Mark Waddell practices in the areas of life sciences and intellectual property, with a particular focus on the representation of branded drug companies in Hatch-Waxman and biosimilars matters. He provides strategic analyses concerning patent and exclusivity protection while helping life sciences clients navigate complex patent and regulatory issues to bring their products to market.
I enjoy working with innovators, entrepreneurs and other creative people whose groundbreaking drug therapies can have an immense impact on improving quality of life. It’s very rewarding.
In addition to acting as lead counsel in U.S. District Court, the Patent Trial and Appeal Board (PTAB) and appellate matters in the Federal Circuit and the U.S. Supreme Court, Mark has also worked on corporate matters, including acquisitions, licensing, collaboration agreements, royalty monetization and securities transactions. He has represented branded pharma clients in REMS/ETASU negotiations as well as a variety of contract disputes and antitrust analyses. His U.S. Patent and Trade Office (USPTO) experience includes post-grant and inter partes review proceedings before the PTAB as well as patent interferences.
With a background in pharmaceutical R&D, Mark has broad experience in oncology, osteoporosis, neuropharmacology, monoclonal antibody therapies and antivirals as well as solid-state chemistry, drug delivery, formulations and API syntheses. He draws upon his industry experiences as a project manager and former in-house counsel to efficiently organize legal processes and accomplish his clients’ substantive and budgetary objectives.
Outside the office, Mark is an avid private pilot who volunteers for Angel Flight Northeast, which provides free air transportation for patients requiring access to medical care as well as military families in need.
- Seton Hall University Law School, J.D.
- New Jersey Institute of Technology, Chemical Engineering, B.S.
- U.S. Court of Appeals, Federal Circuit
- U.S. District Court for the Southern District of New York
- U.S. District Court for the District of New Jersey
- U.S. Supreme Court
- New York
- New Jersey
- United States Patent and Trademark Office
- Ranked in the LMG Life Sciences guide in Patent Strategy & Management (2021)
- Named an “IP Star” by Managing Intellectual Property magazine (2013-2021)
- Guest Lecturer, Patent Litigation, Franklin Pierce Law Center, Concord, New Hampshire (Spring 2003 and 2004)
- Highest "AV Preeminent (5 out of 5)" Professional Rating, Martindale-Hubbell Law Directory
- Named "New York Metro Super Lawyer" in Intellectual Property Litigation by Thomson Reuters (2006, 2012-2021)
- Member, New York Intellectual Property Law Association
- Member, Federal Circuit Bar Association
- Member, Intellectual Property Owners' Pharmaceutical Issues Committee (2010-2011)
- Member, Intellectual Property Owners' Hatch-Waxman Committee (2006-2007)