Assessing Eligibility for Product Development Incentives, Coordination of Patent Claims with Approved Labeling, Product Development, and Evaluation of the Effectiveness of Patent and Regulatory Exclusivities.
Pharmaceutical Law Group founder, Gregory Glover, MD JD, is recognized for his extensive regulatory expertise and insightful analysis of the complex relationships between FDA regulation, intellectual property, and market dynamics.
As a patent attorney and non-practicing physician, Gregory Glover stands among the nation’s foremost authorities on FDA-related legal issues regarding the Hatch-Waxman Act, patent and non-patent market exclusivity provisions, and market exclusivity and intellectual property matters for biologics and biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). Learn More About Gregory Glover.
Pharma Lifecycle Management Strategies Aimed at Extending Patent Life and Regulatory Protections for Drugs, Biologics, And Medical Devices
Dr. Glover offers consultation and expert guidance for life science companies, attorneys, and investors on managing all stages of the pharmaceutical lifecycle. We help clients navigate the intricacies of FDA regulation, market exclusivities, and patent protections, enabling them to align their LCM strategies with market realities and regulatory requirements.
Comprehensive Patent Coordination
Dr. Glover’s expertise uniquely positions Pharmaceutical Law Group to coordinate patent claims with approved product labeling, to position product development efforts to take advantage of regulatory incentives, and to assess potential vulnerabilities by evaluating opportunities for competitive products.
Product Life Extension
Dr. Glover employs targeted strategies designed to enhance product value and to further product development and innovation, ensuring that clients effectively navigate the patent process for new forms and uses of originator drugs, including isomers, fixed-combinations drugs, and extended-release formulations.
Patents for Every Lifecycle Stage
Dr. Glover assists clients in developing LCM strategies tailored to maximizing product development incentives, aiding in gaining independent protection for active ingredients and complementary protection for methods of use, methods of manufacture, formulations, and companion diagnostics, and extending the lifespan of drugs and biologics through further product development and innovation.
Relevant patent protection opportunities include:
- Active Pharmaceutical Ingredient (API) Patents: Protecting the active pharmaceutical ingredient (API), the foundational molecule responsible for the product’s therapeutic effect.
- Method of Use (MOU) Patents: Protecting novel and non-obvious therapeutic uses for existing patented or generic drugs and repositioning drugs to treat a different condition.
- Method of Manufacture Patents: Protecting novel manufacturing methods, including unique purification techniques and innovative production processes.
- Formulation Patents: Protecting innovative drug formulations, including extended-release formulations or specialized delivery systems.
Diverse Industry Expertise
Dr. Glover’s expertise encompasses a wide range of pharmaceutical technologies, including small molecule pharmaceuticals, biologics, biosimilars, drug combinations, companion diagnostics, and pharmaceutical devices.
For more detailed information about our Pharmaceutical Lifecycle Management services, contact Gregory Glover, MD, JD, and Pharmaceutical Law Group
202.589.1780 or Connect Online