CJEU Decision in Royalty Pharma: More Clarity on Requirements for Supplementary Protection Certificates?

The headnotes of the decision are as follows:

1. Article 3(a) must be interpreted as meaning that a product is protected by a basic patent in force within the meaning of that provision if it corresponds to a general functional definition used in one of the claims of the basic patent and necessarily forms part of the invention protected by that patent, without, however, being individualized, it can be inferred as a concrete embodiment from the teaching of the patent, in so far as the product can be specifically identified by a person skilled in the art, on the basis of his general knowledge in the relevant field on the date of filing of the application or on the priority date of the basic patent and taking account of the state of the art at that date in the light of all the information disclosed by the patent.
2. Article 3(a) is to be interpreted as meaning that a product is not protected by a basic patent in force within the meaning of that provision if, although it falls within the functional definition indicated in the patent claims, it has been developed following an independent inventive step after the application for the basic patent.

The CJEU Decision

In its decision, the CJEU closely seems to follow its previous case law, particularly its recent decision in re Teva/Gilead (case C-121/17). However, it raised further interesting aspects:

• Core inventive advance: As an introductory remark, the CJEU addresses the interpretation of the decision in re Teva/Gilead. The CJEU states that the term “core inventive advance” had not be relevant for its interpretation of art. 3(a) of the SPC-decision. Rather, it would have stressed the important role of the claims according to Art. 69 EPC and the respective Protocol. The subject-matter of protection by an SPC must thus be limited to the technical features of the invention protected under the basic patent as claimed.

• Application of Criteria from Teva/Gilead: In its decision, the CJEU applied the two pronged-test as set out in Teva/Gilead. The CJEU repeats that the claims play a major role to determine whether a product is protected as per Art. 3(a). The SPC re Sitagliptin would fulfill the first prong of the Teva/Gilead test. While Sitagliptin would not be explicitly mentioned in the claims of the respective basic patent, it would fall under the functional definition of one of the claims. However, the realization of the second prong of the Teva/Gilead test would be doubtful. In particular, the referring court had asked whether Sitagliptin is specifically identifiable even though it is not identifiable as a specific embodiment. 

• Specific Identification: Therefore, the degree of the specific identification is crucial. To determine whether the second prong is satisfied, it must in particular be ascertained whether the subject-matter of the SPC concerned is within the limits of what a person skilled in the art may deduce directly and unequivocally from the patent specification of that patent, as filed, at the date of filing or at the date of priority of the basic patent, on the basis of his general knowledge in the relevant field at the date of filing or at the date of priority and having regard to the state of the art at the date of filing or at the date of priority.
  
  The grant of an SPC is principally also possible if the product cannot be individually inferred as a concrete embodiment from the basic patent. However, if the product only falls under a functional definition of the claims, the skilled person must be able to deduce directly and unequivocally from the patent specification - as filed - that the product which is the subject-matter of the SPC falls within the scope of the protection conferred by that patent.

• Relevant date: The subject-matter of the protection conferred by the basic must be determined at the application/ priority date. Considering data from thereafter may lead to an unjustified benefit from protection, even though these data were not known then. With reference to the CJEU decision in re Teva/Gilead (and i.a. the therein cited decisions Actavis/Sanofi) the CJEU stresses that it would be contrary to the objective of the SPC-Regulation if the SPC extended the scope of protection conferred by the basic patent beyond the invention protected by it.

• Independent inventive step: According to the CJEU, a product which is the subject of an European Patent or of an application and which, after the date of filing of the application or the date of priority of the basic patent, has been developed according to an independent inventive step, cannot fall within the scope of the protection conferred by that patent. In this regard it would be irrelevant if such a product fell under a functional definition of the claims in the basic patent. In case of an independent inventive step, a skilled person would not be able to specifically identify the product.

Background of the Referral

Royalty Pharma is the proprietor of European Patent EP 1 084 705 (“basic patent”). The patent relates to a method of lowering blood sugar levels in mammals by administering inhibitors of the enzyme dipeptidyl peptidase IV (DP-IV inhibitors), which helps to regulate blood sugar levels. Royalty Pharma applied for an SPC based on the basic patent and the marketing authorization for Januvia for “Sitagliptin”.

Sitagliptin belongs to the group of DP-IV inhibitors. Said product was developed after the priority date of the basic patent by a licensee and a separate patent was obtained for Sitagliptin.

The German PTO rejected Royalty Pharma’s SPC request based on Art. 3(a) of the SPC-Regulation. Royalty Pharma appealed said decision before the German Federal Patent Court who then referred the case to the CJEU.

Initially, the decision was joined with case C-114/18 (Sandoz/Searle). However, the Court of Appeal [England & Wales] referring said case, withdrew its referral following the decision Teva/Gilead. The German Federal Patent Court still requested a decision in view of remaining uncertainties on the interpretation of Art. 3(a) of the SPC-Regulation.