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SELECTBIO Conferences Next Generation Sequencing Asia 2016: Clinical Applications

Barbara Rudolph's Biography



Barbara Rudolph, Partner and IP Lawyer

Dr. 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. Ms. 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 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.

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