SPCs are sui-generis rights similar to patents that protect the active substances of medicinal and plant-protection products that are subject to marketing authorization. Due to the sequences of tests and experiments needed to acquire market approval for new active substances these procedures are very elaborate, which as a rule significantly reduces the effective period of validity of the underlying patents. In order to mitigate this effect, and to keep the EU an attractive location for research, the EU parliament created the SPC, an instrument allowing a de-facto extension of patent protection for up to five years. Even before the EU SPC regulations entered into force in the 1990s, nearly identical provisions had been enacted in the USA and Japan.
In substance, it is uncontested that there is a need to compensate for the shortening of the phase of exclusive marketing of pharmaceutical and plant-protection products due to lengthy authorization procedures. In the practice as well as in the literature, however, individual aspects of the current SPC system have met with criticism and calls for reform. In part this criticism has been directed at the case law of the CJEU; its rulings have led to ambiguity and inconsistencies with respect to central provisions of the SPC regulations whose clarification may require an intervention on the part of the legislature. Furthermore, the generics industry in particular has criticized a lack of balance in the current form of the system. And finally, a need for reform has resulted from the plans to create a patent with unitary effect in the internal market (“unitary patent”), because the SPC regulations do not currently provide for such a uniform certificate of protection.
The Institute was commissioned by the European Commission to examine the questions at issue in this context. Besides carrying out a legal analysis of the foundations of the SPC regulations and their development in case law and practice, the Institute also collected empirical data via surveys (conducted by IfD Allensbach) among affected parties as well as national patent offices, via structured interviews, and from patent registries, and the insights gained from these were subsequently tested and explored in further detail in workshops. Furthermore, extensive reports on extra-European legal systems were prepared in the context of this study which functioned as background material for the legal observations.
Study and Annexes (https://ec.europa.eu/docsroom/documents/29524)
