The supplementary protection certificate (SPC) is a legal instrument designed to extend the protection conferred by a basic patent for certain pharmaceutical and plant protection products in the EU. Its primary purpose is to compensate for the time lost between the filing of a patent and the granting of marketing authorisation, during which the product cannot be commercially exploited. This is particularly relevant in the pharmaceutical sector, where the regulatory approval process can take several years, significantly reducing the effective period of patent exclusivity.
The SPC was introduced through Regulation (EC) No. 469/2009 for medicinal products and Regulation (EC) No. 1610/96 for plant protection products. These regulations provide a harmonised legal framework across EU member states, although applications for, and the granting of, SPCs are handled at the national level by each country’s patent office. In Italy, the competent authority is the Italian Patent and Trademark Office (Ufficio Italiano Brevetti e Marchi, or UIBM), which oversees the examination and issuance of SPCs in accordance with EU regulations and national procedural rules.
SPC eligibility and application process
To be eligible for an SPC, several conditions must be met:
The product must be protected by a valid basic patent in force;
It must have received a valid marketing authorisation within the EU;
The marketing authorisation must be the first authorisation to place the product on the market as a medicinal or plant protection product; and
The SPC application must be filed within six months of the date on which the marketing authorisation was granted or the patent was issued, whichever is later.
The duration of an SPC is calculated by subtracting five years from the time elapsed between the filing date of the patent and the date of the first marketing authorisation in the EU. The resulting period is then capped at a maximum of five years. In certain cases, an additional six-month extension may be granted under Regulation (EC) No. 1901/2006 (the Paediatric Extension Regulation), provided that paediatric studies have been conducted in accordance with an agreed paediatric investigation plan.
In Italy, the SPC application process involves submitting a formal request to the UIBM, along with supporting documentation such as a copy of the basic patent, the marketing authorisation, and proof of payment of the relevant fees. The UIBM examines the application for formal and substantive compliance. If the requirements are met, the SPC is granted and published in the Official Bulletin of Industrial Property.
Judicial interpretation of the SPC regulations
Over the years, the interpretation of SPC regulations has been shaped by numerous rulings from the Court of Justice of the European Union (CJEU). These decisions have clarified key concepts such as what constitutes a “product protected by a basic patent” and whether new formulations or combinations of known active ingredients are eligible for SPC protection. Notable cases include:
C-392/97 (Farmitalia), which addressed the scope of patent protection;
C-121/17 (Teva v Gilead), which introduced stricter criteria for determining whether a product is “implicitly” protected by a patent; and
C-443/17 (Abraxis), which excluded SPCs for new formulations of previously authorised active ingredients.
In the Italian context, national courts have generally aligned with CJEU jurisprudence, although some cases have sparked debate, particularly regarding SPCs for combination therapies or second medical uses. The Italian patent office has also seen a steady increase in SPC filings, reflecting the growing importance of this tool in the pharmaceutical and agrochemical industries. Therapeutic areas such as oncology, rare diseases, vaccines, and antivirals are among the most active sectors for SPC applications.
How SPC benefits extend to the pharmaceutical sector
The SPC offers several advantages. It extends market exclusivity, providing additional time for companies to recoup their investments in R&D. It also aligns the European system with international standards, such as the patent term extension available in the US.
However, the SPC system is not without challenges. The legal framework is complex and subject to evolving interpretations, which can create uncertainty for applicants. The costs associated with filing and maintaining SPCs can also be significant, and disputes over eligibility or scope are not uncommon.
For pharmaceutical companies, particularly those engaged in pharmaceutical innovation, the SPC represents a strategic asset. It is essential to plan early, coordinate patent and regulatory strategies, and monitor deadlines closely to ensure eligibility. Companies should also consider the potential for paediatric extensions (PEs) and seek expert legal and patent advice to navigate the procedural and substantive requirements effectively.
Once a patent extension has been obtained in Europe through an SPC under Regulation (EC) No. 469/2009 (and Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No. 469/2009), it is possible to request an additional extension to the certificate's duration.
PEs, which were introduced by Regulation (EC) No. 1901/2006 and Regulation (EU) 2019/933, provide a six-month extension to an SPC duration for a medicinal product to encourage pharmaceutical companies to develop and test their products for use in the paediatric population. A PE provides additional market exclusivity, enabling companies to recoup R&D costs associated with paediatric studies.
