Harmonizing Rules Governing SPCs for Medicinal Products

In June 2019, it was announced that a targeted recalibration of certain aspects of patent and supplementary protection certificate (SPC) protection aimed at boosting the competitiveness of regulated industries such as the pharmaceutical industry would commence under the auspice of the European Union’s (EU’s) Single Market Strategy (1). While the European Commission (EC) believes that overall, the current legislation on SPCs is fit-for-purpose, its fragmentation has been noted as an issue that needs to be addressed. To this end, the commission believes that the creation of a unified SPC grant procedure and a unitary SPC would not only strengthen the single market for pharmaceuticals, but also align SPCs more harmoniously with the EU’s twin objectives of achieving digital and green transition (2). Against this background, the EC closed a call for evidence on proposals to introduce a single procedure for granting SPCs across the EU in April 2022, to prepare an impact assessment and any necessary legislation. This initiative is aimed at amending the EU’s founding legislation on SPCs for medicinal products (Regulation (EC) No 469/2009) formulated in June 2009 (3).

Supplementary protection certificates

An SPC is a “European Intellectual Property (IP) right granted on a national basis that provides protection for a patented active ingredient or combination of active ingredients of an authorized medicine or plant protection product after expiry of the patent … and is intended to compensate delays in gaining regulatory approval and the resulting curtailment of the duration of effective protection under the patent” (4).

SPCs form a critical component of the European IP rights framework and have played a critical role in the development of innovative medicines for European Patents. European SPCs can extend the term of a medicinal or plant protection patent by up to five years, with the possibility of a further extension period of six months, dependant on circumstances (5). SPCs are designed to ‘compensate’ a patent owner to a degree, for some of the patent term that is effectively lost during the clinical trials and approval process and are available as European patents granted by the European Patent Office (EPO), or as national rights that need to be applied for via the national patent office of each member state where at least one suitable patent extension is sought (6). Once an SPC expires, innovative medicines lose their exclusivity period and become generic.

An SPC may be based on any patent which protects:

• the active ingredient(s) of the authorized medicinal or plant product
• a method of producing the active ingredient(s)
• an application of the active ingredient(s)
• a preparation containing the active ingredient(s), a condition which is more applicable to plant protection products.

To qualify for an SPC, the patent must be in force in the country where the SPC is sought at the time the SPC application is made. The scope of SPC protection is limited to the product for which a marketing authorization (MA) has been granted.

Rationale for change

On 25 Nov. 2020, the EC published its new IP action plan, in which, one of the key objectives was to improve the protection of IP rights by modernizing existing systems or reducing the complexity of existing legislation (7). The findings of the document subsequently decried the fragmented nature of the regulatory framework governing SPCs that, according to the commission, “translates into inefficiencies and a lack of transparency and predictability, which hampers innovators and generic producers, and eventually harms patients” (8).

As such, the commission is proposing legislative changes to set up a centralized SPC system that could encompass a ‘unitary’ SPC to extend the protection of unitary patents; a unified procedure for granting a bundle of SPCs covering multiple territories (equivalent to a European Patent); or a combination of the two (9). However, it is unclear which option maybe pursued.

Inefficiencies of the current system

While the conditions for obtaining SPCs are governed by the same regulations (EC) No. 469/2009 (for medicinal products) and (EC) No. 1610/96 (for plant protection products) in all EU countries, in practice, the application of these regulations often differs, thereby leading to disparities among the different member states. For example, this variance may be in relation to the granting of procedures, the length of the examination period, the SPC expiry date, and/or the outcome of the examination which may also differ from one country to another (10). To illustrate, an SPC application was refused for the combination Zetia (ezetimibe) plus Lipitor (atorvastatin) in France, whereas an SPC was granted for the same combination in Belgium (10).

