345 Park Avenue
New York,
New York
10154
 212.407.4127
 646.619.4540
|
Mark
E.
Waddell
Partner
and
Co-Chair, Patent Litigation Department
Mark Waddell has practiced in the areas of intellectual property and technology for more than 20 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).
Prior Work Experience
Prior to joining Loeb & Loeb LLP, Mr. Waddell was a partner at Sonnenschein Nath & Rosenthal LLP. 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.
-
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
- Author, Civil Actions To Obtain Patent Certainty: Controversy At The Federal Circuit, The Metropolitan Corporate Counsel (June 2008)
- Author, Trapped by a Lack of Controversy (January 22, 2008)
- Speaker, Maximizing Pharmaceutical Patent Life Cycles, New York, New York (October 24-25, 2007)
- Speaker, IQPC's 4th Patent Strategies, New York, New York (September 25-26, 2007)
- Speaker, Maximizing Pharmaceutical Patent Life Cycles (October 2004)
- Author, Antitrust Concerns in Settlement of Pharmaceutical Patent Litigation, Intellectual Property & Technology Law Journal (December 2002)
- Presenter, Key Developments in U.S. Pharmaceutical and Biotech Patent Law (October 2002)
Media Mentions
Affiliations
- Member, New York Intellectual Property Law Association
- Member, Federal Circuit Bar Association
- 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)
|
Seton Hall University Law School, J.D., 1984
New Jersey Institute of Technology, B.S., 1979
New York
New Jersey
United States Patent and Trademark Office
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
|