Alex Alfano

Alex Alfano is a patent trial lawyer and associate in Sterne Kessler’s Trial & Appellate Practice Group, focusing on patent litigation and counseling for pharmaceutical, biotechnology, and medical device companies involved in high-stakes disputes. His practice centers on Hatch-Waxman and Abbreviated New Drug Application (ANDA) Paragraph IV patent infringement suits representing both brand and generic drug manufacturers in district courts. Alex was ranked among Patexia’s Top 10 most active ANDA litigation attorneys representing plaintiffs in the United States in 2025. He has also represented clients before the U.S. International Trade Commission (ITC) in Section 337 investigations and at the Patent Trial and Appeal Board (PTAB) in inter partes review and post-grant review proceedings.

In addition, Alex counsels clients on FDA regulatory issues at the intersection of litigation and patent strategy, including marketing exclusivity, drug labeling and skinny-label carve-outs, Orange Book patent listing, ANDA certifications, and notice requirements relevant to drug approval. He has advocated for clients before the FDA through citizen petitions and agency correspondence.

With a degree in biology and biological sciences, Alex brings a scientific grounding to the technical and legal questions at the heart of pharmaceutical, biotech, and medical device patent litigation. Based in Connecticut, he is active in the region’s intellectual property and life sciences communities, serving on the Judge Janet Bond Arterton Intellectual Property American Inn of Court, participating in the Connecticut Bar Association’s Intellectual Property Section, and engaging with BioCT and Connecticut’s life sciences ecosystem. Alex has been recognized by Best Lawyers: Ones to Watch and Super Lawyers Rising Stars.

Beyond patent litigation, Alex has experience in antitrust and complex commercial litigation, including securing dismissal of class action conspiracy claims and assisting companies with government investigations by the Department of Justice and Federal Trade Commission involving a range of allegations.

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)