Supplementary Proction Certificates Explained

Supplementary protection certificates (SPC) may be obtained in relation to individual medicinal and plant protection products disclosed in a patent. The certificate extends the protection conferred by the patent beyond its 20-year term for a period of up to five years. Medicinal products, and many agricultural chemicals, require market authorisation before they can be sold commercially. Though this process is independent of the patent granting procedure, the owner of such inventions may find that though they have a patent for their product, they may still have to wait for a number of years before they obtain the necessary authorisation to market it. SPCs compensate the patentee for this loss of time, by extending the patent protection for specific products by up to five years.

An SPC does not extend the duration of the patent itself, but only the protection for the specific product subject to market authorisation.

A supplementary protection certificate (SPC) may be obtained in relation to individual medicinal and plant protection products disclosed in a patent. The certificate extends the protection conferred by the patent beyond its 20-year term for a period of up to five years.

A medicinal or plant protection product must be protected by an Irish patent in force (the “basic patent”).

An SPC may be based on any “basic patent” which protects: 

(a) the active ingredient(s) of the authorised medicinal or plant protection product;
(b) a method of producing the active ingredient(s);
(c) an application of the active ingredient(s); or
(d) a preparation containing the active ingredient(s) (at least in the case of plant protection products).

Medicinal products for the treatment of humans and animals, and many agricultural chemicals, require market authorisation before they can be sold commercially. Though this process is independent of the patent granting procedure, the owner of such inventions may find that though they have a patent for their product, they may still have to wait for a number of years before they obtain the necessary authorisation to market it. SPCs compensate the patentee for this loss of time, by extending the patent protection for specific products by up to five years.

An SPC does not extend the duration of the patent itself, but only the protection for the specific product covered by the marketing authorisation to place the corresponding medicinal or plant protection product on the market.

An SPC for a medicinal active ingredient may also be extended for a further six months if it has undergone the appropriate paediatric testing.

The SPC is granted to the holder of the basic patent protecting the active ingredient, not to a licensee or a manufacturer.

Legislation

Council Regulation (EEC) No 1768/92 created a Supplementary Protection Certificate for medicinal products.  It was repealed and replaced with a codified version, Regulation (EC) 469/2009 on 6 May 2009. Any references to the repealed regulation shall be construed as references to Regulation (EC) 469/2009.

Regulation (EC) No 1610/96 created a Supplementary Protection Certificate for plant protection products.

Council Regulation (EEC) No 1768/92 was amended by Regulation (EC) No 1901/2006 to allow for the creation of extensions to the duration of Supplementary Protection Certificates when a medicinal product has been tested for pediatric use.

These Regulations are directly applicable in all Member States of the EU. However, Supplementary Protection Certificates and their extensions have effect only in the State in which they are granted.

SPCs are granted in Ireland in accordance with S.I. No. 307/2008 - European Communities (Supplementary Protection Certificate) Regulations 2008.  These regulations give effect to the above-mentioned Council Regulations in Irish law.

In general, where the Regulations do not lay down a particular procedure for SPC certificates, the provisions of the Patents Act 1992 apply to certificates as they do to for patents.

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