Barbara Rudolph
Barbara Rudolph
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
901 New York Avenue, NW
Washington, DC 20001-4413
Dr. Barbara Rudolph focuses on pharmaceutical, biotechnology, and Hatch Waxman Paragraph IV ANDA litigations. 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. For the past 15 years, she has represented pharmaceutical and biotechnology companies on matters involving blockbuster drugs such as Kaletra®, Enbrel®, Effexor® XR, Nolvadex®, and Gemzar®. She has helped protect clients’ valuable intellectual property in sophisticated technologies including recombinant fusion proteins; HIV diagnostics; cancer therapies (prostate, breast, and pancreatic); antihistaminic compounds; DNA nucleotides encoding the binding region of an NK cell protein; gene transcription factor NF-?B 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 extensive experience in performing pre-suit investigations, developing litigation strategies, briefing and arguing motions, preparing both fact and expert witnesses for depositions and trial, analyzing approaches for appeal, drafting appellate briefs, and arguing before the Federal Circuit.
Highlights
Argued before the Federal Circuit on behalf of Amgen in an appeal of an adverse decision of the Board of Patent Appeals and Interferences regarding a patent application directed to DNA sequences encoding an NK cell protein binding region.
- Argued before the Federal Circuit on behalf of Amgen in an appeal regarding a favorable summary judgment ruling in an infringement case involving Enbrel® (etanercept), a dimeric fusion protein used to treat rheumatoid arthritis.
- 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 (extended release venlafaxine hydrochloride), 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).