Barbara R. Rudolph Ph.D.

Partner

Barbara Rudolph heads Finnegan's biotechnology and pharmaceutical practice group. She focuses her practice primarily on Hatch-Waxman Paragraph IV Abbreviated New Drug Application (ANDA) and biotechnology litigations, as well as other pharmaceutical and biotechnology-related disputes. She has experience in bench and jury trials in federal district courts and has argued cases before the U.S. Court of Appeals for the Federal Circuit. She also provides strategic pre-litigation client counseling, due diligence analyses, and opinions. 

For the past 15 years, Ms. Rudolph has represented pharmaceutical and biotechnology companies on matters involving blockbuster drugs such as Nuvigil^®, Kaletra^®, Enbrel^®, Effexor^® XR, Nolvadex^®, and Gemzar^®. She has helped protect clients' valuable intellectual property in sophisticated technologies including recombinant fusion proteins; HIV diagnostics; small molecule cancer therapies; polymorphs and amorphous formulations; antihistaminic compounds; DNA nucleotides encoding the binding region of an NK cell protein; gene transcription factor NF-ĸB technology; and genetically engineered corn.

Ms. Rudolph has participated in all aspects of pre-trial, trial, post-trial, and appellate proceedings. While acting as trial and appellate counsel, she has performed pre-suit investigations, developed litigation strategies, briefed and argued motions, taken and defended depositions of fact and expert witnesses, prepared fact and expert witnesses for trial, conducted direct and cross examinations of witnesses at trial, analyzed approaches for appeal, drafted appellate briefs, and argued before the Federal Circuit.

Highlights

• Counsel of record for AIPLA as amicus curiae in a biotechnology case before the Federal Circuit.
• Represented Cephalon against several generic companies in Paragraph IV litigations pertaining to Nuvigil^®, Cephalon's prescription medicine used to improve wakefulness.
• Represented Abbott in a Paragraph IV litigation pertaining to Abbott's HIV treatment, Kaletra^®.
• Represented Wyeth in several Paragraph IV ANDA litigations involving Effexor^® XR, a blockbuster treatment for depression and anxiety disorders. 
• Represented Imperial Chemical Industries and Zeneca, Inc. in several Paragraph IV ANDA litigations, including appeals, involving the blockbuster breast cancer treatment Nolvadex^® (tamoxifen citrate).
• Represented American Home Products in a Paragraph IV ANDA litigation involving generic loratadine products.
• Represented Immunex in a patent infringement suit brought by Zymogenetics involving Enbrel^®.
• Represented Eli Lilly in early stage litigation proceedings in a Paragraph IV ANDA litigation pertaining to the pancreatic cancer treatment, Gemzar^® (gemcitabine).
• Served as a law clerk to the Honorable Randall R. Rader of the U.S. Court of Appeals for the Federal Circuit, 1993-1994.
• Wrote her Ph.D. dissertation on the molecular modeling of the interaction between DNA and an intercalator, ethidium bromide.

Professional Recognition

• Received several academic awards and ranked first in her graduating class at the George Washington University Law School.

Professional Activities

• American Bar Association
• District of Columbia Bar Association
• District of Columbia Women's Bar Association
• Federal Circuit Bar Association
• American Intellectual Property Law Association