Definition and Legal Basis of Supplementary Protection Certificates
Supplementary Protection Certificates (abbreviated as SPC, from the English “Supplementary Protection Certificate”) represent a special form of industrial property protection in the field of pharmaceutical and plant protection law. Their purpose is to provide holders of a patent for a medicinal or plant protection product with a limited additional protection for the specific product after the basic patent has expired. The aim is to compensate for the time lost during the mandatory regulatory approval procedures between the grant of the patent and market authorization.
The legal foundations for supplementary protection certificates in the European Union can be found in particular in the following legal acts:
- Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (known as the Medicinal Products SPC Regulation)
- Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (known as the Plant Protection SPC Regulation)
These provisions have been transposed into national law by the Member States of the European Union.
Purpose and Importance of Supplementary Protection Certificates
Economic and Legal Policy Objectives
Pharmaceutical and agrochemical companies invest significant resources in research and development of innovative medicinal and plant protection products. The approval procedures for such products are extensive, costly, and often take several years. The economic value of a patent is diminished by the fact that the actual commercial benefit only arises after the conclusion of these often lengthy regulatory procedures. A supplementary protection certificate is intended to offset this disadvantage by extending the term of protection and providing an incentive for innovation.
Function of the SPC
The supplementary protection certificate extends the exclusive marketing position of the patent holder for a specific product beyond the normal patent term by up to a maximum of five years, thereby ensuring effective protection against imitation products (generics). For pediatric medicines, under certain conditions, an additional six-month extension of the certificate may also be granted.
Requirements for Granting a Supplementary Protection Certificate
Eligible Products
An SPC may only be granted for products that are subject to regulatory approval as either a medicinal product or a plant protection product. “Product” is defined as the active ingredient or combination of active ingredients protected by the basic patent and which forms part of an authorized product.
Basic Patent
A prerequisite for applying for a supplementary protection certificate is the existence of a valid national or European patent that protects the active ingredient, combination of active ingredients, or the use to be protected by the certificate.
First Authorization
The SPC can only be granted if the product is made available on the market of the respective country by a first regulatory authorization. The application for grant must be filed within a certain period after this first authorization and with reference to the basic patent.
Procedural Aspects of the Application Process
Deadline and Form
The application for a supplementary protection certificate must be submitted to the respective competent national authority (e.g. German Patent and Trade Mark Office). According to the regulation, the deadline is generally 6 months after the date on which marketing authorization was granted or—if the basic patent was granted later—6 months after the date of the patent grant.
Examination and Publication
The authority examines whether all legal requirements are met and publishes the grant in the patent gazette or a comparable official publication. Third parties may lodge objections or file revocation requests within certain deadlines.
Effects and Legal Effects of the Supplementary Protection Certificate
Scope of Protection
The supplementary protection certificate essentially grants the same rights as the underlying patent on which it is based. However, the protection only relates to the specifically designated product and its use as a medicinal product or plant protection product as described in the authorization.
Duration of Protection
The SPC enters into force on the day after the expiry of the basic patent and can be granted for a period of up to five years. The exact period of protection is calculated from the time between the filing date of the basic patent and the date of the first authorization of the product in the European Union, minus 5 years.
An example:
- Patent filing date: January 1, 2000
- First authorization: January 1, 2010
- Difference: 10 years
- Minus 5 years: 5 years
- Maximum SPC duration: 5 years (statutory cap)
Extension Options
For pediatric medicines, the protection period can be extended by a further six months under certain conditions, provided that a corresponding authorization for use in children (Pediatric Regulation) is available.
Limitation to the Product
Protection exclusively covers the product named in the authorization; other uses or active ingredients are not automatically included, even if covered by the patent.
Limits and Restrictions of the Supplementary Protection Certificate
Not a New Type of Intellectual Property Right
The SPC does not represent an independent type of intellectual property right, but is closely linked to the underlying patent. It only extends protection in terms of time.
Limitation to Authorized Indications
If the medicinal product is later authorized for additional indications (e.g., further therapeutic uses), the SPC generally extends only to the original use, unless separate SPC applications are filed and granted for the new indications.
Parallel Imports and Exceptions
The rights associated with the SPC may be restricted by compulsory licenses, research exemptions (Bolar exception), or rules on parallel imports. Furthermore, under the so-called “manufacturing waiver” there are specific exemptions allowing manufacturers to produce generic or biosimilar medicines for export to certain third countries during the SPC term.
Practical Importance and Current Legal Developments
Case Law of the Court of Justice of the European Union
The interpretation and application of the SPC regulations have been the subject of numerous decisions of the Court of Justice of the European Union (CJEU), particularly regarding the definition of the product, the scope of protection, and the relationship between patent and supplementary certificate. A frequently discussed topic is whether a separate SPC can be issued for each combination when multiple active ingredients are involved.
