Immaterialgüter- und Wettbewerbsrecht

Is There a Need for Implementation of Due Diligence or Other Control Mechanisms in the EU-SPC System? A Comparative Analysis with the US-PTE System

The present research work aims at determining whether there is a risk of undermining the purpose of the Regulation (EC) No 469/2009 through strategic use of the SPC System by the applicant and, if so, how such a risk could be mitigated.

Letzte Änderung: 10.01.19

In order to be able to bring a medicinal product onto the market, pharmaceutical companies are required to obtain a marketing authorisation from the health authorities of the country in which territory the product is intended to be placed. For this authorisation to be granted, the product must have proved its safety and effectiveness in clinical trials that generally last between 10 and 12 years. Consequently, once a patent has been granted for an active ingredient or a combination of them contained in a drug, originator pharmaceutical companies must spend, in the best cases, half of the patent lifetime collecting the clinical data necessary for the obtention of an authorisation enabling the product to enter the market. This creates an unfair situation for pharmaceuticals in comparison to other inventions that are able to enter the market as soon as the patent is granted. Within the field of patent law, such a disparity is compensated with the grant to the patent holder of a sui generis right called supplementary protection certificate (SPC) in the EU and through the grant of an extension of the patent term in the US (commonly known as patent term extension or PTE).
With regard to the existing European legislation on SPCs (i.e. Regulation (EC) No 469/2009), the original intention of the legislator consisted of the creation of a uniform system at the Community level with standardised requirements for the grant of SPCs, which not only prevented the fragmentation of the Single Market, but also, on the one hand, fostered R&D on new drugs and on the other hand, struck a fair balance between all interests involved  (i.e. those of the originator pharmaceutical industry, the generic pharmaceutical industry and the consumer).
Under the existing SPC System in the EU, two situations that could potentially undermine the above-mentioned legislative intention through strategic use of the System have been identified, namely:
a)    intentional delay of the clinical studies and the marketing authorisation procedure by the SPC applicant
b)    possibility of obtaining SPCs for patents on follow-on products (i.e. patents on new uses, dosages or forms of known components)
The risk that the above-mentioned situations occur in practice seems to have been effectively mitigated in the US. For this reason, this work will assess whether the PTE System could be taken as a model by the European legislator, should the SPC Regulation be amended in the future.



Victoria Rivas


Dr. Roberto Romandini


Prof. Dr. Dana Beldiman


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