Carolyn A. 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.
Ms. Alenci is a member of the Food and Drug Law Institute, where she has served on the drugs and biologics committee and currently serves on the peer-review publications committee. Ms. Alenci is also active in the Greater Boston community, participating in the Greater Boston Chamber of Commerce’s Women’s Leadership Program, the Women’s Bar Association’s Women’s Leadership Initiative, and the young professionals’ groups for the Museum of Fine Arts and the Boston Symphony Orchestra.
Areas of Practice
Food and Drug Law
- Intellectual Property Law and Litigation
- Abbreviated New Drug (ANDA) Litigation
- Patent Litigation
- Generic and Biosimilar Pharmaceuticals
- Trade Secrets
Inter Partes Review
- Medical Devices
- Digital Health
- Life Sciences
- Represented iAnthus Capital Holdings, Inc. (CSE: IAN; OTCQX: ITHUF) in its acquisition of CBD For Life, a top-ranked producer of innovative CBD-infused wellness, self-care, and beauty products.
- Advised publically traded company related to banking covenants and offering of CBD products.
- Conducted a twelve state analysis of federal and state regulatory framework pertaining to the distributing, marketing, and selling of hemp and hemp-derived CBD, including CA, VA, MD, NC, PA, OH, KY, IN, WV, OR, WA and NY.
- Reviewed advertising and promotional material for multiple companies offering CBD products to assure compliance with federal law (FDA and FTC).
- Represent a vertically-integrated operator with licenses in MA, MD, and NH in various aspects of its business, including general corporate, capital raising, and intellectual property.
- Advised a client in the tobacco industry on labeling of CBD products to comply with federal and state law.
- Conducting a 50-state survey of drug and device law.
- Advise digital health companies on regulatory landscape concerning software, apps, and 3-D printing.
- Evaluate medical device classification issues and regulatory pathways, including 510(k) clearance and exemptions.
- 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.
- Reviewing claims made in advertising and promotional materials (e.g., cosmetic vs. drug claims).
- Advise generic pharmaceutical companies on issues such as the selection of reference listed drugs, section viii carve outs, labeling, and off-label use.
- Advise pharmaceutical clients on use of voicemails as source documents.
- Advise clients on warning letter and 483 Observation responses and repercussions.
- Advise on due diligence and audit reports with respect to compliance with requirements of company sale.
- Analyze patent landscapes in pharmaceutical and medical device industries.
- Represented firm client Wockhardt in New Jersey related to Janssen Biotech Inc.’s oncology medication Zytiga. The District Court found the Janssen patent invalid.
- 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.
- Bristol-Myers Squibb Co. et al. v. Prinston Pharmaceuticals Inc., et al., 17-CV-00426 (LPS) (D.Del.) Patent infringement action regarding Prinston's ANDA to make a generic version of BMS’s anticoagulant product Eliquis®, the active ingredient of which is apixaban.
- 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.
- In re Copaxone 40 mg Consolidated Cases, 14-CV-01171 (GMS) (D. Del.) Patent infringement action regarding Amneal's ANDA to make a generic version of Teva's MS product Copaxone®, the active ingredient of which is glatiramer acetate 40 mg.
- Inter Partes Review Nos. 2015-01976, -01980 and -01981. Representing Petitioner Amneal Pharmaceuticals LLC in IPR of U.S. Patent Nos. 8,232,250, 8,399,413 and 8,969,302, owned by Yeda Research and Development Co., Ltd., and listed in the FDA Orange Book for Teva's MS product Copaxone®, the active ingredient of which is glatiramer acetate 40 mg.
- Eli Lilly & Co. et al. v. Amneal Pharmaceuticals LLC, 14-CV-02025 (SEB)(DML) (S.D. Ind.) Patent infringement action regarding Amneal's ANDA to make a generic version of Lilly's testosterone replacement product Axiron®, the active ingredient of which is testosterone.
- Depomed, Inc. et al. v. Actavis Elizabeth et al., 2:13-CV-04507 (CCC) (D. NJ) Patent infringement action regarding Actavis’s ANDAs to make a generic version of Janssen’s opioid analgesic pain products Nucynta® and Nucynta® ER, the active ingredient of which is tapentadol hydrochloride. Won judgment of non-infringement of Depomed's last-to-expire patent. Case now on appeal to the Federal Circuit.
- Commonwealth Laboratories v. Genova Diagnostics (S.D. Fla. 2014) Patent litigation concerning diagnostic test for intestinal bacterial overgrowth. After filed motion to dismiss and indicated our intent to seek attorneys fees, the plaintiff dismissed its case with prejudice.
- Pfizer Inc., et al. v. Wockhardt, Ltd., et al., 12-CV-817 (SLR) (Consolidated) (D. Del.) Patent infringement action regarding Wockhardt's ANDA to make a generic version of Pfizer's antidepressant product Pristiq®, the active ingredient of which is desvenlafaxine succinate.
- Warner-Chilcott Co. LLC et al. v. Ranbaxy, Inc., et al., 12-CV-2474 (FSH) (Consolidated) (D. NJ) Patent infringement action regarding Ranbaxy’s ANDA to make a generic version of Warner-Chilcott’s osteoporosis product Atelvia®, the active ingredient of which is risedronate sodium.
