Reported by Dr. Axel B. Berger and Dr. Wolfgang Bublak
In view of the economic significance of pharmaceutical patents it does not come as a surprise that patent term extension, in Europe by means of Supplementary Protection Certificates (SPCs), is subject to intensive litigation in many countries. According to some estimates, more than 10 % of all SPCs are involved in litigation. The Court of Justice of the European Union has been asked for preliminary rulings regarding the interpretation of the relevant EU Regulations in at least 20 cases. Nevertheless, basic notions of SPC protection, such as the relationship of the product for which an SPC is granted to the underlying patent, are still subject to an intensive debate and controversy.
1. One SPC per patent or one SPC per product per patent?
Cases C 443/12 (Actavis v Sanofi et al – hereafter: “Acatvis”) and C 484/12 (Georgetown University v Octrooicentrum Nederland – hereafter: “Georgetown II”) were referrals by the High Court of Justice (England and Wales) and the Dutch Rechtbank ’s-Gravenhage, respectively, seeking clarification on the requirement for an SPC that “the product has not already been the subject of a certificate” pursuant to Article 3 (c) of Regulation (EC) No 469/2009 (“SPC Regulation”). On this point, the 2011 judgment in C-322/10 (“Medeva”) caused some confusion as it referred to and repeated a statement made in a much earlier judgment, namely Case C-181/95 (“Biogen”) of 1997 where the Court held that only one SPC may be granted for each basic patent.
As this statement was made in a different context and appeared to be in reference to an almost 15 years old decision, some national patent offices continued the existing practice of granting more than one SPC on the basis of one basic patent if the SPCs related to different products, each of them protected by the basic patent. The English High Court, in an infringement action, and the Dutch Court, on review from the Dutch patent office, referred this question to the Court of Justice for further clarification, and some patent offices (including the German Patent and Trademark Office) stayed SPC proceedings in cases in which an SPC had already been granted earlier on the basis of the same patent.
The referral underlying Actavis was made in one of the well-known “irbesartan cases” and the medicinal product “Aprovel”, which contains as single active ingredient irbesartan. An SPC had been granted for this product (“mono SPC”). The question to be answered was whether the SPC to the medicinal product “CoAprovel”, comprising irbesartan and hydrochlorothiazide (HCT) as a diuretic, which itself was not subject to patent protection (“combo SPC”), was invalid or not. Different answers were given to this question across Europe as of 2012.
The Dutch referral related to human papillomavirus (HPV) vaccines. SPCs had already been granted, inter alia, to a vaccine combination of HPV types 16 and 18, while now an SPC to HPV type 16 alone was sought, with both, the combination as well as the single HPV types, being protected by the (same) basic patent.
The answer given by the Court of Justice of the European Union led to a different result for the two cases. In Actavis, the Court based its argumentation on the protection conferred by the first SPC and concluded that “the SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent” (Actavis, para 31). As, in the irbesartan case, the mono SPC for irbesartan already conferred protection to both, irbesartan alone as well as to any combination product containing irbesartan, a later SPC for a combination of irbesartan and an additional ingredient, such as an SPC for irbesartan and HCT, would further prolong the protection for irbesartan. The Court also considered the fact that the combination of irbesartan and HCT is not “the core inventive advance” of the patent (Actavis, para 41). Moreover, the specific diuretic, HCT, was not protected as such by the patent in question (Actavis, para 42).
Contrary to the Actavis case, in the Georgetown II case the protection conferred by a first SPC to HPV-16 and HPV-18 does not cover HPV-16 alone. Therefore, a further SPC may be granted in the latter case.
The Court’s conclusions are summarized in the following Headnotes:
“[W]here, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) of Regulation (EC) No 469/2009 […] must be interpreted as precluding that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients.”
“[W]here, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained a supplementary protection certificate for that combination of active ingredients, protected by that patent within the meaning of Article 3 (a) of Regulation (EC) No 469/2009 […], Article 3 (c) of that regulation must be interpreted as not precluding the proprietor from also obtaining a supplementary protection certificate for one of those active ingredients which, individually, is also protected as such by that patent.”
Thus, Article 3 (c) of the SPC Regulation is to be interpreted as – in general – not precluding the granting of more than one SPC per basic patent. Nevertheless, Actavis suggests that in a case in which the invention relates to an innovative active ingredient on the one hand and to the combination of this ingredient with other substances on the other, where the other substances are not subject to patent protection and where the combination with those substances is probably not considered the “the core inventive advance” of the invention, the grant of one or more additional SPCs for the combination, on the basis of the same patent, is precluded. If these consequences are sought to be avoided, the filing of an additional application, respectively of a divisional application, leading to a separate patent for the combination, might be advisable. This way, an SPC directed to the combination could be requested on the basis of a patent that has not already been subject to an SPC. Also, in such an additional application/patent, “the core inventive advance” would be the claimed combination product.
