Barbara R. Rudolph Ph.D.
Barbara Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application (ANDA) and biotechnology cases over the past twenty years. She serves as lead counsel in pharmaceutical and biotechnology disputes and has extensive litigation experience in federal courts. Dr. Rudolph has also argued appeals before the U.S. Court of Appeals for the Federal Circuit and authored an amicus brief submitted to the U.S. Supreme Court in a landmark biotechnology patent case directed to isolated BRCA genes.
Dr. Rudolph has defeated patent challenges brought by generic companies in cases involving blockbuster drugs such as Nuvigil®, Enbrel®, Effexor® XR, and Nolvadex®. She devises strategies to protect clients' valuable intellectual property involving sophisticated technologies in the pharmaceutical and biotechnology industries. Clients also call on Dr. Rudolph to provide strategic pre-litigation client counseling, due diligence analyses, and opinions. She lectures regularly in the United States and abroad on various aspects of U.S. patent law, with particular emphasis on the challenges and opportunities faced by the biotechnology and pharmaceutical industries.
- Represents AbbVie and Abbott Laboratories in separate Hatch-Waxman litigations pending in different federal courts against several companies seeking FDA approval to market generic copies of AbbVie's important HIV treatment, Norvir® tablets.
- Represents AbbVie in Hatch-Waxman litigation against generic attack on AbbVie's Norvir® capsules.
- Represents AbbVie in Hatch-Waxman litigation involving AbbVie's Kaletra® tablets.
- Represents Duchesnay in Hatch-Waxman litigation, defending against generic attack on Duchesnay's Diclegis® product.
- Successfully represented Cephalon against several generic companies at trial in Paragraph IV ANDA litigations pertaining to Nuvigil®, Cephalon's prescription medicine used to improve wakefulness. The district court found the asserted claim patents valid and infringed and enjoined the defendants from marketing generic versions until patent expiry. The case was ultimately resolved through confidential settlement.
- Prevailed for Amgen before the Federal Circuit in an appeal of a patent infringement suit involving Enbrel®.
- Represented Wyeth in several separate Hatch Waxman litigations involving Wyeth's Effexor® XR, a blockbuster treatment for depression and anxiety disorders. The cases were resolved through confidential settlements at various stages of litigation, including during the midst of trial.
- Represented Imperial Chemical Industries and Zeneca, Inc. in several successful Paragraph IV ANDA litigations, including appeals, involving the breakthrough breast cancer treatment, Nolvadex®.
- Secured a win for American Home Products in a Paragraph IV ANDA litigation involving generic loratadine products.
- Served as leader of the firm's biotechnology and pharmaceutical practice group, 2010-2013, and as a member of the firm's management committee, 2006-2009.
- Served as a judicial law clerk at the U.S. Court of Appeals for the Federal Circuit, 1993-1994.
- American Bar Association
- District of Columbia Bar Association
- District of Columbia Women's Bar Association
- Federal Circuit Bar Association
- American Intellectual Property Law Association
- Coauthor. "Induced Infringement of Method of Treatment Claims: Does 'United We Stand, Divided We Fall' Really Apply?," BNA Pharmaceutical Law and Industry Report, March 3, 2017.
- Coauthor. "Copying as Objective Evidence of Non-Obviousness in ANDA Cases Is Alive and Well," BNA's Pharmaceutical Law and Industry Report, Jan. 13, 2017.
- Coauthor. "2013 Patent Law Decisions of the Federal Circuit," American University Law Review, June 23, 2014.