Our attorneys represent clients in FDA administrative hearings as well as in litigation brought by the U.S. Government on behalf of the FDA such as seizures and injunctions, FTC informal and formal administrative hearings and litigation, in suits brought by competitors concerning false advertising, trademark copyright, and patent infringement, and in NAD proceedings.
Our attorneys have experience in all aspects of Hatch-Waxman litigation, including patent infringement suits brought under that legislation. We also advise other law firms on FDA-related issues involving the Hatch-Waxman Amendments, intellectual property, product liability, consumer fraud and other litigation involving FDA-regulated products.
Transactional Business Assistance
Our qualified FDCPA attorneys assist clients in business transactions involving corporate acquisitions, licensing agreements and co-marketing plans, distribution agreements, confidentiality agreements, consulting agreements, exclusivity sharing agreements, and other agreements involving FDA regulated companies and products. These activities include due diligence for corporate and product acquisitions, review of SEC filings and financing offerings, and developing strategies that clients may use to extend patent and exclusivity protection for their drug products. We routinely advise both manufacturers and clinical research institutions on clinical research investigator research agreements, as well as preparation of all necessary agreements.