• Boston 857.347.5647
  • San Francisco 415.599.1255
  • Seattle 206.222.3862
  • San Diego 858.987.8224

Product Approval Strategies

Gregory Glover is a leading expert on market exclusivity provisions for small molecule drugs and large molecule biologics.

He represents life sciences manufacturers and distributors in a wide range of matters, such as: the regulatory implications of Orphan Drug status and treatment protocols; the unique issues that arise for novel or combination products; expedited review and approval provisions; specialized regulatory incentives and market exclusivity provisions for targeted product development; and the emerging issues related to personalized medicine and companion diagnostics.

His expertise provides valuable insight on strategic approaches to optimize the benefits of regulatory and market incentives, intellectual property protection, and market dynamics.

Greg’s expertise is enhanced by his deep understanding of the development of laws and regulations for drugs and biologics, the unintended consequences of those laws and regulations on product development and investment, and the impact of new regulatory and exclusivity incentives on product life cycles.

His expert consultation is most sought after for strategies and insights regarding the complex interaction of FDA regulation, intellectual property, and market dynamics that are essential for success in the pharmaceutical and biotechnology industries.

Learn More About Greg Glover

Market Exclusivity Strategies and Specialized Regulatory Incentives

Greg also represents life sciences companies and trade associations on strategic intellectual property issues, including: market exclusivity analyses based on product development, FDA regulations, and patent portfolio evaluations; patent claim structure, including the coordination of product labeling; patent listings in the Orange Book, including the development of patent use codes; the implications of legislative proposals; and expert opinions in adversarial proceedings involving contract and licensing agreements and patent infringement.

To Connect with Gregory Glover and Pharmaceutical Law Group

202.589.1780 or [hidden email]