Judgment on SPCs: is the CJEU stepping into the realm of national courts?
January 2019 | SPECIAL REPORT: INTELLECTUAL PROPERTY
Financier Worldwide Magazine
January 2019 Issue
Readers who are Supplementary Protection Certificate (SPC) aficionados will be aware that the road to a SPC is a rather bumpy one. This is particularly true in the case of SPCs that protect a combination of various active principles. Over the years, national courts have struggled to interpret the requirements of article 3 of Regulation (EC) 469/2009 concerning the SPC for medicinal products; in particular, paragraph (a), which requires that “the product is protected by a basic patent in force”, and paragraph (c), which requires that “the product has not already been the subject of a certificate”.
For example, in cases where a patent encompasses active ingredient ‘A’ but also the combination of active ingredients ‘A+B’, and an SPC has already been granted for ‘A’, the question has arisen as to whether paragraphs (a) and (c) of article 3 prevent the grant of a new SPC for ‘A+B’.
How can one decide if the hen is good or bad without having jurisdiction to opine on whether the egg was good or bad?
Deciding whether or not a SPC may be granted for a combination of ‘A+B’ requires, among other aspects, interpreting whether or not the patent at hand ‘protects’ that combination (i.e., article 3 (a)). But, since patent law has not been harmonised, the scope of protection of a patent is not governed by EU law but by national law or by an international treaty (i.e., the European Patent Convention (EPC)), in the case of patents that have been granted by the European Patent Office (EPO).
The EU is not a party to the EPC. Therefore, the Court of Justice of the European Union (CJEU) does not have jurisdiction to interpret the provisions of the EPC. This amounts to saying that it does not have jurisdiction to interpret whether or not the combination of ‘A+B’ is protected by the basic patent. Yet the CJEU does have jurisdiction to interpret article 3 (a) of the SPC regulation which requires that “the product is protected by a basic patent in force”. In the seminal judgment of 16 September 1999 (Farmitalia) the CJEU resolved this conundrum deciding that in order to determine, in connection with article 3 (a): “28. […] whether a product is protected by a basic patent, reference must be made to the rules which govern that patent”.
So far, so good.
Medeva and its aftermath
These clear waters (i.e., Farmitalia) would become muddied over the years. This muddying process reached its peak with the judgment of 24 November 2011 (Medeva), where the CJEU wrote that: “25. […] It follows that article 3(a) of the Regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent”.
Since then, SPC aficionados around the EU struggled to make some sense of the words “specified in the wording of the claims”. What does “specified” mean? That the active ingredients of the combination must be explicitly mentioned in the claims? Is it sufficient for them to be covered by a Markush formula?
The CJEU tried to answer some of these questions on the so-called ‘Super Thursday’ (i.e., 12 December 2013), when it published several judgments dealing with various paragraphs of article 3. For example, in the judgment in Actavis v. Sanofi, the CJEU seemed to interpret paragraph (c) – “the product has not already been the subject of a certificate” – to mean that, even if a SPC had already been granted for ‘A’, another SPC could be granted for the combination of A+B if the combination, as such, was a “separate innovation”. This judgment raised more questions (what does a “separate innovation” mean?) than it answered.
Another fruit of ‘Super Thursday’ was the judgment published in Eli Lilly v. HGS, where the CJEU made it very clear that it lacks competence to interpret the EPC: “40. With regard to the requirements laid down by the EPC, it should, however, be noted that the Court does not have jurisdiction to interpret the provisions of that convention, since, unlike the Member States, the European Union has not acceded to the convention. The Court cannot, therefore, provide further guidance to the referring court concerning the manner in which it is to determine the extent of the claims of a patent issued by the EPO”.
In its judgment of 25 July 2018, the CJEU appears to have forgotten its lack of competence to interpret the provisions of the EPC.
The “sole subject-matter of the invention” test
Another signpost on this bumpy road was set by the judgment of 12 March 2015, Actavis v. Boehringer Ingelheim, where the CJEU concluded that articles 3 (a) and (c): “[…] must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a SPC, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second SPC for that combination”.
Hence a SPC can be granted if ‘A’ is not the “sole subject-matter of the invention”.
The CJEU ventures into interpreting the EPC: Teva v. Gilead
In its judgment of 25 July 2018, Teva v. Gilead, the Grand Chamber of the CJEU has tried to provide more clarity by crafting a more elaborate answer. It has concluded that article 3 (a): “must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent: the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent”.
In addition to the answer, the most interesting aspect of this judgment may be found at paragraphs 35 and 46 to 48, where the CJEU has for the first time ventured into the interpretation of the EPC: “35. So far as, specifically, the European patent is concerned, pursuant to Article 69 of the EPC, the extent of the protection conferred by such a patent is determined by the claims. The information in Article 1 of the Protocol on the Interpretation of Article 69 of the EPC states that those claims must ensure both a fair protection for the patent proprietor and a reasonable degree of legal certainty for third parties. Thus, they are not to serve only as a guideline, nor can they be interpreted as meaning that the extent of the protection conferred by a patent is that defined by the narrow, literal meaning of the wording used in the claims”.
Paragraphs 46 to 48 are also highly illustrative of the CJEU’s eagerness to step for the first time into a territory that thus far had been considered the preserve of national courts: “46. It follows from the above that the subject matter of the protection conferred by an SPC must be restricted to the technical specifications of the invention covered by the basic patent, such as claimed in that patent. 47. With regard to the implementation of that rule, it must in the first place be stated that, in accordance with a principle shared by the patent laws of the Member States and reflected in Article 1 of the Protocol on the Interpretation of Article 69 of the EPC, the claims of a patent are to be interpreted from the perspective of a person skilled in the art and, therefore, the issue whether the product which is the subject of the SPC necessarily falls under the invention covered by that patent must be assessed from that perspective. 48. To that end, it is necessary to ascertain whether a person skilled in the art can understand without any doubt, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent”.
Although to date, the judgment of 25 July 2018 had been interpreted as providing a more sensible test for applying article 3 (a) and even article 3 (c), a view that may be embraced, less attention has been paid to what in this author’s opinion is the most salient aspect of the decision: the CJEU’s eagerness to venture into the interpretation of the provisions of the EPC. This is a rather bold move, particularly taking into account the extreme self-restraint expressed by the court in the past, particularly in its judgment of 12 December 2013, Eli Lilly v. HGS.
Miquel Montañá is a partner at Clifford Chance. He can be contacted on +34 (93) 344 2223 or by email: email@example.com.
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