News
New Orange & Purple Book laws increase transparency of patent information for drugs, biologics
20 January 2021
PartnerWashington, D.C.
Email gary.veron@hoganlovells.com
Phone +1 202 637 5480
Fax +1 202 637 5910
Practice groupGlobal Regulatory
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.
FDA Law
The Best Lawyers in America
Healthcare: Life Sciences
Legal 500 US
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
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.
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
Hogan Lovells Publications
04 February 2019