Supplementary protection certificates (SPCs) in Europe

What an SPC is, and what it protects

An SPC is not a patent extension in the strict sense. It is a separate right, granted by a national patent office, that takes effect at the end of the basic patent's lawful term (Art. 13(1) Regulation 469/2009). It confers the same rights as the basic patent and is subject to the same limitations (Art. 5(1)), but only for the product covered by the marketing authorisation and for any authorised use of that product as a medicine (Art. 4).

"Product" has a narrow meaning: the active ingredient, or combination of active ingredients, of a medicinal product (Art. 1(b)). So an SPC on a blockbuster drug protects the molecule as authorised, not every claim of the patent. A patent with 40 claims covering a compound class, salts, formulations and uses yields one SPC for the authorised active ingredient, in each country where you apply.

The basic patent can be a national patent or a European patent, including a Unitary Patent. Either way the SPC is filed with the industrial property office of each member state that granted the patent, or on whose behalf it was granted, and in which the authorisation was obtained (Art. 9(1)). The EPO plays no part. Plant protection products such as herbicides and fungicides have a parallel regime under Regulation (EC) No 1610/96; this guide focuses on medicines.

Eligibility: the four conditions of Article 3

All four must be met in the member state where you apply, on the date you apply. Most SPC litigation in the Court of Justice has been about what (a) and (d) mean.

The case law that decides most disputes

• Teva, C-121/17 (25 July 2018): a combination not expressly named in the claims is protected under Art. 3(a) only if the claims relate "necessarily and specifically" to it. Each ingredient must be specifically identifiable, and the combination must fall under the invention covered by the patent.
• Royalty Pharma, C-650/17 (30 April 2020): a product covered only by a functional definition in the claims can qualify if a skilled person could specifically identify it at the filing or priority date. A product developed later through an independent inventive step does not.
• Santen, C-673/18 (9 July 2020): an authorisation for a new therapeutic application of an active ingredient already authorised for another use is not a "first" authorisation under Art. 3(d). The Court expressly departed from its 2012 Neurim reasoning, so second medical use SPCs are effectively closed.
• Teva and Merck Sharp & Dohme, joined C-119/22 and C-149/22 (19 December 2024): naming a product in the claims is not enough for Art. 3(a); it must also fall under the invention as the skilled person reads the description and drawings. An A+B combination can be protected where the patent teaches A alone or with B, B being in the public domain, provided the combination falls under the invention. Art. 3(c) does not bar an SPC for A+B just because A alone already had one.

The drafting lesson is clear. If you expect a combination product, the specification should explain why the combination is part of the invention, and the claims should name it, not leave it to a generic "further active agent" clause. Our guide on how to write patent claims covers dependent claims that can carry such combinations.

How long an SPC lasts: the formula and a worked example

Article 13 sets the term in two steps:

1. Take the period between the filing date of the basic patent and the date of the first marketing authorisation anywhere in the EU, and subtract five years (Art. 13(1)).
2. Cap the result at five years from the date the SPC takes effect (Art. 13(2)). Add six months if the paediatric extension applies (Art. 13(3)).

Because the patent runs 20 years from filing, the formula collapses into a simple rule: the SPC expires 15 years after the first EU authorisation, or 5 years after the patent expires, whichever comes first. Two points catch people out. The authorisation that counts for the term is the first one in the EU, even if you apply in a country where the product was authorised later. And for a centralised EMA authorisation, the date is the day the Commission's decision was notified to the applicant, not the decision date (Seattle Genetics, C-471/14, 6 October 2015).

Worked example

A European patent for a new kinase inhibitor was filed on 10 March 2012, so its 20-year term ends on 10 March 2032. Here are three possible dates for the first EU marketing authorisation.

• September 2021: 9 years 6 months 5 days, minus 5 years, gives 4 years 6 months 5 days. Added to 10 March 2032, that is 15 September 2036, exactly 15 years after the authorisation.
• June 2024: the raw result is over 7 years, so the 5-year cap bites. The SPC ends on 10 March 2037. Every month of regulatory delay beyond the tenth year after filing is lost.
• December 2016: the gap is under 5 years, so the SPC has a negative term. It is still worth applying for. In Merck, C-125/10 (8 December 2011) the Court held that an SPC can be granted in this case, and the six-month paediatric extension runs from the patent expiry date minus the shortfall. Here the shortfall is 3 months 10 days, so the extension runs from 1 December 2031 to 1 June 2032: 2 months and 22 days beyond the patent.

Filing deadlines and what to file

The six months run separately from each national authorisation, but with a centralised EMA authorisation they start on the same day everywhere, so every country where you want an SPC has to be covered within the same window. Missing one country's deadline loses the SPC there for good. Under Art. 8, the application contains:

• a request naming the applicant, the basic patent and its title, and the number and date of the authorisation relied on and, if different, of the first EU authorisation;
• a copy of the authorisation identifying the product, with the summary of product characteristics;
• if the authorisation relied on is not the first in the EU, details of the product first authorised and the publication of that authorisation; and
• for a paediatric extension, the statement of compliance with the agreed paediatric investigation plan and, where needed, proof of authorisation in all other member states.

Fees: Germany as an example

Each state sets its own fees (Arts. 8(4) and 12). The DPMA's are among the clearest, set in the Patentkostengesetz schedule. Five full years of German supplementary protection cost €18,340 in annual fees, on top of the €300 application fee.

