Supplementary protection certificate

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In European Union member countries, a supplementary protection certificate (SPC) is a sui generis, extension of a patent under a specific, different, set of right. This type of right is available for medicinal products, such as drugs, and plant protection products, such as insecticides, and herbicides. 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).^[1]

A supplementary protection certificate comes into force only after the corresponding general patent expires. It has a maximum life time of 5 years. The total combined duration of market exclusivity of a general patent and SPC cannot exceed 15 years. It extends the life time of a patent, but under somewhat different rights.

Supplementary protection certificates in the European Union are based on two regulations. Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis.

Contents 1 Determination of term 2 Legal basis 3 Statistics 4 See also 5 References 6 External links

[edit] 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 Switzerland was 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. ^{[2] [3]} 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.

[edit] Legal basis

Supplementary protection certificates in the European Union are based on two regulations:

• Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products ^[4] which entered into force on January 2, 1993
• 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 ^[5] 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, 1991 to 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. " ^[6]

This constituted the first revision of the European Patent Convention since its signature in 1973.

[edit] Statistics

According to research, more than 8,000 SPCs for medicinal and plant protection products have been filed in Europe between 1991 and 2003. ^[7]

[edit] See also

• European Medicines Agency (EMEA)
• Orphan drug
• European Federation of Pharmaceutical Industries and Associations (EFPIA)

[edit] References

[edit] External links

• Supplementary Protection Certificates for Medicinal Products and Plant Protection Products - A Guide for Applicants (PDF file 120Kb), by the UK Patent Office
• The SPC Blog, blog relating to supplementary protection certificates (SPCs) (contributors include Professor Jeremy Phillips)
• Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor [2008] EWHC 2413 (Pat) (15 October 2008), an example a SPC-related dispute in the UK, relating to the "(-) enantiomer of a racemic compound called ofloxacin"