Interaction of Patent Protection and Market Access in the Medical Technology and Pharmaceutical Sector – A Transatlantic Comparison of Patent Law and Authorization Procedures

Abstract This opinion examines the relationship between patent protection and authorization procedures in the field of medical technology and compares the regulatory conditions in the US and the EU. In the US, the Hatch–Waxman Act provides for a close link between intellectual property and the authorization system, including patent extensions and data exclusivity. The EU has so far lacked similar measures. The resulting ‘patent time loss’ leads to strategic challenges for European manufacturers. This article highlights existing research gaps and the need for reforms.