Madrid Commercial Court No. 8
Madrid Court of Appeal
On 13 December 2021 the Madrid Court of Appeal dismissed an appeal filed by Actelion Pharmaceuticals Limited and Actelion Pharmaceuticals España in a patent infringement case regarding the drug bosentan (Tracleer).
The Swiss company Roche was the holder of European patent (EP) 0526708 (EP708) relating to the active pharmaceutical ingredient bosentan. This patent, filed in June 1992, was granted in October 2000 with a special set of process claims only for Spain.
EP708 was the basic patent of a Spanish supplementary protection certificate (SPC) (SPC No. C200200028), granted in 2004, which was in force until 28 August 2017. Roche was the holder of the SPC, whereas Actelion Pharmaceuticals Limited was the exclusive licensee thereof. Actelion Pharmaceuticals España was a non-exclusive sublicensee.
In July 2010, Roche filed a "revised" Spanish translation of the EP708 patent with product and use claims, which was published by the Spanish Patent and Trademark Office in October 2011.
On 3 November 2015, Actelion sued Accord, Sandoz and Kern Pharma before the commercial courts of Madrid, alleging infringement of the SPC based on the product and use claims of the revised translation of EP708. According to the plaintiffs, despite the fact that the product and use claims had been introduced after the patent had been granted, they were effective under the principle of uniqueness of the European patent, as stated by article 118 of the European Patent Convention (EPC).
The defendants opposed Actelion's infringement action, arguing:
- the lack of standing of Actelion Pharmaceuticals España, due to its status as a mere non-exclusive sublicensee of the asserted SPC;
- the ineffectiveness of the product and use claims, or alternatively their invalidity, as they entailed an inadmissible extension of the protection conferred by the patent in Spain (articles 70.3, 123.3 and 138.1(d) of the EPC); and
- the ineffectiveness of the product claims for being contrary to the Spanish Reservation to the EPC (former article 167 of the EPC).
Madrid Commercial Court No. 8 issued a first-instance judgment on 18 March 2020, in which, following the defendants' arguments, it concluded that Actelion Pharmaceuticals España lacked standing to sue and that, in any event, the asserted product and use claims should be held ineffective.
The plaintiffs appealed this decision before the Madrid Court of Appeal, but only with respect to the lack of standing of Actelion Pharmaceuticals España and the ineffectiveness of the use claim.
With its judgment of 13 December 2021, the Madrid Court of Appeal dismissed the appeal filed by Actelion, thus upholding once again the defendants' position.
Firstly, the Court confirmed the lack of standing of Actelion Pharmaceuticals España, considering that the exceptional requirements for the legal standing of a non-exclusive licensee of a patent or SPC had not been met in this case.
Secondly, regarding the dispute on the ineffectiveness of the use claim, the Court concluded that the issue at stake was not about the principle of uniqueness of the European patent (article 118 of the EPC) but concerned an inadmissible broadening of the protection conferred by a patent in Spain years after its grant. This had already been ruled upon by the Court of Justice of the European Union(1) and the Spanish Supreme Court.(2)
Following the doctrine of these previous decisions, the Court confirmed that, once granted with process claims only for Spain, the protection conferred by a European patent cannot be subsequently extended by adding product or use claims by means of an alleged "revised" Spanish translation of the patent. Therefore, the use claim asserted by Actelion had to be deemed ineffective, the EP708 patent thus remaining a process patent in Spain.
Actelion could still file an extraordinary appeal against this judgment.
For further information on this topic please contact José Calvo at Grau & Angulo by telephone (+34 93 202 34 56) or email ([email protected]). The Grau & Angulo website can be accessed at www.ga-ip.com.
(1) In its judgment of 18 July 2013 (C-414/11) and its orders of 30 January 2014 (C-372/13 and C-462/13).
(2) In its judgments of 21 December 2015 (quetiapine) and 20 October 2017 (escitalopram).