James B. Monroe

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. He also has represented clients in trade dress, unfair competition, and antitrust matters. He has presented cases before courts, mediators, and arbitrators.

Mr. Monroe also 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. He 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.

Mr. Monroe’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, beverage compositions, food products, packaging materials, photochemistry, petroleum processing, alloys, paper products, glass making, and medical devices.

Mr. Monroe 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.

Highlights

• Represented Elan in Hatch-Waxman patent infringement action involving Naprelan^®. The district court found the patent claims at issue to be valid, enforceable and willfully infringed by Andrx/Watson, and held that Elan was entitled to recover attorneys fees. Andrx/Watson settled this matter by paying Elan $18 million and agreeing to other confidential terms.
• Represents Otsuka Pharmaceuticals in Hatch-Waxman patent infringement litigations against seven companies seeking FDA approval to market generic versions of Abilify^®.
• Represented GlaxoSmithKline in patent infringement action brought by Pfizer against Levitra^®, ultimately resolved through confidential settlement.
• Defended Elan in antitrust action brought by Andrx directed to the settlement of a Hatch-Waxman litigation with another party. The district court granted judgment on the pleadings in favor of Elan on all issues, and the Eleventh Circuit affirmed the majority of the district court’s holdings. Matter ultimately settled as part of larger settlement.
• Represented Aventis in patent infringement action against Baxter’s Advate^® product for treating hemophilia, ultimately resolved through confidential arbitration. Also represented Aventis and CSL Behring in similar action against Bayer’s Kogenate^® FS product, which settled on confidential terms.
• Represents defendant Elan in patent infringement action brought by Classen Immunotherapies. The district court granted summary judgment of non-infringement in favor of Elan and stayed further action pending the outcome of PTO reexamination proceedings instituted by Elan.
• Has represented Ferring in various litigation and counseling matters, including substituting into a case to successfully defend Ferring against a $5 million attorneys fees claim stemming from prior litigation.
• Represented Elan in Hatch-Waxman patent infringement action involving Ivax request to market generic copies of Permax^®. Involvement ended when Elan transferred product and litigation responsibility to another party.
• Represented nutraceutical company in negotiating the discontinuation of infringing activity by numerous manufacturers, distributors, and sellers of artificial sweetener.
• Represents Elan in Hatch-Waxman patent infringement action involving Eon’s request to market a generic copy of Skelaxin^®. Previously represented Elan in a suit involving Corepharma relating to this same product, which case ultimately settled.
• Represented Elan in Hatch-Waxman litigation against Brightstone and SkyePharma relating to their request to market generic copies of Naprelan^®. Case settled on confidential terms.
• Served as a law clerk to the Honorable Giles Sutherland Rich at the U.S. Court of Appeals for the Federal Circuit, 1992-1994.
• Former U.S. patent examiner for a variety of subject matter, including polymeric and inorganic composites, textiles, coated particles, semiconductor devices and magnetic recording media, 1986-1989.
• Member of the firm’s Management Committee; previously led the firm's Chemical Practice Group; and also served as a recruiting partner.

Professional Recognition

• Recognized as a leader in the field of Life Sciences: Patent Counseling in the U.S. by Practical Law Company’s Which Lawyer, 2010.

Professional Activities

• American Intellectual Property Law Association (past-Chair, Awards Committee; past-Vice-Chair, Young Lawyers Committee)
• American Bar Association (Sections on Litigation and Intellectual Property)
• Virginia Bar Association (Sections on Litigation and Intellectual Property)
• District of Columbia Bar Association (Sections on Litigation, and Intellectual Property
• Federal Circuit Bar Association
• Giles S. Rich American Inn of Court
• American Institute of Chemical Engineers