Sterne Kessler Goldstein Fox

Gaby L. Longsworth, Ph.D., is a Director in the Biotechnology/Chemical Group.  Dr. Longsworth's practice is focused on representing international and domestic generic pharmaceutical companies in patent cases involving Abbreviated New Drug Applications (ANDAs) that include a Paragraph IV (pIV) certification to one or more Orange Book listed patents.  She is involved in multiple ANDA patent infringement cases brought under the Hatch-Waxman Act and has provided litigation and strategic advice concerning claim construction, invalidity and infringement issues, and expert reports, and prepared experts for depositions.

In addition to her extensive litigation experience, Dr. Longsworth also has significant experience counseling generic clients on pIV filing strategies, including assessing the impact of data exclusivity, forfeiture issues (pre-MMA and post-MMA), label carve outs, and Patent Term Extensions (PTE).  In addition, Dr. Longsworth has rendered hundreds of invalidity, noninfringement, freedom-to-operate, and patentability opinions in at least the following areas: therapeutic antibodies, API, polymorphs, crystal forms and salts, chemical synthesis, pharmaceutical formulations (including oral dosage forms, transdermal patches, injectables, ophthalmics, creams, gels, suspensions, and nasal and oral inhalation forms) and so-called pharmacokinetic (pK) patents. 

Dr. Longsworth has also represented clients in patent reexamination and opposition proceedings, and serves on the Editorial Board of The Reexamination Center (www.reexamcenter.com).  Dr. Longsworth has also written on strategic reexaminations of patents listed in the FDA's Orange Book.  Click here to read the full article. 

She further counsels clients in all areas of patent procurement, including domestic and foreign patent preparation.