Sitagliptin - CJEU

On Apr 30, 2020, The Court of Justice of the European Union (CJEU) has handed down its decision in Royalty Pharma case on interpretation of Article 3 (a) of SPC regulation.

This request was made in the course of proceedings between Royalty Pharma and the Deutsches Patent- und Markenamt (German Patent and Trademark Office, DPMA) on the latter's refusal to issue a SPC for sitagliptin used for the treatment of diabetes mellitus.

Background of the case:

Royalty Pharma is the holder of the European patent (DE) EP 1084705. This patent discloses a method of reducing the blood glucose level of mammals by injecting inhibitors of the enzyme dipeptidyl peptidase IV ('DPP IV'), which contributes to the regulation of blood sugar levels. Sitagliptin is one of the DPP IV inhibitors. On 17 December 2014, Royalty Pharma filed a SPC request for sitagliptin with the DPMA, on the basis of this basic patent and a marketing authorization Issued on March 21, 2007 by the European Medicines Agency (EMA) to Merck for theproduct,  Januvia®. That application was dismissed on April 12, 2017 by the DPMA on the grounds that the requirement in Article 3 a) of Regulation No o  469/2009 was not met. This office considered that, if sitagliptin meets the functional definition of the DPP IV inhibitor given by the claims of the basic patent at issue, the patent does not contain any specific disclosure of this product, so that the concrete active ingredient has not been known to the skilled person. Thus, according to the DPMA, the subject-matter of the protection of that patent does not correspond to the medicinal product subsequently developed and marketed under the name of Januvia. It would therefore be contrary to the objectives of Regulation No o  469/2009 issuing an SPC for a product that has not been disclosed by the basic patent at issue.

Royalty Pharma appealed against this decision to the Bundespatentgericht (Federal Patent Court, Germany). It argued that the description of the functional characteristics is sufficient for the grant of SPC. It submitted that sitagliptin meets the functional definition of a DPP IV category of active principle referred to in the basic patent at issue. According to Royalty pharma, any DPP IV inhibitor for treating diabetes mellitus falls within the “heart of the patented invention”, which covers all of the specific compounds meeting this definition. The Bundespatentgericht (Federal Patent Court) decided to stay the proceedings and to refer the following questions to the CJEU:

Questions:

"1) A product is it protected by the basic patent in force in accordance with Article 3 a) of Regulation No o  469/2009, which falls when the object of protection defined by the claims of the patent thus being delivered to the skilled person as a concrete embodiment?

2) The requirements in Article 3 a) of Regulation No o  469/2009 are they therefore not sufficiently fulfilled when the product in question certainly has the general functional definition that patent claims to give 'a category of active principle without being individualized as a concrete embodiment of the education protected by the basic patent?

3) A product is it already protected by the basic patent in force in accordance with Article 3 a) of Regulation No o  469/2009, certainly falls when the functional definition in the patent claims but was not developed until after the filing date of the basic patent application in an independent inventive step? "

CJEU analysis:

Court said that by its first and second questions, which should be examined together, the referring court asks, in essence, whether Article 3 a) of Regulation No o  469/2009 must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of this provision, when it meets a general functional definition used by one of the claims of the basic patent and necessarily falls under the invention covered by this patent , without being individualized as a concrete embodiment to be learned from the teaching of said patent. To this end, two cumulative conditions must be met as set out in “Teva V Gilead, 25 july 2018”. First, the product must necessarily fall in the light of the description and drawings of the basic patent, of the invention covered by patent. Second, the person skilled in the art must be able to identify this product specifically in the light of all the elements disclosed by the said patent, and on the basis of the state of the art at the date filing or priority of the same patent.

In the main proceedings, it is apparent from the order for reference that, if sitagliptin is not explicitly mentioned in the claims of the basic patent, it meets the functional definition used by one of the claims of that patent . In those circumstances sitagliptin necessarily falls, as a DPP IV inhibitor, from the invention covered by the basic patent and, therefore, the first condition is met. In order to determine whether the second condition is satisfied, it is more particularly for the referring court to verify whether the subject-matter of the SPC concerned is within the limits of the personskilled in the art, on the date of filing or priority of the basic patent, to deduce directly and unequivocally from the specification of this patent as it was filed, based on its general knowledge in the field considered the filing or priority date and in the light of the state of the art at the filing or priority date. It follows from the foregoing that the answer to the first two questions that Article 3 a) of Regulation No o 469/2009 must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of this provision, when it meets a general functional definition employed by one of the claims of the basic patent and necessarily relates to the invention covered by this patent, without being individualized as a concrete embodiment to be learned from the teaching of said patent, since it is specifically identifiable, in the light of all the elements disclosed by the same patent, by a person skilled in the art, on the basis of his general knowledge in the field considered on the date of filing or priority of the basic patent and of the state of the art on this same date.

By its third question, the referring court asks whether Article 3 a) of Regulation No o  469/2009 must be interpreted as meaning that a product is not protected by the basic patent in force , within the meaning of this provision, when, although falling within the functional definition contained in the claims of this patent, it was developed after the filing date of the application for the basic patent, at the end of an autonomous inventive step. In this regard, it should be recalled that, for the purposes of applying the condition set by Article 3 a) of Regulation No o  469/2009, the purpose of the protection conferred by the patent base must be determined on the filing date or priority date of this patent. Indeed, if it could be taken into account the results of research carried out after the filing date or priority date of said patent, a SPC could allow its holder to unduly benefit from protection for these results, even though these these were not known on either of these dates. It follows that a product subject to a SPC or a request for a SPC which has been developed, after the filing or priority date of the basic patent, at the end of an autonomous inventive step , cannot be considered to fall within the object of the protection conferred by this patent.

CJEU thus, has now expressly clarified that its interpretation of Article 3(a) endorsed in Teva v. Gilead does not accord any relevance to the “core inventive advance” of the basic patent. Therefore, “core inventive advance” concept has no place in interpretation of Article 3 (a) of SPC.

For these reasons, the Court held that:

1)       Article 3 a) of Regulation (EC) n o 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of this provision , when it meets a general functional definition used by one of the claims of the basic patent and necessarily relates to the invention covered by this patent, without being individualized as a concrete embodiment to be drawn from the teaching of said patent, as soon as it is specifically identifiable, in the light of all of the elements disclosed by the same patent, by a person skilled in the art,on the basis of his general knowledge in the field considered on the date of filing or priority of the basic patent and the state of the art on this same date.

2)       Article 3 a) of Regulation No o  469/2009 must be interpreted as meaning that a product is not protected by a basic patent in force within the meaning of that provision where, although that falling under the functional definition given in the claims of this patent, it was developed after the filing date of the application for the basic patent, at the end of an autonomous inventive step.