Do rules experience culture shock? – Interpreting Article 3(a) of the Supplementary Protection Certificate Regulation: is the donor rule faulty or is the transplanted rule incompatible with its new legal environment?

In order to stimulate product development and innovation in the pharmaceutical industry, the United States Congress in 1984 enacted Title II of the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), also known as the Hatch-Waxman Act. One goal of the Hatch-Waxman Act was to extend patent life to compensate patent holders for a portion of the patent term lost while awaiting review of the safety and efficacy of the product by the Federal Drug Administration.