Disparities also exist between member states in relation to health products that are based on innovative technologies, such as medical devices. For example, patent offices in Denmark, France, Italy, Poland, Portugal, Spain, and the United Kingdom (UK) consider medical devices as products that do not fall within the jurisdiction of SPC Regulation, whereas in Germany and the Netherlands, SPCs have been granted for such products (11). Furthermore, the question as to whether third-party observations are considered also differs from one member state to another (11). For example, French Law does not allow third-party observations for SPC applications, whereas the same is permitted by patent offices in the UK, Germany, and Denmark. With these disparities in mind, it is thought that a unitary SPC would simplify the existing system and ensure consistency between all member states of the EU.

Unified Patent Court

The impetus for this initiative is the approaching opening of the Unified Patent Court (UPC), scheduled for 1 April 2023, which will offer patent protection in up to 25 EU member states and which will allow for the granting of a unitary European patent in the participating countries. The new UPC will have exclusive jurisdiction over unitary patents and all European patents designated to participating EU member states, unless these have been opted out of its jurisdiction (12). Unitary patents will provide patent protection through a single request to the European Patent Office (EPO) and will build on European patents granted by the EPO under the rules of the European Patent Convention.

Proposed new system

Although details of how a new system would operate are yet to be determined, the EC has suggested one option comprising a ‘virtual’ examining office, made up of SPC examiners from national patent offices of member states, designed to perform the functions of a regional office (5). Another possibility is for the ‘virtual’ body to perform the functions of an international organization like the EPO, or as an EU agency such as the European Union Intellectual Property Office, which currently only deals with trademarks and designs but not patents or SPCs (9).

The ‘call for evidence’ study conducted by the EC in April 2022 does not recommend substantive amendments to the legislation. Rather, it acknowledges that a more streamlined process for granting SPCs should rationalize diverging practices and decisions, thereby providing greater commercial certainty for manufacturers of medicinal products.

References

1. EC. Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 Amending Regulation (EC) No 469/2009 Concerning the Supplementary Protection Certificate for Medicinal Products (June 2019).
2. Evroux, C. Revision of the Legislation on Supplementary Protection Certificates (Refit). European Parliament, Legislative Train Schedule, 15 Dec. 2022.
3. EC. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 Concerning the Supplementary Protection Certificate for Medicinal Products (Codified Version). 16 Jun. 2009 (Current Consolidated Version, 1 July 2019).
4. Mathys & Squire. What is a Supplementary Protection Certificate? Mathys-Squire.com/intellectual-property-services/patents/spcs (accessed 18 Jan. 2023).
5. Penningtons, Manches, Cooper LLP. Unitary Supplementary Protection Certificates (SPCs) May Become a Reality. Penningtonslaw.com, 27 Apr. 2022.
6. Mewburn Ellis. Supplementary Protection Certificates (SPCs) and Patent Term Extensions (PTEs). Mewburn.com/law-practice-library/supplementary-protection-certificates-patent-term-extensions (accessed 18 Jan. 2023).
7. EC. Document 52020DC0760. COM/2020/760 Final. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Making the Most of the EU’s Innovative Potential: An Intellectual Property Action Plan to Support the EU’s Recovery and Resilience (25 Nov. 2020).
8. Van Bael and Bellis. European Commission Looks to Harmonize Rules Governing Supplementary Protection Certificates for Medicines and Plant Protection Products. VBB.com, 25 Mar. 2022.
9. Weekes, C.; Fabre, J. European Commission Publishes Study on Options for a Unified SPC System. PinsentMasons.com/out-law/analysis, 1 Nov. 2022.
10. Labarre, I.; Touati, C. Supplementary Protection Certificates (SPC): A New IP Right to Come? Plass.com, 22 Feb. 2022.
11. EC, Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs, Romandini, R.; Slowinski, P.; Wright, G.; et al. Study on the Legal Aspects of Supplementary Protection Certificates in the EU: Final Report. Publications Office, May 2018.
12. EPO. Unitary Patent. EPO.org/applying/european/unitary/unitary-patent (accessed 18 Jan. 2023).

About the author

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 35, No. 2
February 2023
Pages: 7–8

Citation

When referring to this article, please cite it as Piachaud-Moustakis, B. Harmonizing Rules Governing SPCs for Medicinal Products. Pharmaceutical Technology Europe, 2023, 35 (2), 7–8.