The fight for SPC extension in Romania

The Court of Justice of the European Union’s (CJEU) decision in Seattle Genetics v Österreichisches Patentamt (C-471/14) was issued after the Vienna Higher Regional Court asked questions about differences in practice of patent offices in EU member states for determining the period covered by supplementary protection certificates (SPCs) referred to in article 13(1) of Regulation (EC) No. 469/2009.

The CJEU decision, issued on October 6, 2015, stated that:

Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of May 6, 2009 concerning the SPC for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the EU’ is determined by the EU law.

The SPC regulation is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market’ within the meaning of that provision is the date on which the notification of the decision granting marketing authorisation (MA) was given to the addressee of the decision.

Different rules

While the application of the decision for new SPC filings and also for those which are still under examination is clear, and the decision will be implemented by all the patent offices of the member states, its application for already granted SPCs is different among EU states.

Some national patent offices such as those in Belgium, the UK and Slovenia took into account the notification date of the MA for calculating the SPC duration even before the issuance of the CJEU decision in Seattle Genetics. Since October 2015, this way to calculate SPC duration has been mandatory for all member states.

Nevertheless, each national patent office had to consider how to apply the CJEU’s decision for already granted SPCs. For example, France’s National Institute of Industrial Property announced that this decision would not be applied for SPCs already granted. In Slovenia, the practice of the Slovenian Intellectual Property Office in this matter changed as a result of a judgment of the Administrative Court of the Republic of Slovenia with effect from 2013.

In the UK, the change of practice relating to the notification date of the MA as the relevant date for calculating SPC term also came into force before the issuance of the Seattle Genetics decision at the CJEU, as a result of an internal decision of the hearing officer of the Intellectual Property Office (IPO). Consequently, a practice notice was published by which the correction of duration for granted SPCs was also allowed by way of an administrative procedure before the IPO.

"While the Romanian State Office for Inventions and Trademarks immediately started to enforce the ruling for pending SPCs."

Some other EU countries, for example Germany and Denmark, also allow for the correction of duration for a granted SPC if the person entitled follows an administrative procedure before the patent office. For these two countries, the procedure is based on specific provisions provided by their national patent law. However, none of these patent offices will automatically correct the duration of a granted SPC unless a written request is filed by the interested person.

In Romania the CJEU decision resulted in a challenging situation for SPCs holders because our national patent legislation does not contain any specific provision regarding this matter. While the Romanian State Office for Inventions and Trademarks (OSIM) immediately started to enforce the ruling for pending SPCs, it remained unclear how it would deal with granted SPCs, and especially those for which the appeal period had lapsed. We were not able to obtain an official position on this matter without taking an action on a specific case.

Petitioning OSIM

In these circumstances, we started by filing a petition for the recalculation of the SPC duration for a granted SPC with the Examining Department in the hope that the office would be able to issue instructions surrounding this aim. Instead, we received a reply from the Appeals Department stating that our petition had been forwarded to it as the competent department for granted rights. Moreover, the response stated that the Appeals Department would deal with our petition only if we considered making an appeal and the corresponding fee was paid, but it was pointed out that for an appeal to be admissible it would have to have been filed within the prescribed appeal period (three months from grant).

At this point we decided to file with the Appeals Department a “request to rectify the duration of the certificate”, which we have grounded on the basis of article 17(2) of Regulation (EC) No. 1610/96 (for plant protection products) together with recital 17 of the same regulation, stating that article 17(2) is valid also for the interpretation of Council Regulation (EEC) No. 1768/92 (for medicaments).

Article 17 appeals

According to the 1610/96 regulation:

“1. The decisions of the authority referred to in article 9(1) or of the body referred to in article 15(2) taken under this regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.

2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate where the date of the first authorisation to place the product on the market in the Community, contained in the application for a certificate as provided for in article 8, is incorrect.”

Recital 17 states:

“Whereas the detailed rules in recitals 12, 13 and 14 and in articles 3(2), 4, 8(1)(c) and 17(2) of this regulation are also valid, mutatis mutandis, for the interpretation in particular of recital 9 and articles 3, 4, 8(1)(c) and 17 of Council Regulation (EEC) No 1768/92.”

During the proceedings, the Appeal Committee challenged the admissibility of our appeal based on the above provisions, stating that they were open to interpretation and that any appeal filed with the OSIM should nevertheless comply with the provisions of our Patent Law, namely to be filed within the prescribed period (three months from grant). We had to argue that the provisions of article 17(2) institute a special situation, which has been meant as an exception from the general ruling of article 17(1) and therefore could not be interpreted in the same way as this ruling.

Also, we were able to produce a previous decision of the OSIM where a request for the recalculation of a granted SPC (not related with the Seattle Genetics ruling) had been admitted based on the above provisions after the lapse of the appeal time limit and the duration of the SPC had been thus corrected. Our arguments have been considered pertinent and the appeal admissible (for further appeals the admissibility has no longer been questioned).

Furthermore, we attended new hearings to sustain the substance of our appeal on the basis of the Seattle Genetics decision. The Appeal Committee has not challenged our arguments and has granted our request to rectify the duration of the SPCs. This has proved to be a long process, starting in November 2015 and with the first written decisions reaching us only at the end of May 2016. Nevertheless, for all further cases, we will be able to follow this procedure without any further impediments, and expect it to work smoothly and more rapidly from now on.

Cristina Popa is a national and European patent attorney at Rominvent. She specialises in chemical, pharmaceuticals and biotechnological inventions, representation before the OSIM and EPO, and is a representative for Romania at the EPI biotech committee. She joined the firm in January 2000. She can be contacted at: cpopa@rominvent.ro

Miruna Enescu is a national and European patent attorney at Rominvent. She joined the firm in November 1995 and specialises in the fields of chemistry, pharmaceuticals and biotechnology. She can be contacted at: menescu@rominvent.ro