Mind + Muscle

technical minds + legal muscle

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

Mind + Muscle

Paul A. Calvo, Ph.D.

Director

 

Dr. Calvo, a director in the Biotechnology/Chemical Group, 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.  Dr. Calvo 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, Dr. Calvo 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. 

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

Dr. Calvo 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.  

Dr. Calvo is fluent in Italian.

Publications
  • "Global Patent Prosecution Newsletter -- April 2017," Paul A. Calvo, Ph.D., Amy H. Bray, Ph.D. and Erin J. Heenan, Ph.D., Sterne, Kessler, Goldstein & Fox
  • "Global Patent Prosecution Newsletter -- March 2017," Paul A. Calvo, Ph.D., Lori M. Brandes, Ph.D. and Stephanie L. Elmer, Ph.D., Sterne, Kessler Goldstein & Fox, March 2017
  • "Federal Circuit Backs Amgen on Key Provisions on Biosimilars Statute," Tim Shea and Paul Calvo, Sterne, Kessler, Goldstein & Fox, July 2016
  • "Choosing Between Patents And Trade Secret Protection In A Biosimilar World," Paul A. Calvo, Biosimilar Development, January 2016
  • "Court Rules that Apotex Must Give Amgen Notice Upon Biosimilar Licensure," Paul A. Calvo, Ph.D., Sterne, Kessler, Goldstein & Fox, December 2015
  • "FDA Finalizes Guidance For Formal Meetings Between the FDA and Biosimilars Applicants," Paul A. Calvo, Ph.D. and Timothy J. Shea Jr., Sterne, Kessler, Goldstein & Fox, December 2015
  • "4 Questions After Amgen-Sandoz Rehearing Bids Fizzle Out," Paul A. Calvo, Ph.D., Law360, October 2015
  • "Biosimilars in the United States -- where do things stand," Paul A. Calvo, Ph.D., European Biotechnology Magazine, September 2015
  • "The 1st IPR Institution Decisions For Biosimilars," Paul A. Calvo, Ph.D. and Eldora L. Ellision, Ph.D., Law360, August 2015
  • "Amgen v. Apotex -- what is the outcome when biosimilar applicants actually dance?" Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr., Sterne Kessler Client Alerts
  • "Federal Circuit Says Biosimilars Applicants Can Decline Patent Dance," Paul A. Calvo, Ph.D., Managing IP, July 2015
  • "Amgen, Sandoz Both Winners and Losers at Federal Circuit," Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr., Law360, July 2015
  • "The Medicines Company v. Hospira -- Preparation of validation batches by a contract manufacturer for FDA submission creates an on-sale bar," Paul A. Calvo, Ph.D. and H. Keeto Sabharwal, Sterne Kessler Alerts, July 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. and Timothy J. Shea, Jr., Sterne, Kessler, Goldstein & Fox, June 2015
  • "FDA releases additional draft guidance regarding implementation of BPCIA," Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr., Sterne, Kessler, Goldstein & Fox, May2015
  • "Federal Circuits Grants Injunction Keeping Sandoz's Biosimilar Version of Neupogen Off market Until Appeal Decided," Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr., Sterne, Kessler, Goldstein & Fox, May 2015
  • "FDA Finalizes Guidance Documents on Biosimilarity," Paul A. Calvo and Timothy J. Shea, Jr., Sterne, Kessler, Goldstein & Fox, May 2015
  • "BIO Files Brief in Support of Mandatory Notice Requirement in the BPCIA," Paul A. Calvo, Ph.D., Sterne Kessler, Goldstein & Fox, April 2015
  • "Strike Two -- FDA Rejects Amgen's Certification Petition for Biosimilar Applicants," Paul A. Calvo, Ph.D., Sterne Kessler, Goldstein & Fox, March 2015
  • "On the Attack," Olga A. Partington, Ph. D. and Paul A. Calvo, Ph.D., European Biopharmaceutical Review, March 2015
  • "One More Hurdle Cleared - Amgen's Preliminary Injunction Motion for Fligrastim is Denied," Paul A. Calvo and Timothy J. Shea, Jr., Sterne Kessler, March 2015
  • "Post-Grant Proceedings Are Important for Biosimilars," Paul A. Calvo and Eldora L. Ellison, Ph.D., IP Law360
  • "Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers," Timothy J. Shea, Jr. and Paul A. Calvo, IP Litigator, January 2015
  • "Patent Prosecution in the Era of IPR," Paul A. Calvo, Ph.D. and Olga A. Partington, Ph.D., European Biotechnology News, December 2014
  • "US Biosimilar Biologics -- The Ship has Sailed," Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr., European Biotechnology News, October 2014
  • "FDA Accepts the First Biosimilar Application under the BPCIA," Paul A. Calvo, Ph.D., Sterne Kessler, June 2014
  • "The Secret of Success," Paul A. Calvo, European Biopharmaceutical Review, June 2014
  • "FDA Releases New Guidelines for Biosimilar Applications," Timothy J. Shea and Paul A. Calvo, Ph.D., Sterne Kessler, May 2014
  • "USPTO Issues New Subject Matter Eligibility Examination Guidelines for Claims Involving Laws of Nature, Natural Principles, Natural Phenomena, and/or Natural Products," Judith U. Kim, Paul A. Calvo, Miklos Gaszner, Ph.D., Sterne Kessler, March 2014
  • "Inter Partes Review - One Year Later," Paul A. Calvo and Miklos Gaszner, Ph.D., European Biotechnology News, February 2014
  • "Biosimilar biologics: is the US being left behind?" Paul A. Calvo, World Intellectual Property Review, November 2013
  • "Expansion of the Prior-User Rights Defense - Its Implications for Bioproduction Methods," Paul A. Calvo, Bioprocess International, May 2012
  • "FDA Releases Quality Considerations Guideline for Biosimilars Production," Paul A. Calvo, Pharmaceutical Compliance Monitor, February 2012
  • "FDA Releases Long-Awaited Draft Guidelines on Biosimilars," Paul A. Calvo, Sterne Kessler, February 2012
  • Admissions
      • District of Columbia

      • United States Patent and Trademark Office

  • Education
    • J.D., The Catholic University of America
      Ph.D., Molecular and Cell Biology, Medical College of Pennsylvania – Hahnemann University

    • B.S., Biology, University of Scranton

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