Possible change in SPC jurisprudence

Supplementary Protection Certificates (SPCs) for human and veterinary medicinal products, as well as for plant protection products, became available in Romania upon accession to the EU on January 1, 2007, under EU legislation. Almost 150 SPC applications have been examined by the Patent Office (PTO) and the majority have been granted.

However, the procedure has not always gone smoothly. SPC applications for medicinal products placed on the Romanian market before the entry into force of the national law implementing the Council Directive 65/65/ EEC have been rejected by the Examining Division of the PTO.

The originators appealed against these decisions before the Boards of Appeal, which maintained the solution. The Bucharest Tribunal admitted all the appeals against the relevant PTO decisions. The PTO filed second appeals with the court of second instance against some of the decisions, but they were all dismissed.

This was the situation until a couple of months ago. Since these cases were decided upon by almost all the judges in the intellectual property specialised sections of the court, it seemed safe to assume that similar cases in the future would have a similar result.

Then came the recent Court of Justice for the EU (CJEU) memantine and galantamine rulings, clarifying the scope of Art. 2 of the Council Regulation no. 1768/92 (now Council Regulation no. 469/2009). Questions were raised immediately regarding the way these will affect national jurisprudence.The wait was short: a first decision from the Bucharest Court of Appeals seems to indicate that things are about to change. In a case very similar to the ones mentioned above, involving the active ingredient donepezil, the court admitted the appeal filed by the PTO and upheld the latter’s initial decision to reject the SPC application.

“THE DECISION OF THE COURT OF APPEALS TO ADMIT THE APPEAL AND UPHOLD THE INITIAL DECISION OF THE PTO TO REJECT THE SPC APPLICATION CAME AS A SURPRISE.”

In its initial stages the case followed the same route as the other similar cases involving SPC applications for medicinal products placed on the Romanian market before the entry into force of the national law implementing the Council Directive 65/65/EEC.

The PTO initially rejected the SPC application. The first administrative appeal was also rejected by the PTO’s Reexamination Commission. The applicant then filed an appeal before the Bucharest Municipal Court. Here the decision was in line with all the decisions in similar cases, the appeal was admitted and the PTO ordered to issue the SPC.

The PTO decided to appeal against the decision and, hoping that the ruling of the CJEU in the memantine and galantamine cases would come before the appeal was heard and estimating that such a decision would support the position of the PTO, the appeal was pursued.

The decision of the Court of Appeals to admit the appeal and uphold the initial decision of the PTO to reject the SPC application came as a surprise, considering the prior jurisprudence.

The full court decision is not available at the time of writing and therefore we cannot comment on the reasoning of the court. In any case, this 180-degree change in the jurisprudence opens the door for more litigation regarding SPC applications in Romania.

Before this decision, in many similar cases, the courts have irrevocably granted SPC applications. However, manufacturers of generics do have the possibility of challenging these SPCs, which until recently seemed totally unfeasible.

Currently there is one pending revocation action against an SPC granted further to court proceedings (candesartan). The Bucharest Municipal Court should issue a decision in this case in the near future.

The question facing generics companies at this point, especially for SPCs granted for a short period of time (up to one year), is whether to file a revocation action and enter the market immediately (since the revocation has a retroactive effect) or wait for the SPC to expire. Should the first option be more attractive, we should see a number of revocation actions being brought before the courts.