James B. Monroe
James Monroe, managing partner of Finnegan, 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 has also 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, industrial chemicals, beverage compositions, food products, packaging materials, photochemistry, petroleum processing, biofuels, 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.
- Represented Otsuka Pharmaceuticals, Inc. in Hatch-Waxman litigations against seven companies seeking FDA approval to market generic copies of Abilify®, which had 2011 sales of over $5.2 billion. The district court found the asserted patent claims valid, enforceable and infringed in November 2010, and enjoined marketing of any generic until April 2015. The Federal Circuit affirmed that holding in May 2012, with Supreme Court Cert subsequently denied. Represents Otsuka in remaining claims before the district court.
- Represents Pronova BioPharma AS in Hatch-Waxman litigations against two companies seeking FDA approval to market generic versions of Lovaza®, which had 2011 sales of over $900 million. The district court found the asserted patent claims valid, enforceable and infringed in May 2012, thus precluding marketing of any generics until April 2017. A Federal Circuit appeal is pending. A case against a third generic settled at the start of trial.
- Represents Ferring Pharmaceuticals Inc. in Hatch-Waxman litigations against two companies seeking to market generic copies of Lysteda®.
- 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 USPTO reexamination proceedings instituted by Elan.
- Represents Otsuka Pharmaceuticals in Hatch-Waxman patent infringement litigations against four companies seeking FDA approval to market generic versions of Abilify® Oral Solution.
- Represents Ferring BV in patent ownership and misappropriation of trade secrets case pending against several parties regarding desmopressin.
- Represented GlaxoSmithKline in patent infringement action brought by Pfizer against Levitra®, ultimately resolved through confidential settlement.
- Represented Elan in Hatch-Waxman patent infringement action involving Naprelan®, including a successful Federal Circuit appeal. 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.
- 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® product, which settled on confidential terms.
- Defended Elan in antitrust action 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 Ferring in successfully defending against a $5 million attorneys fees claim stemming from prior litigation.
- Represented Elan in Hatch-Waxman action involving Permax®, ultimately concluded after product sold to another party.
- Represented nutraceutical company in negotiating the discontinuation of infringing activity by numerous manufacturers, distributors and sellers of artificial sweetener.
- Represented Elan in Hatch-Waxman patent infringement actions involving Skelaxin®, including in two successful appeals before the Federal Circuit.
- Represented Acorda Therapeutics, Inc. in Hatch-Waxman litigation involving Zanaflex® Capsules.
- 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.
- Recognized as a leader in the field of life sciences in the patent litigation category in the U.S. by Practical Law Company's Which Lawyer, 2010.
- 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