- Stillman v. Novartis Consumer Health Inc. - Represented defendants CVS Pharmacy Inc. and Walgreen Company in a patent infringement suit related to a generic product.
- 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.
- Obtained a $65 million plus settlement on behalf of Tekmira Pharmaceuticals Corp. Tekmira had sued Alnylam Pharmaceuticals Inc. and AlCana Technologies, Inc. in the Business Litigation Session of the Massachusetts Superior Court alleging that Alnylam and AlCana misappropriated Tekmira's trade secrets related to gene-silencing therapeutics. In addition to the payments, the settlement also assigns control to Tekmira over its leading systemic RNAi Therapeutics delivery technology, and brings clarity around the ownership of the intellectual property that protects its lipid nanoparticle (LNP) technology.
- Abbott Laboratories v. Sandoz Inc., 10-538 (D.Del. - S. Robinson). Representing Sandoz in litigation regarding NIASPAN®, the active ingredient of which is niacin.
- King Pharmaceuticals, Inc., et al. v. Actavis Inc., et al., Case No. 07-CV-05041 (GEB) (MCA) (D.N.J.). Patent infringement action regarding Actavis' ANDA to make a generic version of King's pain product Avinza®, the active ingredient of which is morphine sulfate.
- Pfizer Inc., et al. v. Mylan Pharmaceuticals, Inc., Case No. 10-CV-00085 (JJF) (D.Del.). Patent infringement action regarding Mylan's ANDA to make a generic version of Pfizer's cardiovascular product Caduet®, the active ingredients of which are atorvastatin calcium and amlodipine besylate.
- Wyeth v. Apotex Inc. and Apotex Corp., No. 08-022308 (S.D. Fla.) Patent infringement action regarding Apotex's ANDA to make a generic version of Wyeth's antidepressant product EFFEXOR XR® (venlafaxine hydrochloride).
- Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, that resolved Hatch-Waxman litigation initiated by Sepracor Inc. seeking to bar Wockhardt from offering a generic version of the blockbuster insomnia medicine Lunesta®. Sepracor agreed to allow Wockhardt entry into the market before the expiration of its Lunesta patents.
Representative Regulatory Matters
Representative Litigation Matters
- New York
- 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 First Circuit
- U.S. Court of Appeals for the Federal Circuit
- Franklin Pierce Law Center, LL.M., Intellectual Property, cum laude, 2009
- Franklin Pierce Law Center, J.D., cum laude, 2009
- IDEA: The Intellectual Property Law Review, Managing Editor and Articles Editor
- Auburn University, B.C.H.E., summa cum laude, 2006
- Duane Morris LLP
- Associate, 2010-present
- Auburn University Office of Technology Transfer
- Legal Intern, 2006-2010
Honors and Awards
- Recipient, Margery Reed Professional Excellence Award, Duane Morris Women's Impact Network for Success, October 2015
Women's Bar Association
- Board of Directors
- Women's Leadership Initiative Class of 2017-2018
Food and Drug Law Institute
- Publications Peer Review Committee (2018)
- Drugs and Biologics Committee (2014-2017)
- Boston Patent Law Association
- Greater Boston Chamber of Commerce Women's Leadership Program class of 2014-2015
Co-author, "FDA Releases Guidance on REMS Modifications and Revisions," Duane Morris Alert, August 9, 2019
Co-author, "FDA Comments on the Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds and Extends Comment Period," Duane Morris Alert, June 24, 2019
Co-author, "How Will FDA Bring Order to the Wild West of Cannabis Regulations?" Food and Drug Law Institute, June 10, 2019
Co-author, "FDA's Next Steps for Cannabis Products," Duane Morris Alert, April 4, 2019
Co-author, "The 2018 Farm Bill Preserves FDA Right to Regulate Cannabis Products," Duane Morris Alert, February 4, 2019
Co-author, "FDA Issues Final Guidance on Data Integrity and Compliance with CGMP," Duane Morris Alert, January 14, 2019
Co-author, "FDA Announces New UDI Compliance Deadlines via Another Guidance Document," Duane Morris Alert, December 27, 2018
Co-author, "FDA Provides Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals," Duane Morris Alert, November 27, 2018
Co-author, "Redraft of 510(k) Third Party Review Program," Duane Morris Alert, November 8, 2018
Co-author, "CDER's New MAPP on Risk-Based Site Selection Model for Routine Inspections," Duane Morris Alert, November 7, 2018
Co-author, "FDA Unveils New Quality in 510(k) 'Quik' Review Program Pilot," Duane Morris Alert, October 22, 2018
Co-author, "Case Study: Jazz Pharmaceuticals v. Anmeal Pharmaceuticals," FDLI Update, October/November 2018
Co-author, "FDA Publishes Draft Guidance Seeking Innovative Approaches for Nonprescription Drug Product Labeling and Additional Conditions for Use," Duane Morris Alert, August 8, 2018
Co-author, "FDA Publishes Draft Guidance for Field Alert Report Submission," Duane Morris Alert, August 7, 2018
