Alex Alfano

Alex Alfano is an associate in Sterne Kessler’s Trial and Appellate Practice Group. His practice focuses on patent litigation and counseling, particularly in pharmaceuticals, medical devices, and biotechnology. Alex regularly litigates Hatch-Waxman Paragraph IV patent infringement suits and also has experience representing clients before the U.S. International Trade Commission and the Patent Trial and Appeal Board.

Alex also has experience advising clients on FDA regulations, including marketing exclusivity, labeling, patent listing, certification, notification requirements, and other issues relevant to drug approval. In addition, Alex has advocated on behalf of clients before FDA through citizen petitions and correspondences.

Publications

• The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021, Contract Pharma, January 5, 2021 (co-author)
• FDA Informal Guidance Process, Lexis Practice Advisor, July 30, 2020 (co-author)
• Balancing Settlements, Motions After Fed. Circ. Serta IP Ruling, Law360, March 16, 2020 (co-author)
• Chevron’s Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference, Food and Drug Law Institute, February 21, 2020 (co-author)
• FDA Administrative Decision Challenges, Lexis Practice Advisor, January 30, 2020 (co-author)
• Open the Floodgates: The Potential Impact on Litigation Against FDA if the Supreme Court Reverses or Curtails Chevron Deference, Food and Drug Law Institute, December 18, 2019 (co-author)
• Recent FDA Court Decision Shows Potential Impact of SCOTUS Deference Decision, Bloomberg Law and Bloomberg Big Law Business, August 20, 2019 (co-author)
• What High Court’s Kisor Ruling Means for FDA Decisions, Law360, July 16, 2019 (co-author)