Protecting Pharmaceuticals at the Intersection of Patent and Regulatory Law
Over three decades ago, the United States Congress passed the Drug Price Competition and Patent Term Restoration Act. This piece of legislation, known as the Hatch-Waxman Act, tackled the difficult task of protecting pharmaceutical innovator intellectual property while ultimately providing increased competition and decreased cost to consumers through accessible generic drugs. This legislative task was accomplished with two pieces of intersecting laws: (i) the patent provisions under 35 USC which provide for up to five additional years of patent term extension and (ii) the drug exclusivity provisions under 21 USC 355 which provide certain regulatory and marketing exclusivity periods upon drug approval. The intersection of these patent and regulatory/marketing exclusivity periods provide innovator drug developers with a net exclusivity period. Given the immense monetary and time investment for developing new drugs, maximizing this net exclusivity should be a major focus of patent practitioners in the pharmaceutical field. By maximizing this net exclusivity, innovator drug developers can recoup their investment, as well as provide a stable foundation and incentive for continued drug discovery. To understand how to maximize this window, those involved need to understand the important role this intersection of patent and regulatory law holds.