Kevin M. Nelson
Partner
Duane Morris LLP
190 South LaSalle Street, Suite 3700
Chicago, IL 60603-3433
USA
Phone: +1 312 499 6770
Fax: +1 312 277 2999
Email: kmnelson@duanemorris.com

Kevin M. Nelson practices in the area of intellectual property with a focus on complex pharmaceutical patent litigation. For the past 12 years, Mr. Nelson has represented generic drug companies in patent litigation brought under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. He has also represented clients before the U.S. Food and Drug Administration in regulatory matters and in opposing citizen petitions. In addition, Mr. Nelson has advised clients regarding biosimilars applications and litigation. He also has experience in copyright and trademark litigation, trademark oppositions, antitrust litigation and client counseling on electronic discovery readiness.

Mr. Nelson is a 2001 graduate of DePaul University College of Law and a graduate of Indiana University.

Hatch-Waxman (ANDA) Litigation Experience

Mr. Nelson's practice focuses primarily on large-scale patent infringement actions brought under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, where he has significant trial experience. He has served as lead attorney for trial and has been an author of several briefs submitted to the Court of Appeals for the Federal Circuit. He has also argued before the Federal Circuit. One of the skills that Mr. Nelson has developed is the ability to convey complex concepts so that they are relevant and understandable.

In his work on Hatch-Waxman cases, Mr. Nelson has experience with a wide array of issues relating to the pharmaceutical field, including oral and ophthalmic dosage forms, extended- and modified-release dosage forms, polymorphic drug substances, formulation and process development, analytical testing of drug substances and drug products, organic and inorganic chemistry, process chemistry, bioequivalence studies, Food and Drug Administration (FDA) regulations, drug delivery systems, pharmacokinetics, and pharmacodynamics. The cases that Mr. Nelson has litigated have involved many well-known pharmaceutical products in a variety of therapeutic classes, including Paxil® and Paxil® CR (antidepressants), Neurontin® (treatment of epilepsy), Eloxatin® (chemotherapy), Zymar® (ophthalmic antibiotic), Zantac® (acid reflux), Zanaflex® Capsules, Adderall® XR (ADHD), Biaxin® XL (antibiotic), Valcye® (anti-infective prodrug), Gralise® (post herpetic neuralgia) and Vyvanse® (psychostimulant prodrug).

FDA Regulatory Counseling and Litigation/Citizen Petition Oppositions

Mr. Nelson has also counseled clients on design-around and invalidity issues before filing of an Abbreviated New Drug Application (ANDA) as well as regulatory issues relating to the filing of an ANDA. Further, Mr. Nelson has worked to assert his clients' rights against FDA in litigation. In particular, Mr. Nelson has assisted clients in successfully opposing Citizen Petitions filed to prevent or delay the launch of a generic drug product.

Biosimilars

With the passage of the Patient Protection and Affordable Care Act and FDA's issuance of its draft guidances, the U.S. took a bold step toward implementing an approval process for biosimilar drug therapies. Mr. Nelson has counseled clients on the regulatory issues associated with filing an abbreviated biologics license application (aBLA) to approve a biosimilar under Section 351(k) or a biologics license application (BLA) under Section 351(a). Mr. Nelson has been an invited speaker on regulatory aspects of the biosimilars legislation and guidances.

Other Intellectual Property and Litigation Experience

Mr. Nelson's patent practice is complemented by his work in the areas of trademark and copyright law. Mr. Nelson has handled Lanham Act cases concerning a variety of issues, including cases involving likelihood of confusion, false or unfair advertising and unfair competition claims. He has also represented clients relating to trademark oppositions before the Trademark Trial and Appeals Board. His experience in the copyright field ranges from litigation involving literary and pictorial works to computer source code and Internet websites. In addition to his experience in these traditional intellectual property areas, Mr. Nelson also has experience addressing antitrust, licensing, breach of contract, defamation, and e-commerce issues. Mr. Nelson has further served as a guest lecturer on intellectual property issues, particularly patent law issues, for members of India's pharmaceutical industry and for the Pharmaceutical Care Management Association. He also has been a guest speaker on document retention and e-discovery issues in federal litigation.

Service

Service is an important aspect of Mr. Nelson's professional and personal life. As a litigator, Mr. Nelson is focused on working closely with the client to understand and to address the client's needs. Outside for work, Mr. Nelson was honored by the Chicago Chapter of the Multiple Sclerosis Society as a future community leader and was involved in their fundraising efforts. Mr. Nelson also has been involved in various volunteer work and community outreach programs.

Areas of Practice

• Intellectual Property
• Complex Pharmaceutical Patent Litigation

Professional Activities

• American Bar Association
• American Intellectual Property Law Association
• Intellectual Property Law Association of Chicago

Admissions

• Illinois
• U.S. District Court for the Northern District of Illinois
• Trial Bar of the U.S. District Court for the Northern District of Illinois
• U.S. Court of Appeals for the Federal Circuit

Education

• DePaul University College of Law, J.D., 2001
• Indiana University, B.A., 1998

Experience

• Duane Morris LLP
  - Partner, 2013-present
• Locke Lord LLP
  - Partner, 2010-2013
  - Associate, 2001-2009

Selected Publications

• "FDA Sets Initial Fees and Deadlines for ANDAs and Related Submissions Under GDUFA," Locke Lord Quick Study, October 25, 2012

Selected Speaking Engagements

• "The Impact of FDA's Guidance on Biosimilars for the Generics Industry," 5th Product and Pipeline Enhancement for Generics Conference, Washington, D.C., July 17-19, 2012
• "U.S. Patent Litigation Landscape: Pruning the Law of Direct and Indirect Infringement," Global Intellectual Property Convention 2012, New Delhi, India, January 5-8, 2012