Immaterialgüter- und Wettbewerbsrecht

Extension of Exclusivity Rights for Pharmaceuticals under the European, Canadian and American Patent Systems: a Comparative Analysis

From a comparative law perspective and within the framework of the pharmaceutical industry, this thesis analyses the effects on innovation of legally extending certain exclusivity rights of the patentee beyond the 20-year term of the patent, through the grant of special intellectual property titles.

Letzte Änderung: 02.10.17

In order to be able to bring a medicinal product in 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 such authorisation to be granted, the product must have proved its safety and effectiveness in clinical trials, which 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 special intellectual property title called supplementary protection certificate (SPC) in the EU and certificate of supplementary protection (CSP) in Canada, and through the grant of an extension of the patent term in the US (commonly known as patent term extension or PTE).
The implementation of these three systems has a two-fold purpose: on the one hand, fostering research and development on new drugs, and on the other hand, safeguarding market competition and the rights of consumers to access cheaper medicines.
The present research aims at determining whether these three regimes have met their ultimate goal of promoting innovation in the pharmaceutical sector, while striking a fair balance between the interests at stake (i.e. those of the originator pharmaceutical industry, the generic pharmaceutical industry and the consumer). Within this context, it will also be assessed which of the three systems provides greater incentives for the SPC, CSP or PTE applicant to bring the product to the market as soon as possible and which of them might favour evergreening or delaying strategies.
The above-mentioned research questions will be addressed with a focus on the possibility of obtaining SPCs, CSPs or PTEs for second medical uses or doses of known active ingredients and how the SPC, CSP and PTE term is calculated by the corresponding authority. Regarding the latter, special attention will be given to the notion of “diligence of the applicant”, foreseen under the Canadian and American legislations but not in Europe, and pursuant to which the behaviour of the PTE or CSP applicant during the regulatory review period is taken into consideration for the calculation of the PTE or CSP term.



Victoria Rivas


Dr. Roberto Romandini


Prof. Dr. Dana Beldiman


Immaterialgüter- und Wettbewerbsrecht zwischen Markt und Regulierung


Rechtliche und ökonomische Rahmenbedingungen der Pharmaindustrie