Alex Alfano is an associate in the firm’s Patent Litigation and FDA groups. His patent litigation practice covers a broad range of technologies, including pharmaceuticals, medical devices, and wireless communications. His experience includes representing companies before the ITC, in inter partes reviews, and under the Hatch-Waxman Act.
Alex also counsels pharmaceutical, biologic, medical device, digital health, and consumer product companies on FDA regulatory issues, including marketing exclusivity, patent notice letters, section viii carve-outs, advertising, promotion, labeling review, interactions with FDA, and citizens petitions.
Professional Activities
- Food and Drug Law Institute, New to Food and Drug Law Planning Committee (2020-2021)
- New York State Bar Association
- American Bar Association, Section of Intellectual Property Law
Experience
- Represented generic pharmaceutical company in Hatch-Waxman patent infringement action at the District of Delaware involving a boronic acid proteasome inhibitor.
- Represented generic pharmaceutical company in Hatch-Waxman patent infringement action at the District of Delaware involving a hematopoietic stem cell mobilizer.
- Represented generic pharmaceutical company in Hatch-Waxman patent infringement action at the District of Delaware involving hydrocodone extended release capsules.
- Represented generic pharmaceutical company before the Patent Trial and Appeal Board in an inter partes review.
- Counseled medical device startup seeking guidance on FDA regulatory issues.
- Counsel to generic pharmaceutical companies seeking guidance on ANDA submissions.
- Represented biotechnology company in arbitration involving a supply agreement dispute.
- Represented pro bono client seeking damages for copyright infringement.
- Represented pro bono client seeking increase in child support payments.
Honors
- Best Lawyers “Ones to Watch” (2021, 2022)
- Super Lawyers (2021)
- Fordham University School of Law
- Archibald R. Murray Public Service Award, cum laude
Thought Leadership
- The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021, Contract Pharma, January 5, 2021
- Axinn FDA Update: A Difficult Analysis Is Not Necessarily a Deferential Analysis, Axinn Update, September 21, 2020
- FDA Informal Guidance Process, Lexis Practice Advisor, July 30, 2020
- Balancing Settlements, Motions After Fed. Circ. Serta IP Ruling, Law360, March 16, 2020
- Chevron’s Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference, FDLI, February 21, 2020
- Axinn IP Update: Settlement Practice in Light of Pending Motions, Axinn Update, February 20, 2020
- FDA Administrative Decision Challenges, Lexis Practice Advisor, January 30, 2020
- Open the Floodgates: The Potential Impact on Litigation Against FDA if the Supreme Court Reverses or Curtails Chevron Deference, FDLI, December 18, 2019
- Axinn IP Update: PTAB Abused its Discretion in Denying Patentee Leave to Correct Chain of Priority, Axinn Update, October 4, 2019
- Recent FDA Court Decision Shows Potential Impact of SCOTUS Deference Decision, Bloomberg Law and Bloomberg Big Law Business, August 20, 2019
- What High Court's Kisor Ruling Means for FDA Decisions, Law360, July 16, 2019
- Axinn IP Update: Federal Circuit Affirms No Public Use Via Implied Confidentiality, Axinn Update, January 30, 2019
- Axinn IP Update: U.S. Supreme Court Ruling Leaves On-Sale Bar Unchanged, Axinn Update, January 23, 2019
Events
- FDLI’s Careers Over Coffee
- FDLI: Introduction to Drug Law and Regulation
- Celesq® CLE Program: FDA in the Year of COVID – How FDA Tackled the Pandemic and What to Expect from FDA in 2021
- The Potential Impact of the New Supreme Court Justice on FDA and FDA-Regulated Industry
- The Potential Impact of the New Supreme Court Justice on FDA
Education
- JD – Fordham University School of Law (2015)
- BS, Biology – Quinnipiac University (2012)
Admissions
- New York
- Connecticut
- US District Court District of Connecticut
- US Patent and Trademark Office