Protective Letters in Spain. An Important Development for the Health Sector

By Manuel Lobato


A protective letter is a well-known instrument by which a company which is likely to be sued for patent infringement files a document (in German, 'Schutzfrist' or in English 'protective letter') with the competent courts. It is an anticipatory defence explaining why the potential infringement claim is unfounded. The intention is to avoid or render more difficult the granting of an ex parte Preliminary Injunction (PI), even if normally the court is not legally bound to take the protective letter into account. This practice is admitted in countries including Germany, Holland, Belgium and Switzerland. Significantly, protective letters are also mentioned in the draft Rules of Procedure for the Unitary Patent Court.

Protective letters in the unitary patent system will have an efficacy of 6 months (unless renewed). They are communicated to the panel or appointed judge together with the application for the PI (the applicant is served with a copy of the protective letter after it has been sent to the judges). The Registry will also provide details of the protective letters to all local and regional divisions.

The Spanish Judicial system is very complex; it has more than 30 first-instance courts with jurisdiction on patent matters in all 17 Autonomous Communities. This poses a serious difficulty as the protective letter must be filed in a multitude of competent courts. There are also procedural problems as any writ before a court must take the form of a claim. Consequently, any informal communication will be disregarded and not accepted.

This tough Spanish environment is beginning to change however. A recent decision of the Barcelona Commercial Court admitted protective letters for the first time in Spain. The case involved potential PI proceedings against a generic medicament for the treatment of osteoarthritis. The Barcelona Courts are specialised in patent matters and most of the Spanish patent cases are dealt with here. It is therefore a very relevant precedent.

The Barcelona Commercial Court has shown the legal process and requirements that should be followed to file such preventive briefs. The protective letter will be handled as a non-contentious jurisdictional matter (so called voluntary jurisdiction), which is an innovative and intelligent way to solve the procedural problems. When a protective letter is filed in Barcelona, the Court to which the case is assigned will inform the Barcelona Court Registry, so any future PI application on that matter will also be assigned to the same court. The effect of the protective letter is therefore limited to cases lodged in Barcelona and there is no coordination with other courts that may also have jurisdiction in patent matters.

The scope of this non-contentious matter is that the interested party will have any PI request directly served to its legal representative at the Court (the Attorney at Court or, in Spanish, Procurador, who acts as a liaison between the parties and the Court so any notification is immediate). This avoids the need for an ex parte injunction as the claim will not be served through the usual and lengthy procedures.

The Court, while accepting the protective letter, will normally declare that an ex parte injunction would not be admissible. However, this declaration does not exclude the granting of an ex parte PI in exceptional circumstances, (which was precisely what happened in the present case). The efficacy of protective letters is limited to 6 months under the Barcelona decision (following the draft rules of the unitary patent). After that date, it is probable  the PI would not be justified for lack of urgency. Another feature of Spanish protective letters (contrary to other jurisdictions) is that they are served to the potential applicants for a PI. This is a two-fold obligation. If the applicant files a PI outside Barcelona (an unlikely “if”), the patentee would be obliged to disclose the existence and content of the notified protective letters.

There are some limitations of the protective letters as admitted by the Barcelona Courts. The main one is that because their use is limited to Barcelona, it will not affect PIs filed in other regions outside Catalonia (although the majority of cases are handled in Barcelona).

However, even though Spain is, for the moment, outside the Unitary Patent System, the above-described decision allows the use of a process which is well known in other jurisdictions. This could be used as way of aligning the Spanish patent legal system with other EU jurisdictions.