Kevin M. Nelson

Partner

Kevin is an intellectual property attorney with a focus on large-scale complex patent infringement litigation.

Kevin Nelson Portrait

For more than 20 years, Kevin has guided clients through legal and regulatory challenges with a focus on the life sciences industry. He is a first-chair trial lawyer who has helped clients obtain approval to commercially market products under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. In addition to developing strategies for filing an abbreviated new drug application (ANDA), Kevin has represented clients in every phase of patent litigation and has successfully argued before the United States Court of Appeals for the Federal Circuit. His matters have involved patents purportedly covering well-known pharmaceutical products and methods for using those products. In the face of an evolving and uncertain biosimilar industry in the United States, Kevin has counseled clients on navigating the biosimilar legal and regulatory pathways. He also has successfully represented clients in inter partes review (IPR) proceedings. 

Kevin advises clients on various corporate matters including mergers and acquisitions, due diligence evaluation, and corporate restructuring, and has served as outside general counsel for emerging companies. He counsels clients on regulatory matters before the U.S. Food and Drug Administration, such as opposing citizen petitions. Rounding out his experience, Kevin has handled cases involving trademark and copyright infringement, false or unfair advertising, and unfair competition claims.

Client Work

  • Obtained the first stay of district court litigation in view of pending inter partes review proceeding by a defendant generic pharmaceutical manufacturer.
  • Led a team in securing a final written decision of unenforceability of all claims of two Orange Book listed patents related to methods for treating disease caused by thrombus. 
  • Lead trial attorney, including a recent case in which the district court found the asserted patent not infringed and invalid.
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Professional Activities

Pro Bono 

Kevin has provided pro bono representation to songwriters to assist them in obtaining royalties owed for use of their works.

Civic and Charitable Memberships

Along with his family, Kevin is involved in various fundraising and community outreach projects that are close to his heart. He served as Board President for Family Promise Chicago North Shore, which gets families back into permanent housing. As a firm believer in the power of teamwork and fair play, Kevin often serves as a volunteer coach for several different youth sports.

Publications, Presentations, & Recognitions

Publications

  • “IP Attorneys Propose a New Biosimilar Pathway in Case of ACA Repeal,” (co-author) The Center for Biosimilars (Jul. 25, 2020)
  • “A New Antitrust Approach After Humira ‘Patent Thicket’ Ruling,” Law360 (Jun. 26, 2020)
  • “If Successful, Teva Suit Could Decrease Generic Competition,” (co-author) Schiff Hardin Insight (Mar. 27, 2020)
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Presentations

  • “A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding and Alternative Fee Arrangements,” American Conference Institute, Conference (Oct. 25, 2023)
  • “U.S. Patent Litigation Landscape: Pruning the Law of Direct and Indirect Infringement,” Global Intellectual Property Convention 2012, New Delhi, India (Jan. 5-8, 2012)
  • “The Impact of FDA’s Guidance on Biosimilars for the Generics Industry,” 5th Product and Pipeline Enhancement for Generics Conference, Washington, D.C. (Jul. 17-19, 2012)
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Recognitions

  • Chambers USA – Intellectual Property
  • Life Sciences Star – Hatch-Waxman Patent Litigation, LMG Life Sciences (2020-2022)
  • The Best Lawyers in America, Best Lawyers (2022-2024)
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Awards

Awards

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