The wake of FTC v. Actavis: practical implications on the pharmaceutical industry

摘要

In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch—Waxman Act, attempts to balance a public interest in having generic pharmaceutical products while maintaining incentives for innovator companies [l]. Under the Act, a generic drug manufacturer may challenge a patented drug by filing an Abbreviated New Drug Application ('ANDA') for a proposed generic product, together with an appropriate certification. The most common of the latter certifies that the proposed ANDA product does not infringe the patent or patents covering the drug as listed in the US FDA's Orange Book, and/or that the patents are invalid or unenforceable. In response, the innovator often initiates patent litigation to protect its market exclusivity.