Gaby L. Longsworth, Ph.D., is a director in Sterne Kessler's Biotechnology & Chemical Practice Group and chair of the firm's Diversity & Inclusion Committee. Gaby has been consistently recognized as a “Life Sciences Star” by LMG Life Sciences since 2016. In 2017 and 2020, she was a finalist for "Patent Strategy and Management Attorney of the Year, District of Columbia," in LMG's annual Life Sciences Awards. In 2019, Profiles in Diversity Journal listed her among their “Women Worth Watching®” award.
Gaby is particularly well-known by innovator and generic pharmaceutical companies world-wide for her insights and knowledge of intellectual property and Hatch-Waxman law. Capitalizing on her extensive generic pharmaceutical expertise, Gaby is uniquely qualified to evaluate complex innovator IP portfolios from a generic perspective, including method-of-use claim coverage relative to the product label, Orange Book patent listing and data exclusivity, 505(b)(2) strategies, labeling carve-outs, and Patent Term Extensions.
Gaby also counsels biopharmaceutical clients from around the world in all areas of patent procurement, including domestic and foreign patent preparation and lifecycle management strategies. Gaby practices primarily in the fields of biotherapeutics, small molecules, biologics, immunotherapy, antibody technologies, microbiome-based technologies, probiotics, synthetic biology, DNA amplification/PCR, diagnostics, vaccines, viral vectors, formulations and drug delivery.
Gaby has rendered more than a thousand invalidity, non-infringement, freedom-to-operate, and patentability opinions in areas such as: small molecules; polymorphs; crystal forms and salts; chemical synthesis; agricultural chemicals, pharmaceutical formulations, including oral dosage forms and parenterals; transdermal patches; ophthalmics, creams, gels, suspensions, nasal and oral inhalation forms, pharmacokinetics, nucleic acids, medical devices and therapeutic antibodies.
In addition, Gaby has strong experience in biopharmaceutical Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB).
In addition to maintaining a vibrant practice, Gaby is one of the organizers of “INSPIRED by the Women of Sterne Kessler," an affinity group designed to engage female attorneys through participation in a variety of programs that support personal and professional development. She is also a sustaining member of the Women’s Bar Association of the District of Columbia.
Gaby earned a J.D. at Georgetown University Law Center, a Ph.D. in human genetics and molecular biology at The Johns Hopkins University and a B.S. in molecular biology from the Florida Institute of Technology. She is fluent in Dutch.
When not practicing law, Gaby can be found writing a blog on natural hair and spending time with her family on the water.
- LMG Life Sciences, "Finalist - Patent Strategy and Management Attorney of the Year (District of Columbia) Category" (2020, 2017)
- LMG Life Sciences, "Life Sciences Star" (2022 - 2016)
- Profiles in Diversity Journal, "Women Worth Watching®" (2019)
- Catalyst Pharm. v. Jacobus Pharm. Co., Civil Action 20-14590 (MAS) (DEA) (D.N.J. Jul. 31, 2021). Representing patent owner Catalyst Pharmaceuticals, Inc. concerning infringement of muscle disorder drug patent.
- Eli Lilly and Company v. Teva Pharmaceuticals International GmbH et al, Nos. IPR2018-01711, -01712, -01710, -01422, -01423, -01424, -01425, -01426, -01427 (P.T.A.B. 2018) (Representing patent owner Teva Pharmaceuticals International GmbH in defense of 9 patents challenged in IPR proceedings).
- Represented generic pharmaceutical company in IPR proceedings concerning acne drug.
- Represented generic pharmaceutical company in Hatch-Waxman case concerning leading overactive bladder drug.
- Represented generic pharmaceutical company in Hatch-Waxman case concerning leading antipsychotic drug.
- American Intellectual Property Law Association
- Maryland State Bar Association, Intellectual Property Committee
- Women's Bar Association of the District of Columbia
- BNA Medical Devices Law & Industry Report, Advisory Board Member (2018-2014)