The Commission looks again at SPCs in the EU

This article is part of our Biotech Review of the Year - Issue 11 publication

On 27 April 2023 the Commission put forward new proposals for the Supplementary Protection Certificates (SPCs) for medicinal and plant protection products.

This took the form of 4 different proposals.¹ Of particular interest to readers will be the recast proposal for the regulation on SPCs for medicinal products² and the proposal for Unitary SPCs (uSPCs) for medicinal products.³  The introduction of a scheme for a uSPC had overwhelmingly been supported by industry and professionals. Further, changes to the current SPC Regulation⁴ were also much needed given a number of references to the Court of Justice of the European Union (CJEU) on the SPC Regulation over the last decade. 

The recast proposal for the regulation of SPCs for medicinal products

The recast proposal suggests changes to the procedure as well as the substance of the underlying SPC law which users of the system will be familiar with. On the procedural side, it proposes a centralised application procedure. This procedure would be a requirement for those who have a centralised marketing authorisation in the EU and would be applying for an SPC (or an extension to a SPC) on the basis of a European Patent. Applications for an SPC under the proposals in these circumstances would be made to the European Union Intellectual Property Office (EU-IPO) who would consider it through an examination body made up of 2 people from national IPOs experienced in the grant of SPCs. Following examination, the EU-IPO would issue an opinion which, if positive, would be transmitted to the national patent offices in each of the countries where an SPC is sought. The national office would then have to implement the opinion and grant a national SPC. It is proposed that third parties may submit observations during the application procedure and have the ability to file an opposition against the opinion issued by the EU-IPO. Appeals would also be possible against opinions issued, with an ultimate right of appeal to the CJEU in certain circumstances. 

In relation to the substantive provisions of law, the proposal suggests it is making updates on clarification to already established law. However, this was met with some surprise in relation to at least 2 provisions. First, the proposal seeks to amend Article 3 of the SPC Regulation (conditions for grant of an SPC) to introduce a restriction that more than one certificate cannot be granted to two or more different patents for the same product where those holders are economically linked. 

Second, the proposal seeks to amend Article 6 (entitlement to an SPC) in that where an authorisation is held by a third party (and not the patent holder), a certificate based on that product will not be granted to the holder of the basic patent without the consent of the third party marketing authorisation holder. Both these provisions have been subject to CJEU references which are unanswered and remain live issues within the SPC community. 

The uSPC proposal 

This proposal is applicable to the newly-established European Patents with unitary effect. The procedure for obtaining a uSPC is essentially the same as that for centralised marketing authorisations referred to above. However, at the end of the examination procedure by the EU-IPO, the office would grant the uSPC (as opposed to issue an opinion). It would also be possible under the proposals to make a combined application, in which applicants can seek a uSPC in the 17 Members States of the UPC plus an SPC in EU member states not participating in the UPC as part of a single application examined by the EU-IPO. Appeals of decisions to grant uSPCs would be possible, in a similar way to those against opinions issued following a centralised application. Further, the proposal envisages claims of invalidity to uSPCs being made to the EU-IPO as well as making provision for the holder of a uSPC to apply to the court in any counterclaim for invalidity to stay the proceedings before the court and transfer the invalidity case for the uSPC to be heard by the EU-IPO. 

The SPC manufacturing waiver

Introduced in 2019, the SPC Manufacturing Waiver Regulation⁵ was provided to remedy a competitive disadvantage that generic and biosimilar manufacturers faced in terms of manufacturing, particularly for export to third countries, during the lifetime of an SPC. 

While still in its relative infancy as a part of the SPC system in Europe, Article 5 of both the proposed recast SPC Regulation and the proposed uSPC Regulation transpose the provisions of the SPC Manufacturing Waiver Regulation into the proposed legislation. The only substantive change to the waiver provisions is in the proposed uSPC Regulation, where the notification requirement has been amended to require the maker to inform the EU-IPO of their intention to use the waiver (in addition to the rights holder and the competent authority in the Member State of making).

Whilst the wording of Article 5 of the recast SPC Regulation and the proposed uSPC Regulation closely mirrors that of Regulation (EU) 2019/933, there have been fairly extensive deletions to the associated Waiver recitals. In circumstances where the underlying provisions remain largely unchanged, it is not clear why the explanatory text has been removed, or the consequences that this will have on the interpretation of the provisions.

Comments from stakeholders on the new proposals

In September 2023 a number of stakeholders made comments on the proposals. These overwhelming concerned whether the EU-IPO is the correct body to examine SPCs under this new regime and requested more detail on how the panels will be set up and expertise put in place to ensure the applications are reviewed appropriately. There were also a number of comments on whether it is appropriate for oppositions to be made pre-grant. This could delay an SPC from being granted and could even, in some cases, mean that an SPC would not be granted before the underlying basic patent expires which would lead to uncertainty for all parties. Comments were also made by stakeholders about the clarifications, mentioned above, made to the substance of the law. 

Next steps

The proposals are making their way through the committee stage at the European Parliament. The rapporteur issued his reports in October 2023 and in November 2023 with some suggested amendments to the drafted text, including to those in Article 3 on whether an entity is economically linked. The proposals are tabled for their first reading in Parliament on 26 February 2024. It will be interesting to follow the amendments and timetable for this legislation, given the upcoming parliamentary election in early summer 2024. 

Additionally, the SPC Manufacturing Waiver Regulation itself will face its first 5 yearly review in summer 2024. With comments on the workings of this system having been made by Medicines for Europe during 2023 and the first cases under this Regulation starting to emerge (e.g. the Janssen Biotech v Formycon case in Germany), any developments to this Regulation or the way the waiver provisions are transposed into the proposed recast SPC Regulation and the proposed uSPC Regulation should be carefully monitored.

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^{1 2 in relation to plant protection products and 2 in relation to medicinal products
2 COM(2023) 231
3 COM(20203) 222
4 Regulation (EC) No 469/2009
5 Regulation (EU) 2019/933}