Pharmaceutical Law Group
Pharmaceutical Law Group was founded by Gregory Glover MD JD, a registered patent attorney and non-practicing physician. He is one of the nation’s experts on the complex interaction of food and drug laws and intellectual property, including the patent and non-patent provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
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:
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).
Lifecycle Management
The breadth and depth of 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.
As a leading authority on FDA-related legal and regulatory matters, including the Hatch-Waxman Act, patent and non-patent market exclusivity provisions, and related intellectual property issues, Pharmaceutical Law Group provides consultation and expert opinion for attorneys, life science companies, and investors on matters involving FDA-related litigation, regulatory exclusivities, statutory and regulatory compliance, expedited review programs, and specialized incentives.
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.
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 lifecycle management.
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.
Contact Pharmaceutical Law Group 202.589.1780 or EMAIL