John J. Molenda, Ph.D.

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Areas of Work

Patent, Appeals & Advocacy, Patent Litigation, Post-Grant Proceedings

Overview

John Molenda is a first-chair trial and appellate litigator who co-chairs Steptoe's Healthcare & Life Sciences practice and serves as head of the Intellectual Property practice for the New York office. He has also served on the firm's Executive Committee. John focuses on patent litigation before US district courts and the US Court of Appeals for the Federal Circuit, along with inter partes reviews (IPRs), opinions of counsel, and due diligence. He represents clients across a wide range of technologies, including small molecule pharmaceuticals (Hatch-Waxman), biotherapeutics (biologics), biochemical research tools, genetically modified plants, medical devices, computer software, semiconductors, fiber optics, and automotive parts. Chambers USA has ranked John for Intellectual Property (Patent) in New York since 2022, noting that "John is knowledgeable, thorough and most importantly, he is business-focused." IAM Patent 1000 has ranked John in the United States since 2015, similarly noting that he is "excellent in developing legal strategies, advocating in court and providing sound advice that meets his clients' business needs."

John has developed a particular expertise in high-stakes life sciences patent litigation and post-grant proceedings and has been recognized for his talents in handling those types of matters. He was named a 2021 Healthcare/Life Sciences Trailblazer by the National Law Journal and a 2019 Life Sciences MVP by Law360. IAM has likewise recognized John as an "extremely smart and meticulous" litigator who has created a "strong [brand] on both the small and large molecule sides."

With respect to small molecule pharmaceuticals, John has served as lead counsel in numerous high-value Hatch-Waxman litigations, including those involving treatments for chronic myeloid leukemia, mantle cell lymphoma, renal cell carcinoma, blood clotting disorders, opioid dependence, and dry eye disease. With respect to large molecule pharmaceuticals (biologics), John led Steptoe's team in litigating groundbreaking antibody therapies used to treat high cholesterol. He has also managed the legal strategy for a global biosimilars program involving a diverse portfolio of monoclonal antibodies and fusion proteins. At the same time, John routinely counsels clients on the strategic use of IPRs as part of litigation and settlement strategy, and he has served as lead counsel in numerous life sciences-related IPRs.

As a complement to his district court practice, John also maintains an active appellate practice. He regularly argues before the US Court of Appeals for the Federal Circuit and has held substantial roles in nearly 30 such appeals. John is active in the Federal Circuit community, currently serving as Chair of the Regional Programs Committee of the Federal Circuit Bar Association. Prior to private practice, he served as a Federal Circuit law clerk for the Honorable Alan D. Lourie.

Representative Publications

"Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'," Law360, June 4, 2024
"A Comprehensive Overview of PTAB Trends for Biologics," Law360, June 26, 2023
"Unpacking the Latest Trends in Biologics-Related IPRs," Law360, June 4, 2021
"Current Trends In Biologics-Related Inter Partes Reviews," IP Law360, July 20, 2017
"Retractable Technologies, Inc. v. Becton, Dickinson & Co.: The Federal Circuit's Debate over Claim Construction Methodology and Deference Rages on," NYIPLA Bull., October/November 2011
"Strategic Approaches to the Doctrine of Claim Differentiation: A Guide for Patentees and Accused Infringers," 12 IP Litig., no.1, January/February 2006
"Understanding the Federal Circuit’s Internal Debate and Its Decision to Rehear Phillips v. AWH Corp. En Banc," 86 J. Patent & Trademark Office Soc'y 911, 2004

New York
Supreme Court of the United States
US Court of Appeals, Federal Circuit
US Court of Appeals, Seventh Circuit
US District Court, Southern District of New York
US District Court, Eastern District of New York
US Patent & Trademark Office

