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Barbara_Rudolph
Barbara R. Rudolph, Ph.D.
Partner
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  • 901 New York Avenue, NW
  • Washington, DC 20001-4413
+1 202 408 4346
barbara.rudolph@finnegan.com barbara.rudolph@finnegan.com

Barbara R. Rudolph, Ph.D.

Partner

  • +1 202 408 4346 +1 202 408 4346
  • barbara.rudolph@finnegan.com barbara.rudolph@finnegan.com
  • 901 New York Avenue, NW
  • Washington, DC 20001-4413
  • vCard
Barbara_Rudolph
Barbara Rudolph, Ph.D., is an accomplished trial lawyer with extensive experience litigating complex pharmaceutical and biotechnology cases for over two decades.  She has secured favorable outcomes for clients in contentious matters in district court proceedings, on appeal before the U.S. Court of Appeals for the Federal Circuit, and through negotiated settlements.

Barbara has successfully litigated patent infringement cases involving blockbuster drugs for Fortune 500 companies as well as the "crown jewel" products of smaller companies. Clients also call on Barbara to provide strategic pre-litigation client counseling, due diligence analyses, and opinions. Barbara has also argued appeals before the U.S. Court of Appeals for the Federal Circuit, where she served as a law clerk, and authored an amicus brief submitted to the U.S. Supreme Court in a landmark biotechnology patent case directed to isolated BRCA genes. She also has experience with contentious matters before the International Trade Commission (ITC) and the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). Barbara has been listed in LMG Life Sciences as an Intellectual Property: Life Sciences Star.

Barbara has served as leader of the firm's biotechnology and pharmaceutical practice group, and as a member of the firm's management committee.

Experience

Duchesnay Inc. v. Actavis Laboratories FL, Inc. et al.

Lead counsel for Duchesnay in a Hatch-Waxman Act patent infringement litigation based on Actavis’s and Teva’s filing of an ANDA seeking to market a generic copy of Bonjesta®.  The case is currently pending in the District of Delaware.

1:18-cv-01895, D. Del., Judges Andrews, Fallon

Vifor (International) AG and American Regent, Inc. v. Mylan Labs. Ltd.

Lead counsel for Vifor and American Regent in two Hatch-Waxman Act cases against Mylan and Sandoz regarding their attempts to obtain FDA approval for their respective ANDAs directed to generic copies of Injectafer®.  The cases are currently pending in the District of New Jersey.

3:19-cv-13955, 3:19-cv-16305, D.N.J., Judges Wolfson, Arpert

Certain L-Tryptophan, L-Tryptophan Products, and Their Methods of Production

Successfully represented Ajinomoto as trial counsel in an extremely rare biotech investigation at the U.S. International Trade Commission (ITC).  The investigation involved patents related to genetically modified organisms and the use thereof to make commercial quantities of tryptophan. After a full evidentiary hearing, the ITC issued a final determination finding the Ajinomoto patents valid and that Cheil Jedang (“CJ”) infringes the asserted patents. The commission issued limited exclusion and cease-and-desist orders barring CJ and other respondents from importing infringing products for sale in the United States, resulting in a victory for Ajinomoto. 

337-TA-1005, ITC, Judges Bullock, Essex
IPR2017-01551, -01698, PTAB, Judges Franklin, Mitchell, Moore, Sawert, Yang

AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG v. Hetero USA Inc. and Hetero Labs Ltd.

Lead counsel for AbbVie in multiple patent infringement actions in two district courts against several generic companies based on their respective efforts to market generic versions of AbbVie’s Norvir® tablet or capsule products.  Obtained favorable Markman rulings, and the cases all settled on favorable, confidential terms at various stages of litigation.

1:13-cv-00852, 1:13-cv-01072, 1:14-cv-00543, 1:14-cv-00959, 1:14-cv-01137, 1:14-cv-01236, 1:14-cv-01288, D. Del., Judge Andrews
2:12-cv-00312, 2:13-cv-00645, 2:13-cv-00708, 2:14-cv-00085, S.D. Ohio, Judges Watson, Sargus, King, Deavers

AbbVie Inc. v. Mylan Laboratories, Inc.

Lead counsel for AbbVie in a patent infringement action brought under the Hatch-Waxman Act against Mylan and Matrix, who sought to market generic versions of Kaletra® tablets.  The case settled prior to trial on confidential, favorable terms.  Assisted AbbVie in the settlement of later cases against other challengers involving Kaletra® tablets.

1:09-cv-01586, N.D. Ill., Judges Dow, Cole
1:15-cv-00889, 1:17-cv-01631, D. Del.

