Patent term extensions in the form of supplementary protection certificates (SPCs) are a key instrument for protecting medicinal and plant protection products in Europe. Given the crucial importance of effectively safeguarding such products, it is essential to understand and master the complex, EU law-driven legal framework governing SPCs.
As the European Court of Justice (ECJ) has been confronted with a steadily growing number of referrals concerning patent term extensions over the past two decades, the interpretation of the relevant law has become increasingly complex. Moreover, the EU legal architecture governing SPCs will undergo significant changes should the new draft regulations for reforming the present SPC regime enter into force.
What is an SPC?
SPCs can provide a patent term extension of up to five years and compensate patent owners for the regulatory delays caused by marketing authorisation procedures for medicinal and plant protection products.
In which European countries can SPCs be obtained?
In Europe, there is a distinction between the legal framework for SPCs in EU member states and non‑EU countries. In all EU member states, SPCs for medicinal products are governed in a harmonised manner by EU Regulation 1768/92, later codified and replaced by EU Regulation 469/2009 (the SPC Regulation). An analogous statute exists for plant protection products. In non‑EU countries for which European patents can be granted, SPC protection is based on national legislation, and only some (eg, Switzerland and the United Kingdom) provide for SPCs. The following discussion is confined to SPCs within the European Union.
The duration of an SPC
SPCs extend the patent term for a period that is equal to the time that elapsed between filing the patent application and the first EU marketing authorisation (MA), minus five years. The overall term of an SPC may not exceed five years. In calculating the duration of SPCs, the first MA in the European Economic Area (EEA) (the EU plus Iceland, Liechtenstein and Norway) is important (article 13 of the SPC Regulation). In Seattle Genetics the ECJ clarified that the date of the first MA is the date of notification of the decision granting the MA.[1] SPCs can be corrected accordingly on request, as clarified by the ECJ in Incyte (C-492/16). A first MA in non-EEA country Switzerland can also count as a first authorisation in the EEA because, up to 1 June 2005, it automatically extended to Liechtenstein (an EEA member) on the same day.[2] Today, this extension applies only with a certain delay but may still be essential for calculating the SPC term.
According to EU Regulation 1901/2006, the SPC term can be further extended by six months if the MA preparations included clinical trials specifically addressing paediatric use of a drug. The ECJ clarified in Merck that an SPC can also be granted with a zero or negative term.[3] This can be desirable, as paediatric extensions are possible only if an SPC is in place. A six-month extension of a six-month negative-term SPC will result in a positive term extension.
Apart from SPC protection, regulatory data protection also must be kept in mind as further safeguarding an MA holder’s interests. For eight years after MA grant (for human medicines), submitted data may not be relied on by third parties without consent (article 14(11) of Regulation 726/2004), and generics are barred from entering the market for another 2-3 years (the “8+2(+1)” rule). This statutory data exclusivity period may influence the choice of the basic patent to ensure that SPC-based product protection extends beyond the end of data exclusivity.
Subject matter eligible for SPC protection
According to article 2 of the SPC Regulation, SPCs may be granted only for a “product”, which is defined in article 1b as “the active ingredient or combination of active ingredients of a medicinal product”, including derivatives thereof, such as salts or esters.[4]
The pending case Halozyme before the ECJ seeks to clarify whether a substance classified as an excipient in the MA decision can be considered an active ingredient for SPC purposes under article 1(b) of the SPC Regulation.[5] This case is significant as it can be expected to provide guidance on whether the regulatory classification in the MA procedure is binding for SPC granting proceedings or whether patent offices can conduct an independent assessment.
Conditions for obtaining an SPC
SPC applications must be filed with each national IP office on a country-by-country basis (article 9 of the SPC Regulation). The filing deadline is six months from receiving the MA for that country (nationally or centrally via the European Medicines Agency) or within six months of obtaining the basic patent, whichever is later (article 7 of the SPC Regulation). Calculation of the SPC filing deadline takes into account the notification date of the first market approval in the country of filing, not the first market approval in the EEA. If the MA is granted only after expiry of the basic patent, this leads to an irremediable deficiency, as confirmed in MSD (C-567/16).
In addition to the regular SPC term, a six-month paediatric extension is possible. Paediatric extensions can be applied for together with the SPC application or up to two years before expiry of the SPC.
