Barbara R. Rudolph Ph.D.
Barbara Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application (ANDA) and biotechnology litigations, as well as other pharmaceutical and biotechnology-related disputes. She serves as lead counsel and has prevailed in trials in federal district courts and appeals before the U.S. Court of Appeals for the Federal Circuit.
Ms. 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 Ms. 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.
- Roxane Laboratories, Inc. v. Abbott Laboratories (S.D. Ohio); AbbVie v. Roxane Laboratories, Inc. (S.D. Ohio); and AbbVie v. Hetero (D. Del.). Lead trial counsel in Paragraph IV ANDA litigations; defends AbbVie's important HIV treatment, Norvir® tablets, against attacks by a generic manufacturers.
- AbbVie v. Mylan (D. Del.). Lead trial counsel for AbbVie in Paragraph IV ANDA litigation involving Norvir® capsules.
- Association for Molecular Pathology v. U.S. Patent and Trademark Office (Myriad) (Fed. Cir.). Counsel of record for amicus brief filed in a landmark Supreme Court biotechnology case.
- In re Armodafinil Patent Litigation (D. Del.). 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.
- AbbVie Inc. v. Matrix Laboratories, Inc., (N.D. Ill.). Lead counsel representing AbbVie Inc. in Paragraph IV litigation related to AbbVie's HIV treatment, Kaletra®.
- Israel Bio-Engineering Project v. Amgen, Inc. (Fed. Cir.). Prevailed for Amgen before the Federal Circuit in an appeal of a patent infringement suit involving Enbrel®.
- Successful settlement of several Paragraph IV ANDA litigations involving Wyeth's Effexor® XR, a blockbuster treatment for depression and anxiety disorders.
- Successfully defeated patent challenges in several Paragraph IV ANDA litigations, including appeals, involving the blockbuster breast cancer treatment Nolvadex® on behalf of Imperial Chemical Industries and Zeneca, Inc.
- Schering Corporation v. American Home Products (D.N.J.). 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 law clerk to the Honorable Randall R. Rader of 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