UnmeshShah Ph.D.

Associate

New York + 1.212.326.8324

Dr. Unmesh Shah focuses his practice on obtaining and defending patents for clients in the pharmaceutical, chemical, and biotechnology fields. A substantial part of Unmesh's practice includes conducting due diligence evaluations and providing freedom-to-operate, patentability, infringement, and validity opinions. Unmesh also advises clients with matters relating to patent term extension (PTE) and Orange Book listings.

Unmesh has significant experience in developing, managing, and evaluating global patent portfolios related to diverse technologies, including small-molecule pharmaceuticals, peptides, macromolecules, antibody-drug conjugates (ADCs), immunotherapy, mRNA-lipid nanoparticles, polymorphs, drug formulations, dosing regimens, chemical syntheses and purifications, ocular inserts, packaging, and drug repurposing. Unmesh also advises clients on patent life-cycle management strategies and regulatory extension opportunities.

Unmesh's practice also includes Hatch-Waxman litigations and inter partes review (IPR) proceedings, where he is involved with analyzing paragraph IV letters, conducting inventor interviews, retaining and interacting with subject matter experts, drafting infringement and validity contentions, and preparing experts for depositions and trial.

Prior to joining Jones Day, Unmesh worked for nearly 15 years as a medicinal chemist in the drug discovery group at Merck and Schering-Plough, and he was involved with various therapies, including CNS disorders, CV diseases, metabolic disorders, and infectious diseases. Unmesh's efforts in these areas led to candidates that were advanced to clinical trials.

Unmesh holds a Ph.D. in organic chemistry. His doctoral research involved total synthesis of natural products. He is an inventor on several patents and has authored multiple peer-reviewed articles, including review articles and book chapters. Unmesh has also given oral and poster presentations at national meetings.

Esperienze

  • Merck wins bench trial over patent term extension issue in Hatch-Waxman multi-party dispute involving BRIDION®Jones Day is representing Merck Sharp & Dohme, B.V. in Hatch-Waxman patent infringement actions originally against 16 generic drug maker defendant groups, relating to the defendant groups' submissions of Abbreviated New Drug Applications (ANDA) to the FDA seeking approval of generic versions of BRIDION®, a first-in-class agent for the reversal of certain types of neuromuscular blockade induced in adults undergoing surgery.
  • VasoRx develops patent portfolios relating to lipid nanoparticles for RNA-based therapiesJones Day is representing VasoRx, Inc. in connection with the development of patent portfolios relating lipid nanoparticles (LNP) and their use in the delivery of RNA-based therapeutics (e.g., RNAi, siRNA and miRNA) to endothelial cells for the treatment of vascular disorders, such as cardiovascular diseases and pulmonary arterial hypertension (PAH).
  • Puma Biotechnology asserts patent infringement claims under Hatch-Waxman Act related to Nerlynx® against SandozJones Day is representing Puma Biotechnology, Inc. in a Hatch-Waxman patent infringement action against Sandoz relating to Sandoz's submission of an Abbreviated New Drug Application to the FDA seeking approval of a purported generic version of Nerlynx® (neratinib) tablets.