Hon. Alan Lourie, US Court of Appeals, Federal Circuit, 1998-2000

J.D., University of Michigan Law School, 1998
Postdoctoral Research, New York University, 1995, Biochemistry
Ph.D., Vanderbilt University, 1994, Chemistry
M.S., Vanderbilt University, 1994, Chemistry
B.S., Vanderbilt University, 1991, cum laude, with Honors in the College of Arts & Science, Chemistry and History

Areas of Work

Speaking Engagements

Panelist, "Strategies for Managing Litigation Budgets More Effectively," ACI 21st Annual Paragraph IV Disputes, April 29-30, 2025
Program Co-Chair, "Fundamentals of Patent Litigation," PLI, New York, 2015-2025
Moderator, "The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes," ACI 19th Annual Paragraph IV Disputes, April 26, 2024
Moderator, "One Year After Amgen v. Sanofi: Its Impact on Biotech and Pharmaceutical Patents," FCBA Regional Program (Boston), April 5, 2024
Panelist, "Hedging Your Bets Ahead of Amgen v. Sanofi: Anticipating How the Supreme Court's Enablement Ruling Will Affect Biologic Patent Portfolio Strategies," ACI 14th Summit on Biosimilars & Innovator Biologics, June 27, 2023
Co-Moderator, "The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes," ACI 18th Annual Paragraph IV Disputes, April 20, 2023
Moderator, "Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum," ACI 13^th Summit on Biosimilars & Innovator Biologics, June 28, 2022
Co-Moderator, "The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes," ACI 17^th Annual Paragraph IV Disputes, April 27, 2022
Co-Moderator, "The PTAB Live! Practice, Policy, and Procedure in the New World of Pharmaceutical Patent Validity Challenges," ACI 16th Annual Paragraph IV Disputes, November 10, 2021
Moderator, "Current Trends in Written Description and Enablement," FCBA Major Regional Programs, September 22, 2021
Panelist, "Latest Trends in Biologics IPRs," ACI 12^th Summit on Biosimilars & Innovator Biologics, June 22, 2021
Panelist, "Patents, Prices, and Politics: Legislative, Administrative, and Geopolitical Developments Impacting the Pharmaceutical Industry," ACI 15th Annual Paragraph IV Disputes, April 26, 2021
Moderator, "Optimizing the Relationship Between In-House and Outside Counsel in Paragraph IV Litigation," ACI 14th Annual Paragraph IV Disputes, October 6, 2020
Moderator and Presenter, "PTAB Practice, Policy and Procedures," ACI 11th Summit on Biosimilars and Innovator Biologics, September 23, 2020
Moderator, "The In-House Perspective: Current Topics in Biosimilars Development," ACI 10th Summit on Biosimilars, June 24, 2019
Moderator, District Judge Panel, "Reviewed Adjudicators," FCBA Annual Bench & Bar Conference, June 14, 2019
Moderator, In-House Pharma Attorney Panel, "Competency: Overcoming Talent Limitations with Time-Proven Tips," ACI 13th Annual Paragraph IV Disputes Conference, New York, NY, April 29, 2019
Panelist, "Biosimilars Litigation and Its Impact on Market Access and Commercialization," ExL Events 2nd Biosimilar Market Access and Commercialization Strategies Summit, September 17, 2018
Panelist, "Update on Hot-Button Litigation Issues and the Impact on the Biologics Market and Strategies: Strategic Takeaways from Rituxan® and Herceptin® Biosimilars Litigation," ACI 9th Summit on Biosimilars, June 25, 2018
Panelist, "Paragraph IV Litigation Year in Review: Present Developments and Future Forecasts," ACI 12th Annual Paragraph IV Disputes, April 23, 2018
Speaker, "The Impact of Biosimilars Litigation on the Commercialization of Biosimilars," World Congress' Biosimilars Market Access and Commercialization Summit, February 7, 2018
Moderator, "PTAB-Practice Pharma," FCBA Annual Bench & Bar Conference, June 24, 2017
Speaker, "Untangling the Inner Workings of IPRs for Biosimilars,” ACI 8th Annual Summit on Biosimilars, June 12, 2017
Panelist, “The Ongoing Jurisdiction Debate: From Mylan to TC Heartland,” ACI 11th Annual Paragraph IV Disputes, April 25, 2017. Click here for Bloomberg BNA article.
Panelist, “Impact of CBMRs and IPRs on Litigation,” FCBA Annual Bench & Bar Conference, June 24, 2016
Speaker, “Strategic Considerations in Litigating Biologics and Biosimilars Cases,” ACI 7th Summit on Biosimilars, June 14, 2016
Speaker, “The Strategic Use of IPRs in Biologics and Biosimilars Litigation,” Knowledge Group, May 26, 2016
Speaker, “AbbVie v. Janssen and Its Impact on Biologics and Biosimilars,” ACI 6th Summit on Biosimilars (New York, June 2, 2015) and ACI US Biosimilars (Munich, April 20, 2015)
Speaker, “Recent Legal Developments Impacting Biologics and Biosimilars,” Knowledge Group, October 2, 2014
Speaker, “Association for Molecular Pathology v. Myriad Genetics, Inc. and Its Impact on In-House Counsel Practice,” AIPLA Corporate Practice Committee, August 20, 2013
Speaker, “Implications of Lovenox^® and Abbott’s Citizen Petition on Biosimilars Development,” Knowledge Congress, July 13, 2012
Speaker, “An Insider’s Guide to the Federal Circuit,” ACI 6th Annual Paragraph IV Disputes, April 24, 2012
Speaker, “Overview of the Biologics Act and Recent Developments Concerning Its Implementation,” BIOTECanada, November 15, 2011
Speaker, “The Biologics Act: Impact on Regulatory Success of Follow-On Biologics,” Canaccord Genuity 31st Annual Growth Conference, August 9, 2011
Moderator, “Industry Perspectives on the Impact of the Federal Circuit's Therasense Decision,” FCBA, June 14, 2011
Moderator, “Industry Perspectives on the Biologics Act,” FCBA, April 26, 2011
Moderator, "Overview of the Biologics Price Competition and Innovation Act," FCBA, March 2, 2011

