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Clifford Chance

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Draft SPC Regulations propose creation of unitary SPC and centralised examination procedure

Creation of unitary SPCs

The purpose of the unitary SPC is to complement European patents with a unitary effect ("EPUEs"), avoiding the need for such patents to be extended by national SPCs granted independently by Member States' authorities, which would undermine their unitary nature. According to the proposed regulations, the unitary SPC will be effective in all Member States in which the basic patent has unitary effect. It is not intended to replace national SPCs but to coexist with them; in fact, nothing in the proposed regulations prevents a national SPC from having a EPUE designated as its basic patent.

To ensure consistency between national and unitary SPCs, the examination procedure to grant a unitary SPC will be the same as that envisaged for "centralised SPC applications" (applications for the grant of national SPCs in Member States designated by the applicant following a single examination procedure), as explained below.

The provisions governing the substantive conditions for grant, duration, and effects of unitary SPCs are identical to those under the existing SPC regime.

Centralised SPC examination procedure

The other two proposed regulations published on 27 April introduce amendments to the current SPC Regulations, establishing a centralised examination procedure with the intention of simplifying the existing SPC system, reducing costs, and tackling the fragmentation between Member States – and resultant legal uncertainty – when it comes to granting or refusing SPCs.

In the case of medicinal products, the centralised procedure is mandatory when: (i) the basic patent is a European patent (a "classical" EP patent or a EPUE) and (ii) the marketing authorisation has been granted through the centralised procedure. For plant protection products, this procedure will be available when the basic patent is a European patent and at least one national marketing authorisation has been obtained.

Applicants will be entitled to use the centralised procedure to apply for a unitary SPC, national SPCs (filing a single application and designating those Member States where SPCs are sought) or a combination thereof (i.e. a unitary SPC for Member States where the basic patent has unitary effect, and national SPCs for the other Member States).

Applications for SPCs before a national patent office will thus be residual, reserved for unlikely cases where the designated basic patent is a national patent, or – for medicinal products – when the corresponding marketing authorisation was not obtained via the centralised procedure; as stressed by the explanatory memorandums accompanying the proposals, most authorisations are currently obtained via the centralised procedure.

A central authority is appointed to conduct the centralised examination procedure; specifically, a new SPC Division within the EUIPO (which to date has had no responsibility for or experience in patents or SPCs). Examination of the substantive conditions for grant will be entrusted to a panel composed of a member of the EUIPO plus two qualified examiners belonging to Member States' national patent offices.

The proposed regulations also envisage submitting third-party observations concerning the eligibility of the SPC within the three months following publication of the application. After assessing the application for all the relevant Member States, the EUIPO will issue a reasoned opinion, which may be challenged by a third-party opposition (to be filed within two months before the EUIPO) or appealed by the applicant (within two months before an EUIPO Board of Appeal). Decisions handed down by the Board of Appeal may in turn be contested before the General Court of the EU and ultimately before the CJEU, if the admissibility criteria are met. The ability to file third-party observations or post-grant oppositions against an SPC grant is a novelty with respect to several Member States' current regimes.

Following grant of the unitary SPC, the proposals introduce the possibility for third parties to apply for a declaration of invalidity before the EUIPO.

As for national SPCs, once a final examination opinion has been handed down it will be submitted to the national authorities of the designated Member States, which will be bound by the opinion with some limited exceptions (for example, if the basic patent has been revoked in a designated Member State).

New recitals and clarifications

The substantive requirements to obtain an SPC (Article 3 of the existing SPC Regulations) remain unchanged in the proposed regulations. In this regard, the explanatory memorandums accompanying them state that there is no intention to "modify, nor further clarify" those requirements. The reason, according to the memorandums, is that CJEU case law is "progressively but effectively converging, and steadily reducing uncertainty" (although immediately thereafter it is acknowledged that "further clarifications are, however, necessary in certain areas", citing pending referrals C-119/22 and C-149/22).

The above notwithstanding, the proposed regulations use the recitals to reflect certain CJEU case law on Article 3; in particular, the judgments – identified as "settled case law" by the explanatory memorandums – handed down in cases C-121/17 and C-673/18 (on Articles 3(a) and 3(d), respectively) and in case C-471/14, on the interpretation of the date of the first marketing authorisation (i.e. the date on which the addressee was given notification of the decision granting the authorisation). To what extent the inclusion of these new recitals will actually curtail further interpretative doubts remains to be seen.

The proposed regulations also introduce language to clarify certain unresolved issues. For example, they set out that an SPC will not be granted to the holder of a basic patent in respect of a product that is the subject of a marketing authorisation held by a third party without such party's consent (so-called "third-party SPCs"). The possibility of obtaining such SPCs (sometimes called "SPC squatting" when the use of the marketing authorisation is not consented to) is thus far not entirely clear; a referral for a preliminary ruling was submitted by the High Court of Justice (England and Wales) in case C-239/19, but it was declared inadmissible by the CJEU.

The approval process for the four proposed SPC Regulations is still in the early stages; more light will be shed on the implications of the new SPC regime as the process nears completion.

Key issues

  • The proposed regulations create a unitary SPC to extend European patents with unitary effect in all Member States in which such patent has unitary effect.
  • The proposed regulations establish a centralised examination procedure entrusted to the EUIPO and envisaged for, most likely, the majority of SPC applications (both unitary SPCs and national SPCs granted by the national authorities following the binding centralised examination opinion).
  • The substantive requirements to obtain an SPC are not changed, but the proposed regulations include language intended to reflect certain CJEU case law and aimed at clarifying certain unresolved issues, such as "third-party SPCs".
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