An SPC may be granted only to the basic patent owner or its successor in title (article 6 of the SPC Regulation) if the following conditions are met at the SPC application filing date (article 3 (a) to (d) of the SPC Regulation):
- the product is protected by a basic patent in force (article 3 (a));
- a valid MA has been granted (article 3 (b));
- the product has not already been the subject of an SPC belonging to the same person (article 3 (c)); and
- the MA is the first to have been granted for this product in the country for which the SPC application is filed (article 3 (d)).
Regarding the requirement under article 3(b) of the SPC Regulation, the ECJ confirmed in Boston Scientific that medical devices, even if they comprise active ingredients, cannot be the subject of an SPC.[6]
Concerning the requirement under article 3(d) of the SPC Regulation that the MA must be the first authorisation for the product, the ECJ held in Abraxis Bioscience that an SPC cannot be granted for a new formulation of an old active ingredient where that active ingredient has already been the subject of an MA.[7] Similarly, in Santen, the ECJ ruled that an SPC cannot be granted for a different therapeutic application of an active ingredient, as an MA cannot be considered the first authorisation for the purpose of article 3(d) where it covers a new therapeutic application of an active ingredient or combination that has already been authorised for a different therapeutic application.[8] The debate on what constitutes a first authorisation has recently been revived by a referral from the German Federal Patent Court concerning Boehringer Ingelheim’s drug ciclesonide. The ECJ must now clarify whether a veterinary authorisation qualifies as the first MA where the active ingredient was previously approved for human use.
What criteria should be used to determine whether a product is protected by a basic patent?
What is meant by the product needing to be protected by the basic patent in article 3(a) of the SPC Regulation is one of the most highly debated and open questions in SPC law, despite the many ECJ decisions on the matter. In November 2011 in a quintet of landmark decisions led by Medeva, the ECJ put an end to the fight between advocates of the infringement and disclosure tests.[9] The ECJ took the middle ground by setting out a unique criterion – namely, that the product must be “specified [or identified] in the wording of the claims”.
However, what degree of specification/identification in the wording of the claims is necessary and sufficient remained unclear and is still a major matter of dispute. In Eli Lilly, the ECJ provided some guidance, stating that the active ingredient need not be identified in the claims of the patent by a chemical name or structural formula, but that functional claim language (in that case an antibody binding to a specific target) may also suffice.[10] Claims would not have to expressly mention but would need to “relate, implicitly but necessarily and specifically” to the active ingredient in question.
A general question on the interpretation of article 3(a) of the SPC Regulation was again referred to the ECJ in Teva UK, which was heard and decided by the Grand Chamber in 2018.[11] The ECJ held that for combination products that article 3(a) required, at the filing or priority date of the basic patent: (1) the combination of active ingredients must necessarily, in the light of the description and drawings of the patent, fall under “the invention covered by that patent”; and (2) each of the active ingredients must be “specifically identifiable”.
For the latter, all information disclosed by the basic patent and the prior art (ie, not only the common general knowledge) at the filing or priority date of the basic patent can be taken into account.
Regarding the first criterion, the ECJ in Teva UK again emphasised the primacy of the claims and their interpretation as governed by article 69 of the European Patent Convention for determining what is protected under article 3(a) of the Regulation. That this is a matter of national or European patent law (ie, non-EU law) and must be decided by the national courts, was already the ECJ’s position in its first judgment on article 3(a).[12] In Royalty Pharma Collection Trust, the ECJ decided that a product is not protected by a basic patent in force, within the meaning of article 3(a), if, although it is covered by the functional definition given in the claims of that basic patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step.[13]
When prosecuting patent applications for new active pharmaceutical ingredients, it is highly advisable to ensure that all potential products (individually and in combination) are expressly mentioned in the claim language to avoid any later article 3(a) discussions. Should this not already be the case for a granted European patent that later turns out to be the best choice as basic patent for an SPC, central or national limitation proceedings should be considered as a means to obtain a solid article 3(a)-proof claim scope.
