Chris Galligan is an associate at Rakoczy Molino Mazzochi Siwik LLP.
Mr. Galligan’s practice focuses on intellectual property litigation, with emphasis on patent infringement suits arising under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act. Mr. Galligan’s practice also involves litigation under the Administrative Procedure Act, in both support of, and against, the Food and Drug Administration.
Mr. Galligan has experience representing clients in proceedings before U.S. District Courts, the Federal Circuit, and the United States Supreme Court. Mr. Galligan has experience in all stages of litigation, including pre-litigation diligence, fact and expert discovery, dispositive motion practice, pretrial and trial, and appeals.
Mr. Galligan has experience with respect to a wide range of pharmaceutical technologies, including with respect to small molecule chemistry, polymorphic forms of active pharmaceutical ingredients, complex polypeptides, injectable dosage forms, pharmaceutical dosing methods, and methods of manufacturing pharmaceuticals.
Regulatory and Legislative Counseling
Mr. Galligan is also involved in the firm's regulatory counseling practice, including statutory and regulatory issues arising under the Hatch-Waxman Act, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), and the Biologics Price Competition and Innovation Act (BPCIA). Mr. Galligan also has experience in several regulatory disputes arising under the Administrative Procedure Act, including actions brought against and in support of the FDA. Mr. Galligan also has experience with the filing of citizen petitions, related comments, and other administrative submissions with the FDA, including controlled correspondence related to exclusivity eligibility and FDA’s approval requirements.
Mr. Galligan also has experience assisting clients with protecting the interests of the generic drug and biosimilar pharmaceutical industry by evaluating federal legislative proposals affecting the pharmaceutical sector, including amendments to the Hatch-Waxman Act, the BPCIA, and patent reform under the America Invents Act (AIA). Mr. Galligan has experience with legislative analysis, drafting white papers, and preparation of presentations and materials for meetings with Congressional members and staff in both the U.S. Senate and House.
Teva v. Sandoz, et al. (D. Del.): Represented Sandoz in a Hatch-Waxman litigation concerning patents related to Copaxone. Member of a trial team that obtained a decision in favor of Sandoz finding all asserted claims invalid. Member of appellate team that obtained an affirmance from the Federal Circuit affirming all asserted claims invalid.
Teva v. FDA, et al. (D.D.C.): Represented Sandoz as an intervenor in support of FDA as part of an Administrative Procedure Act challenge by Teva seeking to transition Copaxone from a drug regulated under the Federal Food, Drug and Cosmetic Act to a biologic regulated under the Public Health Service Act. Member of litigation team that obtained a decision in favor of FDA and Sandoz on a Motion for Summary Judgment.
Prior to joining Rakoczy Molino Mazzochi Siwik LLP as an associate, Mr. Galligan worked at the firm as a law clerk while enrolled in law school. He also has experience as a law clerk at Greer, Burns & Crain, where he focused on patent prosecution and overseas trademark enforcement.
Before joining the legal profession, Mr. Galligan worked as a laboratory technician at DNA Polymerase Technology, Inc. He focused his work on the optimization of a specialized Taq DNA polymerase used to detect small amounts of DNA in soil in order to efficiently test the soil for pests and pathogens.