Patents

Always seek the court’s permission before requesting the limitation of the patent outside the judicial proceeding: the tiotropium case

Sonia Sarroca & Oriol Ramon

On 9 February 2023 the Supreme Court upheld a Judgment issued by the Barcelona Provincial Court (Section 15th, specializing in intellectual property matters) which confirmed the nullity of a patent as limited in the court proceedings and ruled that another limitation requested by the proprietor outside them was not valid. The Supreme Court Judgment is available for consultation here. A summary of the case at second instance is available here.

Background

Boehringer Ingelheim Pharma Gmbh & Co (hereinafter “BI”) was the holder of European patent EP 1,379,220 (hereinafter “EP’220”) validated in Spain as ES 2,236,590 (hereinafter “ES’590”). The patent, which relates to inhalation capsules with the active ingredient tiotropium, was published by the Spanish Patents and Trademarks Office (hereinafter “SPTO”) on 16 July 2005 with 16 claims.

In March 2012, Laboratorios Liconsa, S.A. (hereinafter “LICONSA”) filed a nullity claim seeking the declaration of nullity of said patent for lack of novelty and inventive step.

With the statement of defence, BI also filed a counterclaim seeking the limitation of the claims of the ES’590 patent pursuant to art. 138.3 of the European Patent Convention (hereinafter, “EPC”). The patent as thus limited should therefore form the basis for the court proceedings.

LICONSA argued subsequently that the patent as limited was nevertheless null and void for added subject matter and lack of inventive step.

At first instance, Commercial Court No. 1 of Barcelona upheld LICONSA’s arguments and declared the (limited) patent null and void for added subject matter and lack of inventive step. BI appealed this decision to the Barcelona Provincial Court and LICONSA opposed to said appeal.

However, in the course of the appeal, BI filed a written statement informing the Court that it had limited (again) the patent, but this time behind the back of the court proceedings, i.e. before the SPTO. It did so relying on a provision contained in the Patent Act of 2015, which had recently entered into force. Consequently, according to BI, the proceedings should be terminated on the grounds of supervening lack of object. 

LICONSA filed an opposition to the termination of the proceedings substantially arguing that such a limitation was not valid because BI had not asked permission to the Court to do so, as also provided for in the Patent Act of 2015 for the case where nullity proceedings are already ongoing. Consequently, it asked the Court to continue with the proceedings and order the cancellation of the registry of the patent, which should affect both the text subject to the court proceedings and the text as limited by the SPTO.  

The issue was so unusual that the Barcelona Provincial Court agreed to hold a hearing to hear the parties’ arguments.  

Subsequently the Court, by way of an Order, ruled that the judicial proceeding should continue because BI had not asked the permission of the Court to request a limitation of the patent outside the proceedings. In the Court’s opinion, it was clear that the former Patent Act of 1986 (relied on by BI to argue that it needed no permission from the Court to request the limitation) did not apply to this factual situation. 

In the words of the Court “The authorisation of the court ensures a minimum of coordination between the judicial nullity proceeding and the administrative proceeding before the SPTO, and guarantees what both the Patent Act (articles 103.4 and 120.4) and the EPC (article 138.3) seek: that the limited patent integrates the procedural object and forms the basis for the proceeding. On the other hand, the limitation of the patent before the SPTO cannot become an instrument that empties the judicial proceeding of content, as can be seen from the rationale of the amendment to article 105 of the Patent Act, duly cited by LICONSA’s counsel at the hearing. Hence, authorisation is only justified to the extent that the court proceeding are at such a stage that their subject matter can be changed while preserving the rights of the litigants”.  

In the subsequent Judgment, the Barcelona Provincial Court confirmed that the limitation outside the proceedings was not valid and upheld the nullity of the ES’590 patent as limited inside the proceedings for added subject matter and lack of inventive step. Consequently, the Court ordered the cancellation of the registry of the patent subject to the proceedings and the patent as limited at the SPTO.

BI appealed then the Judgment to the Supreme Court on three grounds:

  • Infringement of the rules on jurisdiction, as any challenge to the validity of the limited patent at the SPTO should have been made before the administrative courts (first extraordinary appeal for procedural infringement)
  • Infringement of the right to effective judicial protection (right of defence), as the Barcelona Provincial Court ordered the cancellation of the limited patent without having previously been subject to a judicial proceeding and a judgment on the merits (second extraordinary appeal for procedural infringement)
  • Infringement of the Patent Act of 2015, in particular, of the provisions regarding the possibility to request a limitation of the patent before the SPTO (appeal for cassation)

We note that the appeal before the Supreme Court in Spain is exceptional and is subject to the fulfilment of certain requirements. In LICONSA’s opinion, such requirements were not fulfilled and therefore opposed to its admission. However, the Supreme Court dismissed such objections and decided to process the case.

The Supreme Court decision

The Supreme Court, in any case, dismissed all three grounds of BI’s appeal.

On the alleged infringement of the rules of jurisdiction (first extraordinary appeal for procedural infringement) it ruled that the Barcelona Provincial Court was competent to confirm the nullity of the ES’590 patent in the text subject to the court proceedings and to order the cancellation of said text and the text limited at the SPTO. The Barcelona Provincial Court was also right to conclude that BI should have seek the permission of the Court to request a limitation outside the proceedings and therefore any limitation made outside of them without said permission was invalid. All of the foregoing was something that fell within the competences of the Court and the fact that the limited text was not questioned before the administrative jurisdiction did not change this conclusion.

On the alleged infringement of the right to effective judicial protection (second extraordinary appeal for procedural infringement) the Supreme Court ruled that the Judgment of the Barcelona Provincial Court did not cause defencelessness to BI because the cancellation of the patent in both versions is a consequence of granting a claim of nullity against its patent. Furthermore, it gives an answer (in the negative) to its own petition that the effectiveness of the patent limited at the SPTO is recognized and the court proceedings are terminated. 

On the alleged infringement of the Patent Act of 2015 (appeal for cassation) the Supreme Court confirmed that the provision obliging the patent proprietor to seek the permission of the Court to request a limitation before the SPTO was fully applicable to the case.

Such provision states that when court proceedings on the validity of the patent “are pending” the limitation request before the SPTO must be authorised by the court. The rationale underlying is avoiding any contradiction between the judicial and the administrative decisions. Therefore, once court proceedings are running, any limitation must be granted either by the own Court or by the SPTO with its consent. 

This conclusion is also in accordance with the transitional rules provided for in the Patent Act of 2015 because it allows making use of the new faculty of requesting a limitation before the SPTO although the court proceedings were initiated when the Patent Act of 1986 was in force. However, if the patent proprietor wants to make use of such faculty it must necessarily ask permission to the court; as such permission is inseparable and linked to the faculty.

Finally, the Supreme Court mentions that, in this type of cases, patent proprietors must always attach the mandatory court permission to the limitation request before the SPTO. The absence of such permission renders ineffective any decision by the SPTO accepting a limitation.    

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