The Pharmaceutical Law Group
The Pharmaceutical Law Group was founded by Gregory Glover MD JD, a patent lawyer and non-practicing physician. He is one of the nation’s leading experts on food and drug law and intellectual property.
We represent pharmaceutical and biotechnology developers, manufacturers, and investors regarding market exclusivity strategies and domestic intellectual property issues. Our clients include:
- Established manufacturers and distributors
- Investors including investment banks, VCs, and other funding sources
- Business development executives
- IP & regulatory specialty law firms
- Emerging product development companies
We are expert advisors when FDA regulation and intellectual property converge.
Typical engagements and consultations relate to strategic intellectual property issues that drive success in the following areas:
Due Diligence and Transaction Advice
Our firm’s expertise at the intersection of FDA regulation and intellectual property for pharma and biotech helps life sciences companies, investors, and other clients identify risks and uncover opportunities in product development, regulatory incentives, and life cycle management.
Hatch-Waxman and BPCIA
The Pharmaceutical Law Group has particular expertise in the patent and non-patent exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act). We are also deeply experienced 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).
Strategic Product Development
PLG expertise helps companies considering investments in new products or in product development efforts by analyzing a product’s regulatory status, approval strategies, and eligibility for exclusivity rights or specialized product incentives.
Life Cycle Management
The breadth and depth of the Pharmaceutical Law Group’s expertise is uniquely valuable in the coordination of patent claims with approved product labeling, product development, and evaluation of potential avenues for competition.
We also offer insight into emerging conflicts and opportunities for the pharmaceutical industry including the developing market dynamics between innovator biologic products and biosimilars, the rise of personalized medicine and the role of companion and complementary diagnostics, and the impact of drug pricing disputes on pharmaceutical research and development.
How Can We Help? Call Us for a Confidential Discussion
Our expert consultation frequently focuses on 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 sectors.