In Re: Armodafinil Patent Litigation

Successfully represented Cephalon as trial counsel against five generic companies in consolidated Hatch-Waxman Act 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 settled on appeal.

1:10-md-02200, D. Del., Judge Sleet

17 more

Insights

Webinar

Orange Book Listing Recent Developments Orange Book Listing Recent Developments

November 17, 2020

Webinar

Webinar

Hatch-Waxman Litigation and 30-Month Stays: Multiple Stays, Late-Listed Patents, and More Hatch-Waxman Litigation and 30-Month Stays: Multiple Stays, Late-Listed Patents, and More

October 29, 2020

Webinar

Webinar

Patent Exclusivity Health Checks for Small Molecules: Are Your U.S. Patents Ready to Maximize ROI? Patent Exclusivity Health Checks for Small Molecules: Are Your U.S. Patents Ready to Maximize ROI?

August 11, 2020

Webinar

Prosecution First Blog

“All Substantial Rights” and Right to Prosecute May Be Informative for Assessing Obviousness-Type Double Patenting Common Ownership but Was Not Found Where Assignee Retained Secondary Right of Enforcement “All Substantial Rights” and Right to Prosecute May Be Informative for Assessing Obviousness-Type Double Patenting Common Ownership but Was Not Found Where Assignee Retained Secondary Right of Enforcement

July 8, 2020

Webinar

Protecting Privileged Information in Life Sciences Patent Cases

Protecting Privileged Information in Life Sciences Patent Cases Protecting Privileged Information in Life Sciences Patent Cases

April 16, 2020

Webinar

Webinar

Divided Patent Infringement and Inducement: Protecting IP Rights and Allocating Liability Divided Patent Infringement and Inducement: Protecting IP Rights and Allocating Liability

January 21, 2020

Webinar

54 more

Professional Recognition

“Trial veteran and chemistry PhD Barbara Rudolph…is deemed a great choice for the most sensitive matters.”

Intellectual Asset Management Patent 1000

“Trial veteran and chemistry PhD Barbara Rudolph…is deemed a great choice for the most sensitive matters.”

Intellectual Asset Management Patent 1000

News

Press Release

Finnegan Celebrates Two Wins at the 2020 LMG Life Sciences Awards and Top Honors in the Rankings Finnegan Celebrates Two Wins at the 2020 LMG Life Sciences Awards and Top Honors in the Rankings

October 5, 2020

Media Mention

Finnegan Shortlisted for 2020 LMG Life Sciences Awards Finnegan Shortlisted for 2020 LMG Life Sciences Awards

August 4, 2020

Press Release

Finnegan Maintains Top Rankings in 2020 IAM Patent 1000 Guide Finnegan Maintains Top Rankings in 2020 IAM Patent 1000 Guide

June 17, 2020

Intellectual Asset Management

Media Mention

Fed. Circ. Backs ITC's Infringement Ruling on E. Coli Patent Fed. Circ. Backs ITC's Infringement Ruling on E. Coli Patent

August 6, 2019

Law360

Media Mention

Supreme Court Rejects Idea of Patenting Natural Human Genes Supreme Court Rejects Idea of Patenting Natural Human Genes

June 13, 2013

McClatchy Newspapers

Media Mention

U.S. Supreme Court Says “Natural” Human Genes May Not Be Patented U.S. Supreme Court Says “Natural” Human Genes May Not Be Patented

June 13, 2013

MIT Technology Review
4 more

Professional Activities

  • American Bar Association
  • Colorado Bar Association
  • District of Columbia Bar Association
  • District of Columbia Women's Bar Association
  • Federal Circuit Bar Association
  • American Intellectual Property Law Association
Admissions and Education

Admissions

  • Colorado
  • District of Columbia
  • Pennsylvania
  • U.S. Court of Appeals, Federal Circuit
  • Supreme Court of the United States
  • U.S. Patent and Trademark Office

Education

George Washington University Law School
J.D., with highest honors, 1993
University of California, Davis
Ph.D., Chemistry, 1986
Syracuse University
B.S., Chemistry, cum laude, 1981

Clerkships

  • U.S. Court of Appeals, Federal Circuit, Hon. Randall Ray Rader

Barbara's Practices

Patent Litigation
Appeals
Branded Hatch-Waxman (ANDA)
ITC Section 337
Patent Trial
Pre-Trial Strategy
Settlement
Patent Portfolio Management, Monetization, and Transactions
Due Diligence
Opinions and Counseling
Post-Grant Proceedings
IPR, PGR, and CBM

Barbara's Industries

Life Sciences
Biologics
Biotechnology
Pharmaceutical

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