Danielle A. Duszczyszyn, Ph.D.
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  • 901 New York Avenue, NW
  • Washington, DC 20001-4413

Danielle A. Duszczyszyn, Ph.D.

Partner

  • 901 New York Avenue, NW
  • Washington, DC 20001-4413

Danielle Duszczyszyn, Ph.D., focuses her practice on patent litigation before U.S. district courts, patent prosecution, and client counseling in the areas of biotechnology, pharmaceuticals, and chemical arts. She works on litigation matters in a variety of technologies in the pharmaceutical, cosmetic, medical device and biotechnology fields, and has experience in cases arising from the filing of Abbreviated New Drug Applications (ANDA).

Danielle has been involved in all stages of district court litigation, from complaint to trial and post-trial. Her litigation experience includes analyzing patent portfolios for assertion; formulating claim construction, infringement, and validity positions; drafting discovery requests and responses; taking and defending fact and expert depositions; preparing witnesses for deposition, Markman hearings, and trial; examining expert witnesses at trial; and drafting summary judgment motions and briefs, Markman briefs, pre- and post-trial motions and briefs, findings of fact, and conclusions of law.

 

In addition to her litigation practice, Danielle advises clients on a variety of patent matters, including patent procurement, and pre- and post-litigation strategies.

 

Prior to her legal career, Danielle worked in the pharmaceutical and cosmetic industries. She worked as a research assistant at small biotechnology companies and at the W.M. Keck Center for Transgene Research at the University of Notre Dame. She also gained experience in clinical trial research by working on Phase II, III, and IV clinical trials at two major pharmaceutical companies. Danielle received her Ph.D. from McGill University, where she studied perturbed naïve T cell homeostasis and thymic abnormalities in patients with relapsing-remitting multiple sclerosis.

 

Danielle is a current member of the firm’s management committee. She has been recognized by Managing Intellectual Property (MIP) as a notable practitioner. 

 

Et Cetera

  • Coauthor.  "Coordinating New Drug Application (NDA) and Patent Portfolio Strategy," Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second Edition, 2018.
  • Coauthor.  "Coordinating New Drug Application (NDA) and Patent Portfolio Strategy," Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, 2014.
  • Coauthor.  "Reduced Thymic Output and Peripheral Naïve CD4 T-cell Alterations in Primary Progressive Multiple Sclerosis (PPMS)," Journal of Neuroimmunology, 2011.
  • Coauthor.  "Thymic Involution and Proliferation T-Cell Responses in Relapsing-Remitting Multiple Sclerosis," Journal of Neuroimmunology, 2010.
  • Samuel J. Rebecca and Albert Aaron Fellow, 2010.
  • Heller-Stiller Leadership Scholar, 2007-2010.
  • Research assistant to University of Maryland School of Law Associate Dean Diane Hoffmann in preparation for the June 2010 meeting of researchers and administrators, attorneys, government regulators, legal academics, consumer advocates and industry representatives studying federal regulation of probiotics under a grant from National Institutes of Health's Human Microbiome Project.
  • Intern for the Honorable Richard D. Bennett of the U.S. District Court for the D. Maryland, Fall 2008.
  • Coauthor.  "Altered Naïve CD4 and CD8 T Cell Homeostasis in Patients with Relapsing-Remitting Multiple Sclerosis: Thymic Versus Peripheral (Non-Thymic) Mechanisms," Clinical Experimental Immunology, 2006.
  • Coauthor.  "Accelerated Skin Wound Healing in Plasminogen Activator Inhibitor-1-Deficient Mice," American Journal of Pathology, 2001.

Experience

Alzheimer's Institute of America, Inc. v. Avid Radiopharmaceuticals

Member of trial team for Avid in suit concerning amyloid beta technology and its use in animal models in searching for drugs to treat Alzheimer's disease (AD). Obtained jury verdict for Avid on issue of inventorship and patent ownership in 2012; affirmed by the Federal Circuit in 2013. Also obtained a finding of exceptional case, entitling Avid to an award of attorneys' fees. The trial disposed of a series of suits by the AIA against numerous companies involved in scientific research relating to Alzheimer's disease.

2:10-cv-06908, E.D. Pa., Judges Angell, Savage, Cohen (Special Master)
13-1544, 16-2647, Fed. Cir., Judges Hughes, Lourie, Moore, Newman, Plager

Eli Lilly and Company v. Actavis Labs. UT Inc.

Representing Eli Lilly in Hatch-Waxman action against several defendants relating to Cialis®.

1:16-cv-01119, E.D. Va., Judges Nachmanoff, Trenga

In re Rosuvastatin Calcium Patent Litigation

Assisted appellate counsel for AstraZeneca in briefing and preparation for oral argument in action to prevent generic competition with respect to cholesterol lowering drug Crestor®. Judgment for patent owner on all issues.

