Stacie’s practice focuses on intellectual property litigation, due diligence and client counseling, with an emphasis on the life sciences. Her IP counseling and due diligence experience includes extensive counseling for product development efforts relating to biologics and reconstructive biomaterials, including products that utilize adult stem cells. In addition, Stacie has served on the trial team for several patent lawsuits involving major pharmaceutical companies.
Prior to attending law school, Stacie held a faculty position at SUNY Upstate Medical University. She also spent many years as a research scientist in the fields of neurology, virology and immunology, both at Northwestern University and SUNY Upstate Medical University, and has presented her original research at numerous scientific conferences.
Professional Activities
- American Bar Association, Section of Intellectual Property Law
- The American Society for Microbiology
- The Antibody Society
- Named on The Center for Biosimilars’ Board of Advisors (2021)
Experience
- Provide IP counseling and due diligence for several life science, biologic and pharmaceutical companies.
- Trial team member on several patent litigations for major generic pharmaceutical client.
Honors
- Order of the Coif
- Justinian Honor Society
- Searle Award Recipient
- Named to "Women Worth Watching 2015" by Profiles in Diversity Journal
- Named to "Women Worth Watching in STEM® 2017" by Profiles in Diversity Journal
- Named a "Remarkable Women in Business" by Hartford Business Journal
News
- Litigator of the Week Honors for Patent Trial Success
- Axinn Achieves Trial Success for Norwich Pharmaceuticals as it Seeks to Market a Generic of Xifaxan®
- Axinn Partner Stacie Ropka Named to The Center for Biosimilars’ Board of Advisors
- Stacie Ropka Named Among Hartford Business Journal's Remarkable Women in Business
- Dr. Stacie Ropka Identified as a Woman Worth Watching in STEM® Award Winner
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Thought Leadership
- Drug Prices are Prime Target in Biden's Competition Order, Law360, July 9, 2021
- Not So Different: Axinn Patent Litigator Discusses Implications of ACA Ruling, The Center for Biosimilars, July 4, 2021
- New U.S. Legislation Creates Momentum for Biosimilars, BioProcess Online, June 25, 2021
- FDA's Longtime Approach to New Chemical Entity Designations Now Codified, Outsourced Pharma and Pharmaceutical Online, June 14, 2021
- Opinion: Purple Book Patent Listings Are Only a First Step, The Center for Biosimilars, May 8, 2021
- Axinn IP Update: Federal Circuit Says Functional Patent Claims Must Clear "High Hurdles", Axinn Update, February 12, 2021
- Opinion: The Legal and Regulatory Year in Review, The Center for Biosimilars, December 24, 2020
- Biosimilars Caught in Crosshairs of Supreme Court ACA Fight, Law360, November 9, 2020
- California's Governor Signs Bill for State to Produce its Own Biosimilars, Insulins, The Center for Biosimilars, September 29, 2020
- Axinn Patent Attorneys Discuss Insulins Under the BPCIA vs Hatch-Waxman, The Center for Biosimilars, July 21, 2020
- BPCIA in Crosshairs as Opponents File Arguments With High Court to End Health Law, The Center for Biosimilars, June 25, 2020
- Old Drug, New Tricks? How the BPCIA Could Increase Generic Competition for Insulins, BioProcess Online / Biosimilar Development, June 23, 2020
- Rush for Generic Go-Ahead on Novel Drugs Roils Pharma Industry, Bloomberg Law, June 19, 2020
- AAM Makes a Plea to Save the BPCIA, Center for Biosimilars, May 27, 2020
- Axinn Patent Attorneys Talk ACA Pushback and the BPCIA, The Center for Biosimilars, May 4, 2020
- Insulin Under the BPCIA: Opportunities and Obstacles, Biosimilar Development, April 22, 2020
- Balancing Settlements, Motions After Fed. Circ. Serta IP Ruling, Law360, March 16, 2020
- Axinn IP Update: Six Patents Directed to Humanized Monoclonal Antibodies Fall at PTAB, Axinn Update, February 27, 2020
- What ACA's Uncertain Future Means for Biologics Patents, Law360, February 27, 2020
