Hogan Lovells 2024 Election Impact and Congressional Outlook Report
Gary L. Veron
Partner Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
For more than 25 years, Gary Veron has advised clients regarding the development, approval, and marketing of pharmaceutical and biological products. Gary is committed to helping life science companies successfully manage legal and business complexities to achieve their goals. His practice focuses on Hatch-Waxman Act, biosimilars, and life cycle management issues.
With a degree in biology and prior experience as a registered patent attorney, Gary understands how the science fits in the legal framework. In particular, he has considerable experience handling issues that occur at the intersection of FDA and intellectual property laws. He draws on his unique background to counsel clients regarding comprehensive development strategies, including market exclusivity periods, Orange Book issues, and therapeutic equivalence determinations. In addition, Gary assists clients in resolving the novel issues raised in biosimilar and 505(b)(2 ) applications.
Gary also has experience negotiating technology transfer and license agreements and managing patent prosecution matters. Before joining Hogan Lovells, Gary practiced both food and drug law and patent law at another international law firm. He also served as a Technology Development Specialist at the National Institutes of Health (NIH), where he was the intellectual property manager for four NIH institutes.
Gary's experience and skills have earned recognition in the Best Lawyers in America (FDA Law) and Legal 500 USA.
Representative experience
Citizen petition regarding labeling carve-out and orphan drug exclusivity issues related to generic bendamustine products.
Citizen petition regarding the approval standards for a 505(b)(2 ) application for a bortezomib product.
Comments to a draft product-specific bioequivalence guidance regarding issues related to complex products that are not fully characterized.
Comments to an FDA regulatory review period determination for a gene therapy product for purposes of patent term extension.
Citizen petition regarding issues raised by a 505(b)(2 ) application for a palonosetron product that differed from the reference product.
Comments to a suitability petition seeking approval for different strengths of the reference product.
Citizen petition regarding generic approval standards for a topical corticosteroid product.
Comments to FDA regarding eligibility for a patent term extension for a combination product.
Citizen petition regarding three-year exclusivity, labeling carve-out, and 505(b)(2 ) issues related to generic colchicine.*
Citizen petition regarding safety and orphan drug exclusivity issues raised by an Abbreviated New Drug Application (ANDA) for generic thalidomide.*
Citizen petition regarding reference drug and patent certification issues raised by a 505(b)(2 ) application for an extended-release oxycodone product.*
*Matter handled prior to joining Hogan Lovells.
Credentials
Education
- J.D., University of Virginia School of Law, 1993
- B.S., Virginia Tech, cum laude, 1990
Bar admissions and qualifications
- District of Columbia
- Maryland
- U.S. Patent and Trademark Office
Court admissions
- U.S. Court of Appeals, District of Columbia Circuit
- U.S. Court of Appeals, Federal Circuit
- U.S. District Court, District of Columbia
- U.S. District Court, District of Maryland
Recognition
Events
Hogan Lovells Events
8 February 2024 | 12:00 p.m. - 1:00 p.m. (ET)
Webinar
06 June 2023 | 3:00 PM - 4:30 PM (JST)
Webinar
22 March 2023 | 3:00 PM - 4:30 PM (JST)