The six-month paediatric extension

Under Art. 36 of Regulation (EC) No 1901/2006, a product whose authorisation application includes the results of all studies under an agreed paediatric investigation plan earns a six-month extension of the SPC. The reward applies even if the studies do not lead to a paediatric indication, provided the results are reflected in the summary of product characteristics. Three limits matter:

• where the national authorisation procedures were used, the product must be authorised in all member states (Art. 36(3));
• orphan medicinal products are excluded (Art. 36(4)); and
• the extension can be granted only once (Art. 13(3) Regulation 469/2009), and must be requested at least two years before the SPC expires (Art. 7(4)).

The manufacturing waiver (2019)

Regulation (EU) 2019/933 rewrote Art. 5 to let EU-based generic and biosimilar makers compete outside the EU, and be ready on day one inside it. During the SPC, a "maker" established in the Union may:

• make the product for export to non-EU countries, at any time during the SPC (Art. 5(2)(a)(i)); and
• make and store it for sale in the EU after expiry, but no earlier than six months before the SPC expires (Art. 5(2)(a)(iii)).

The conditions are strict. The maker must notify the national office, on the standard form in Annex -Ia, and inform the SPC holder at least three months before making starts (Art. 5(2)(b) and (6)). Export packs carry the EU export logo from Annex -I and must not bear an active unique identifier under the falsified medicines rules (Art. 5(2)(d) and (8)). Imports into the EU merely to repackage, re-export or store are not covered (Art. 5(3)). The waiver applies to SPCs applied for on or after 1 July 2019, and from 2 July 2022 to SPCs applied for earlier but taking effect on or after 1 July 2019 (Art. 5(10)). SPCs that took effect before 1 July 2019 are outside it.

For SPC holders, the practical consequence is to watch the national registers: the office must publish each notification (Art. 11(4)), which is often the first public sign of a generic launch.

Lapse, invalidity and the Unified Patent Court

An SPC lapses at the end of its term, on surrender, if an annual fee is not paid in time, or while the product can no longer be marketed because the authorisation was withdrawn (Art. 14). It is invalid if it was granted contrary to Art. 3, if the basic patent lapsed early, or if the patent is revoked or limited so that the product is no longer protected (Art. 15). An SPC therefore stands or falls with its patent, which is why generics companies often attack the patent by EPO opposition or revocation action years before the SPC starts.

The UPC Agreement applies to SPCs issued for a product protected by a patent (Art. 3(b)). An SPC based on a Unitary Patent or a European patent can therefore be enforced or invalidated in the UPC. During the transitional period, the holder of an SPC based on a European patent can opt it out, as with the patent itself (Art. 83(3)). See our guide to the Unitary Patent and the UPC for the opt-out deadline.

The unitary SPC proposal: status in October 2026

The Unitary Patent left a gap: there is one patent for 18 states but still 18 separate SPC applications, examined by 18 offices that sometimes reach different results on the same product. On 27 April 2023 the Commission proposed a package of four regulations: a unitary SPC for medicinal products (COM(2023) 222), a unitary SPC for plant protection products (COM(2023) 221), and recasts of the two existing regulations adding a centralised procedure for national SPCs (COM(2023) 223 and 231). Under the proposals, the EU Intellectual Property Office (EUIPO) would run the examination, with panels that include examiners from national offices, and third parties could file observations and oppositions.

Progress since then:

• 28 February 2024: the European Parliament adopted its first reading position on all four proposals.
• 28 January 2025: the Council Legal Service issued a written opinion on the legal basis of the unitary SPC proposals, which has held up the Council since.
• 27 May 2026: Coreper told the Council working party to keep working on Article 118 TFEU under the ordinary legislative procedure, building on a "specific attributes" approach, under which certain effects of the SPC depend on attributes of the underlying patent, such as unitary effect (Council doc. 11163/26, 30 June 2026).
• As of October 2026: the Council has not adopted its first reading position (European Parliament Legislative Train, updated 20 September 2026). Nothing has been adopted, and there is no start date.

For now, plan on national SPCs in every country that matters, filed within the six-month window.

The United Kingdom after Brexit

The UK kept the EU regulations as retained law from 1 January 2021, amended for the UK, and the UKIPO continues to grant SPCs (Manual of Patent Practice, SP0.13). The term formula is unchanged, but the first authorisation that counts is the first one in the area comprising the European Economic Area and the United Kingdom (UK Art. 13(1)), so an earlier EU approval still shortens a UK SPC. The paediatric extension now runs through regulation 58A of the Human Medicines Regulations 2012. Since 1 January 2025, centralised EU authorisations for human medicines no longer allow a product onto the Northern Ireland market and are not valid for a UK SPC (MOPP SPM1.07.4); the MHRA grants a single UK-wide authorisation instead (SP0.15.3).

The US analogue: patent term extension under 35 U.S.C. 156

The United States solves the same problem differently. Rather than a separate certificate, the USPTO extends the term of one patent claiming the approved product (35 U.S.C. 156). The extension equals the regulatory review period after the patent issued, counting only half of the clinical testing phase, less any period without due diligence (156(c); our section 156 annotation has the details). It is capped at 5 years (156(g)(6)), and the patent's remaining term after approval plus the extension cannot exceed 14 years (156(c)(3)). The application must reach the USPTO within 60 days of FDA approval (156(d)(1)), a much tighter window than Europe's six months.

For the US fees that keep the underlying patent alive, see our USPTO patent fees guide.

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