Carolyn Alenci provides integrated, industry-focused strategic counseling and advocacy for clients in the pharmaceutical, medical device, cosmetic, and digital health industries. Ms. Alenci combines her understanding of science, intellectual property, U.S. Food and Drug Administration (FDA) practice, and federal and state statutes, regulations, and rules with industry-specific knowledge to define and drive client-centered strategies that align clients’ business and legal goals.
Ms. Alenci concentrates on assisting generic pharmaceutical companies filing Abbreviated New Drug Applications and 505(b)(2) Applications with the FDA with all stages of strategic planning, including product formulation and reference listed drug decisions and invalidity and non-infringement analyses, and with patent litigation, settlement negotiations, and appeals.
Ms. Alenci also assists clients with securing intellectual property rights in the United States and abroad, providing freedom-to-operate, invalidity, and infringement/non-infringement analyses, petitioning for inter partes review before the U.S. Patent and Trademark Office (USPTO), analyzing license agreements, policies, warning letters, and due diligence/audit reports, as well as advocating for and defending clients in patent, trade dress, trade secret, and commercial litigation.
Ms. Alenci also provides in-depth regulatory analyses and strategy for compliance, class selection, 510(k) clearance and exemption, labeling, advertising/marketing/promotion, state licensing and registration for manufacturers, wholesalers, and retailers, compliance with Good Manufacturing Practices, inspections, and data integrity.
Ms. Alenci regularly authors alerts and presents on industry topics, such as FDA regulations and guidance on ANDA and 505(b)(2) Applications, NCE exclusivity, data integrity, compliance with current Good Manufacturing Practices, labeling, abuse deterrence, the Drug Supply Chain Security Act, and violation and enforcement.
Ms. Alenci is also the co-author of “Chapter 11, Generic Drugs: ANDAs, Section 505 (b)(2) Applications, Patents, and Exclusivities,” Food and Drug Law and Regulation, 3rd Edition, March 2015.
- Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.
- Conducting a 50-state survey of drug and device law.
- Advise digital health companies on regulatory landscape concerning software, apps, and 3-D printing.
- Advise company with respect to changes to policies to comply with both state and federal statutes and regulations.
- Advise on the interrelation of federal statute, including developing and implementing legal theories on matters of first impression.
- Advise generic pharmaceutical companies on issues such as the selection of reference listed drugs, section viii carve outs, labeling, and off-label use.
- Part of a team of lawyers representing a Fortune 100 pharmaceutical company in a multibillion-dollar trade secret and antitrust litigation arising out of technology relating to the pharmaceutical application of recombinant proteins.
- Avanir Pharmaceuticals, Inc., et al. v. Wockhardt, Ltd., et al., 11-CV-704 (Consolidated) (LPS) (D. Del.) Obtained a settlement in a patent infringement action allowing Wockhardt to market a generic version of Avanir’s PBA product Nuedexta®, the active ingredients of which are dextromethorphan hydrobromide and quinidine hydrobromide.
- Franklin Pierce Law Center, LL.M., Intellectual Property, cum laude, 2009
- Franklin Pierce Law Center, J.D., cum laude, 2009
- Auburn University, B.C.H.E., summa cum laude, 2006
- U.S. Patent and Trademark Office
- District of Columbia
- U.S. District Court for the District of Massachusetts
- U.S. Court of Appeals for the Federal Circuit
- Duane Morris LLP, – Associate, 2010-present
- Auburn University Office of Technology Transfer, – Legal Intern, 2006-2010
- Women’s Bar Association Women’s Leadership Initiative Class of 2017-2018
- Food and Drug Law Institute
- Boston Patent Law Association
- Women’s Bar Association
Rate : $$$