PRACTICE AREAS

  • Patent Litigation
  • Intellectual Asset Portfolio Mgmt.
  • Technology Licensing
  • Inter Partes Reviews (PTAB)

Bar Admissions

  • New Jersey

Admissions to Courts

  • US Dist. Ct., (D. NJ)

Bar Admissions

  • New Jersey

Education

  • J.D. Seton Hall University School of Law, 2000
  • M.S., Pharmaceutical Sciences, Rutgers University, 1994
  • B.A., Pharmacy, Rutgers University, 1989

Ken Cappel, J.D.

Senior Counsel

EMAIL V-CARD PDF BIO

Ken Cappel joined AddyHart P.C. as Senior Counsel in 2022, bringing with him three decades of in-house experience in intellectual property protection and litigation for pharmaceutical and biotechnology companies. A registered pharmacist and attorney, Cappel’s expertise includes 30+ years of work in ANDA (Hatch-Waxman) and biologics litigations, alongside experience as in-house counsel for biologic and pharmaceutical companies. He has managed more than 100 pharmaceutical patent litigations, PTAB proceedings, settlements, and appeals, including for drugs Allegra®, AndroGel®, Livalo®, Namenda®, Nasonex®, Norvase®, NuvaRing®, Opana ER®, Precedex®, Prilosec®, Vyvanse®, Xyrem®, Zofran®, and Zyprexa®.

As Chief IP Counsel at Kashiv BioSciences, Cappel was responsible for all the company’s US legal matters. He managed one of the first biosimilar litigations—for bone-marrow stimulant filgrastim, which included numerous PTAB challenges, and resulted in favorable settlement. He advanced and expanded Kashiv’s proprietary drug delivery technology and biosimilars portfolio, which led to the sale of the company’s 505(b)(2) specialty products subsidiary to a major US pharmaceutical company.

Prior to his work at Kashiv, Cappel was for 11 years Chief IP Counsel at generic drugmaker Amneal Pharmaceuticals, which he helped grow until its $6.4 bn. merger with Impax to form the 5th-largest generics company in the US. At Amneal, Cappel headed the US- and India-based IP department as Vice President, Global Intellectual Property; under his guidance, Amneal was an early adopter of inter partes reviews in ANDA (Hatch-Waxman) patent cases. Before his decade at Amneal, Cappel was general counsel at Interpharm, where he filed a first-to-file Paragraph IV patent challenge against cognition-enhancing medication memantine (Namenda®). Before that, he was Director, Intellectual Property at Dr. Reddy’s Labs and worked with a cross-functional team to build a robust portfolio of 505(b)(2) NDA, API, and generic products.

Cappel began his career in IP law as an associate at Budd Larner, P.C., where he drafted patent clearance opinions in advance of Hatch-Waxman Paragraph IV filings and was involved in Hatch-Waxman cases for ondansetron (Zofran®), olanzapine (Zyprexa®), and omeprazole (Prilosec®), and was a scientist and regulatory coordination associate at Schering-Plough Research Institute.

Cappel earned his J.D. from Seton Hall University School of Law. He holds an M.S. in pharmaceutical sciences and a B.S. in pharmacy from Rutgers University. He is based in our Chicago office.

  • Representative Hatch-Waxman Patent Litigations and PTAB Proceedings

    • Amgen Inc. v. Kashiv BioSciences, LLC (formerly Adello Biologics, LLC) – Neupogen® biosimilar
    • AstraZeneca Pharmaceuticals v. Amneal Pharmaceuticals LLC et al. – Nexium® alt. salt 505(b)(2) NDA
    • Galderma Laboratories, LP v. Amneal Pharmaceuticals LLC – Oracea®
    • Purdue Pharma LP et al v. Amneal Pharmaceuticals LLC – Oxycontin®
    • Reckitt Benckiser LLC v. Amneal Pharmaceuticals LLC – Mucinex®
    • Endo Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC – Opana® ER
    • Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC – Xyrem®
    • Takeda Pharmaceuticals USA Inc. v. Amneal Pharmaceuticals LLC – Colcrys®
    • Novo Nordisk Inc. v. Anmeal Pharmaceuticals LLC – Vagifem®
    • Otsuka Pharmaceutical Co., Ltd. v. Amneal Pharmaceuticals LLC – Abilify®
    • Mallinckrodt LLC v. Amneal Pharmaceuticals LLC – Pennsaid®
    • Forest Laboratories Inc. v. Amneal Pharmaceuticals LLC – Savella®
    • Forest Laboratories, Inc. v. Amneal Pharmaceuticals LLC – Namenda® XR
    • Shire LLC. v. Amneal Pharmaceuticals LLC – Vyvanse®
    • Teva Pharmaceuticals USA, Inc. v. Amneal Pharmaceuticals LLC – Copaxone®
    • Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC – Nasonex®
    • Eli Lilly and Company v. Amneal Pharmaceuticals LLC – Axiron®
    • Forest Laboratories, LLC v. Amneal Pharmaceuticals LLC – Namzaric®
    • UCB Inc. v. Amneal Pharmaceuticals LLC – Vimpat®
    • Sucampo AG v. Amneal Pharmaceuticals LLC – Amitiza®
    • Biogen International GmbH v. Amneal Pharmaceuticals LLC – Tecfidera®