One requirement for the incentive is that the product undergoes a paediatric investigation plan (PIP), which is an R&D programme designed to generate data on the safe and effective use of medicines in children. The European Medicines Agency (EMA) and its Paediatric Committee oversee PIPs. The EMA provides free scientific advice and protocol assistance to companies developing paediatric medicine.
Another requirement for obtaining the PE incentive is including the results in a marketing authorisation application for a new product or indication, a pharmaceutical form, or a route of administration for an existing product.
Lastly, applications for a PE must be submitted at least two years before the SPC expires.
It is important to note that the six-month PE is granted even if the studies carried out for the paediatric assessment under the PIP do not reach a positive conclusion; i.e., if it is concluded that the new product, a new indication of a known product, a new pharmaceutical form, or a new route of administration for an existing product cannot be used in the paediatric population.
From a procedural point of view, the request for a PE is filed with individual national patent offices, including the UIBM. The extension request must be accompanied by a copy of the declaration of compliance with an approved PIP and proof of the existence of marketing authorisations for all EU member states, as the six-month extension is only granted if the product is authorised in all member states.
The PE will begin when the SPC patent extension period ends, effectively extending the patent for another six months.
This assumes that the SPC (and the original patent) has been maintained in accordance with the relevant regulations. In Italy, for example, patents must be maintained by paying an annual maintenance fee that increases from the fifth year (see Tariffe Brevetti per Invenzione Industriale, or Patent Fees for Industrial Inventions).
Fees for SPCs
SPCs are also subject to an annual fee (see Tariffe Certificati di Protezione, or Protection Certificates Rates) and annual fees for SPCs are payable in Italy from the 21st year, given that a patent lasts 20 years from the date of first filing. Annual fees must be paid in advance within the month in which the basic patent application was filed, once the period covered by the previous payment has expired (pursuant to Article 227 of the Italian Industrial Property Code).
Unlike the increasing fee for maintaining a patent, the amount payable for each year and/or fraction of a year for maintaining an SPC is fixed (see Protection Certificates Rates). Furthermore, as with patent annuities, it is possible to pay the SPC annuity with a surcharge within six months of the payment due date in Italy. If annual fees are not paid within six months of the due date, the certificate will be forfeited (see Chapter 7 of the Italian Industrial Property Code).
This raises the question of whether the patent maintenance fee must also be paid during the six-month PE period.
Firstly, it should be noted that the aforementioned Article 227 of the Italian Industrial Property Code, relating to fees for maintaining industrial property rights, provides no indication as to the payment of a maintenance fee for PEs.
This is confirmed by the fact that the lists of maintenance fees for patents and SPCs published on the UIBM website (see Patent Fees for Industrial Inventions and Protection Certificates Rates) do not include any for PEs in Italy. However, the website contains no official information on how to proceed in this regard.
Answers to UIBM FAQs can be found online and it can be read that maintenance fees for PEs are not payable in Italy (see No. 5). Additionally, according to the answers, maintenance fees for PEs are not required, as the last annual fee paid for SPC maintenance also covers the six-month PE.
Bugnion’s pursuit of clarity on fees for maintaining a PE
Bugnion wondered where the answer to the above FAQ came from. Perhaps these six additional months of protection provided by the PE were equated to the six-month grace period during which it is possible to pay the maintenance fee for a patent and/or an SPC.
However, neither the statement in the FAQ nor this possible interpretation is reflected in any article of the Italian Industrial Property Code or its associated regulations.
Furthermore, the date of publication of the aforementioned FAQs cannot be traced, and while they can be found via an online Google search, they are difficult to locate on the UIBM website. Therefore, the answers to these FAQs cannot be considered official.
To clear up the matter, Bugnion therefore requested an interview with a UIBM official, who verbally confirmed that no fees are payable in Italy for maintaining a PE. However, he did not explain the legal basis for this statement.
To find a legal basis to support this, the relevant SPC and PE regulations were analysed in detail. While Regulation (EC) No. 469/2009 on SPCs expressly states that member states may require annual fees for SPCs (see Article 12), no such provision exists in Regulation (EC) No. 1901/2006 on paediatric extensions.
In conclusion, the authors believe that fees for the six months of the PE are not due, as they are not required by the Paediatric Extension Regulation itself.
