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Litigation Star

James Monroe is a leading patent litigator with extensive ANDA litigation experience involving the Hatch-Waxman Act governing the approval of pharmaceutical products. He focuses on U.S. district court and appellate litigation and has been lead counsel for numerous matters involving U.S. patent rights. 

James’s practice is focused on the pharmaceutical, biotechnology and medical device arts, but he also has represented clients in a wide array of technologies, including industrial chemicals, beverage compositions, food products, packaging materials, photochemistry, petroleum processing, biofuels, alloys, paper products and glass making. James also has represented clients in trade dress, unfair competition, and antitrust matters. He has presented cases before courts, mediators, and arbitrators. He counsels domestic and international clients regarding U.S. intellectual property law by providing infringement, validity, enforceability and clearance opinions, and by advising them in licensing, antitrust, due diligence, and IP portfolio matters. James also advises clients regarding the interplay between the U.S. patent laws and the process of obtaining FDA approval to market pharmaceutical products and medical devices. 

James regularly lectures on the protection of U.S. intellectual property rights, with an emphasis on Hatch-Waxman issues. He has also served as an adjunct professor on the topic of patent litigation. He has been recognized as a leading patent litigator by various publications, including Intellectual Asset Management, LMG Life Sciences, and The Legal 500 U.S., which also recognized him for patent portfolio management and licensing. 

Representative Experience: 

  • Lead counsel for Otsuka at trial and on appeal in Hatch-Waxman litigations against several companies seeking to market generic copies of Abilify®, which had sales of over $5.2 billion in 2011 alone. 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 from 2010-2015. 
  • 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.

Updated Sep 2023