Scope of protection afforded by an SPC
The protection conferred by an SPC should – within the limits of protection conferred by the basic patent – extend only to the product covered by the MA, including salts and other forms if applicable, and for any medicinal use of the product authorised before expiry of the SPC (article 4 of the Regulation). In Novartis, the ECJ confirmed that an SPC provides the same protection as the basic patent against unauthorised use of the product in the form of any medicinal product that contains that product.[14] Accordingly, sale of a combination product A and B infringes an SPC for A. SPCs can usually also be worded as to cover salt forms and other forms if they have the same medical effect and are also included in the scope of protection of the basic patent. Paramount is the scope of protection provided by the basic patent.
How many SPCs per product and per patent?
As a rule, an SPC can cover only a single product. The ECJ addressed the question of whether a patent protecting different products can also serve as a basis for more than one SPC in Actavis I,[15] Actavis II[16] and Georgetown II.[17]
In Actavis I, the ECJ considered that, in principle, it is possible to obtain several SPCs on the basis of a patent protecting several different products, provided that each (combination) product presents a core inventive advance and is protected as such by the basic patent. The additional core inventive advance criterion that the ECJ introduced in its assessment of article 3 of the SPC Regulation makes it necessary to evaluate each case individually. In Actavis I and II, patents claiming an active ingredient A as the subject matter of the invention, and for which an SPC had already been obtained, were found to contravene article 3(c) and therefore could not serve as the basis for a second SPC on the combination of this active ingredient with another substance.
In Georgetown II, the ECJ allowed a basic patent claiming a combination of active pharmaceutical ingredients A and B, for which a combination SPC had already been obtained, to serve as a basis for a second SPC for one of those active pharmaceutical ingredients if this was also individually protected as such by that patent.
In Royalty PharmaCollection Trust, it was found that the core inventive advance criterion set out in Actavis I does not apply to article 3(a).[18] This opened the question whether a reassessment of the prior ECJ case law on article 3(c) would be needed.
In the joined cases Teva BV and Merck Sharp & Dohme, the ECJ clarified that single active ingredients and combinations of active ingredients are different products, which do not block each other under article 3(c). [19] However, this does not mean it is easier to obtain an SPC for a combination of active ingredients. The ECJ stated that where the product is a combination of the form “A+B”, it must be apparent why this specific combination is essential for solving the technical problem highlighted in the basic patent. This requirement is met if the combination “A+B” produces its own “combined effect”.
For future SPCs on combinations of active ingredients, applicants should explain why specific combinations are of particular significance, for example by specifying the technical effect achieved.
Article 3(c) as interpreted by the ECJ prohibits the grant of a second SPC for the same product only in case of identity of the applicants. Multiple SPCs for the same product based on the same MA are possible when the underlying patents are owned by different parties, which is known as a “third-party SPC”.[20] To avoid any article 3(c) discussions, it is worth exploring the option of splitting up subject matters (eg, mono and combination products) into patent applications owned by different legal entities.
How can SPCs be forfeited or lost?
SPCs can be invalidated if they were granted contrary to the provisions of article 3. In addition, SPCs are linked to the validity of the basic patent for which they were issued. Therefore, an SPC becomes invalid if the underlying basic patent prematurely lapses or is revoked, or if it is limited to an extent that it no longer protects the product for which the SPC was granted (article 15 of the Regulation). Depending on the nature of the basic patent and on the opt-out status thereof, SPCs can be invalidated by third parties in national nullity proceedings before the competent national courts or in nullity proceedings before the UPC at least during a transitional period of seven years.
What impact will the entry into force of the Unified Patent Convention have on SPCs?
An SPC can also be granted on the basis of a European patent with unitary effect (unitary patent) if the unitary patent is effective in the respective EU member state in which the SPC application is filed. The SPC applications based on unitary patents must still be filed with each national IP office on a country-by-country basis. The territorial scope of protection of such an SPC is limited to the EU member state that granted the SPC, although the underlying unitary patent is uniformly valid in all participating member states. An SPC with unitary effect in all participating member states does not yet exist (although there are plans to introduce a unitary SPC in the future).