1:08-md-01949, D. Del., Judges Farnan, Stark
10-1460, -1461, -1462, -1463, -1464, -1465, -1466, -1467, -1468, -1469, -1470, -1471, -1472, -1473, Fed. Cir., Judges Mayer, Newman, Plager

Cumberland Pharmaceuticals Inc. v. Mylan Institutional, LLC

Represented for Cumberland in ANDA litigation and breach of contract arbitration. Successful outcome in bench trial, arbitration, arbitration fee award, and on appeal.

16-1155, -1259, Fed. Cir., Judges Moore, Reyna, Taranto
1:12-cv-03846, N.D. Ill., Judge Pallmeyer

Incyte Corporation et al. v. Sun Pharmaceutical Industries Limited et al.

Successfully represented Incyte in patent litigation, including preliminary injunction proceedings related to Sun Pharmaceuticals’ deuterated Janus kinase (JAK) inhibitor, LEQSELVI™. Case settled favorably for our client.

2:24-cv-06944, D.N.J., Judge Padin

Merck Sharp & Dohme LLC v. Hetero USA Inc., Lupin Limited et al.

Representing Merck in Hatch-Waxman litigation involving the HIV drugs ISENTRESS® and ISENTRESS® HD.

2:23-cv-00094, 2:23-cv-02364, D.N.J., Judges Cecchi, Padin, Wettre

More

Insights

Articles

A Look at Ex Parte Seizures 8 Years Post-DTSA

A Look at Ex Parte Seizures 8 Years Post-DTSA A Look at Ex Parte Seizures 8 Years Post-DTSA

April 17, 2024

Law360

Articles

Potential Implications of Inflation Reduction Act on Pharmaceutical Patent Litigation

Potential Implications of Inflation Reduction Act on Pharmaceutical Patent Litigation Potential Implications of Inflation Reduction Act on Pharmaceutical Patent Litigation

May 1, 2023

Bloomberg Law

At the PTAB Blog

Moderna’s Appeal of PTAB Decision Dismissed for Lack of Standing Moderna’s Appeal of PTAB Decision Dismissed for Lack of Standing

December 20, 2021

Articles

Ex Parte Seizure Under the Defend Trade Secrets Act: Insights on the New Remedy Ex Parte Seizure Under the Defend Trade Secrets Act: Insights on the New Remedy

April 8, 2020

Westlaw Journal Intellectual Property

Articles

Three Years Later: How the Defend Trade Secrets Act Complicated the Law Instead of Making It More Uniform Three Years Later: How the Defend Trade Secrets Act Complicated the Law Instead of Making It More Uniform

July/August 2019

IP Litigator

Books

Coordinating New Drug Application (NDA) and Patent Portfolio Strategy Coordinating New Drug Application (NDA) and Patent Portfolio Strategy

2018

Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second Edition
More

News

Award/Ranking

Finnegan Earns Top Rankings in 2026 IAM Patent 1000 Guide; Nearly 60 Attorneys Ranked Finnegan Earns Top Rankings in 2026 IAM Patent 1000 Guide; Nearly 60 Attorneys Ranked

May 28, 2026

Intellectual Asset Management (IAM)

Award/Ranking

61 Finnegan Attorneys Recognized on the 2025 Capital Pro Bono Honor Roll 61 Finnegan Attorneys Recognized on the 2025 Capital Pro Bono Honor Roll

May 7, 2026

Award/Ranking

56 Finnegan Attorneys Recognized on the 2024 Capital Pro Bono Honor Roll 56 Finnegan Attorneys Recognized on the 2024 Capital Pro Bono Honor Roll

April 24, 2025

DC Bar

Media Mention

NJ Judge Blocks Sun Pharma from Launching Hair Loss Drug NJ Judge Blocks Sun Pharma from Launching Hair Loss Drug

November 4, 2024

Law360

Award/Ranking

Finnegan Ranks at the Top of the Managing Intellectual Property IP Stars Rankings Finnegan Ranks at the Top of the Managing Intellectual Property IP Stars Rankings

June 28, 2024

Managing Intellectual Property

Award/Ranking

60 Finnegan Attorneys Named to 2023 Capital Pro Bono Honor Roll

60 Finnegan Attorneys Named to 2023 Capital Pro Bono Honor Roll

May 15, 2024

More

Professional Activities

  • American Bar Association
Admissions and Education

Admissions

  • Maryland
  • District of Columbia
  • U.S. Court of Appeals, Federal Circuit

Education

University of Maryland School of Law
J.D., 2010
McGill University
Ph.D., Faculty of Medicine, 2008
McGill University
M.Sc., Faculty of Medicine, 2005
University of Waterloo
B.Sc., Honors Biology - Co-operative Program, 2002

Languages

  • French

Danielle's Practices

Appeals, Issues, and Legal Strategy
Federal Circuit and Supreme Court Appeals
Global IP Enforcement, Litigation, and Trials
Branded Hatch-Waxman (ANDA) Litigation and Trials
Pretrial Strategies
Prosecution and Portfolio Management
Opinions and Counseling

Danielle's Industries

Chemicals, Industrials, and Materials
Chemical
Life Sciences
Biologics
Biotechnology
Pharmaceutical

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