Service Offerings

Pharmaceutical Law Group focuses on advising research-based life sciences companies, trade associations, and investors on the strategic interaction of FDA regulations and intellectual property law.

Areas of Expertise

Market Protection Strategies
Hatch-Waxman Act
Orange Book listings
Orphan Drug Exclusivity
Pediatric Exclusivity
180-day Exclusivity
Follow-on Biologics

Service Offerings

Legal analysis of the application of market protection provisions on particular products; legal consultation on the operation of the Hatch-Waxman Act
Advice to investors about anticipated market protection
Opinions regarding Orange Book listings
Expert witness consultation in litigation
Corporate education on the interaction of FDA regulation and intellectual property

Practice Expertise

Regulatory IP:

Essentials of Lifecycle Management

The lifecycle management tools covered in this guide will help enhance value for biopharmaceutical investors, developers, and manufacturers and strengthen the incentives for continued medical progress.

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Gregory Glover | Blog

May 24, 2023

What GSK v. Teva Means for ANDA Skinny Labels

On August 5, 2021, a Federal Circuit panel upheld a $235 million verdict against Teva Pharmaceuticals over induced infringement of GlaxoSmithKline's Coreg (carvedilol). The precedent setting decision has generic applicants questioning what exactly constitutes induced... More

Washington D.C.
Pharmaceutical IP Lawyer of the Year