Xiaomei Cai is an associate at Rakoczy Molino Mazzochi Siwik LLP.
Ms. Cai’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 and/or Biologics Price Competition and Innovation Act (BPCIA).
Ms. Cai has experience representing clients in proceedings before U.S. District Courts and the Federal Circuit. Ms. Cai has experience in a number of stages of litigation, including pre-suit strategy development, fact and expert discovery, the pre-trial and trial phases of federal litigation, and at the federal appellate level.
Ms. Cai has experience with respect to a wide range of pharmaceutical technologies, including with respect to small molecule chemistry, pharmaceutical compounds, pharmaceutical formulations, polymorphic forms of active pharmaceutical ingredients, injectable dosage forms, and/or pharmaceutical dosing methods.
Opinion Work and Patent Counseling
Ms. Cai is active in the firm’s patent counseling practice group. In this context, Ms. Cai has prepared opinions of counsel for clients on a variety of intellectual property issues and with respect to a wide range of pharmaceutical technologies, including with respect to small molecule chemistry, pharmaceutical compounds, pharmaceutical formulations, and/or pharmaceutical dosing methods.
Ms. Cai has also prepared a number of detailed statements in support of a number of different regulatory filings including with respect to Abbreviated New Drug Applications and 505(b)(2) New Drug Applications.
Vifor Fresenius Medical Care Renal Pharma Ltd. et al. v. Lupin Atlantis Holdings SA, et al. (D. Del.): Represented Lupin in a Hatch-Waxman litigation concerning patents related to sucroferric oxyhydroxide (Velphoro®). Case resolved by settlement with favorable terms for client.
Prior to joining Rakoczy Molino Mazzochi Siwik LLP as an associate, Ms. Cai was a summer associate with the firm.
Prior to attending law school, Ms. Cai performed biopharmaceutical research at Vcanbio Cell & Gene Engineering Corp Ltd.