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.

  • B.S., Medical College of Pennsylvania - Hahnemann University
  • B.S., Molecular and Cell Biology, Medical College of Pennsylvania - Hahnemann University
  • B.S., Biology, Medical College of Pennsylvania - Hahnemann University

  • District of Columbia
  • United States Patent & Trademark Office

  • Spanish
  • Italian

Speaking Engagement

Navigating the Unique Challenges of Patenting and Protecting Personalized Medicine

Munich, Germany, smartvillage Bogenhausen, September 28, 2023

Speaking Engagement

2023 Focus on Pharma

Washington, DC, April 14, 2023 8:30 AM - 6:00 PM EST

Webinar

Patent Term Extensions for Pharma Products in Europe and the USA

Virtual, March 15, 2023 11:00 AM - 12:00 PM EST

Speaking Engagement

Patenting Antibodies in the Current Climate: Global Considerations and Strategies

Virtual, October 7, 2021 11:15 AM - 12:00 PM EST

Speaking Engagement

Intellectual Property as a Tool to Protect Innovation

Virtual, October 28, 2020 12:00 PM - 1:30 PM EST

Speaking Engagement

IP Forum for Life Sciences

Newport Beach, CA, Fashion Island Hotel, December 8, 2019 1:00 PM - 11:30 AM EST

Speaking Engagement

Biosimilars Commercialisation Summit

Amsterdam, Netherlands, Hotel Novotel Amsterdam Schiphol Airport, May 14, 2019

Biosimilars World 2016

March 30, 2016

Biosimilars 2015

May 19, 2015

BioProduction 2011

October 19, 2011

EU Biopharm Law Conference

October 11, 2011

Related News & Insights

From Paul A. Calvo, Ph.D.

In the News

March 14, 2024

How Firms Jostle for Talent in ‘Competitive’ Life Sciences Market

Managing IP

In the News

March 31, 2022

EU Unified Patent Court Spurs Delight and Fear for Experts

Law360

Bylined Articles

November 25, 2020

The USPTO's First Action Interview Pilot Program

Sterne, Kessler, Goldstein & Fox P.L.L.C. Paul A. Calvo, Ph.D.

Bylined Articles

November 25, 2020

After Final Consideration Pilot Program 2.0 – Still Going Strong

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Bylined Articles

October 16, 2020

Protecting Innovation in Asia

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

October 16, 2020

Patent Prosecution Highway: The JPO and USPTO

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Client Alert

July 7, 2020

IP Hot Topic: Patent Prosecution Tool Kit

Carla Ji-Eun Kim

Reports

July 7, 2020

Patent Prosecution Tool Kit

Sterne, Kessler, Goldstein & Fox Multiple Authors

Bylined Articles

July 7, 2020

Implications of the BPCIA on the IP Strategies of Brand Companies and Biosimilar Developers

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Bylined Articles

May 26, 2020

WIPO's COVID-19 IP Policy Tracker

Sterne, Kessler, Goldstein & Fox P.L.L.C. Paul A. Calvo, Ph.D.

Client Alert

May 20, 2020

IP Hot Topic: The USPTO's COVID-19 Prioritized Examination Pilot Program

Paul A. Calvo, Ph.D.

Bylined Articles

May 1, 2020

INSIGHT: The Scope of a Sextillion—How Courts Misapply Law of Enablement to Life Sciences

Bloomberg Law Paul A. Calvo, Ph.D., Kristina Caggiano Kelly

Bylined Articles

April 23, 2020

Patenting Personalized Nutrition Is Challenging But Feasible

Law360 Eldora L. Ellison, Ph.D., Paul A. Calvo, Ph.D.

Bylined Articles

November 15, 2019

Patent Law Amendments in Singapore - Closure of Reliance on the Foreign Examination Option

Sterne, Kessler, Goldstein & Fox P.L.L.C Paul A. Calvo, Ph.D.

Bylined Articles

November 15, 2019

New Patent System in Hong Kong - Original Grant Patent Route

Sterne, Kessler, Goldstein & Fox P.L.L.C Paul A. Calvo, Ph.D.

Bylined Articles

September 25, 2019

Submission of Post-Filing Data – The Dichotomy between Enablement and Obviousness in the United States, China, and Japan

Sterne, Kessler, Goldstein & Fox P.L.L.C Paul A. Calvo, Ph.D.

