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May a part of a fusion protein be considered an "active ingredient"? Yes, says the ECJ in Forsgre

Authors: Dr. Oliver Ladendorf, Dr. Alexander Kleefen

Supplementary protection certificates (SPCs) compensate for the delay in commercializing patented medicinal or plant protection products, which is caused by marketing authorization (MA) procedures that are a prerequisite for placing the respective product on the market. In many cases, the extended protection conferred by SPCs is a necessary instrument for applicants to render the development of new plant protection and medicinal products profitable at all. They may therefore be regarded as pivotal incentives for innovation in their respective fields.

In order to obtain an SPC, it is necessary, inter alia, that the product is protected by a basic patent and is subject of a MA. These requirements are set out in Article 3 (a) and 3 (b) of EC Regulation (ECR) 469/2009, respectively.

In the recent years, a controversial debate emerged about how Article 3 (a) should be interpreted with regard to combination products. […]

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