News
New Orange & Purple Book laws increase transparency of patent information for drugs, biologics
20 January 2021
PartnerWashington, D.C.
Email george.obrien@hoganlovells.com
Phone +1 202 637 5497
Fax +1 202 637 5910
Practice groupGlobal Regulatory
George O'Brien works with innovative pharmaceutical and biotech companies on lifecycle management issues. He's probably best known for his substantial experience with orphan drug designation and exclusivity matters.
In particular, George helps clients avoid the pitfalls that can delay an orphan designation or award of orphan exclusivity, such as issues related to prevalence, orphan subsets, and clinical superiority. When clients must resolve a dispute with an agency over orphan issues, George's comprehensive knowledge of relevant precedent is a valuable tool.
George assists companies at all stages of product development to maximize their FDA regulatory exclusivities, including Hatch-Waxman, orphan drug, and pediatric exclusivities. Drafting citizen petitions is a key part of his practice, and he's collaborated with other organizations to create drafts on a wide range of issues, including bioequivalence and approval requirements for generic products, the operation of 180-day exclusivity, therapeutic equivalence issues, and new chemical entity exclusivity.
George recently served on the Drugs & Biologics Committee of the Food and Drug Law Institute. He also has spoken on orphan drug issues at FDLI conferences and elsewhere.
Rising Stars, Food & Drugs
Washington, D.C. Super Lawyers
Healthcare: Life Sciences, Recommended
Legal 500 US
Education
J.D., University of Maryland, Francis King Carey School of Law, magna cum laude, Order of the Coif, 2008
A.B., Dartmouth College, cum laude, 1995
Bar admissions and qualifications
District of Columbia
Maryland
Submitted citizen petition convincing FDA to recognize five-year "new chemical entity" exclusivity for certain fixed-dose combination products.
Represented Depomed, Inc. in regulatory proceedings and federal litigation regarding orphan drug designation and exclusivity.
News
20 January 2021
News
28 October 2020
Insights
Registered Content
05 February 2020
Insights
Registered Content
31 January 2020
Insights
Registered Content
08 January 2020
Press Releases
06 January 2020