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Practice Area | Hatch-Waxman Exclusivity

Leading Authority on Hatch-Waxman Exclusivity

Gregory Glover is a leading expert on market exclusivity provisions for small molecule drugs and large molecule biologics. His expertise provides valuable perspective regarding 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 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

Relevant Issues

Greg has expertise in the market exclusivity and intellectual property issues for biologics and biosimilars that arise from the provisions of the Biologics Price Competition and Innovation Act (“BPCIA”).

BPCIA provides a new approach to the patent and regulatory exclusivity provisions that are analogous to the provisions that govern the interaction of innovator and generic manufacturers in the Hatch-Waxman Act.

For small molecules, the patent and regulatory issues are linked explicitly through provisions such as Orange Book patent listings and the 30-month stay of regulatory approval following the initiation of a patent infringement suit. However, there are no such patent and regulatory linkages in BPCIA; regulatory approvals can proceed independently of any ongoing patent disputes.

In lieu of the patent and regulatory linkage of the Hatch-Waxman Act, BPCIA provides for a highly complex patent information exchange process and related infringement litigation whose interpretation is still being disputed.

In addition, the five-year (new chemical entity) and three-year (new product) exclusivities in the Hatch-Waxman have been replaced by a single 12-year reference product exclusivity in BPCIA. There is no independent exclusivity provided to the innovator for developing new indications or formulations.

These differences in patent and regulatory exclusivity provisions have a significant impact on product development strategies for biologics.

To Connect with Gregory Glover and Pharmaceutical Law Group

202.589.1780 or [hidden email]