James B. Monroe is a leading patent litigator with extensive experience in Abbreviated New Drug Application (ANDA) litigation under the Hatch-Waxman Act, which governs the approval of pharmaceutical products. His practice centers on U.S. district court and appellate litigation, where he has served as lead counsel in numerous matters involving U.S. patent rights.
James focuses on the pharmaceutical, biotechnology, and medical device industries, while also representing clients across a broad range of technologies, including industrial chemicals, beverage compositions, food products, packaging materials, photochemistry, petroleum processing, biofuels, alloys, paper products, and glass manufacturing. His litigation experience also includes trade dress, unfair competition, and antitrust matters, with appearances before courts, mediators, and arbitrators.
He advises domestic and international clients on U.S. intellectual property law, providing opinions on infringement, validity, enforceability, and clearance. James also counsels on licensing, antitrust, due diligence, and portfolio strategy, and regularly guides clients through the intersection of patent law and FDA regulatory processes for pharmaceuticals and medical devices. A significant portion of his practice is also devoted to handling settlement and licensing negotiations for his clients.
James is a frequent lecturer on U.S. intellectual property protection, with a particular emphasis on Hatch-Waxman litigation. He has also served as an adjunct professor, teaching patent litigation. James has been recognized by multiple industry organizations and award programs for his excellence in patent litigation, portfolio management, and licensing. In 2023, he was named Litigator of the Year for Branded Products in the pharmaceutical space.
Updated Dec 2025
- Lead counsel for Neurocrine in Hatch-Waxman patent litigations against multiple companies seeking to market generic copies of Neurocrine’s multi-billion-dollar product INGREZZA®. Negotiated settlements with all parties maintaining patent and regulatory protection until 2038.
Lead counsel for Otsuka and Lundbeck in Hatch-Waxman patent litigations against numerous companies seeking to market generic copies of their multi-billion-dollar product Rexulti®. Negotiated settlements with all 18 companies, maintaining patent and regulatory protection for many years.
Lead counsel for Otsuka at trial and on appeal in Hatch-Waxman patent litigations against several companies seeking to market generic copies of Otsuka’s multi-billion-dollar product Abilify®. Following a month-long trial, district court ruled in favor of Otsuka on all issues, Federal Circuit affirmed, and Supreme Court denied cert, thus maintaining patent and regulatory protection for Abilify® in the United States for five years. Subsequently lead counsel for Otsuka and Lundbeck in Hatch-Waxman patent litigation involving their blockbuster Abilify Maintena® product, and negotiated the settlement thereof.
Lead counsel for Pronova at trial and on appeal in Hatch-Waxman patent litigation against several companies seeking to market generic versions of Lovaza®. District court found in favor of Pronova on all issues, including patent infringement, validity, and enforceability.
- Lead counsel for Elan at trial and on appeal in Hatch-Waxman litigation involving Andrx’s efforts to market generic copies of Naprelan®. District court found in favor of Elan on all issues, including a finding of willful infringement, and the parties ultimately settled an at-risk launch damages case in a confidential settlement involving significant payments to Elan.
- Appellate
- District Court Litigation
- Intellectual Property
- Consumer goods and services
- Food and beverage
- Healthcare
- Industrials
- Oil and gas
- Pharmaceutical and life sciences
- J.D. - George Washington University Law School (1991)
- B.S., Chemical Engineering - Washington University (1986)
- American Bar Association (Sections on Litigation and Intellectual Property)
- American Institute of Chemical Engineers
- American Intellectual Property Law Association
- District of Columbia Bar Association (Sections on Litigation and IP)
- Federal Circuit Bar Association
- Giles S. Rich American Inn of Court
- Virginia Bar Association (Sections on Litigation and Intellectual Property)
- U.S. Patent and Trademark Office (1989)
- District of Columbia (1996)
- Virginia (1991)
- U.S. Court of Appeals, Federal Circuit (1994)
- Supreme Court of the United States (2006)