In addition to managing a robust practice working with clients in the biotechnology and pharmaceuticals industries, Paul is the co-editor of the firm’s “Global Patent Prosecution” newsletter.

Paul A. Calvo, Ph.D.

Director

pcalvo@sternekessler.com
+1 202.772.8846
LinkedIn

Overview

Paul A. Calvo, Ph.D., is a director in Sterne Kessler’s Biotechnology & Chemical Practice Group. Paul represents a diverse group of U.S. and international companies innovating in the biotechnology and pharmaceuticals industries. He provides counsel with regard to global patent portfolio strategy, licensing, patent validity, infringement, and design around strategies. Paul is experienced in U.S. and international patent procurement and enforcement matters (particularly patent prosecution and oppositions), FDA/ANDA practice, technology transfer, invalidity, noninfringement, freedom-to-operate and patentability opinions, and due diligence investigations.

Additionally, Paul has extensive expertise in prosecuting and investigating patents related to bioproduction methods and therapeutic formulations. He is a recognized leader in understanding the significance and challenges of bioprocessing patents from both an originator and biosimilar perspective. He has authored articles and presented on these topics in both the U.S. and internationally.

Paul is a contributing author of Patent Office Litigation, Second Edition, published in 2017, and the two-volume set Patent Office Litigation, published in 2012 by Thomson Reuters Westlaw. The first edition focused on the new contested proceedings under the America Invents Act that year, while the second edition provides a fresh and comprehensive exploration of these proceedings. Both books examine how the proceedings interact with other aspects of patent procurement and enforcement, and deliver practical analysis and advice.

Prior to joining Sterne Kessler, Paul gained extensive technical expertise in the areas of therapeutic antibodies, biotherapeutics, vaccines, cellular immunology, and cell and molecular biology during his graduate studies and post-doctoral fellowships at The University of Pennsylvania and National Institutes of Health.

Paul earned his B.S. in biology from the University of Scranton, his Ph.D. in molecular and cell biology from the Medical College of Pennsylvania – Hahnemann University, and his J.D. from The Catholic University of America Columbus School of Law.

Paul is fluent in Italian.

Education

  • J.D., The Catholic University of America Columbus School of Law
  • Ph.D., Molecular and Cell Biology, Medical College of Pennsylvania - Hahnemann University
  • B.S., Biology, University of Scranton

Admissions

  • District of Columbia
  • United States Patent & Trademark Office

Languages Spoken

  • Spanish
  • Italian

Events

Speaking Engagement Navigating the Unique Challenges of Patenting and Protecting Personalized Medicine Munich, Germany, September 28, 2023
Speaking Engagement 2023 Focus on Pharma Washington, DC, April 14, 2023
Speaking Engagement Intellectual Property as a Tool to Protect Innovation Virtual, October 28, 2020
Speaking Engagement IP Forum for Life Sciences Newport Beach, CA, December 8, 2019
Speaking Engagement Biosimilars Commercialisation Summit Amsterdam, Netherlands, May 14, 2019
Biosimilars World 2016 March 30, 2016
Biosimilars 2015 May 19, 2015
2015 IIPLA Annual Congress January 5, 2015
BioProduction 2011 October 19, 2011
EU Biopharm Law Conference October 11, 2011

Related Resources From Paul A. Calvo, Ph.D.

In the News Supreme Court won’t force fast-track litigation over biologic drug patents Westlaw Journal Intellectual Property June 21, 2017
In the News Sandoz Seeks High Court Take On Biosimilar Law Law360 February 17, 2016
In the News Full Fed. Circ. May Blunt On-Sale Bar's Risk to Small Cos. Law360 November 18, 2015
In the News 4 Questions After Amgen-Sandoz Rehearing Bids Fizzle Out Law360 October 16, 2015
In the News Spotlight On: Amgen's Biosimilar Identity Remains Conflicted FirstWord Pharma January 12, 2015
In the News Biosimilars Get Their Day in Court The National Law Journal September 8, 2014
In the News FDA Sheds New Light on Biosimilars Approval Pathway Law360 May 13, 2014