- Supplementary protection certificate
European Unionmember countries, a supplementary protection certificate (SPC) is a " sui generis", patent-like, intellectual propertyright. This type of right is available for medicinal products, such as drugs, and plantprotection products, such as insecticides, and herbicides.
A supplementary protection certificate comes into force only after the corresponding patent expires. It has a maximum life time of 5 years. The market exclusivity cannot however exceed 15 years. It may be viewed as an extension of life time of a patent, although the rights are somewhat different.
Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market).
Applications for a supplementary protection certificate must be filed on a country-by-country basis. There is no unitary European supplementary protection certificate, but national ones only.
Determination of term
The term of an SPC depends on the date of issuance of the first market authorisation within the EEA:
* If the first market authorisation is issued less than five years after the filing date of the corresponding patent, no SPC is granted.
* If the first market authorisation is issued more than five years but less than ten years after the filing date of the corresponding patent, an SPC is granted for a term corresponding to the period elapsed between the five-year point and the market authorisation issuance date.
* If the first market authorisation is issued more than ten years after the filing date of the corresponding patent, an SPC is granted for a five-year term.
A market authorisation in
Switzerlandwas also considered as being a first market authorisation for the calculation of the SPC duration, even though Switzerland is not part of the European Economic Area(EEA). This is because such a market authorization was automatically effective in Liechtenstein, which is a member of the EEA (since May 1, 1995). This was decided by the European Court of Justice(ECJ) in joined cases "Novartis et al. v. Comptroller-General" and "Ministère de l'Economie v. Millennium Pharmaceuticals". [ [http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/c_158/c_15820030705en00170017.pdf Case C-207/03] ] [ [http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/c_200/c_20020030823en00120012.pdf Case C-252/03] ] However, as answer to the decision of the ECJ the contract between Switzerland and Liechtenstein was amended. Since July 1st 2005 the automatic effect of a Swiss market authorization in Lichtenstein is abolished. The recognition is now delayed by a time period, which is normally 12 months.
Supplementary protection certificates in the European Union are based on two regulations:
* Council Regulation (EEC) No 1768/92 of
18 June 1992concerning the creation of a supplementary protection certificate for medicinal products [ [http://europa.eu/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31992R1768:EN:HTML Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products] ] which entered into force on January 2, 1993
* Regulation (EC) No 1610/96 of the
European Parliamentand of the Council of 23 July 1996concerning the creation of a supplementary protection certificate for plant protection products [ [http://europa.eu/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31996R1610:EN:HTML 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] ] which entered into force on February 8, 1997
Supplementary protection certificates may come into life at the expiry of a national or European patent. However, the
European Patent Convention(EPC) needed to be modified to allow such "extension" of the term of European patent. Article 63 of the EPC was modified on December 17, 1991to specify to, although European patents have a term of 20 years as from the date of filing of the application (Art. 63(1)),
:" nothing (...) shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: (...):(b) if the subject-matter of the European patent is a product or a process of manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State. " [ [http://www.european-patent-office.org/legal/epc/e/ar63.html#A63 Article 63 of the European Patent Convention] ]
This constituted the first revision of the European Patent Convention since its signature in
According to research, more than 8,000 SPCs for medicinal and plant protection products have been filed in Europe between
1991and 2003. [ EurActiv, [http://www.euractiv.com/en/health/eu-ruling-extension-pharma-patents-harder/article-154974 "EU ruling makes extension of pharma patents harder"] , May 5, 2006]
European Medicines Agency(EMEA)
European Federation of Pharmaceutical Industries and Associations(EFPIA)
* [http://www.patent.gov.uk/patent/info/spctext.pdf Supplementary Protection Certificates for Medicinal Products and Plant Protection Products - A Guide for Applicants] (PDF file 120Kb), by the UK Patent Office
* [http://thespcblog.blogspot.com/ The SPC Blog] , blog relating to supplementary protection certificates (SPCs) (contributors include Professor
Wikimedia Foundation. 2010.
Look at other dictionaries:
Supplementary Protection Certificate — Mit Ergänzenden Schutzzertifikaten (englisch: SPC für Supplementary Protection Certificates) ist es in der Europäischen Union, den USA und weiteren Ländern möglich, die Dauer des Patentschutzes für Patente betreffend Erzeugnisse wie Arzneimittel… … Deutsch Wikipedia
Supplimental Protection Certificate — Mit Ergänzenden Schutzzertifikaten (englisch: SPC für Supplementary Protection Certificates) ist es in der Europäischen Union, den USA und weiteren Ländern möglich, die Dauer des Patentschutzes für Patente betreffend Erzeugnisse wie Arzneimittel… … Deutsch Wikipedia
Intellectual property protection of typefaces — Intellectual property law Primary rights Copyright · authors rights … Wikipedia
List of Statutory Instruments of the United Kingdom, 1992 — This is a complete list of all 1922 Statutory Instruments published in the United Kingdom in the year 1992. NOTOC 1 100* North Hull Housing Action Trust (Transfer of Property) Order 1992 S.I. 1992/1 * Merchant Shipping (Radio Installations)… … Wikipedia
List of Statutory Instruments of the United Kingdom, 1996 — This is a complete list of all 2071 Statutory Instruments published in the United Kingdom in the year 1996. NOTOC 1 100* Insurance Companies (Pension Business)(Transitional Provisions) (Amendment) Regulations 1996 S.I. 1996/1 * Sea Fishing… … Wikipedia
Glossary of patent legal concepts — Patent law (patents for inventions) … Wikipedia
Term of patent — The term of a patent is the maximum period during which it can be maintained into force. It is usually expressed in number of years either starting from the filing date of the patent application or from the date of grant of the patent. In most… … Wikipedia
Trademark — For other uses, see Trademark (disambiguation). For guidelines on using trademarks within Wikipedia, see Wikipedia:Manual of Style (trademarks). Intellectual property law … Wikipedia
Patent law of the European Union — European Union patent law is a subset of European patent law. It also serves as the superset of the patent laws of the individual states of the European Union (EU). The most recent (proposed) addition to the range of measures currently in place… … Wikipedia
Copyright — Copyrighting redirects here. For the use of words to promote or advertise something, see Copywriting. Copyrights redirects here. For Wikipedia policy about copyright issues, see Wikipedia:Copyrights. Intellectual property l … Wikipedia