Kevin Michael Nelson is an intellectual property attorney with a focus on large-scale complex patent infringement litigation.
For more than 15 years, he has guided clients through the legal and regulatory challenges and changes associated with obtaining approval to commercially market a product under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.
In addition to helping clients develop a strategy 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. He also has successfully represented clients in inter partes review (IPR) proceedings.
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 has also advised 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.
- 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.
- Successful argument before the United States Court of Appeals for the Federal Circuit that resulted in a Rule 36 affirmance of district court judgement on all grounds.
- Defeated citizen petition that sought delay of market entry of generic manufacturer, resulting in a decision by the FDA that the petition was meritless.
- Argued discovery, Markman and dispositive motions in more than a dozen patent cases involving pharmaceutical products across various therapeutic categories. Cases involved drug and finished dose formulation, crystallization and polymorphs, dosing schedules, drug indications and use, adverse events, pharmacokinetics, organic chemistry, process chemistry, analytical testing methods and results, and route of drug administration.
- Lead negotiator for several favorable settlement agreements that have allowed client early market entry.
- Trial attorney for series of cases that led to important changes in Hatch-Waxman law including law relating to the 180-day exclusivity period, limitations on willful infringement, and multiple 30-month stays of regulatory approval.
- DePaul University College of Law, J.D., 2001
- Indiana University, B.A., Political Science, 1998
- U.S. Court of Appeals for the Federal Circuit
- U.S. District Court for the Northern District of Illinois (Trial Bar)
CIVIC AND CHARITABLE MEMBERSHIPS:
- Along with his family, Kevin is involved in various fundraising and community outreach projects that are close to his heart. As a firm believer in the power of teamwork and fair play, Kevin often serves as a volunteer coach for several different youth sports.
Rate : $$$