Bylined Articles

September 25, 2019

Post-Filing Experimental Data at the European Patent Office

Sterne, Kessler, Goldstein & Fox P.L.L.C Paul A. Calvo, Ph.D.

Bylined Articles

May 8, 2019

Strategic Use of the Patent Prosecution Highway

Sterne, Kessler, Goldstein & Fox P.L.L.C Paul A. Calvo, Ph.D.

Bylined Articles

October 10, 2018

The State of Patentable Subject Matter Internationally

Paul A. Calvo, Ph.D., Adil B. Moghal, Ph.D.

Bylined Articles

September 12, 2018

Third Party Submissions in the U.S.: What You Need to Know

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D., Lori M. Brandes, Ph.D.

Bylined Articles

September 12, 2018

Third Party Observations in Europe, China, Japan, and for the PCT - To File or Not to File?

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D., Lori M. Brandes, Ph.D.

Bylined Articles

April 11, 2018

Patents and Patentability in Taiwan

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

April 11, 2018

Hatch-Waxman goes to Taiwan

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

January 10, 2018

Obviousness-Type Double Patenting Dangers in the U.S.

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

January 10, 2018

Worldwide Divisional Strategy Considerations

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

December 18, 2017

Bolar Exemptions in North America

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

December 18, 2017

Bolar Exemption in Europe and Asia

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

December 18, 2017

Worldwide Bolar-type Provisions*

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

November 13, 2017

Proposed Emergency Patent Grant Measures in Brazil

Sterne, Kessler, Goldstein & Fox

Bylined Articles

November 13, 2017

Enforcing Patents in Brazil: An Injunction Paradise?

Sterne, Kessler, Goldstein & Fox

Bylined Articles

October 16, 2017

March-in Rights and Compulsory License in the United States

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

October 16, 2017

Compulsory Licensing of Biopharmaceutical Inventions

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Presentations

September 15, 2017

Focus on Pharma Conference 2017 PowerPoint Presentations

Bylined Articles

September 15, 2017

A Seismic Shift in UK Patent Infringement Law - Actavis v. Eli Lilly

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

September 15, 2017

Doctrine of Equivalents and Prosecution History Estoppel Around the World

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D., Lori M. Brandes, Ph.D.

Bylined Articles

August 25, 2017

Strategy Considerations for Biosimilar Applicants after Sandoz v. Amgen

Bloomberg BNA Multiple Authors

Bylined Articles

August 15, 2017

Global Patent Term Extension/Supplementary Protection Certificate Provisions

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

July 17, 2017

You Can Dance If You Want To

Sterne, Kessler, Goldstein & Fox Multiple Authors

Bylined Articles

July 17, 2017

Biosimilars in Europe

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

July 17, 2017

Biosimilar Uptake and Patent Litigation in Japan

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Publication

July 17, 2017

Approved Biosimilar Products Around the World

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Reports

June 28, 2017

Patent Prosecution Tool Kit

Multiple Authors

In the News

June 21, 2017

Supreme Court won’t force fast-track litigation over biologic drug patents

Westlaw Journal Intellectual Property

Bylined Articles

June 15, 2017

A Comparison of US and EPO Post Grant Practices

Sterne, Kessler, Goldstein & Fox Olga A. Partington, Ph.D., Paul A. Calvo, Ph.D.

Client Alert

June 12, 2017

The Patent Dance is Optional

Multiple Authors

Bylined Articles

May 15, 2017

Worldwide Public Disclosure Grace Periods - May 2017

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

May 15, 2017

Grace Periods Around the World

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

April 17, 2017

The 实质性内容 (Nuts and Bolts) of Application Formalities in China

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

April 17, 2017

An Update on Patent Enforcement in China

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Bylined Articles

March 16, 2017

Putting the Pedal to the Medal at the EPO

Sterne, Kessler, Goldstein & Fox Paul A. Calvo, Ph.D.

Books and Chapters

February 17, 2017

Patent Office Litigation - Second Edition 2017

Thomson Reuters Westlaw Multiple Authors

Client Alert

July 8, 2016

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

In the News

May 4, 2016

Fed. Circ. Could Ease On-Sale Bar Threat To Pharma Patents

Law360

In the News

February 17, 2016

Sandoz Seeks High Court Take On Biosimilar Law

Law360

Bylined Articles

January 13, 2016

Choosing Between Patent And Trade Secret Protection In A Biosimilar World

Biosimilar Development Paul A. Calvo, Ph.D.