- Axinn IP Update: Settlement Practice in Light of Pending Motions, Axinn Update, February 20, 2020
- Life Sciences Cases to Watch in 2020, Law360, January 1, 2020
- Little Impact Post-Arthrex for Biologic Patents at the PTAB, The Center for Biosimilars, December 3, 2019
- Can the FDA Salvage Interchangeable Follow-On Biologics?, BioProcess Online / Biosimilar Development, November 19, 2019
- Axinn IP Update: Section 287(c) Immunity Has Its Limits, Axinn Update, November 18, 2019
- Axinn IP Update: No Collateral Estoppel after PTAB Ruling on IPR, Axinn Update, October 9, 2019
- Failure to Launch: The Patent Thicket Delay of US Biosimilars, Law360, October 9, 2019
- Axinn IP Update: PTAB Abused its Discretion in Denying Patentee Leave to Correct Chain of Priority, Axinn Update, October 4, 2019
- Supreme Court's Alice Decision Leaves Drug, Device Firms in AI Wonderland, BioWorld, August 26, 2019
- How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy, Biosimilar Development, July 23, 2019
- Biologic Labels and Induced Patent Infringement: A Perspective on Evolving U.S. Law, BioProcess International, May 17, 2019
- Axinn IP Update: FDA Issues Final Guidance on Interchangeability of Biologics, Axinn Update, May 14, 2019
- FDA Finalizes Interchangeable Biosimilar Advice, with Insulin Focus, BioPharma Dive, May 13, 2019
- Drug Pricing Conversation Continues as 'Fixes' Move Through Congress, BioWorld, May 10, 2019
- FDA Eases Way for Gold-Standard Biosimilars, Law360, May 10, 2019
- Axinn IP Update: Hikma Pharmaceuticals USA, Inc. v. Vanda Pharmaceuticals, Inc., Axinn Update, March 18, 2019
- A Hard Choice for Abbreviated Biologics License Applicants, Law360, February 4, 2019
- Axinn IP Update: Federal Circuit Affirms No Public Use Via Implied Confidentiality, Axinn Update, January 30, 2019
- Attorneys React to Teva's High Court Win in "Secret" Patent Sale Case, Westlaw Journal Intellectual Property, January 24, 2019
- Axinn IP Update: U.S. Supreme Court Ruling Leaves On-Sale Bar Unchanged, Axinn Update, January 23, 2019
- Helsinn Loses Supreme Court Bid to Revive Patents on Aloxi (1), Bloomberg Law U.S. Law Week, Bloomberg Law Pharma & Life Sciences, January 22, 2019
- SCOTUS Upholds Lower Court's Ruling in Helsinn Patent Case, BioCentury, January 22, 2019
- Patent Dance Developments: A Tale of 2 Antibodies, Law360, October 26, 2018
- Biosimilars Prepare to Take On Abbvie's Golden Goose in the European Union, BioWorld, October 17, 2018
- The CRISPR Tug of War, IPWatchdog, August 17, 2018
- FDA Lambastes Payment Model and its Impact on U.S. ‘Anemic’ Biosimilar Market, BioWorld, July 20, 2018
- PTO Says Patent Holders May Amend Claims in PTAB Hearings, BioWorld MedTech, July 3, 2018
- CAR-T in the Courts, Genetic Engineering & Biotechnology News, September 11, 2017
- FDA Guidance on Biosimilar Substitution Needs Work, Commenters Say, Bloomberg BNA Life Sciences Law & Industry Report, May 25, 2017
- FDA's Biosimilar Interchangeability Guidance Needs Work, Commenters Say, Life Sciences Law & Industry Report, May 25, 2017
- FDA’s Final Guidance: Steering Studies to Support Biosimilar Approval, Contract Pharma, March 7, 2017
- US Biosimilars Will Continue to Blossom Under Trump, Says Experts, BioPharma-Reporter, January 6, 2017
- A Rocky Start for Biosimilar Inflectra?, MedPage Today, December 27, 2016
- Positive EMA Opinions Could Bode Well For US Approvals of Biosimilars, The Pharma Letter, September 7, 2016
- It’s Your Party, And You Can Dance If You Want To, Life Sciences Intellectual Property Review, August 23, 2016
- Everything You Need to Know About Biosimilars, Regulatory Focus, August 10, 2016
- Federal Appeals Court Reaffirms Biosimilar Launch Rules, BioPharma Dive, July 6, 2016
- Second Amgen Biosimilar Decision Provides More Clarity, Bloomberg BNA, July 6, 2016
- Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory, Regulatory Focus, July 5, 2016
- Will the Approval of Inflectra be a Biosimilar Adoption Tipping Point?, BioPharma Dive, June 9, 2016
- Legislative Riddles Hand Courts Vital Role in Shaping Biosimilar Path, BioWorld Today, April 27, 2016
