Gaby L. Longsworth, Ph.D., is a director in Sterne Kessler's Biotechnology & Chemical Practice Group and is the chairperson of the firm's Diversity Committee. Gaby is sought out by innovator and generic pharmaceutical companies world-wide for her insights and knowledge of intellectual property and Hatch-Waxman law.
Gaby counsels biopharmaceutical clients from around the world in all areas of patent procurement, including domestic and foreign patent preparation and lifecycle management strategies. Gaby also counsels clients in IP due diligence evaluations for raising and investing in growth capital, executing strategic partnerships and M&A transactions, and going public. Gaby practices primarily in the fields of biotherapeutics, small molecules, biologics, immunotherapy, antibody technologies, microbiome-based technologies, synthetic biology, DNA amplification/PCR, diagnostics, vaccines, viral vectors and drug delivery.
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 has rendered more than a thousand invalidity, non-infringement, freedom-to-operate, and patentability opinions in the following areas among others: 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). She is a contributing author of Patent Office Litigation, Second Edition, published in 2017 by Thomson Reuters Westlaw. In particular, Gaby co-authored Chapter 21 entitled: Interplay Between Hatch-Waxman and the America Invents Act: the New Face of Pharmaceutical Litigation. The book provides a fresh and comprehensive exploration of patent office litigation proceedings, including how the proceedings interact with other aspects of patent procurement and enforcement, while delivering practical analysis and advice.
In addition to maintaining a vibrant practice, retaining and advancing female lawyers is important to Gaby. She is especially passionate about training and retaining lawyers, who are also moms, to be thought leaders in their fields. 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, seminars, book clubs, lunches, and other activities that support personal and professional development. Gaby has participated in several organizations that encourage the advancement and leadership of women in the legal profession and is 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.
- Profiles in Diversity Journal, "Women Worth Watching®" (2019)
- LMG Life Sciences, "Finalist - Patent Strategy and Management Attorney of the Year (District of Columbia) Category" (2017)
- LMG Life Sciences, "Life Sciences Star" (2019 - 2016)
Gaby's representative inter partes matters include:
- 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)