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ES – Cinfa & Actavis v. Boehringer / Telmisartan + HCTZ SPC / Invalidity Appeal

17 Oct 2014

Laboratorios Cinfa, S.A. & Actavis Group PTC EHF v. Boehringer Ingelheim Pharma GmbH & Co. KG, Court of Appeals (3rd Section) of Navarra, Spain, 20 May 2014, Docket No. 278/2012.

In a Decision rendered on 20 May 2014, the Court of Appeals of Navarra confirmed the invalidity of Boehringer’s SPC for the combination product Telmisartan + Hidrochlorotiazide (“HCTZ”) (MICARDIS PLUS), which ratified the previous first instance decision in the same sense issued on 20 June 2012. In a clear example of the Spanish Courts’ embracing of the European Court of Justice’s (“ECJ”) current stance with regards to combination SPCs, these proceedings were substantially decided upon on the basis of the doctrine stemming from Medeva (C-322/10; 24 November 2011) and Actavis (C-443/12; 12 December 2013).


Plaintiffs Laboratorios Cinfa, S.A. and Actavis Group PTC EHF had brought a revocation action against Boehringer’s SPC above on the grounds that its grant had taken place in infringement of the provisions under Art. 3 of the EC Regulation No. 469/2099 (“SPC Regulation”), namely because: i) the combination Telmisartan + HCTZ was not protected under the basic patent, which protected Telmisartan only when produced according to the patent; and because ii) on the date of filing the product was already subject-matter of a previous SPC, that one granted for Telmisartan on the basis of an earlier marketing authorization (MICARDIS).

Boehringer opposed to the revocation action and, subsidiary, for the event that the Court found that the Telmisartan + HCTZ combination was not protected under the basic patent, it raised a counterclaim for this be limited under Art. 138(3) EPC, by modifying claim 7 to expressly mention the combination of Telmisartan with other candidate active substances, HCTZ among them.

In early stages of the proceedings, the first instance Court declared Boehringer’s subsidiary counterclaim inadmissible for not being competent to deal with it. Indeed, the Court found that the limitation mechanism under Art. 138(3) EPC was only available to the patentee within the framework of invalidity proceedings against the patent to be limited, while, in the dispute at stake, the validity of the basic patent was not an issue. The above, together with the fact that the parties had requested that the case on the merits was decided upon only after the ECJ had ruled in Medeva, ultimately led the first instance Court to rule for the plaintiffs –by considering the findings in that Judgment-, and hence to the revocation of Boehringer’s SPC for Telmisartan + HCTZ.

Boehringer then appealed such decision and also the previous resolution which had declared its subsidiary counterclaim inadmissible for processing. However, its claims did not fare better in appeal stage, as the Judgment of 20 May 2014 confirms.

Concerning the subsidiary counterclaim aimed at limiting the basic patent, Boehringer argued in its appeal that the first instance Court had rejected its processing after assessing a substantive issue such as Boehringer’s right to or lack of action, which, if appropriate, should have been addressed in the judgment on the merits. It further contended that Art. 138(3) EPC was likewise applicable in revocation proceedings against SPCs, given that this title merely extends patent protection in time. As a result –Boehringer asserted-, the decision disallowing the counterclaim should be revoked, the counterclaim accepted, and the proceedings be brought back to that stage for it to be decided upon in consideration of Boehringer’s subsidiary claim for limiting the basic patent.

Contrary to Boehringer’s interests, however, the Court of Appeals of Navarra first of all found that the counterclaim lacked subject-matter, since a revised translation of the basic patent had been published before the first instance Court declared the counterclaim non-admissible, and this revised translation did no longer contain claim 7 as raised for limitation or an identical one. 

In any case, regarding the possibility to limit the basic patent under Art. 138(3) EPC, the Court of Appeals agreed with the first instance Court in that said mechanism is only available within patent invalidity proceedings, to overcome any grounds for invalidity in the patent claims which may have been prompted. In reply to Boehringer’s statements, the Court added that, while the SPC confers the same substantive protection as the basic patent, this does not mean that it grants the same procedural powers under Art. 138(3) EPC. According to the Court of Appeals, the SPC Regulation itself prevents from limiting the basic patent afterwards with the aim of legitimating a SPC, since the relevant date for ascertaining whether or not a product is protected under a patent in force is the filing date of the SPC. This is confirmed –the Court continued- by the fact that, while the SPC Regulation foresees the effects on the SPC when the basic patent is nullified, or limited in a way that the SPC product falls outside of protection (in Art. 15), nothing is said, by contrast, about the potential effects on the SPC in case that the basic patent is limited by adding products to the patent claims.

Accordingly, the Court of Appeals backed up the first instance Court decision not to admit for leave Boehringer’s subsidiary counterclaim.