- A Rocky Start for Biosimilar Inflectra?, MedPage Today, April 7, 2016
- Second U.S. Biosimilar Approval Shows FDA's Confidence, Bloomberg BNA, April 7, 2016
- Celltrion’s Biosimilar to Remicade Likely to be Approved for All Indications, PharmTech.com / BioPharm International, February 12, 2016
- Remicade Biosimilar FDA Panel Vote Shows How It Can Be Done, Life Sciences Law & Industry Report, February 10, 2016
- Navigating Biosimilar Approvals: Start Conversations Early, Says IP Lawyer, BioPharma-Reporter.com, January 5, 2016
- FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users, GxP Lifeline, August 2015
- 5 Takeaways After Fed. Circ. Amgen-Sandoz Ruling, Law360, July 21, 2015
- Biosimilar Sponsors Can Avoid Patent Dance, But Innovators Win Extra Exclusivity, "The Pink Sheet" Daily, July 21, 2015
- Federal Circuit Delays Sandoz Biosimilar, Bloomberg BNA Pharmaceutical Law & Industry Report, July 21, 2015
- Novartis May Sell Copy of Amgen’s Neupogen Drug in September, Bloomberg News, July 21, 2015
- Biosimilar Guidances: Broader Populations Permitted; More Immunogenicity Requested, The Pink Sheet, May 18, 2015
- Kyle Bass’ IPR Challenges Could See Some Success Due to Nature of Patents Challenged - Analysis, May 8, 2015
- What Should Payers Be Doing Now to Prepare for Biosimilars?, Specialty Pharmacy News, March 2015
- 3 Things To Watch After Sandoz's Biosimilars Win, Law360, March 20, 2015
- FDA's First Biosimilar Approval Greeted with Optimism; Naming, Pricing Still Issues, Bloomberg BNA Life Science’s Law & Industry Report, March 9, 2015
- FDA Approves First US Biosimilar from Sandoz, BioPharma-Reporter.com, March 6, 2015
- Now Comes The Hard Part: Sandoz Must Sell Its Biosimilar, The Pink Sheet, March 6, 2015
- US FDA Postpones Celltrion's Remicade Biosimilar Review Meeting, BioPharma Reporter.com, February 27, 2015
- A Call for Antibody Quality Control, BioPharm International, February 18, 2015
- Patents Are Back as Top Issue for 2015, Life Sciences Attorneys Say, Bloomberg BNA Life Sciences Law & Industry Report, January 9, 2015
- 5 Lessons We Can Learn from FDA’s First Biosimilar Review, Law360, January 8, 2015
- Biosimilar Firms Must Be Ready for US ‘Patent Dance,’ Says IP Lawyer, BioPharma-Reporter.com, August 13, 2014
- Growing Pains: The Seagate Standard After Powell v. Home Depot, April 5, 2012
- Machine-Or-Transformation Test After Myriad: Implications To The Prosecution Of Process Claims, Patent Law Practice Center, August 15, 2011
Events
- ACI 8th Annual Women Leaders in Life Sciences Law Virtual Conference
- ACI 12th Annual Summit on Biosimilars & Innovator Biologics
- 2021 Festival of Biologics: World Biosimilar Congress USA
- ACI 7th Annual Women Leaders in Life Sciences Law Virtual Conference
- ACI Summit on Biosimilars & Innovator Biologics Virtual Conference
- 2020 Festival of Biologics: World Biosimilar Congress USA
- Navigating Patent Thickets in BPCIA Litigation
- 2019 Festival of Biologics: World Biosimilar Congress Europe
- Managing Unconscious Bias to Increase Diversity and Promote Inclusion in Corporate and Law Firm Leadership
- 2019 Centerforce Women, Diversity & Change Summit - Boston
- 2019 Festival of Biologics: World Biosimilar Congress USA
- 2018 Festival of Biologics: World Biosimilar Congress Europe
- ACI 9th Annual Summit on Biosimilars
- 2017 Festival of Biologics: World Biosimilar Congress Europe
- 2017 AAM Biosimilars Council Conference
- ACI 8th Annual Summit on Biosimilars
- 2017 Festival of Biologics: World Biosimilar Congress USA
- ACI 3rd Annual Post Grant PTO Proceedings Conference
- ACI 7th Annual Summit on Biosimilars
- HCT/P: FDA’s Newest Regulatory Battleground
- Demonstrating Biosimilarity: Guidance from the FDA
Education
- JD, magna cum laude – Syracuse University College of Law (2005)
- PhD, with Honors – Upstate Medical University (1999)
- MBA – DePaul University (1987)
- MS – DePaul University (1984)
- BS – DePaul University (1982)
Admissions
- Connecticut
- New Jersey
- US District Court District of New Jersey
- US District Court District of Connecticut