Significance for the Pharmaceutical and Agrochemical Industries
For research-based companies, SPCs are of considerable economic importance. The extended monopoly position enables the recovery of development costs and the financing of further R&D projects. Supplementary protection certificates also exert an important steering effect for the development of innovative therapies and the supply of modern pharmaceuticals.
Planned Reforms
Currently, reform proposals for harmonization and modernization of SPC regulations are being discussed at the European level, particularly with regard to the so-called “unitary supplementary protection certificate”, which would provide for a single application process for all EU member states.
References and Further Information Sources
- Regulation (EC) No. 469/2009 (Medicinal Products SPC, consolidated version)
- Regulation (EC) No. 1610/96 (Plant Protection SPC)
- Guidelines and Communications of National Patent Offices on SPCs
- Case Law of the Court of Justice of the European Union (e.g., C-130/11)
- Publications and Working Papers of the European Commission on Planned SPC Reforms
Supplementary protection certificates form a central element of industrial property protection for research-intensive sectors and are subject to continuous legal and legislative development.
Frequently Asked Questions
What requirements must be met for the grant of a supplementary protection certificate (SPC)?
The grant of a supplementary protection certificate (SPC) requires that a valid basic patent for the product in question (e.g., medicinal product or plant protection product) exists and is effective in the territory of the respective EU member state. Furthermore, it is essential that, pursuant to Article 3 of the SPC Regulations, the product has a valid, first-time market authorization (medicinal product authorization or plant protection product authorization) issued by the competent authority in the relevant member state. The SPC can only be issued for the first actual marketing authorization decision regarding the relevant product. Additionally, no certificate must have been granted previously for the same product, and the product must fall within the scope of the basic patent, which is generally determined by a careful assessment of the patent claims. The application must be filed no later than within a statutory deadline depending on the marketing authorization (for medicinal products: six months from authorization or from basic patent grant, whichever is later).
What is the maximum protection period of a supplementary protection certificate and how is it calculated?
The duration of a supplementary protection certificate is a maximum of five years from the expiry of the basic patent. The exact duration of protection is calculated from the difference between the date of the first marketing authorization and the filing date of the basic patent, minus five years (Article 13 of Regulation (EC) No. 469/2009 for medicinal products or Article 13 of Regulation (EC) No. 1610/96 for plant protection products). This calculated period must not exceed five years. For pediatric medicines, under certain conditions, a further six-month period as a “pediatric extension” (Article 36 of Regulation (EC) No. 1901/2006) may be granted if the required studies for use in children have been properly conducted.
What is the scope of protection conferred by the supplementary protection certificate?
The supplementary protection certificate grants, for the product designated in the certificate, the same rights as those defined in the scope of the basic patent. Patent protection is thus not extended in scope, but only in time for the selected product. In particular, this means that the SPC applies to the same acts by third parties (manufacture, offering, marketing, use, import) that would fall under the basic patent. It should be noted, however, that the SPC is only effective for the specific product to which the authorization specified in the certificate relates. Protection is therefore regularly limited to the active ingredient (or the combination of active ingredients), but does not extend to differently composed products or methods.
Can supplementary protection certificates also be granted for combination products or new uses?
The SPC Regulations generally allow the application for a supplementary protection certificate for combination products, that is, for example, a combination of several known active ingredients. However, it is crucial that the specific combination is sufficiently disclosed and protected in the basic patent and that a first-time marketing authorization exists for that combination. New uses of a known active ingredient (for example, new indications, new formulations) generally do not entitle the grant of a SPC unless the new use forms the basis for an independent authorization for what is considered a new product, and the basic patent expressly covers this form of use. In case of doubt, authorities and European case law assess on a case-by-case basis whether an independent product is involved.
How is the application for a supplementary protection certificate made and which formal requirements must be observed?
The application for a supplementary protection certificate must be filed with the competent national patent authority. The application deadline is generally six months after publication of the marketing authorization or, if the basic patent had not yet been granted at that time, six months after the patent grant for the product. The application must be accompanied by extensive documentation, including a copy of the basic patent, a copy of the first valid marketing authorization, translations if applicable, as well as a detailed identification and description of the product. In addition, evidence of compliance with the deadlines and fulfillment of the material requirements as well as information on priority must be provided. Errors in the application, incomplete submissions or missed deadlines will generally result in rejection of the application.
What legal remedies are available in the event of refusal or challenge of a supplementary protection certificate?
In the event of refusal of a SPC application, the applicant basically has the right to legal recourse, which depending on the member state may include filing an objection, opposition, or appealing to the competent courts. Similarly, granted SPCs of third parties may be challenged by third parties (e.g., competitors) through appropriate legal means, such as nullity actions or oppositions, if material or formal requirements have not been met. Substantive examination always takes place at the national level, with the increasing relevance of CJEU jurisprudence for interpreting the SPC regulations. In the event of a dispute, proceedings may be conducted across several instances, up to and including the Court of Justice of the European Union at the national level. A legally binding refusal or annulment of the SPC results in the permanent loss of supplementary protection for the product.
