Uniformity for SPCs

Regulation (EC) No. 469/2009 (which amended Council Regulation [EEC] No. 1768/92), concerning the creation of a supplementary protection certificate (SPC) for medicinal products, and Regulation (EC) No. 1610/96, covering the creation of an SPC for plant protection products, entered into force in Romania on January 1, 2007, the date Romania joined the EU. On the same date, Regulation (EC) No. 1901/2006 on medicinal products for paediatric use entered into force in Romania.

Since no national legislation was in place before January 1, 2007, the following provision article 19(l) of the amended 1768/92 regulation, was applicable:

“Any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007.”

Accordingly, between January 1 and June 30, 2007, roughly 90 SPC applications were filed with the Romanian State Office for Inventions and Trademarks (OSIM) on the basis of a first marketing authorisation (MA) in Romania issued after January 1, 2000.

"at the request of the SPC owner, the SPC expiry date can be re-calculated on the basis of the date of the MA notification."

The OSIM implemented internal instructions in respect of the SPC regulation, and created its standard practice for examining requests for SPCs. Only a few of the applications have been rejected on the ground of non-compliance with the requirements of the regulation.

From 2007 until now, the number of the SPC applications filed with the OSIM has increased yearly, from about 20 in 2008 to about 55 in 2015.

After October 6, 2015, the examining commission of the OSIM decided that the expiration date for all SPC applications currently under examination should be calculated by taking into account the date of the notification of the first MA, in compliance with the judgment of the Court of Justice of the European Union (CJEU) in the Seattle Genetics v Österreichisches Patentamt case (C471/14).

Pre-Seattle SPCs

The OSIM has recently decided to apply the judgment of the CJEU in the Seattle Genetics case to SPCs granted before October 6, 2015 based upon a first MA issued by the European Medicines Agency and granted before October 6, 2015. Consequently, at the request of the SPC owner, the SPC expiry date can be re-calculated on the basis of the date of the MA notification.

This OSIM decision was ruled according to the provisions of article 4 of the Treaty on European Union (to which Romania adhered on January 1, 2007, after the adherence treaty was signed on April 25, 2005), article 17 of the 1610/1996 regulation, and articles 18 and 19 (1) of the 469/2009 regulation, in conjunction with article 5 of the new Civil Code, which provides that:

“In the issues regulated by the present Code, the rules of the law of the European Union are applicable, regardless the quality or the status of the parties.”

These are the main legal arguments for which the OSIM decided to re-calculate the term of SPCs granted before October 6, 2015 through an appeal procedure in front of the re-examining commission as provided by article 51(7) of the implementing regulations to the national Patent Law:

“Any modifications requested after the communication of the decision to grant shall be carried out only by appeal, according to article 51 of the law and subject to payment of the legal fee.”

The decision of the CJEU in the Seattle Genetics case is therefore uniformly implemented for SPCs granted both before and after the date of the decision’s issuance, satisfying the spirit of the Community rules, with all the manufacturers of medicinal products in Romania benefiting from the same additional term of their SPCs.  

Margareta Oproiu is a senior partner at Cabinet M Oproiu. She can be contacted at: moproiu@oproiu.ro