Marsha Rose Gillentine, Ph.D., is a director in Sterne Kessler’s Biotechnology & Chemical and Trial & Appellate Practice Groups. Marsha is primarily focused on the pharmaceutical industry. She is intimately familiar with the Hatch-Waxman Act and Biologics Price Competition and Innovation Act and understands patent litigation strategy in the context of the statutory schemes and Patent Office Litigation. Marsha is sought by both innovator and generic pharmaceutical and biopharmaceutical companies for assistance with intellectual property issues related to their pharmaceutical products, including freedom-to-operate analyses and lifecycle management strategies.

Marsha has provided hundreds of patentability, noninfringement, and invalidity opinions. She has rendered opinions in a variety of technology areas including: small molecules, therapeutic antibodies, polymorphs, salts, synthesis, pharmaceutical formulations, and pharmacokinetics.

Marsha also assists clients in implementing lifecycle management strategies, including those for precision medicine patent portfolios. Her practice encompasses both domestic and foreign patent prosecution, including patent drafting and patent prosecution. She has drafted and prosecuted patents related to various pharmaceutical issues. For example, Marsha has prosecuted patents related to small molecules, polymorphs, chemical synthesis, pharmaceutical formulations, methods of treatment, drug delivery devices, animal models, vaccines, polymers, genes, gene expression systems, proteins, and antibodies.

Marsha has been involved in multiple pharmaceutical patent litigations brought under the Hatch-Waxman Act, and has also assisted clients with proceedings before the U.S. Patent Trial and Appeal Board (PTAB).

Marsha was one of the first recipients of the Sterne, Kessler, Goldstein & Fox Intellectual Property Scholarship at the George Mason University School of Law, where she was also a member of the Moot Court Board. She earned her Ph.D. in biological chemistry from the University of North Carolina – Chapel Hill, and her B.S., cum laude, in Chemistry from Berry College.

  • Profiles in Diversity Journal, “Women Worth Watching® in STEM” (2021)

  • J.D., George Mason University Antonin Scalia Law School, cum laude
  • Ph.D., Biological Chemistry, University of North Carolina at Chapel Hill
  • B.S., Chemistry, Berry College, cum laude

  • District of Columbia
  • U.S. Court of Appeals for the Federal Circuit
  • United States Patent & Trademark Office
  • Virginia

  • American Bar Association
  • American Chemical Society
  • American Intellectual Property Law Association

Webinar

Drug Development Pathway Series: Intellectual Property Workshop

Virtual, October 28, 2020 4:00 PM - 5:00 PM PST

Speaking Engagement

2019 Global IP Strategy Conference

Washington, DC, March 15, 2019

Speaking Engagement

Clinical Innovation: Fair and Effective Incentives for New Uses of Established Drugs

Washington, DC, February 8, 2018 8:30 AM - 5:30 PM PST

EPPICon 2015

March 28, 2015

Related Resources

From Marsha Rose Gillentine, Ph.D.

Firm Announcements

January 3, 2024

Federal Circuit Affirms Sweet Win for SweeGen in Patent Invalidity Battle

Sterne, Kessler, Goldstein & Fox

Books and Chapters

July 29, 2022

Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition

ABA Book Publishing Multiple Authors

In the News

May 25, 2022

Tastes Like Invalidity—Judge Knocks Out Sweetener Patents, Despite PTAB Ruling

The Recorder Multiple Authors

Firm Announcements

May 25, 2022

Sterne Kessler Team Secures Summary Judgment of Patent Invalidity on Behalf of Sweegen, Inc. in District Court

Sterne, Kessler, Goldstein & Fox Multiple Authors

In the News

May 24, 2022

Stevia Patent Claims Fall After SweeGen Challenge

Law360 Multiple Authors

In the News

May 24, 2022

Sweegen Wins Challenges to Rival’s Artificial Sweetener Patents

Bloomberg Law Multiple Authors

Press Release

July 26, 2021

Sterne, Kessler, Goldstein & Fox Earns 13 Market-Leading Awards for Excellence in the First Six Months of 2021

Sterne, Kessler, Goldstein & Fox Multiple Authors

Press Release

June 29, 2021

Directors Gillentine and Nannenga-Combs Deemed “Women Worth Watching® in STEM”

Sterne, Kessler, Goldstein & Fox Multiple Authors

In the News

September 11, 2020

In Case You Missed It: Hottest Firms And Stories On Law360

Law360 Multiple Authors

Bylined Articles

September 4, 2020

Patent License Considerations After Fed. Circ. Enbrel Ruling

Law360 Eric K. Steffe, Marsha Rose Gillentine, Ph.D.