Client Alert

December 31, 2015

FDA Finalizes Guidance For Formal Meetings Between the FDA and Biosimilars Applicants

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

December 11, 2015

Court Rules that Apotex Must Give Amgen Notice Upon Biosimilar Licensure

Paul A. Calvo, Ph.D.

In the News

November 18, 2015

Full Fed. Circ. May Blunt On-Sale Bar's Risk to Small Cos.

Law360

In the News

October 16, 2015

4 Questions After Amgen-Sandoz Rehearing Bids Fizzle Out

Law360

Bylined Articles

September 29, 2015

Biosimilars in the United States – where do things stand

European Biotechnology Magazine Paul A. Calvo, Ph.D.

Bylined Articles

August 21, 2015

The 1st IPR Institution Decisions For Biosimilars

Law360 Eldora L. Ellison, Ph.D., Paul A. Calvo, Ph.D.

Client Alert

August 17, 2015

Amgen v. Apotex – what is the outcome when biosimilar applicants actually dance?

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

In the News

July 23, 2015

Federal Circuit Says Biosimilar Applicants Can Decline Patent Dance

Managing IP

Bylined Articles

July 21, 2015

Amgen, Sandoz Both Winners and Losers At Federal Circuit

Law360 Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

June 4, 2015

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 22, 2015

FDA releases additional draft guidance regarding implementation of BPCIA

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 7, 2015

Federal Circuit Grants Injunction Keeping Sandoz’s Biosimilar Version of Neupogen Off Market Until Appeal Decided

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

May 1, 2015

FDA Finalizes Guidance Documents on Biosimilarity

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Client Alert

April 17, 2015

BIO Files Brief in Support of Mandatory Notice Requirement in the BPCIA

Paul A. Calvo, Ph.D.

Client Alert

March 27, 2015

Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants

Paul A. Calvo, Ph.D.

Bylined Articles

March 24, 2015

On the Attack

European Biopharmaceutical Review Paul A. Calvo, Ph.D., Olga A. Partington, Ph.D.

Client Alert

March 23, 2015

One More Hurdle Cleared - Amgen's Preliminary Injunction Motion for Filgrastim is Denied

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Bylined Articles

March 19, 2015

Post-Grant Proceedings Are Important For Biosimilars

Law360 Paul A. Calvo, Ph.D., Eldora L. Ellison, Ph.D.

Bylined Articles

January 29, 2015

Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

IP Litigator Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

In the News

January 12, 2015

Spotlight On: Amgen's Biosimilar Identity Remains Conflicted

FirstWord Pharma

Client Alert

December 10, 2014

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

Bylined Articles

December 1, 2014

Patent Prosecution in the Era of IPR

European Biotechnology News Paul A. Calvo, Ph.D., Olga A. Partington, Ph.D.

Bylined Articles

October 30, 2014

US Biosimilar Biologics – The Ship has Sailed

European Biotechnology News Paul A. Calvo, Ph.D., Timothy “Tim” J. Shea, Jr.

In the News

September 8, 2014

Biosimilars Get Their Day in Court

The National Law Journal

Client Alert

July 24, 2014

FDA Accepts the First Biosimilar Application under the BPCIA

Paul A. Calvo, Ph.D.

In the News

July 24, 2014

Biosimilars Clarity Coming as FDA Eyes Sandoz Application

Law360

Bylined Articles

July 2, 2014

The Secret of Success

European Biopharmaceutical Review Paul A. Calvo, Ph.D.

Client Alert

May 14, 2014

FDA Releases New Guidance for Biosimilar Applications

Timothy “Tim” J. Shea, Jr., Paul A. Calvo, Ph.D.

In the News

May 13, 2014

FDA Sheds New Light on Biosimilars Approval Pathway

Law360

Bylined Articles

February 28, 2014

Inter Partes Review - One Year Later

European Biotechnology News Paul A. Calvo, Ph.D.

Books and Chapters

January 1, 2012

Patent Office Litigation

Thomson Reuters Westlaw Multiple Authors