Partner
James Monroe is experienced in all aspects of intellectual property law. He focuses on U.S. district court and appellate litigation and has been lead counsel for numerous matters involving U.S. patent rights. In particular, he has extensive litigation experience involving the Hatch-Waxman Act governing the approval of pharmaceutical products.
James has also 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's practice encompasses a wide array of technologies with a focus on the pharmaceutical, chemical, biotechnology and mechanical arts. He has assisted clients in the fields of pharmaceutical products, industrial chemicals, beverage compositions, food products, packaging materials, photochemistry, petroleum processing, biofuels, alloys, paper products, glass making, and medical devices.
James lectures often regarding the protection of U.S. intellectual property rights, with an emphasis on Hatch-Waxman issues. He also has served as an adjunct professor in the area of patent litigation. James was honored as the 2023 Hatch-Waxman Litigator of the Year Branded by LMG Life Sciences. He has also been recognized as a leading patent litigator by the former as well as other publications, including Intellectual Asset Management, The Legal 500 U.S., which also recognized him for patent portfolio management and licensing, and Benchmark Litigation, which named him a litigation star.
Over the course of his long tenure with the firm, James has served as global managing partner, global firm chair, leader of the chemical practice group, and recruiting partner.
Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc.
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.
3:07-cv-01000, D.N.J., Judges Cooper, Goodman, Hughes
11-1126, -1127, Fed. Cir., Judges Lourie, Moore, Reyna
Horizon Pharma v. Dr. Reddy's Laboratories, et al.
Lead counsel for Horizon in Hatch-Waxman patent infringement litigations against several companies seeking to market generic copies of Vimovo®. District court ruled in favor of Horizon, and appeal now pending.
3:11-cv-02317, 3:11-cv-04275, 3:13-cv-00091, 3:13-cv-04022, D.N.J., Judge Cooper
17-2473, -2481, -2484, -2486, -2487, -2488, -2489, -2491, -2491, -2493, Fed. Cir.
Elan Corporation PLC v. Andrx Pharmaceutical
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.
0:98-cv-07164; 0:00-cv-07057; 0:05-cv-60158, S.D. Fla., Judge Jordan
03-1354, -1355, -1386, -1387, Fed. Cir., Judges Michel, Lourie, Dyk
Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc.
Lead counsel for Pronova at trial and on appeal in Hatch-Waxman patent litigation against three companies seeking to market generic versions of Lovaza®. District court found in favor of Pronova on all issues, including patent infringement, validity, and enforceability.
1:09-cv-00286, 1:10-cv-00800, D. Del., Judges Farnan, Robinson, Thynge
12-1498, -1499, Fed. Cir., Judges Dyk, O'Malley, Wallach
Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc.
Lead counsel in defending Elan at district court and in two appeals with respect to Classen’s infringement allegations regarding Elan’s Skelaxin® portfolio. District court granted summary judgment of non-infringement in favor of Elan. Federal Circuit affirmed, and Supreme Court denied cert. Also successfully represented Elan in related reexamination proceedings before the U.S. Patent and Trademark Office (USPTO).
1:04-cv-03521, D. Md., Judges Bennett, Quarles, Sullivan
14-1671, Fed. Cir., Judges Prost, Lourie, Gilstrap
17-1033, Fed. Cir., Judges Prost, Lourie, Taranto
Aventis Pharma, S.A. v. Baxter Healthcare Corp.
Represented Aventis in patent infringement action asserting infringement against Baxter’s Advate® product for treating hemophilia. Case successfully resolved through a confidential arbitration trial, resulting in award to Aventis of the highest damages amount available under parties’ arbitration agreement.
1:06-cv-00636, D. Del., Judge Sleet
Event
Finnegan Tokyo Office 30th Anniversary Seminar & Reception Finnegan Tokyo Office 30th Anniversary Seminar & Reception
October 18, 2018
Tokyo
Articles
Trusted Advisor Interview: The Power of Collaboration Trusted Advisor Interview: The Power of Collaboration
September 25, 2017
Event
Seminar on Issues of Intellectual Property Seminar on Issues of Intellectual Property
October 10-15, 2014
Washington
Seminar
Strategies for a Changing IP Landscape Strategies for a Changing IP Landscape
February 26, 2014
London
Articles
Obviousness of DNA Fragments in the Post-Kubin Era Obviousness of DNA Fragments in the Post-Kubin Era
April 30, 2013
Life Sciences Intellectual Property Review"Monroe is hard to compete with when it comes to Hatch-Waxman litigation."
Intellectual Asset Management Patent 1000
"Monroe is hard to compete with when it comes to Hatch-Waxman litigation."
Intellectual Asset Management Patent 1000
Award/Ranking
Finnegan Ranks at the Top of the Managing Intellectual Property IP Stars Rankings Finnegan Ranks at the Top of the Managing Intellectual Property IP Stars Rankings
June 28, 2024
Managing Intellectual PropertyAward/Ranking
46 Finnegan Attorneys Ranked in 2024 IAM Patent 1000 46 Finnegan Attorneys Ranked in 2024 IAM Patent 1000
June 6, 2024
Intellectual Asset ManagementAward/Ranking
Finnegan Receives Tier 1 Benchmark Litigation Rankings; Nine Attorneys Named Litigation Stars Finnegan Receives Tier 1 Benchmark Litigation Rankings; Nine Attorneys Named Litigation Stars
October 5, 2023
Benchmark LitigationAward/Ranking
Finnegan Upholds Tier 1 Marks in 2023 LMG Life Sciences Rankings Finnegan Upholds Tier 1 Marks in 2023 LMG Life Sciences Rankings
September 21, 2023
LMG Life SciencesPress Release
Finnegan Takes Home Three Wins at the 2023 LMG Life Sciences Americas Awards Finnegan Takes Home Three Wins at the 2023 LMG Life Sciences Americas Awards
September 8, 2023
LMG Life SciencesAward/Ranking
Finnegan Shortlisted in 10 Categories in the LMG Life Sciences Awards 2023 Finnegan Shortlisted in 10 Categories in the LMG Life Sciences Awards 2023
July 25, 2023
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