Co-author, "Federal Circuit Confirms PTAB Decision Invalidating Certain Claims of Xyrem Patents," Duane Morris Alert, July 23, 2018
Co-author, "FDA Proposes to Amend Product Jurisdiction Regulations Without Any Significant Substantive Changes," Duane Morris Alert, June 12, 2018
Co-author, "Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA," Duane Morris Alert, November 21, 2017
- Co-author, "FDA Outlines Its Operation for Facility Evaluation," Duane Morris Alerts, September 14, 2017
- Co-author, "FDA's Draft Guidance for Industry on 180-Day Exclusivity," Duane Morris Alert, March 1, 2017
- Co-author, "Supreme Court Rules Exporting a Single Component of a Patented Invention Isn't Infringement Under 35 U.S.C. Section 271(f)(1)," Duane Morris Alert, February 23, 2017
- Co-author, "FDA Issues Final Hatch-Waxman Regulations," Duane Morris Alert, October 7, 2016
- Co-author, "FDA Issues Guidance on Self-Identification of Generic Drug Facilities," Duane Morris Alert, October 6, 2016
- Co-author, "FDA Issues Draft Guidance on Data Integrity and Compliance with CGMP," Duane Morris Alert, May 3, 2016
- Co-author, "FDA Publishes Draft Guidance on Abuse-Deterrence Testing of Generic Solid Oral Opioid Drug Products," Duane Morris Alert, April 22, 2016
- Co-author, "FDA Proposed Rule on Fixed-Combination and Co-Packaged Drugs," Duane Morris Alert, March 16, 2016
- Co-author, "FDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers," Duane Morris Alert, November 4, 2015
- Co-author, "Chapter 11, Generic Drugs: ANDAs, Section 505 (b)(2) Applications, Patents, and Exclusivities," Food and Drug Law and Regulation, 3rd Edition, March 2015
- Co-author, "FDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act," Duane Morris Alert, February 25, 2015
- Co-author, "FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate," Duane Morris Alert, February 24, 2015
- Co-author, "FDA Establishes the Office of Pharmaceutical Quality," Duane Morris Alert, February 23, 2015
- Co-author, "FDA's Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection," Duane Morris Alert, December 23, 2014
- Co-author, "FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act," Duane Morris Alert, November 17, 2014
- Co-author, "FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA," Duane Morris Alert, November 10, 2014
- Co-author, "FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings," Duane Morris Alert, August 11, 2014
- Co-author, "FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA," Duane Morris Alert, August 4, 2014
- Co-author, "FDA Issues Draft Guidance for Identification and Notification of Suspect Products," Duane Morris Alert, June 24, 2014
- Co-author, "Supreme Court Establishes "Totality of the Circumstances" Framework for Determining Whether Attorney's Fees Should Be Shifted in Patent Cases," Duane Morris Alert, May 6, 2014
- Co-author, "FDA Seeks Information for Implementation of Drug Supply Chain Security Act," Duane Morris Alert, April 11, 2014
- Co-author, "FDA's New Interpretation of the Five-Year NCE Exclusivity Provisions of Federal Food, Drug, and Cosmetic Act," Duane Morris Alert, February 26, 2014
- Co-author, "FDA's Guidance for Industry Concerning Receipt Dates," Duane Morris Alert, February 14, 2014
- Co-author, "Chapter 8: Krelec et al. v. Mutual Pharmaceuticals Co., Inc.," Top 20 Food and Drug Cases, 2013 & Cases to Watch 2014, January 2014
- Co-author, "FDA Issues Guidance for Industry on Generic Drug User Fee Amendments of 2012: Q&A," Duane Morris Alert, August 29, 2012; republished with edits by GenericsWeb INNsight, September 2012
- Co-author, "FDA's Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013," Duane Morris Alert, August 8, 2012
- Co-author, "FDA's Guidelines for Petitions Filed Under Section 505(q) of Food, Drug, and Cosmetic Act," Duane Morris Alert, June 16, 2011
Selected Speaking Engagements
Speaker, "Introduction to Drug, Biologics and Biosimilars Law and Regulation," FDLI's Introduction to Drug, Biologics and Biosimilars Law and Regulation, Boston, July 24, 2019
Moderator, "Finding Regulatory Zen for Cannabis and Hemp Products After the 2018 Farm Bill," Food and Drug Law Institute, July 23, 2019
Presenter, "Cannabis 201: CBD and Hemp Regulatory Update," Duane Morris Cannabis Webinar Series, May 7, 2019
Speaker, “Your Ideas Are Your Greatest Asset – How to Protect and License Them,” MassChallenge Boston, July 25, 2018
Panelist, “Center for Devices and Radiological Health: What’s Ahead for 2018 and Beyond,” July 17, 2018
- Speaker, "Violations and Enforcement," FDLI Introduction to U.S. Drug Law and Regulation, Boston, June 15, 2017
- Speaker, "Interpretation of the FDA Data Integrity Draft Guidance & Preparing for Compliance," Pharmaceutical Manufacturing Execution Systems Conference, October 4, 2016
Panelist, "All Associates" Event, WBA's Women in the Courtroom Committee, October 2015