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Aaron F. Barkoff, Ph.D.

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

Practice Areas
Patent Litigation; Pharmaceutical and Biotechnology Patent Law

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

Bar Admissions
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 specializes in pharmaceutical and biotechnology patent law.  He has over fifteen years of experience in all aspects of ANDA litigation, representing both innovator and generic drug companies.  He also prepares legal opinions concerning patent infringement and validity, and drafts Paragraph IV notice letters.  In addition, he provides FDA regulatory advice relating to pharmaceuticals, including advice concerning Orange Book patent listings, patent term extensions under Section 156, and patent certification strategies.

Dr. Barkoff is the founder and author of Orange Book Blog, a weblog reporting on legal developments at the intersection of patent and FDA law, and he is a frequent speaker at pharmaceutical patent law conferences.

Representative Matters
  • Novartis Pharms. v. Torrent Pharms. et al., No. 12-596 (D. Del.), involving EXFORGE HCT
  • Allergan Sales v. Akorn, No. 12-175 (E.D. Tex.), involving ACULAR LS
  • Allergan v. Akorn, No. 11-1270 (D. Del.), involving ACUVAIL
  • Seattle Children's Hospital et al. v. Akorn, No. 10-5118 (N.D. Ill.), involving TOBI
  • Universal Beauty Prods. v. Morning Glory Prods., No. 10-3212 (N.D. Ill.)
  • AstraZeneca Pharms. et al. v. Biovail Labs. et al., No. 09-128 (D.N.J.), involving SEROQUEL XR
  • Sanofi-Aventis Deutschland v. Genentech et al., No. 08-4909 (N.D. Cal.), involving RITUXAN and AVASTIN
  • Aventis Pharms. v. Barr Labs., No. 06-286 (D. Del.), involving NASACORT AQ
  • Purdue Pharma Products et al. v. Par Pharma. et al., No. 07-255 (D. Del.), involving ULTRAM ER
  • Aventis Pharms. et al. v. Barr Labs. et al., No. 04-1064 (D.N.J.), involving ALLEGRA and ALLEGRA-D
  • Impax Labs. v. Aventis Pharms., No. 02-581 (D. Del.), involving RILUTEK
Recent Speaking Engagements
  • “Biosimilar Patent Litigation:  The 101, Potential Hurdles/Loopholes and Compare/Contrast to Hatch-Waxman,” presented at Barclays “Generic Pharmaceuticals Symposium,” April 2014
  • “Forfeiture of 180-Day Exclusivity,” presented at Momentum Events “International Congress on Paragraph IV Litigation,” September 2013
  • “Regulatory Challenges and Current Trends,” presented at International Bar Association World Life Sciences Conference, May 2013
  • “Practical Implications of Recent Decisions on Inducement of Infringement,” presented at ACI “Paragraph IV Disputes” conference, December 2012
  • “Potential Controversies in BPCIA Patent Litigation,” presented at IIR USA “Business of Biosimilars & Generic Drugs” conference, September 2012
  • “Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges,” presented at ACI “Paragraph IV Disputes” conference, April 2012
  • "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
Professional Associations
  • American Bar Association
    • Section of Intellectual Property Law
    • Section of Litigation
  • American Intellectual Property Law Association
  • Intellectual Property Owners Association
    • Pharmaceutical and Biotechnology Issues Committee
  • The Food and Drug Law Institute

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