Alex Alfano practices primarily in the firm’s patent litigation and Food and Drug Administration (“FDA”) groups. His patent litigation practice focuses on biotechnology, pharmaceuticals, medical devices, diagnostics, and the life sciences. His experience includes pre-litigation client counseling, inter partes proceedings, and cases brought under the Hatch-Waxman Act.
Alex also provides counseling services related to FDA matters, such as citizen petitions, REMS, biosimilars, user fee statutes, 505(b)(2) applications, marketing exclusivity, Orange Book issues, labeling, bioequivalence, patent notice letters, and approvals of drugs, biological products, HCT/Ps, and medical devices.
He received his law degree from Fordham University School of Law, where he worked in the Samuelson-Glushko Intellectual Property and Information Law Clinic and was recognized for his commitment to public service. While in law school, Alex interned at the Federal Trade Commission. Alex graduated from Quinnipiac University in 2012 with a degree in Biology.
Professional Activities
- Food and Drug Law Institute, New to Food and Drug Law Planning Committee (2020)
- 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)
- 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: 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