Rick Ball

Carolyn Alenci

BOSTON, May 19, 2015—Duane Morris LLP attorneys Frederick "Rick" Ball and Carolyn Alenci, both of the firm's Boston office, have authored a chapter in the Food and Drug Law Institute's Food and Drug Law and Regulation, Third Edition. The book is a comprehensive guide that explores the FDA's vast and complex regulatory systems and standards. Ball and Alenci's chapter is titled, "Generic Drugs: ANDAs, Section 505(b)(2) Applications, Patents, and Exclusivities." It provides an overview of the history of generic drugs and abbreviated new drug applications (ANDAs), the ANDA approval process, the FDA Amendments Act, generic drug user fees, section 505(b)(2) applications, antibiotics, enantiomer exclusivity, and reorganization of the Office of Generic Drugs.

Ball is vice-chair of the White-Collar Criminal Defense division of Duane Morris' Trial Practice Group. He focuses his practice on assisting companies and individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters with the FDA, FTC, DEA, CMS, OIG and others. Ball works with generic pharmaceutical companies, biologics manufacturers, food companies (including supplement manufacturers), pharmacies, long-term care providers and other healthcare providers. Additionally, he helps companies maintain their competitive advantage through trade secrets litigation and enforcement of restrictive covenants. A 1996 cum laude graduate of Cornell Law School, Ball is a graduate of the University of Colorado at Boulder and an adjunct professor of law at DePaul University College of Law.

Carolyn Alenci practices in the area of intellectual property litigation, concentrating on the chemical and pharmaceutical industries by assisting generic pharmaceutical companies filing Abbreviated New Drug Applications with the FDA with pre-litigation strategic planning and litigation. She also assists clients in the life sciences and medical devices fields with securing patent rights in the United States and abroad and in patent litigation. Alenci is a cum laude graduate of Franklin Pierce Law Center, where she received a joint degree with an emphasis on intellectual property and was managing editor and articles editor of IDEA: The Intellectual Property Law Review. She is a summa cum laude graduate of Auburn University, where she studied chemical engineering.

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