In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based. This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products (e.g. insecticides, and herbicides). Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market).[1]
A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum lifetime of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006[2]).
The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years. However, the reward of a 6-month SPC extension for the submission of data from an agreed PIP can extend this combined duration to 15.5 years.
SPCs extend the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent. For many SPC applications, there is no controversy about the definition of the "product" or whether it is protected by the patent upon which the SPC application was based. However, there are other SPC applications (particularly for medicinal products containing multiple active ingredients) where there may not be clear answers to questions such as what is a permissible definition of a "product", and what test should be applied for determining whether a patent protects that "product".
Supplementary protection certificates in the European Union are based primarily upon 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.
^"... Whereas at the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorization to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research ..." in Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products
^Regulation (EC) No 1901/2006 on medicinal products for paediatric use
and 30 Related for: Supplementary protection certificate information
member countries, Iceland, Liechtenstein and Norway), a supplementaryprotectioncertificate (SPC) is a sui generis intellectual property (IP) right that...
application Submarine patent Supplementaryprotectioncertificate (SPC), provides a limited time extension to the protection conferred by certain patents...
The Berne International Copyright Convention of 1886 finally provided protection for authors among the countries who signed the agreement, although the...
circuit design rights (called mask work rights in the US), supplementaryprotectioncertificates for pharmaceutical products (after expiry of a patent protecting...
which is a form of intellectual property protection law. Trade dress is an extension of trademark protection to "[t]he design and shape of the materials...
Brand protection is the process and set of actions that a right holder undertakes to prevent third parties from using its intellectual property without...
jurisdictions, protections for unregistered trademarks are usually weaker than for registered trademarks. However, some countries have no legal protections for unregistered...
ensure sufficient punishment and deterrence of wrongful activity". Brand protection Allegations of intellectual property theft by China Saisie-contrefaçon...
given an extension and became the crux of the litigation. Supplementaryprotectioncertificate 35 U.S.C. § 154(a)(2) 35 U.S.C. § 365(c) 2701 Patent Term...
an examiner and found to be entitled to registration a registration certificate is issued subject to the mark being open to opposition. The overall length...
works not intended for publication, do not deserve legal protection, but that any such protection should come from laws about privacy, rather than laws about...
for individual creative expression, a sanctuary conferring affirmative protection against the forces of private appropriation that threatened such expression"...
feature of the legal protection of inventions in the USSR is that legislation establishes two means of protection: the author's certificate and the patent....
unfair competition, consumer protection laws, laws for the protection of certification marks or special laws for the protection of geographical indications...
Statistical process control, a method of quality control Supplementaryprotectioncertificate, a sui generis, patent-like, intellectual property right...
European People's Party concluded that international instruments for the protection of copyright no longer seem capable of guaranteeing creators and investors...
genericized in the pharmaceutical industry refers to products whose patent protection has expired. For example, Lipitor was genericized in the U.S. when the...
the particular types of information that are subject to trade secret protection. Three factors are common to all such definitions: A trade secret is information...
1999 and also under the common law remedy of passing off. Statutory protection of trademark is administered by the Controller General of Patents, Designs...
indication, as an indication of the product's source, is intended as a certification that the product possesses certain qualities, is made according to traditional...
many, including Pennsylvania, use the term Fictitious Name. For consumer protection purposes, many U.S. jurisdictions require businesses operating with fictitious...
State to the EPC but has signed an extension agreement under which the protection conferred by European patent applications and patents is extended to the...
automatically protected worldwide, there are international treaties which provide protection automatically for all creative works as soon as they are fixed in a medium...
design protection Moral rights Patent Peasants' rights Plant breeders' rights Plant genetic resources Related rights Supplementaryprotectioncertificate Trade...
copyright protection. The database right extends protection over databases which does not depend on the condition required for copyright protection, and is...
supplementaryprotectioncertificate for medicinal products (1768/92, 18 June 1992) Regulation concerning the creation of a supplementaryprotection certificate...
the Protection of New Varieties of Plants (UPOV – French: Union internationale pour la protection des obtentions végétales) offers legal protection of...
regulatory approval. For EEA member states this is by means of a supplementaryprotectioncertificate (SPC). A European patent application may result from the...
Global Information