Intellectual and industrial property 2020/06/05
C‑650/17 (Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt)
Judgement of the Fourth Chamber
30 April 2020
The Court of Justice of the European Union ruled that, in order to obtain a supplementary protection certificate, a medicinal product is only required to meet a general functional definition used by one of the claims of the basic patent in force without being explicitly stated in that patent. The Court also held that a product does not enjoy the protection of a basic patent if it has been developed after the filing date of the application for that patent following an independent inventive step.
The dispute concerned the interpretation of Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products: Is a product protected by the basic patent in force only when it forms part of the subject-matter of protection defined by the claims of the patent? Is it sufficient that the active ingredient constituting the product meets a general functional definition given by the claims, or is an explicit indication of the product required in order for it to be considered an integral part of the method protected by that patent? In addition, the applicant raised the question of whether a product is protected by the basic patent if it was developed after the filing date of the application of the basic patent through as a result of an “independent inventive step”.
Royalty Pharma is the proprietor of a European patent (the basic patent) which covers a method for treating diabetes mellitus, namely the regulation of blood sugar levels by injecting enzyme inhibitors. In 2014, Royalty Pharma filed an application for a supplementary protection certificate (SPC) for sitagliptin in connection with the basic patent and with a market authorisation for the medical product called “Januvia”, which consists of sitagliptin. Sitagliptin is a type of inhibitor of an enzyme that contributes to the regulation of blood sugar levels. It was developed by a licensee of the basic patent after the filing date of the application for this patent. The developer was granted a new separate patent for sitagliptin.
In 2017, the German Patent and Trademark Office (the “DPMA”) refused to grant the SPC for sitagliptin to Royalty Pharma on the basis of Article 3 of Regulation (EC) No 469/2009. According to the DPMA, sitagliptin only meets the functional definition of an inhibitor in accordance with the claims of the basic patent, but the patent does not contain any specific disclosure of the product so that the active ingredient could not be provided to an expert. Hence, the DPMA considered that the subject matter of the protection of the basic patent does not correspond to the medicine subsequently developed and marketed under the name Januvia ;Therefore, the DPMA decided that the application for a supplementary certificate remains unjustified. Royalty Pharma appealed against the decision of the DPMA to the Federal Patent Court (Bundespatentgericht), which stayed the proceedings and referred the previously mentioned questions to the Court of Justice.
The Court first considered that a product is protected by a basic patent if “it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent“. Following the judgement of Teva UK and Others (C-121/17), the Court found that the active ingredient concerned must necessarily and specifically be covered by the claims of the patent that explicitly or implicitly relate to the active ingredient. According to the Court, a state of the art person must also be objectively able to infer directly and unambiguously from the specification of the patent as filed that the product covered by the SPC falls within the scope of the subject matter protected by the patent.
Moreover, the Court held that a product is not protected by a basic patent if it was developed after the filing date of the application for the basic patent following an independent inventive step. The Court thus argued that the grant of an SPC in this case could enable its holder to unduly benefit from protection for research results that were unknown at the filing date or priority date of the patent. Therefore, allowing such an SPC would be contrary to the objective of Regulation (EC) No 469/2009.
This judgment sets a precedent which will encourage patent authorities and national courts to carefully examine existing patents in the context of SPC applications so that SPC are not granted to products that result from an inventive and independent activity.