Revision of the European Supplementary Protection Certificate System

Author: Vilhelm Schröder

Introduction

The supplementary protection certificate (“SPC”) system for medicinal products in the EU is currently under revision. The Commission is planning to introduce a novel unitary SPC regulation as well as revise the existing SPC Regulation. On 27 April 2023, the Commission issued proposals for both the recast of the SPC Regulation and the new unitary SPC regulation.

The objective of the two proposed SPC regulations is to simplify the SPC system and make SPCs more accessible and efficient in the health sector. Furthermore, the proposals aim to improve the market positions of European manufacturers of medicinal products by encouraging R&D efforts in the health sector.

The current SPC Regulation has resulted in a large amount of referrals and case law from the Court of Justice of the European Union (”CJEU”). As a consequence of CJEU case law, the interpretation of the SPC Regulation is still unclear on certain central points. While the main scope of both of these renewals is on clarifying the existing SPC framework and creating a new unitary SPC system, some changes in the legal environment will likely follow also for traditional SPCs since CJEU case law interpretations have been proposed to be incorporated into the recast regulation.

The Novel Unitary SPC System

Currently, while European unitary patents for medicinal products can be applied for in a centralised procedure, SPCs can only be applied for individually in each Member State. The new unitary SPCs will complement European unitary patents which relate to medicinal products. The basic patent under the new unitary SPC Regulation will therefore be a unitary patent, so it would not be possible to apply for a unitary SPC for a national patent or a European patent that does not have a unitary effect.

While the core substantive provisions applicable to the unitary certificates remain the same as those of the existing SPC system, the proposed regulations would create a new centralised procedure handled by the European Union Intellectual Property Office (“EUIPO”) for issuing the unitary SPCs. There would also be a combined application procedure for acquiring a unitary SPC for the Member States in which the basic patent has a unitary effect as well as national SPCs in Member States not covered by the underlying European unitary patent. Double protection by both a unitary SPC and a national SPC would not be allowed.

Applicants who receive a negative decision from the EUIPO would be able to appeal to the Boards of Appeal of the EUIPO and further to the CJEU. Litigation regarding unitary SPCs will be conducted before the body with competence to revoke the underlying patent, or before the Unified Patent Court (“UPC”), provided of course that the UPC has jurisdiction in the matter and the definition of an SPC in the Agreement on the Unified Patent Court (“UPCA”) is amended to allow for this.

Changes to the Existing SPC System

As the original SPC Regulation has been amended on multiple occasions and requires further amendments to be compatible with the new unitary SPC system, the EU legislator has decided to recast the entire Regulation in the interest of clarity. While the proposal explicitly states that the intention is not to alter the substantive legal framework for traditional SPCs and national SPCs can still be applied for regularly, there are a few clarifications and adjustments which may impact the current legal framework of traditional SPCs. However, the main focus of the amendments to the old SPC Regulation is setting up the new centralised procedure as well as ensuring combability with the new unitary SPC system.

The proposal creates a centralised procedure to grant multiple national SPCs by filing a single centralised SPC application. The procedure is mutatis mutandis the same as the centralised procedure for acquiring a unitary SPC. The examination of the application is proposed to be conducted by the EUIPO in close cooperation with national IP offices, while the actual SPCs will be granted by the national offices. The competence of national offices remains unchanged.

The new recitals of the recast proposal also aim to clarify questions which have been reoccurring before the CJEU. Firstly, recital 8 of the recast sets out that one of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art by the description of the patent on its filing date. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. In the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims, provided that each of them is specifically identifiable in the light of all the information disclosed by that patent.

Secondly, as stated in recital 9, in order for a certificate to be granted, the product or any therapeutically equivalent derivative should not have already been the subject of a prior certificate. It would be required that the product, or any therapeutically equivalent derivative, such as salts, esters, ethers, isomers, mixtures of isomers, complexes, or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one.

Thirdly, the proposal clarifies that the SPC rights cover not only the product itself, but also therapeutically equivalent derivates of the product. According to recital 11 of the recast, this entails that the certificate holder can prevent a third party from manufacturing not only the product identified in the certificate but also therapeutically equivalent derivatives of that product, such as salts, esters, ethers, isomers, mixtures of isomers, or complexes, as well as biosimilars, even where such derivatives are not explicitly mentioned in the product description on the certificate.

Fourthly, recital 12 of the recast sets out that the holder of more than one patent for the same product should not be granted more than one SPC for that product. However, where two patents protecting the product are held by two patent holders, both holders could each be granted an SPC for said product, provided that they can demonstrate that they are not economically linked. Moreover, recital 12 also sets forth that an SPC cannot be granted to a patent holder when a third party holds the marketing authorisation for the product without the consent of said third party (so-called third-party SPCs).

It remains to be seen how the adjustments of the recast may impact SPC protection. If a new unitary SPC will be introduced in the EU, this will be a significant administrative change for the innovative pharmaceutical industry. The application of both regulations will begin a year after entry into force. The regulations will also be subject to evaluations conducted on a five-year basis. The proposed regulations will be subject to discussion between the European Parliament and the Council of the European Union before the proposals can move forward.

Sources:

Proposal for a Recast of the Old SPC Regulation

Proposal for the New Unitary SPC System