CJEU clarifies the use of functional patent claims to obtain patent term extensions
Supplementary protection certificates (SPCs) are a form of patent term extension in Europe that can provide up to five additional years of patent protection for medicinal and plant protection products that have gained regulatory approval. There is an additional 6 month extension also available for products subject to a paediatric investigation plan. The SPC Regulation lists the requirements for grant of an SPC. Article 3(a) of the SPC Regulation states that an SPC will only be granted if the product is protected by a basic patent in force.
The CJEU (Court of Justice of the European Union) was asked to clarify in C-650/17 Royalty Pharma whether broad functional patent claims can be used to obtain SPCs in Europe. They decided that functional patent claims covering products which were only developed after the filing date of the patent, after an independent inventive step, are not eligible for SPC protection. Their reasoning was that such products are not “protected” by such a broad basic patent because they were invented later.
Background of the referral
Royalty Pharma is the proprietor of European Patent EP1084705 (“basic patent”), which relates to a method of lowering blood sugar levels in mammals by administering inhibitors of the enzyme dipeptidyl peptidase IV (DP-IV inhibitors). Royalty Pharma applied for an SPC based on the basic patent and a European marketing authorisation for the compound Sitagliptin. However, while Sitagliptin belongs to the enzyme family protected by the basic patent, Sitagliptin was developed after the priority date of the basic patent by a licensee and a separate patent was obtained for Sitagliptin.
The German patent office refused the SPC application because, although the product was encompassed within the broad functional definition of the basic patent as a dipeptidylpeptidase (DP IV) inhibitor, the basic patent did not contain any specific disclosure of Sitagliptin either in the claims or description because Sitagliptin was not developed until after the basic patent’s filing date. Therefore, the German patent office asserted that Sitagliptin was not “protected by” the basic patent contrary to Article 3(a) of the SPC Regulation.
Royalty Pharma appealed the decision to the German Federal Patent Court arguing that the correct test for determining whether a product is protected by a basic patent is to assess the “core inventive advance” of the basic patent. Royalty Pharma argued that the core inventive advance was the use of DP-IV inhibitors for lowering blood glucose levels and that, because Sitagliptin was an example of a DP-IV inhibitor, Sitagliptin was necessarily protected by the basic patent. However, the German Federal Patent Court considered that this test was not the relevant for the assessment of Article 3(a) of the SPC Regulation, despite other national courts having applied this test. For clarity, the German Federal Patent Court referred this case to the CJEU to establish the correct test for assessing whether a product is “protected by” a basic patent when functional claims are used as the basis for the SPC application.
The CJEU considered their earlier decision in C-121/17 Teva, which established the test for determining whether a product that is a combination of active ingredients is protected by a basic patent. The CJEU decided that this test can also be applied to a product consisting of a single active ingredient covered by a functional definition for establishing whether a product is protected by a basic patent.
In Teva, the CJEU found that active ingredients do not need to be expressly mentioned in the claims to be “protected by” them. They held that the test for whether a combination product was protected by a basic patent was that, from the point of view of the skilled person in the art and on the basis of the prior art available at the priority/filing date of the basic patent:
- The combination of those active ingredient must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- Each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.
Applying those principles to the functional patent claims in Royalty Pharma’s patent, the CJEU found:
- Importantly, that the grant of an SPC for a product that falls within a general functional definition used in the claims of the patent but is not derivable from the patent as a specific embodiment in individualised form, is not in principle precluded from grant of an SPC;
- In such a case, the product is nevertheless “protected by” the basic patent if 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;
- However, in qualifying this, the CJEU held that a product which was developed only after the filing/priority date of the basic patent as the result of an independent inventive activity is not “protected by” the basic patent within the meaning of Article 3(a) of the SPC Regulation.
In practice, this may restrict the patentee’s ability to choose which patent(s) to rely on to obtain SPCs for new products, and so could restrict the overall term of any SPC depending on the filing/priority date of the basic patent. It remains to be seen how the patent offices and national courts will examine whether a product is the subject of a later inventive step that was “independent”. It is clear that if the product is not specifically mentioned in the patent specification, the patentee will need to go to greater lengths to prove when the product was developed, to ensure the correct patent is used as a basis for the SPC application.
If you have any questions concerning SPCs, please contact your usual Forresters attorney who will put you in touch with our SPC experts.