Regulation (EC) No 469/2009 of the European Parliament and of the CouncilShow full title

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

(Codified version)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

Whereas:

(1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products(3) has been substantially amended several times(4). In the interests of clarity and rationality the said Regulation should be codified.

(2) Pharmaceutical research plays a decisive role in the continuing improvement in public health.

(3) Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.

(4) At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation 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.

(5) This situation leads to a lack of protection which penalises pharmaceutical research.

(6) There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.

(7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market.

(8) Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument.

(9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.

(10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.

(11) Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law,

HAVE ADOPTED THIS REGULATION:

(1)

OJ C 77, 31.3.2009, p. 42.

(2)

Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 6 April 2009.

(3)

OJ L 182, 2.7.1992, p. 1.

(4)

See Annex I.