Gary L. Veron

Gary L. Veron

Partner, Washington, D.C.

Email gary.veron@hoganlovells.com

Phone +1 202 637 5480

Fax +1 202 637 5910

Practice groupRegulatory

For more than 20 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. 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. His experience includes serving 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.

Awards and recognitions

2016-2018

FDA Law
The Best Lawyers in America

2014

Healthcare: Life Sciences
Legal 500 US

Education and admissions

Education

J.D., University of Virginia School of Law, 1993

B.S., cum laude, Virginia Polytechnic Institute and State University, 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

Representative experience

Citizen petition regarding issues raised by a 505(b)(2) application for a palonosetron product that differed from the reference product.

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.

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.

Comments to a draft bioequivalence guidance regarding bioequivalence issues related to complex products that are not fully characterized.

Comments to a suitability petition seeking approval for different strengths of the reference product.

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