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Monday, 23 December 2013

Particular about particles: Spain gets to grips with multivalent vaccines

The SPC Blog is delighted to have received the following detailed information from José Ángel García-Zapata (Associate,  Bird & Bird (Spain) LLP) on some recent case law in which the Spanish courts had the opportunity to apply some of the burgeoning jurisprudence of the Court of Justice of the European Union.  Thanks so much, José Ángel, for making this huge effort on behalf of the SPC community!
Spanish Courts apply the recent case law by the CJEU on SPCs for multivalent vaccines (University of Queensland and CSL Limited v Spanish Patent and Trade Mark Office)
Between February and December 2007, the University of Queensland and the company CSL Limited filed eight applications for Supplementary Protection Certificates (SPCs) at the Spanish Patent and Trade Mark Office (SPTO) for the particles contained in the multivalent vaccines Gardasil® and Cervarix®, two well-known medicines for the prevention of the cervical cancer. The applicants had also filed identical applications in other European countries such as the United Kingdom, Austria, Belgium, Switzerland, Greece, France, Italy, Luxembourg, The Netherlands and Sweden.
Specifically, the applicants intended to obtain one SPC for each particle contained in Gardasil® (virus-like particles of the human papillomavirus types 6, 11, 16, and 18) and each particle contained in Cervarix® (virus-like particles of human papillomavirus types 16 and 18), as well as two additional SPCs for the combination of particles contained in each medicine, thus resulting in the following eight SPC applications: 
1.       Virus-like particles (VLPs) of human papillomavirus (HPV) type 6 in Gardasil.
2.       VLPs of HPV 11 in Gardasil.
3.       VLPs of HPV 16 in Gardasil.
4.       VLPs of HPV 18 in Gardasil.
5.       VLPs of HPV 16 in Cervarix.
6.       VLPs of HPV 18 in Cervarix.
7.       The combination of VLPs of HPV types 6, 11, 16 and 18 in Gardasil.
8.      The combination of VLPs of HPV types 16 and 18 in Cervarix.
In order to fulfill the requirements provided by art. 3 of the SPC Regulation 1768/92 (SPCR), which was in force on the date of filing, the applicants referred in the applications to basic patents in force and also a valid marketing authorizations for the products. Thus, the basic patents quoted (art. 3.a) were EP 595 935 (for SPCs 1, 2 and 7), EP 1 298 211 (for SPCs 3 and 5) and EP 1 359 156 (for SPCs 4, 6 and 8). The marketing authorizations included (art. 3.b) were Gardasil® [Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine, Recombinant] and Cervarix® [Human Papillomavirus (Types 16 and 18) Vaccine, Recombinant].

In December 2009, the SPTO rejected the granting of all the SPC applications, arguing that the owner of various patents referred to the same product cannot obtain various SPCs over the same product, and also that the authorized product was not covered by a basic patent in force. In order to support this latter argument, the Office quoted a decision issued by the Supreme Court on 4 July 2007 (Asociación Española de Fabricantes de Sustancias y Especialidades Farmacéuticas Genéricas v SPTO/E.R. Squibb & Sons, Inc.) whereby the Supreme Court had refused to grant a SPC for a process to prepare products derived from proline.
The applicants filed administrative appeals against these decisions, based on the following arguments: (a) there are different active principles or products in the vaccines Gardasil® and Cervarix® which are the specific VLPs of HPV individually considered, as each particle is conceived to address a specific serotype; (b) each basic patent included in the application covers a different VLP; (c) the reasons given by the SPTO to reject the applications are inspired by a strict interpretation of the SPCR that is contrary to its underlying principles and also contrary to the interpretation given by the European Court of Justice (CJEU) - e.g., in Case C-392/97 Farmitalia - which stated that where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent; and (c) other national patent offices had already granted the SPCs. 
Despite the above arguments, the appeals were dismissed by the Board of Appeals on the same basis that had already served to reject the granting of the SPCs. 
Dissatisfied with these decisions, the patent owners filed 8 appeals before the Tribunal Superior de Justicia de Madrid (the regional High Court of Justice for administrative matters), one for each application. 
In parallel, the applicants had faced the same trouble in the UK, where the UKPTO had dismissed the SPCs and also the appeals filed against the refusal decisions, so they brought the case to the High Court of Justice (CH/2010/APP0620), where Justice Arnold decided, on December 2010, to request the CJEU to give a preliminary ruling on the interpretation of arts. 3.a and 3.b of the SPCR (case C-630/10). The questions referred were aligned with those referred in other cases (C-322/10 Medeva, C-422/10 Georgetown University, C-518/10 Yeda Research & Development, or C-6/11 Daiichi Sankyo Company Ltd.). Among others, Mr Justice Arnold asked the CJEU to give response to these key questions: 1) For the purposes of art. 3.a, is a multi-disease vaccine comprising multiple antigens protected by a basic patent if one antigen of the vaccines is protected by the basic patent in force?; 2) Does art. 3.b permit the grant of a SPC for a single active ingredient where (i) a basic patent in force protects the single active ingredient within the meaning of art. 3.a of the SPCR, and (ii) a medicinal product containing the single active ingredient together with one or more other active ingredients is the subject of a valid marketing authorization? 
In Spain, the applicants asked the Court to stay the proceedings until these questions were answered by the CJEU, but this petition was dismissed on two occasions. As a result of this, the applicants were obliged to submit their arguments without knowing the outcome of Case C-630/10. The arguments referred to the strict and incorrect interpretation of the SPCR made by the SPTO, in contrast to the interpretation made by the CJEU in previous rulings, taking into special consideration the rationale of the Regulation (e.g. in the Recitals 3, 7 and 8), which had been quoted by the Court in previous cases (C-392/97 and C-482/07). The claim also challenged the citation by the SPTO of the judgment of the Supreme Court dated 4 July 2007, stating that it was a different case: there the basic patent did not mention one of the two active principles which were included in the marketing authorization, whereas in case of the SPCs filed by the University of Queensland and CSL Limited, all the VLP of HPV types were expressly mentioned in both the basic patent and the marketing authorization of Gardasil® and Cervarix®. 
Interestingly, despite of the dismissal to stay, the Spanish Court waited for the CJEU’s decision of in Case C-630/10 on 25 November 2011 prior to issue the judgments on 6 pending appeals, which were rendered between July and September 2013.

In line with the response given by the CJEU to the preliminary ruling request, the Spanish Court stated that art. 3.a of the SPCR does not allow the granting of SPCs for active ingredients that are not identified in the wording of the claim of the basic patent, and that art. 3.b allows the granting of a SPC for an active ingredient specified in the wording of the claims of the basic patent where the medicinal product of the marketing authorization included in the SPC application contains not only that active ingredient but also other active ingredients.
Before the Tribunal Superior de Justicia rendered the judgments, and in view of the interpretation given by the CJEU to art. 3.a SPCR in C-630/10, the applicants had withdrawn the appeals involving the combination of VLPs of HPV in Gardasil and Cervarix (i.e., applications 7 and 8 listed above), as the wording of the basic patents quoted in the application, individually considered, did not specify all the VLPs for which the SPC had been applied for.

In contrast, the remaining six appeals concerning SPCs of single active ingredients were upheld by the Tribunal Superior de Justicia, following the reasoning given by the CJEU. The State Attorney, defending the SPTO, has filed appeals to the Supreme Court against three of these judgments (SPCs 2, 4 and 5 of the list), but he missed the deadline for the other 3, so these decisions became non-appealable. The SPTO accordingly granted the applications in December 2013.

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