SPCs that have been granted or are being applied for on the basis of a European or unitary patent fall under the jurisdiction of the UPC, while national courts retain jurisdiction for SPCs that have been granted or are being applied for on the basis of national patents. During a transitional period of at least seven years for SPCs based on classical European bundle patents there will be a competing jurisdiction of both the UPC and the national courts. During this period, it will be possible to opt out of the UPC jurisdiction by filing an opt-out declaration for the respective European patent (thereby automatically including granted or future SPCs based on this patent), as long as no legal action related to this European patent is pending at the UPC. Opting out is not possible for unitary patents and, therefore, SPCs granted on the basis of unitary patents fall under the exclusive jurisdiction of the UPC.
Draft proposals for reforming the SPC regime
In April 2023, the European Commission submitted four regulatory proposals for reforming the SPC regime for plant protection and medicinal products. Regarding medicinal products, the Commission issued the following two proposals: a regulation on SPCs for medicinal products, which is a recast of Regulation 469/2009;[21] and a regulation on unitary SPCs for medicinal products, which contains all the regulations defining the procedure regarding unitary SPCs. [22]
Under the new draft regime, applicants would have several filing routes. A “unitary SPC application” would be available only for products approved by EMA via the centralised procedure and a unitary patent. It would be examined and granted by the EUIPO, a suggestion that has led to considerable controversy. The examination would be carried out by a new panel composed of one member of the EUIPO and two qualified examiners from the national patent offices of the member states.
A “centralised SPC application” may be filed based on a centralised procedure for an MA and both types of European patents (bundle or unitary). It would lead to a bundle of national SPCs in the designated member states. The EUIPO would conduct the examination, and the national offices would grant the SPCs.
A “combined application” would add a request for a unitary SPC to a centralised SPC application. It would result in a unitary SPC for all states covered by the unitary patent and in national SPCs for the remaining designated member states. The EUIPO would examine and grant the unitary SPC, while the national offices would grant the national SPCs.
Where the SPC is based on a national MA, the traditional national route remains available. In that case, the relevant national office would examine the SPC application. The application may rely on a national patent or on a European (including unitary) patent that is effective in that state.
Contrary to the present system, the proposals also provide the possibility of filing third-party observations with the EUIPO within three months from the publication of the SPC application, and central third-party oppositions within two months from the grant of the SPC. Decisions may be appealed (before an EUIPO Board of Appeal) and further contested before the General Court of the EU and ultimately the Court of Justice of the European Union. Designating the EUIPO – an authority without prior experience in patent and SPC matters – as the central decision maker on SPC validity remains a major point of criticism and a key obstacle to the new SPC regime’s adoption.
The road ahead
The low number of SPC applications filed annually, coupled with complex filing strategy, changing case law requirements and tremendous economic importance of each SPC, calls for appointing an experienced lead counsel in Europe to advise on and manage appropriate SPC filing strategies.
Although it has been in force for more than 20 years and has given rise to a plethora of ECJ decisions, the existing SPC Regulation remains one of the most unsettled and controversial areas of European IP law. Building on this already complex foundation, the draft “recast regulations” for the current regime, together with the new draft Regulation on unitary SPCs, are expected to have far-reaching implications for SPC protection in Europe. At this stage, their substantive and procedural contours remain the subject of intense debate and controversy among legislators, courts, practitioners and industry stakeholders alike.
The work in the Council on the SPC reform package was resumed in 2025, with the question of the competent granting authority continuing to play a central role. It remains to be seen what form the final adopted version will have upon its entry into force.
Endnotes
[1] C-471/14, [2] See AstraZeneca, C-617/12, [3] C-125/10, [4] Farmitalia/Idarubicin, C-392/97, [5] C-456/24, [6] C-527/17, [7] C-443/17, [8] C-673/18, [9] C-322/10, [10] C-493/12, [11] C-121/17, [12] Farmitalia, C-392/97, [13] C-650/17, [14] C-442/11 and C-574/11, [15] C-443/12, [16] C-577/13, [17] C-484/12, [18] C-650/17, [19] C-119/22 and C-149/22, respectively, [20] See ARP Manufacturing (C-482/07) and Biogen (C181/95), [21] COM(2023) 231, [22] COM(2023) 222
This article was first published on IAM in June 2026; for further in-depth analysis, please visit IAM The Guide to Life Sciences: Key issues for senior life sciences executive 2026.
Picture credits: AI-generated using ChatGPT (OpenAI)
