1 January 2010CopyrightRaluca Vasilescu

A big year for Romania

2010 is shaping up to be a crucial year for IP practitioners in Romania, says Raluca Vasilescu.

Supplementary protection certificates

The grant of a supplementary protection certificate (SPC) for pharmaceutical products is made in European Union member states according to Council Regulation (EC) No. 1768/92—since replaced by Regulation (EC) No. 469/2009. The procedure applicable is based on the national law corresponding to the basic patent.

The first applications for SPCs were filed in Romania on January 1, 2007. The transitional provisions referred to a period of six months to June 30, 2007, during which the patent owners could file a request for an SPC for patents whose related medicinal product received its first marketing authorisation after January 1, 2000.

Some of the SPC applications filed during the grace period were rejected by the Romanian Patent Office’s examining division. These were then upheld by the patent office’s board of appeal in proceedings that ended in the last quarter of 2009 and the first quarter of 2010. The main reasons for the rejections were that all the corresponding products were put on the market before 2000, based on marketing authorisations issued according to the applicable laws of that time.

In essence, the patent office believes that the old “authorisation to place the product on the market” issued before 2000 is in accordance with the requirements set by Directive 65/65/EEC, since replaced by Directive 2001/83/EEC.

"The new law clarifies that if there is a request for exhaustion of rights when a mark has not been used for a continuous period of five years, this period commences on the date that the mark was entered into the National Registrar."

Essentially, the defence is based on the fact that a Certificate of Registration issued prior to 2000 is not a valid marketing authorisation, because it was not issued in line with the current directive. The line of reasoning is that certificates issued under a law of 1979 do not constitute an “authorisation to place the product on the market” in the EU and that authorisations lodged under the law of 2002 should be the ‘first’ authorisation according to the legal provisions. These appeals generated a lot of debate among professionals, both at the patent office and in private practice.

Well-known European case law has been quoted extensively by both the patent office and the attorneys.

At the time of writing this chapter, the first decisions of the board of appeal had just been issued, denying protection to the SPC application, thus confirming that the old authorisations to put the product on the market before 2000 comply with the requirements of Directive 65/65/EEC, since replaced by Directive 2001/83/EEC.

The first appeals for these SPC applications were filed in the first quarter of 2010 with the Municipal Court of Bucharest, as the next tier of justice.

New Trademark Law

On May 9, 2010, a new Trademark Law will enter into force in Romania. The main features of the new law are as follows:

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