Test for obtaining SPCs clarified in Royalty Pharma case

Supplementary Protection Certificates (SPCs) serve to extend the life of a patent by up to a maximum of five years for products which are authorised under the relevant regulatory framework in the field of medicinal and plant products.

Under the SPC Regulation, SPCs can only be granted if, in the EU country in which the application is submitted, the product is protected by a basic patent in force and market authorisation has been issued to place that product on the market as a medicinal product, so long as that authorisation is the first of its kind and an SPC has not already been issued for the product.

In a case referred to it by the German Federal Patent Court, the Court of Justice of the EU (CJEU) was asked to clarify what criteria needs to be satisfied for a product to be 'protected' by a basic patent, under the Regulation.

The German court asked the CJEU to help it interpret EU law to enable it to rule on an underlying dispute between Royalty Pharma Collection Trust and the German Patent and Trademark Office. The dispute is over whether sitagliptin, a product developed by a licensee of Royalty Pharma for treating diabetes, meets the test for SPC eligibility by qualifying as product 'protected' by a basic patent.

In a preliminary ruling, the German Federal Patent Court said it believed it was relevant to assess whether the product had formed part of the "core inventive advance" of Royalty Pharma's underlying patent. However, the CJEU has now confirmed that this test is irrelevant to the question of whether a product is 'protected' by a basic patent for the purposes of the SPC Regulation.

Reaching that view, the CJEU referred back to a two-part test it had outlined for determining whether a product is 'protected' by a basic patent in a previous case between a number of generic medicines manufacturers and Gilead, known as the Teva v Gilead test.

In the Teva v Gilead case the CJEU said that the combination of the active ingredients of a product must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and that each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent. The assessment of whether that criteria is met must be carried out through the eyes of a "person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent". The combination of active ingredients does not need to be expressly mentioned in the claims of the basic patent if those claims relate necessarily and specifically to that combination.

In its latest ruling the CJEU confirmed that while an SPC must be limited to the technical characteristics of the invention protected by the basic patent, there is no requirement that SPC applicants must overcome a 'core inventive advance' test to meet the criteria for eligibility.

The CJEU said a product covered by a functional definition in the basic patent is not precluded from being viewed as 'protected' by that patent, provided that the product is necessarily and specifically covered by one of the claims in the patent. The CJEU reiterated that for this assessment, the two-limb test set out in the Teva v Gilead case must be met.

The CJEU also held that where a product is covered by a functional definition in a claim in a basic patent but is not individualised, that product is protected by a basic patent in force only if the product necessarily forms part of the invention protected and can be specifically identified by a person skilled in the art, on the basis of his general knowledge in the relevant field on the filing or priority date of the basic patent, taking account of the state of the art at that date in the light of all the information disclosed by the patent.

In its judgment, the CJEU also confirmed that the relevant date for assessing the subject matter of the protection covered by the basic patent is the filing or priority date of the patent. An SPC cannot be based on a basic patent if the relevant product was developed after the filing date of the patent following an inventive step.

According to the CJEU, it would be contrary to the aim of the SPC Regulation to take into account the results of research carried out after the filing or priority date of the patent as this would extend the scope of protection afforded by the patent beyond the invention it protects.

The CJEU therefore held that a product which is the subject of an SPC and was developed after the application for the basic patent following an independent inventive step, cannot be covered by the basic patent even if it falls under a functional definition in the patent claims.

In relation to the underlying dispute in Germany, the CJEU said it is up to the German Federal Patent Court to first determine whether sitagliptin is the specific type of inhibitor Royalty Pharma claims it is. If it does, the CJEU said it is of the view that the product would be covered by a functional definition in the patent claims and would therefore fall under the invention covered by the basic patent, thereby satisfying the first limb of the test developed in the Teva v Gilead case.

However, the CJEU said it is doubtful that the skilled person would be able specifically to identify sitagliptin, which is not individually identified in the patent. If that view is shared by the German Federal Patent Court, the product would not satisfy the second limb of the Teva v Gilead test and therefore not be eligible for an SPC.

Patent law expert Samantha Carter of Pinsent Masons, the law firm behind Out-Law, said: "It is pleasing to see that the CJEU has followed its earlier decision in Teva v Gilead but has also helpfully sought to clarify the position with regard to the 'core inventive advance' test and the relevant date for assessing whether a product is protected by a basic patent. This should assist in the harmonisation of relevant future decisions in the national courts and authorities."

Jules Fabre, who specialises in patent litigation at Pinsent Masons, said some issues remain unresolved, however.

Fabre said: "Unfortunately the CJEU did not get the opportunity to confirm whether this approach for functional claims should apply to patent claims using so-called Markush formulae as well. Markush claims are claims which encompass a very large class of compounds – potentially millions – sharing a common structural element, with substituents to be chosen within the class. These claims specifically disclose the chemical structure of only a very limited number of all the compounds they intend to cover."

"This was the question asked to the CJEU in another case, Sandoz v Searle, which was joined and heard together with the Royalty Pharma case. The SPC in question related to the product darunavir and the basic patent featured a Markush claims encompassing darunavir. However, darunavir was not specifically disclosed. The advocate general, in a non-binding opinion in the darunavir case, took the view that the two part test of from the Teva v Gilead case should also apply to Markush claims. As the case was subsequently withdrawn, however, the CJEU did not address the question in its ruling," he said.