1. Background to preliminary injunction applications in Spain.

a. Applicable law

The procedure for obtaining a preliminary injunction in a patent action in Spain is governed by Articles 133 to 139 of the Spanish Patents Act 11/1986 (PA) and Articles 721 et seq of the Spanish Civil Procedure Act 1/2000 (CPA).

The specific injunctions to be requested by a patent holder against a third party are foreseen in Article 134 PA, whilst the procedural stages and general requirements of a preliminary injunction as such are regulated by the CPA.

b. “Periculum in mora” and “Fumus boni iuris”

There are two prerequisites to any claim for a preliminary injunction (i) the existence of a danger in delay (“periculum in mora”) and (ii) a prima facie case that the patent is valid and infringed (“fumus boni iuris”).

The “periculum in mora” requirement means that the claimant has to prove that the activity of the alleged infringer has caused the claimant damage, and that delay may cause the final judgment to lack any effectiveness.

The “fumus boni iuris” requirement means that the claimant has to prove that he is entitled to enforce his alleged rights and there are good reasons to believe that these rights are being infringed by the defendant. When assessing this second requirement, the Court does not analyse the issue of infringement in detail but merely considers whether, in light of the evidence, it appears that his rights are being infringed. Accordingly, the decision issued by the Court in this regard does not prejudge the issue in the main action.

c. “Use of the patent”

The PA establishes a third requirement specific to claims for a preliminary injunction in a patent action. Article 133 PA states that a preliminary injunction claim based on an infringement of a patent can only be made when the patent is used by its holder, or at least, when serious and real preparations have been made by the holder to do so.

d. Bond and counter-bond

Pursuant to Article 728.3 CPA, the claimant is obliged to offer a bond to cover any damages caused to the defendant by the granting of the injunction should the defendant win the main action. The amount of this bond is hard to assess since it depends on a number of factors such as the nature of the injunction being claimed and the extent of the infringement taking place.

The bond is filed with the claim for a preliminary injunction specifying both the nature and the amount of the bond.

Where the court decides not to grant the injunction, it specifies the amount of the counter-bond to be provided by the defendant at the time of hearing the preliminary injunction claim.

2. Recent judicial decisions issued by the Spanish Commercial Courts

Several decisions have been issued recently regarding preliminary injunction applications filed by patent holders in actions concerning pharmaceutical patents.

The 28th Section of the Appeal Court of Madrid, the specialist chamber which hears appeals in patent actions, heard an appeal on 16 April 2008 regarding the medicinal product venlafaxine. The claimant was the patent holder of a product patent for a sustained release form of venlafaxine and alleged the patent was infringed by a generic sustained release capsule containing the same active ingredient.

At first instance the Court considered that the preliminary injunction claim complied with the requirements of “periculum in mora”, “fumus boni iuris” and “use of the patent” by the holder. The Court based its decision on the fact that the function of the excipients in the generic product were intended to permit the same effect as the product the subject of the claim i.e. the sustained release of the active ingredient.

On appeal, the first instance judgment was revoked on the following grounds:

  • The fact that the generic products contained venlafaxine was irrelevant since the patent on that active ingredient had already expired.
  • The excipients and their function in the composition of the generic product were not the same as those in the claim.
  • Sustained released compositions were well known and the claim did not cover a sustained release form of venlafaxine per se.

The Appeal Court judgment also analysed all of the arguments raised by the parties on the issue of infringement by equivalents.

The Court established that the infringement cannot be based on an interpretation of the claims where the elements that are not included in the claims seem to be more relevant than the technical features that are included. It was held that the claimant had disregarded the content of the claims, using it as a mere starting point, and had included within their scope any product reproducing the same basic ideas and obtaining the same basic result. The Appeal Court asserted that the doctrine of equivalents cannot be applied in a wide manner and that the comparison between the alleged infringing product and the patent shall be made “element by element”. It was established that the patent’s scope is not the result obtained, but the way it is obtained.

When assessing the actual alleged infringement by equivalents in this case, the Court addressed two specific issues:

  • one of the arguments raised by the claimant’s expert was that the modifications introduced into the infringing products (as compared to the features of the claim) did not provide any additional development other than the state of the art. The Court considered that this was not relevant to the assessment of the alleged infringement. They held that the product in issue needed to reproduce, literally or by equivalents, all the features of the patented invention and that, it was irrelevant whether or not any difference between alleged infringement and claim was inventive or not.
  • as regards the scope of protection of the claims, the Court reviewed carefully the description of the patent to find out (i) the technical problem the invention was intended to solve and (ii) the role played by the excipients and the active ingredient in the alleged infringing product.

The Appeal Court held that the generic product did not infringe the patent because their composition and the function of their excipients differed from those claimed in the patent.

Another judgment by the 28th Section of the Appeal Court of Madrid on 18 October 2007 concerned a procedure initiated by a pharmaceutical company in respect of the launch of a generic product containing ebastine.

Although the patent covering ebastine had expired in March 2005, the patentee argued that the alleged infringing acts had begun in December 2002. On that basis, the patentee wanted the Court to examine whether their patent had been infringed while it was still in force. It was also argued that the failure by the defendant to file any samples of the product during the assessment of the Marketing Authorisation (MA) before the Spanish Medicines Agency, was an act of unfair competition since the defendant would have obtained an MA without running the risk of being sued for patent infringement.

The preliminary injunction claim was rejected both by the Court of First Instance and by the 28th Section of the Appeal Court of Madrid.

With regard to the issue of patent infringement, the Appeal Court commented that the patentee’s right to exclude third parties from infringing its rights was directly related to the existence of the patent. Moreover, it noted that Article 133 PA foresees the exploitation of the patent as one of the requirements to file a preliminary injunction claim. Therefore, it held that “a preliminary injunction cannot be claimed against a third party outside the duration of the patent”.

With regard to the issue of unfair competition, the Appeal Court held that the acts performed before the Spanish Medicines Agency in order to obtain an MA for a generic product during the validity of a patent cannot be considered an infringing act even if product samples were filed with the MA application. Referring to the “Bolar” exemption, the Appeal Court held that “the preparation of samples, the performance of equivalence tests and the filing of MA applications before the expiry of a patent shall not be considered acts of infringement”. Therefore, the defendant was not placed in a better position and did not obtain any competitive advantage by not filing the samples.

One of the most important aspects of patent litigation in Spain is that of the expert reports. Since the Spanish Commercial Courts do not have Judges with a technical background, the reports filed by persons skilled in the art become the touchstone to decide whether the “fumus boni iuris” requirement is met in a patent preliminary injunction procedure. These reports must be filed at the very first stage of the proceedings, that is, together with the preliminary injunction claim.

It is sometimes difficult for the Judge to decide which report it is going to base its decision on, particularly when a court expert has not been designated. Should that be the case, the Court may take into account the expertise of and arguments raised by each of the experts. The outcome of the preliminary injunction claim will therefore often turn on the credibility of the expert reports filed by each side. This is why the Commercial Court Number 1 of Madrid rejected the preliminary injunction claim filed by the holder of a patent for “wheel socks” - devices designed to cover car wheels to perform a similar function to snow chains. Whilst the methods performed by the patentee’s experts to measure the infringing products were based on subjective criteria, the tests performed by the infringer’s expert were based on ascertained values and certified methods. The Court considered that the results shown in the defendant’s report were more accurate than the ones reproduced in the patentee’s report and decided to reject the claim. This decision was subsequently upheld by the 28th Section of the Appeal Court of Madrid.