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 served as lead counsel in both trial and appellate proceedings. Her experience includes bench and jury trials in federal district courts and appellate arguments 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 more than 15 years, Ms. Rudolph has represented pharmaceutical and biotechnology companies on matters involving blockbuster drugs such as Norvir^®, Nuvigil^®, Kaletra^®, Enbrel^®, Effexor^® XR, and Nolvadex^®. She has helped protect clients' valuable intellectual property in sophisticated technologies including antiretroviral therapies; recombinant fusion proteins; HIV diagnostics; small molecule cancer therapies; polymorphs and amorphous solid state forms; antihistaminic compounds; DNA nucleotides encoding the binding region of a cell protein; gene transcription factor technology; and genetically engineered corn.

Ms. Rudolph 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.

Highlights

• Abbott Laboratories v. Roxanne Laboratories Inc. (D. Del.). Represents Abbott Laboratories in ANDA litigation involving Norvir^®, an important HIV treatment.
• Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") (Fed. Cir.). Counsel of record for AIPLA as amicus curiae in a landmark biotechnology case.
• Represents Cephalon against several generic companies in Paragraph IV litigations pertaining to Nuvigil^®, Cephalon's prescription medicine used to improve wakefulness.
• Represents Abbott Laboratories in Paragraph IV litigations in N.D. Illinois related to Abbott's HIV treatment, Kaletra^®.
• Israel Bio-Engineering Project v. Amgen, Inc. (Fed. Cir.). Argued before the Court of Appeals for the Federal Circuit on behalf of Amgen in the appeal of a patent infringement suit brought by IBEP involving Enbrel^®.
• 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).
• Schering Corporation v. American Home Products (D.N.J.). Represented American Home Products in a Paragraph IV ANDA litigation involving generic loratadine products.
• 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 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