chicago
The Food and Drug Law Institute