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Mark E. Waddell
Partner and Chair, Patent Litigation and Counseling Department

Mark Waddell has practiced in the areas of intellectual property and technology for more than 25 years. He litigates pharmaceutical and chemical patent disputes, with particular focus on Hatch-Waxman issues, as well as patent interference practice and ITC proceedings. He also has substantial experience in providing strategic counseling to a wide variety of industries (pharmaceuticals, specialty chemicals, polymerization catalysts, diagnostics and chemical processing).

Mr. Waddell is also a volunteer pilot for Angel Flight Northeast, which provides transportation free of charge for patients requiring access to medical care and their family members, as well as service men and women in need of compassion flights. Angel Flight also provides a vital mode of transportation for organs, blood, and patients awaiting organ transplants.

Prior Work Experience

Prior to joining Loeb & Loeb LLP, Mr. Waddell was a partner at Sonnenschein Nath & Rosenthal LLP. Mr. Waddell previously led the IP group at Bryan Cave LLP where he also served on the firm's Executive Committee and Strategic Planning Committee. He has also worked in the chemical industry as a process development engineer (various technologies, e.g., fermentation, hydrogenation and sulfonation).

Representative Experience

  • Representation of Hoffmann-La Roche Inc. in nine pending Hatch-Waxman cases in the District of New Jersey involving Boniva®.
  • Hatch-Waxman dispute on the breast cancer drug Nolvadex® (tamoxifen). Won at trial invalidating the patent, with the case later settling on appeal leading to generic market entry under license from the patent owner. Numerous other generics attempted to challenge this patent but failed.
  • Represented the prevailing party in a Hatch-Waxman dispute on the antidepressant Prozac® (fluoxetine), in which the Federal Circuit invalidated the patent due to double patenting.
  • Hatch-Waxman dispute on the antidepressant Paxil® (paroxetine). Resolved by license permitting immediate market entry of client's product.
  • Developed patent prosecution and appeal strategies for several basic olefin polymerization inventions that had been stalled during earlier prosecution (the oldest of which had been pending since 1955).
  • Worked with pharmaceutical industry lobbyists on passage of 1988 process patent amendments, assisting in meetings with Congressional staff and drafting report language regarding what constitutes a "material change" for purposes of determining liability when products are modified prior to importation.

Publications/Speeches


Media Mentions


Affiliations

  • 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)

Distinctions

  • 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

Practice Areas
Education
Seton Hall University Law School, J.D., 1984
New Jersey Institute of Technology, B.S., 1979
Bar Admissions
New York
New Jersey
United States Patent and Trademark Office
Court Admissions
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
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