Alexander Alfano is an associate in Axinn’s Hartford office and practices primarily in the firm’s intellectual property, patent litigation and Food and Drug Administration (“FDA”) groups.
Alex’s litigation practice focuses on U.S. district court patent litigation and appeals, with a particular emphasis in the fields of biotechnology, pharmaceuticals, medical devices, diagnostics and the life sciences. His experience includes handling pre-litigation client counseling. Additionally, Alex also has experience with Hatch-Waxman and other complex litigation.
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, medical devices and tobacco products.
He received his law degree from Fordham University School of Law, where he worked in the Samuelson-Glushko Intellectual Property and Information Law Clinic. 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
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
Fordham University School of Law
- Archibald R. Murray Public Service Award, cum laude
Thought Leadership
- 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
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