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 EST

Hosted Event

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 EST

EPPICon 2015

March 28, 2015

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

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Stevia Patent Claims Fall After Sweegen Challenge

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

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September 11, 2020

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

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September 4, 2020

Patent License Considerations After Fed. Circ. Enbrel Ruling

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July 7, 2020

IP Hot Topic: Patent Prosecution Tool Kit

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Patenting the Product Label

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U.S. Chemical Patent Law: A Practical Guide

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June 28, 2017

2017 Patent Prosecution Tool Kit

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April 18, 2017

Divided Infringement After Eli Lilly V. Teva

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February 12, 2017

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

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In the News

May 19, 2016

Diversity & Flexibility Alliance May 2016 Spotlight on Flex

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February 9, 2016

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

Bloomberg BNA: Life Sciences & Industry Report Multiple Authors

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June 16, 2015

Digital Health: Issues of Patentability

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

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February 24, 2015

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

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Client Alert

December 8, 2014

The Latest on Inherent Obviousness

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November 27, 2014

Divide and Conquer

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November 17, 2014

Post-Grant Review May Impact Biosimilars Litigation

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Client Alert

August 27, 2014

Selection Invention Found Unpatentable For Obviousness-Type Double Patenting

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July 15, 2014

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

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June 20, 2014

Another Layer of Complexity

The Patent Lawyer Multiple Authors