Colleen Tracy James

Specialty / focus. Colleen Tracy James is a life sciences patent litigator and first-chair trial lawyer, currently Co-Chair of Cahill Gordon & Reindel's Life Sciences Patent Litigation practice. Her practice centers on pharmaceutical and biotech patent disputes — particularly Hatch-Waxman/ANDA litigation against generic challengers — plus PTAB proceedings, ITC actions, and Federal Circuit appeals. Her firm materials and Chambers USA profile specifically note her handling of PTAB work and Hatch-Waxman cases; she also handles non-life-sciences matters (e.g., cybersecurity, solar technology, sports betting) for certain clients.

Side preference. Her tracked docket shows work on both sides: plaintiff-side counsel for Merus N.V. in its Delaware enforcement action against Xencor over heterodimerization antibody patents, and defense counsel for Merus in the parallel Xencor v. Merus matter (including IPR2025-00604/-00605, where she appears as patent-owner counsel). More broadly, her career has been dominated by representing innovator/operating pharma companies — mostly patent owners enforcing drug patents (Janssen, Gilead, Sanofi-Aventis, AstraZeneca, Allergan, Takeda) rather than NPE/PAE work.

Firm context and notable matters. James joined Cahill in January 2024 from White & Case; earlier firms include Quinn Emanuel, Mayer Brown, and Fitzpatrick Cella Harper & Scinto (a 15-year stint at the New York IP boutique acquired by Venable in 2018). Her most prominent tracked matter is Merus N.V. v. Xencor, Inc. (D. Del., No. 24-913-JCB), where Merus asserted patents covering bispecific antibody "heterodimerization" and common-light-chain technology; in September 2025 Judge Barker granted Xencor's motion to dismiss, holding the accused pre-commercialization activities protected under the 35 U.S.C. § 271(e)(1) safe harbor — an adverse ruling for her client. Other notable representations include Janssen's Invokana ANDA litigation (Quinn Emanuel), Gilead's Complera (Mayer Brown), and Sanofi-Aventis's Eloxatin (Fitzpatrick Cella), per her firm bio and Law360 coverage.

Bar / education. Admitted in New York and New Jersey; J.D. Seton Hall University School of Law (1996), B.S. Manhattan College (1992).