Romania: Legal Aspects Of Supplementary Protection Certificates In Romania

Sometimes, the lack of Court of Justice for the European Union (CJEU) case law is the magic pill that delays the death of a patent granted for a medicinal product.

The effect of a supplementary registration certificate (SPC) is to extend the patent protection of a medicinal product beyond its expiration date for a period that cannot exceed five years. Such extension is necessary because the period that elapses between the moment of filing the patent and the moment of obtaining the authorisation to place the medicinal product on the market determines an insufficient patent protection period to cover the investment in the research.

An SPC confers the same rights conferred by the basic patent and is subject to the same limitations and obligations.

The EU legal ground of the SPC is Regulation 469/2009, which abrogated Regulation 1768/92.


The conditions for obtaining an SPC, set forth in art. 3 of Regulation 469/2009, are:

(i) the product is protected by a basic patent in force;

(ii) a valid authorisation to place the product on the market (APPM) as a medicinal product has been granted in accordance with Directive 2001/83/EC on the Community code relating to medicinal products for human use or Directive 2001/82/EC on veterinary medicinal products, as appropriate (note: Directives 2001/83/EC and 2001/82/EC repealed Directives 65/65/EEC and 81/851/EEC; therefore, the corresponding art. 3 of the Regulation 1768/92 provides that an APPM should be obtained in accordance with the repealed directives);

(iii) the authorisation is the first authorisation to place the product on the market as a medicinal product; (iv) the product has not already been the subject of an SPC. As regards Romania, any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania (art. 20 (j) of the Regulation 469/2009, corresponding to art. 19a (l) of Regulation 1768/92).

Pharmaceutical case

In 2010, a pharmaceutical company (the Company) appealed the decision of the Romanian Patent Office (RPTO) refusing an SPC for a medicinal product of the Company (the Product). The Romanian Court (Tribunalul Bucuresti) held that, contrary to the RPTO's findings, the existence of the Product on the Romanian market before 1 January 2000 (the date of entering into force of the harmonised national legislation on the APPM) constituted a reason of non-compliance with the SPC grant provisions laid down in the Regulation 1768/92. The registration certificates for placing the Product on the market had been issued under a procedure not harmonised with the Directive 65/65/EEC, meaning the registration certificates could not be considered the first APPM and should have been disregarded when the eligibility conditions for granting the SPC were assessed. The Court further stated that it is not clear from the wording of Regulation 1768/92 whether the first APPM should be for the Romania market or for other markets including Romania.

"Market" defined

In a recent preliminary ruling, the CJEU interpreted the term "market" from the community text. The CJEU held that the placement of a medicinal product subject to an SPC grant is for the EU market (case C-195/09 Synthon BV vs Merz Pharma GmbH. para 44). As to the decision of the Romanian Court, since the registration certificates for placing the Product on the market issued by a Romanian authority under a national procedure are effective only for the Romanian territory and, at the time of granting, Romania was not an EU member, the term "market" should be deemed only the Romanian market. By disregarding this conclusion and the interpretation of the term "market" in the sense of Regulation 1768/92, the Romanian Court used an incorrect justification.

The outcome of the Romanian Court judgement was to admit the Company's appeal and grant the SPC for the Product. The Court decision became definitive after the RPTO's appeal was rejected.

Any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania.

This article was originally published in the schoenherr roadmap`12 - if you would like to receive a complimentary copy of this publication, please visit:

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