In order for a generic drug pharmaceutical manufacturer to enter the market before the expiration of a patent covering an FDA-approved drug or method of treatment, it must file an Abbreviated New Drug Application (ANDA) and a Paragraph IV certification under the Hatch-Waxman Act. The certification alleges that the applicable patent listed in the FDA’s list entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” the so-called Orange Book, is invalid or will not be infringed.
The Paragraph IV certification is commonly followed by an infringement action, which results in an automatic 30-month stay of approval of the ANDA by the FDA, with resolution of validity challenges presented in the Paragraph IV notice being delayed by fact and expert discovery, and occurring after trial or by summary judgment.
IPLL’s approach is to synergize the efforts of patent prosecutors, litigators and combine regulatory expertise to set the course for the litigation. Our value proposition is placing highly skilled patent litigators with leading scientists and investigators, to navigate the matter to the most optimum solution for our clients. Core to our approach is pharmaceutical expertise from counsel having served with the nation’s most prestigious pharmaceutical companies, and a keen awareness and understanding of Federal Circuit case law. Our expertise is value driven to yield our clients the highest return on their investment dollars and years of research.