Gary L. Veron
From the laboratory to the marketplace, Gary Veron advises pharmaceutical and biotechnology companies on the wide range of U.S. Food and Drug Administration (FDA) issues that arise during drug development and commercialization. In particular, Gary focuses on Hatch-Waxman Act and life cycle management issues.
As a registered patent attorney, Gary has vast experience handling with 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's practice includes the novel issues raised by 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 food and drug law and patent law at another international law firm and was a Technology Development Specialist at the National Institutes of Health (NIH), where he served as the intellectual property manager for four NIH institutes.
Areas of Focus
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.
Healthcare: Life Sciences
Legal 500 U.S.