Staff Attorney
Dorothy has experience in all aspects of pre-trial litigation, including legal and scientific research in preparation for expert depositions and trial; preparing memoranda summarizing research results; preparing questions for expert witnesses depositions; evaluating and recommending demonstratives for trial; and preparing rebuttals to expert reports. She advises litigation teams concerning FDA regulatory matters and U.S. Pharmacopeial Convention requirements and performs electronic discovery to identify scientific-, relevance-, and privilege-related issues.
Dorothy has broad experience in the areas of pharmaceutical, food additive, and controlled substance analytical method development and testing. As a pharmaceutical research scientist and manager at the United States Pharmacopeia, she developed analytical methods, managed a staff of chemists, and oversaw the testing of reference standards. She has also advised clients on the FDA requirements for food contact substances and biologics.
Dorothy has served on numerous federal and trade association advisory panels, committees, and task forces within the environmental, health and safety, and food and drug communities, including the Environmental Protection Agency Common Sense Initiative, the National Advisory Council for Environmental Policy and Technology Compliance Assistance Advisory Committee, the United States Pharmacopeia, the National Formulary, and the Food Chemicals Codex, as well as collaborative method development programs and task forces with industry representatives and the Food and Drug Administration. She also previously routinely chaired and moderated the national environmental health and safety symposia for the Newspaper Association of America.
Dorothy has been recognized by the Capital Pro Bono High Honor Roll for her pro bono practice.
Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc.
Assisted in pre-trial litigation e-discovery for relevance and privilege issues as part of team represented Pronova in Hatch-Waxman patent litigation concerning multiple ANDAs for generic versions of drug Lovaza®, resulting in judgment of patent infringement, validity, and enforceability in Pronova's favor.
1:09-cv-00286, 1:10-cv-00800, D. Del., Judges Farnan, Robinson, Thynge
12-1498, -1499, Fed. Cir., Judges Dyk, O'Malley, Wallach
Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc.
Involved in legal and scientific pre-trial litigation matters for Otsuka Pharmaceuticals, Inc. in Hatch-Waxman litigations against seven companies seeking FDA approval to market generic copies of Abilify®, which had 2011 sales of over $5.2 billion. The district court found the asserted patent claims valid, enforceable and infringed in November 2010, and enjoined marketing of any generic until April 2015. The Federal Circuit affirmed that holding in May 2012, with Supreme Court Cert subsequently denied.
3:07-cv-01000, D.N.J., Judges Cooper, Goodman, Hughes
11-1126, -1127, Fed. Cir., Judges Lourie, Moore, Reyna
Valeant Pharmaceuticals Int’l, Inc. v. Actavis Laboratories FL, Inc.
Assisted regarding pre-trial litigation matters and e-discovery for Valeant in Hatch-Waxman patent infringement litigation concerning an ANDA for generic oral versions of Relistor® tablets.
2:16-cv-09038, D.N.J., Judges Chesler, Waldor
Valeant Pharmaceuticals Int’l, Inc. v. Mylan Pharmaceuticals, Inc.
Assisted regarding pre-trial litigation matters and e-discovery for Valeant, Salix, and Progenics in Hatch-Waxman patent infringement litigation concerning multiple ANDAs for generic subcutaneous versions of Relistor®. The District of New Jersey granted summary judgment in favor of Valeant, Salix and Progenics on U.S. Patent No. 8,552,025 covering Subcutaneous Relistor™ through 2024.
2:15-cv-08180, 2:17-cv-06714, D.N.J., Judges Chesler, Waldor
Grünenthal GmbH et al. v. Actavis Elizabeth LLC et al.
Assisted regarding multilingual legal and scientific pre-trial litigation matters in multiple Hatch-Waxman suits involving analgesic drugs Nucynta® and Nucynta® ER; the district court enjoined the defendants from marketing generic versions until patent expiry.
2:13-cv-04507, -06929, -07803; 2:14-cv-03941, -04617; 2:15-cv-06797, D.N.J., Judges Cecchi, Falk
Award/Ranking
54 Finnegan Attorneys Named to 2022 Capital Pro Bono Honor Roll 54 Finnegan Attorneys Named to 2022 Capital Pro Bono Honor Roll
July 21, 2023
Press Release
46 Finnegan Attorneys Named to 2021 Capital Pro Bono Honor Roll 46 Finnegan Attorneys Named to 2021 Capital Pro Bono Honor Roll
June 3, 2022
Press Release
55 Finnegan Attorneys Named to 2020 Capital Pro Bono Honor Roll 55 Finnegan Attorneys Named to 2020 Capital Pro Bono Honor Roll
April 2, 2021
Press Release
62 Finnegan Attorneys Named to 2019 Capital Pro Bono Honor Roll 62 Finnegan Attorneys Named to 2019 Capital Pro Bono Honor Roll
June 8, 2020
Press Release
62 Finnegan Attorneys Named to 2018 Capital Pro Bono Honor Roll 62 Finnegan Attorneys Named to 2018 Capital Pro Bono Honor Roll
April 5, 2019
Press Release
48 Finnegan Attorneys Named to 2017 Capital Pro Bono Honor Roll 48 Finnegan Attorneys Named to 2017 Capital Pro Bono Honor Roll
February 20, 2018
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.