News & Publications

Press Releases

June 6, 2024

Press Releases

June 6, 2024

Publications

June 4, 2024

By: Michael I. Green, John J. Molenda, Ph.D.

Press Releases

July 7, 2023

Publications

June 26, 2023

By: Michael I. Green, Lawrence Kass, John J. Molenda, Ph.D.

Press Releases

June 1, 2023

Press Releases

June 30, 2022

Press Releases

June 3, 2022

Publications

Law360

June 4, 2021

By: John J. Molenda, Ph.D., Michael I. Green, Justin Rosinski, Richard Praseuth

Media Mentions

April 6, 2021

View All

Noteworthy

Chambers USA, New York, Intellectual Property: Patent (2022-2024)
LMG Life Sciences, United States, General Patent Litigation (2023)
LMG Life Sciences, United States, Patent Strategy & Management (2023)
National Law Journal, "Trailblazer in Healthcare and Life Sciences" (2021)
Law360, Life Sciences "MVP" (2019)
IAM Patent 1000, Litigation: New York (2015-2024)
IAM Patent 1000, US Court of Appeals for the Federal Circuit: National (2015-2024)
FCBA Legislation Committee Individual Leadership Award (2011)
FCBA Legislation Committee Leadership Award (2011)

Professional Affiliations

Federal Circuit Bar Association
- Vice-Chair, Bench & Bar Planning Committee (July 2016-present)
- Vice-Chair, Regional Programs Committee (May 2020-present)
- Co-Chair, Rules Committee (December 2011-October 2014)
- Co-Chair, Legislation Committee (October 2008-October 2011)
- Vice Chair, Patent Litigation Committee (October 2005-October 2008)
New York Intellectual Property Law Association
New York State Bar Association