John J. Molenda, Ph.D.

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Areas of Work

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

Overview

John Molenda是Steptoe医疗保健与生命科学行业执业领域的联合主席，知识产权实务纽约办事处的主管，并在律所的执行委员会任职。他的执业重点在于地区法院和上诉级别的专利诉讼、提供律师意见、开展尽职调查和核准后复审程序，包括多方复审（IPR）和复审。他代表的案件涉及技术广泛，包括生物治疗（生物制剂）、制药（《药品价格竞争与专利期补偿法》）、生物化学研究工具、医疗器械、半导体和计算机软件。

John的长期专注于生物制剂和生物仿制药领域的法律服务。他目前代表两家制药公司参与一项涉及降低胆固醇的重磅生物制剂的案例，并正在协调针对涉及高价值单克隆抗体和细胞因子产品的全球生物仿制药项目的诉前战略、给予咨询建议。John还领导生物制剂团队负责在提交知识产权申请之前进行与交易相关的勤勉尽职调查和预审。在发言中，他谈到了ACI、知识集团、BIOTECanada、Canaccord Genuity和联邦巡回律师协会（FCBA）的生物制剂和生物仿制药的最新发展。

关于John的上诉执业实践，他经常在美国联邦巡回上诉法院进行诉讼，包括提交书状、进行口头辩论和复杂的动议实践。他曾在20个联邦巡回上诉中担任过重要角色，包括最近在第一个与制药相关的知识产权上诉中进行答辩。John在联邦巡回社区表现积极，目前担任联邦巡回律师协会法官和律师规划委员会的副主席。他曾担任联邦巡回律师协会的专利诉讼、立法和规则委员会的领导职务。在私人执业之前，他曾担任Alan D. Lourie阁下的联邦巡回法律书记员。

关于John在地区法院的执业经验，他在美国各地的地区法院进行诉讼，包括在多次审判中扮演重要角色，管理预审程序的各个方面，担任调解和马克曼预审程序的主要负责人，并负责管理复杂的证据开示程序。John自2014年起担任PLI专利诉讼基础方案的联合主席。

代表性论文

《与生物制品有关的多方复审的最新趋势》，《知识产权法360》，2017年7月20日
《Retractable Technologies, Inc.诉Becton，Dickinson＆Co.：联邦巡回法院关于权利要求解释方法论和顺从泛滥的辩论》，纽约知识产权法律协会公告，2011年10月/ 11月
《索赔差异化学说的战略方法：专利权人和被控侵权者指南》，12知识产权诉讼，第一卷，2006年1月/ 2月
《理解联邦巡回法院的内部辩论及其决定重审Phillips诉AWH Corp. En Banc,的决定》，第86期，专利和商标局协会911号，2004年

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

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Noteworthy

当选纽约“超级律师”，《知识产权诉讼》（2017-2018年）
《 IAM专利1000》，诉讼：纽约（2015-2020年）
《IAM专利1000》，美国联邦巡回上诉法院：全国范围（2015-2020年）
FCBA立法委员会个人领导奖（2011年）
FCBA立法委员会领导奖（2011年）

Professional Affiliations

联邦巡回律师协会
- 法官和法庭计划委员会副主席（2016年7月至今）
- 规则委员会联席主席（2011年12月至2014年10月）
- 立法委员会联席主席（2008年10月至2011年10月）
- 专利诉讼委员会副主席（2005年10月至2008年10月）
专利诉讼委员会副主席（2005年10月至2008年10月）
纽约州律师协会