Then in what concerns the case on the merits, Boehringer’s appeal was based on several arguments which ultimately challenged the interpretation made by the first instance Court of Medeva in relation to the requirement under Art. 3(a) of the SPC Regulation (“the product is protected by a basic patent in force”), and the Court’s disregarding of the expert evidence filed by Boehringer to sustain that, in light of the patent description, the Telmisartan + HCTZ combination should be deemed mentioned in the patent claims.

The Court of Appeals did neither dissent from the first instance Court’s view in this respect. By appealing to the Actavis ruling, the Court reminded that, in assessing the validity of a SPC on a combination of an active substance with another compound, where the first is already subject-matter of a SPC derived from the same patent, the main point is establishing whether the compound which is combined with the patent-protected active substance is also protected as such under that patent or, if appropriate, whether the combination is thereby protected as such as an autonomous invention. It is under these premises that the Court of Appeals found Boehringer’s SPC invalid as well for HCTZ or the Telmisartan + HCTZ combination (whose autonomous inventiveness had not been alleged either) not being protected by the basic patent. The patentee’s exclusive rights over the combination while the patent was in force, the Court stated, only stemmed from the very protection of Telmisartan when produced according to the patent; however, as the Telmisartan + HCTZ combination was not protected in the basic patent, according to the ECJ case law, then Boehringer’s SPC had been unduly granted, in breach of Art. 3(a) of the SPC Regulation.

The Court of Appeals further added that, even where the combination had been protected as such in the basic patent, the SCP would still be invalid for failing to comply with the requirement under Art. 3(c) of the SPC Regulation (“the product has not already been the subject of a certificate”). Again, by reference to the ECJ doctrine in Actavis, the Court noted that the product, at least partially (Telmisartan), had already been subject-matter or a prior SPC granted on the basis of the same patent, with reference to an earlier marketing authorization. Accordingly, also for this, the SPC for Telmisartan + HCTZ had properly been nullified in the first instance in the Court’s view.

So, in the end, the Court of Appeals of Navarra confirmed the invalidity of the SPC granted in Spain for the Telmisartan + HCTZ combination. Boehringer, however, has appealed this decision before the Spanish Supreme Court.

It must be noted that when the Court of Appeals of Navarra issued the commented Judgment, another proceedings for the invalidation of Boehringer’s Telmisartan + HCTZ SPC was running in parallel before the Courts of Barcelona, following a similar revocation action filed on that occasion by Laboratorios Normon and Laboratorios Liconsa. Only few weeks before the Court of Appeals of Navarra issued its Judgment, the Court of Appeals of Barcelona did likewise and rendered its own Appeal Judgment in that case, on 3 April 2014; however, the outcome was significantly different.

Also in that case, Boehringer had filed a subsidiary counterclaim for limiting the basic patent and this was not admitted for leave by the first instance Court in Barcelona, which later ruled for the plaintiffs. Said Court understood that the main action (for the revocation of the SPC) and the counterclaim (for the limitation of the basic patent) were not connected to the extent required by Spanish procedural law for them being simultaneously handled within the same proceedings, since they were founded on different titles (SPC / basic patent) and the nullity of the basic patent had not been claimed so as to entitle Boehringer to seek its limitation under Art. 138(3) EPC.

In appeal stage, however, and differently from the events in the Navarra proceedings, the Court of Appeals of Barcelona understood that Boehringer’s subsidiary counterclaim had been improperly unadmitted. Aligning with Boehringer’s allegations, it found that there indeed existed the necessary connection between the actions, given that ultimately they stemmed from the very same (basic) patent, and the determination of whether the SPC had been granted in breach or Art. 3(a) of the SPC Regulation required assessing the scope of protection of the basic patent: whether it protected or not the product subject-matter of the challenged SPC. Moreover, contrary to the Court of Appeals of Navarra, the Court of Appeals of Barcelona found that Boehringer’s entitlement to amend the basic patent under Art. 138(3) EPC in those proceedings was actually an issue on the merits to be decided upon in the eventual Judgment, and as such, could not serve as a basis for denying leave to the counterclaim. As a result, the Court of Appeals of Barcelona annulled the first instance decision not admitting the counterclaim, and all procedural acts thereafter, and ordered the resumption of the process from the moment when Boehringer’s subsidiary counterclaim should have been accepted for processing, without then entering into the appeal on the merits against the first instance judgment.   So, thanks to this Decision, at least Boehringer is now offered a new opportunity to defend the limitation of its basic patent to try to overcome the grounds for invalidity found on the SCP, without prejudice that this possibility might still be ultimately rejected in a judgment on the merits. As long as there is no critical turnaround in the ECJ’s current approach to combination SPCs, triggered from Medeva, we will continue to see creative strategies from patentees aimed at finding a way out for preserving their rights stemming from those SPCs, which exemplify better and gone days in the ECJ’s interpretative work on the subject.

Read the decision (in Spanish) here.

Read the invalidity appeal decision (in Spanish) here.

Reported by Luis Fernández-Novoa, Hoyng Monegier