Client Alert

July 7, 2020

IP Hot Topic: Patent Prosecution Tool Kit

Carla Ji-Eun Kim

Reports

July 7, 2020

Patent Prosecution Tool Kit

Sterne, Kessler, Goldstein & Fox Multiple Authors

Bylined Articles

July 7, 2020

Patenting the Product Label

Sterne, Kessler, Goldstein & Fox Eric K. Steffe, Marsha Rose Gillentine, Ph.D.

Bylined Articles

June 23, 2020

Biopharma Patentees Must Navigate Inherent Obviousness

Law360 Multiple Authors

Books and Chapters

October 1, 2019

U.S. Chemical Patent Law: A Practical Guide

Bloomberg Law Multiple Authors

Press Release

October 1, 2019

Sterne Kessler Attorneys Author U.S. Chemical Patent Law

Sterne, Kessler, Goldstein & Fox P.L.L.C Multiple Authors

Presentations

September 15, 2017

Focus on Pharma Conference 2017 PowerPoint Presentations

Multiple Authors

Books and Chapters

June 28, 2017

Patent Prosecution Tool Kit

Multiple Authors

Bylined Articles

April 18, 2017

Divided Infringement After Eli Lilly V. Teva

Law360 Eric K. Steffe, Marsha Rose Gillentine, Ph.D.

Bylined Articles

February 12, 2017

Biologics and the Right to Exclude During the Patent Term Extension Period

Westlaw Journal Intellectual Property Eric K. Steffe, Marsha Rose Gillentine, Ph.D.

In the News

May 19, 2016

Diversity & Flexibility Alliance May 2016 Spotlight on Flex

Diversity & Flexibility Alliance Eric K. Steffe, Marsha Rose Gillentine, Ph.D.

Bylined Articles

February 9, 2016

Drug Label, Method-of-Use Patents and Infringement by Inducement

Bloomberg BNA: Life Sciences & Industry Report Multiple Authors

Bylined Articles

June 16, 2015

Digital Health: Issues of Patentability

Life Science Intellectual Property Review Marsha Rose Gillentine, Ph.D., Michelle K. Holoubek

Press Release

June 3, 2015

Sterne, Kessler, Goldstein & Fox Highlighted in The Legal 500 United States 2015

Marsha Rose Gillentine, Ph.D., Michelle K. Holoubek

Bylined Articles

February 24, 2015

The Best Offense Is a Good Defense: Patent Prosecution Strategies During Personalized Medicine Drug Development

Biotechnology Law Report Marsha Rose Gillentine, Ph.D., Robert C. Millonig, Ph.D.

Webinar Recordings & Materials

January 22, 2015

USPTO 101 Guidelines: What is Left for Diagnostics?

Marsha Rose Gillentine, Ph.D., Robert C. Millonig, Ph.D.

Client Alert

December 8, 2014

The Latest on Inherent Obviousness

Gaby L. Longsworth, Ph.D., Marsha Rose Gillentine, Ph.D.

Bylined Articles

November 27, 2014

Divide and Conquer

World Intellectual Property Review Marsha Rose Gillentine, Ph.D., Robert C. Millonig, Ph.D.

Bylined Articles

November 17, 2014

Post-Grant Review May Impact Biosimilars Litigation

Law360 Marsha Rose Gillentine, Ph.D.

Client Alert

August 27, 2014

Selection Invention Found Unpatentable For Obviousness-Type Double Patenting

Multiple Authors

Bylined Articles

July 15, 2014

The Federal Circuit Expands Obviousness-Type Double Patenting in Gilead v. Natco.

MSBA Annual IP Law Update 2014 Multiple Authors

Press Release

June 30, 2014

Sterne, Kessler, Goldstein & Fox Highlighted in The Legal 500 United States 2014

Multiple Authors

Bylined Articles

June 20, 2014

Another Layer of Complexity

The Patent Lawyer Multiple Authors