Darlene C. Staines

Darlene C. Staines is an associate in Goodwin Procter's Litigation department, where her practice focuses on complex patent and intellectual property disputes, primarily within the life sciences sector. Her experience encompasses pharmaceutical, biotechnology, and genomics litigation, frequently involving the Biologics Price Competition and Innovation Act (BPCIA). Ms. Staines also handles broader technology disputes and trade secret matters, drawing on her strong scientific background, which includes a Ph.D. in Genetics. She is an active contributor to Goodwin's "Big Molecule Watch" blog, offering insights on biologics, biosimilars, and BPCIA-related developments.

In terms of client representation, Ms. Staines predominantly works on the plaintiff side, particularly for biosimilar and life sciences companies challenging innovator patents. This is exemplified by her role as lead counsel for Alvotech in Alvotech v. Regeneron Pharmaceuticals, Inc., a significant biopharma patent dispute. Her work in BPCIA litigation often involves strategic pre-suit activities and post-grant review proceedings.

Ms. Staines is actively involved in post-grant proceedings before the Patent Trial and Appeal Board (PTAB). She has contributed to cases involving the filing of Post Grant Reviews (PGRs) against Regeneron's patents, such as those related to high-dose aflibercept, and Inter Partes Reviews (IPRs) challenging golimumab patents. Beyond the Alvotech case, her firm profile indicates involvement in patent litigation for other life sciences entities, including Bicara Therapeutics and Factor Bioscience, and trade secret litigation for LG Electronics.

Admitted to practice in New York, Ms. Staines holds a J.D. from Fordham University (2024). She earned her Ph.D. in Genetics from The University of Chicago (2008) and an S.B. from the Massachusetts Institute of Technology (2001).