2. Interpretation of “identified (or specified) in the wording of the claims”
Case C 493/12 (Eli Lilly v Human Genome Sciences – hereafter: “Eli Lilly”) was also a referral by the High Court of Justice (England and Wales), and equally sought clarification on a question unresolved by the 2011 Medeva et al decisions of the Court of Justice of the European Union, this time relating to Article 3 (a) of the SPC Regulation, i.e. on the SPC granting requirement that “the product is protected by a basic patent in force”. Until 2011, there was a “struggle” between two extreme opinions, the “disclosure theory” on one hand and the “infringement theory” on the other. While the “disclosure theory” stipulates that the product must be literally mentioned or at least structurally defined in the claims to fulfil the prerequisite of Article 3 (a) SPC Regulation, the “infringement theory” stipulates that the concerned active ingredient simply needs to be protected, i.e. covered by the scope of protection conferred by the basic patent.
In 2011, the Court of Justice apparently decided in favour of the “disclosure theory” in ruling that the product to be protected by an SPC needs to be “identified (or specified) in the wording of the claims”. However, as (i) the judgments were made with respect to pharmaceuticals containing more than one active ingredient, (ii) there was no clear turn away from earlier case law, being rather in line with a broader understanding of “protected by a basic patent” such as in C-392/97 (“Farmitalia”), and (iii) the Court nonetheless seemed to require an identification of the product “in the wording of the claims”, these 2011 judgments, rather than solving the issue, actually resulted in additional confusion.
In the case at hand, Human Genome Sciences is the proprietor of a patent relating to a (at the filing date) new protein. One of the claims is directed to an antibody binding the newly discovered protein, another one to a pharmaceutical comprising such an antibody. However, neither the claims nor the description of the patent provide information as to the structure of such antibodies; the description does not even disclose a single identified example of such an antibody. Therefore, the functional definition of such antibodies in the claims gives rise to a potentially unlimited number of individual molecules that all fulfil the claimed function, namely in specifically binding the relevant protein. Accordingly, the questions referred to the Court of Justice sought clarification on what is to be understood by the requirement that the product is “identified (or specified) in the wording of the claims” and more specifically, whether the functional definition of an antibody, such as in the case at hand, would suffice in this respect.
The Court of Justice decided that both concepts, the “disclosure theory” and the “infringement theory”, are too extreme in their positions. Referring, inter alia, to Article 69 of the European Patent Convention (EPC) pursuant to which the description is to be considered when interpreting the claims, the Court concluded that, on the one hand, for a product to be “protected” within the meaning of Article 3 (a) SPC Regulation does not require its structural definition (Eli Lilly, para 44). On the other hand, however, the Court also decided that the claims play a key role for the determination of whether a product is considered “protected” and that the rules governing infringement proceedings, i.e. the “scope of protection”, are not to be applied (Eli Lilly, paras 34 and 33).
The Court of Justice emphasized that it considered itself not in the position to interpret Article 69 EPC, since the EU has not acceded to the Convention, leaving the final interpretation to the national courts of the EPC member states. The guidance that the Court gives is that the claims interpreted in the light of the description have to “relate, implicitly but necessarily and specifically, to the active ingredient in question” (Eli Lilly, para 39).
The Court summarised its holding as follows:
“Article 3 (a) of Regulation (EC) No 469/2009 […] must be interpreted as meaning that, in or-der for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3 (a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.”
Therefore, while the Court of Justice clarified that it did not intend in its previous rulings to limit Article 3 (a) of the SPC Regulation to products that are literally or structurally “mentioned” in the claims and, thus, refrained from a strict interpretation of the so-called “disclosure theory”, the guidance as to the required functional definition still leaves space for discussion regarding the circumstances for a claim to relate, implicitly but necessarily and specifically, to the relevant active ingredient.
As regards “one SPC per patent”, Actavis and Georgetown II have clarified that it depends on the circumstances of the case, and in particular whether or not the basic patent actually protects more than one active ingredient, whether more than one SPC may be granted on the basis of the same patent. Further references seeking more clarification regarding this issue do not appear to be necessary.
As regards the identification of the active ingredient in the patent (claim), the Court leaves national authorities and courts somewhat in the dark about the manner in which they must decide whether the “claims relate, implicitly but necessarily and specifically, to the active ingredient in question”. Functional claims do not prevent the granting of an SPC, at least as a matter of principle. The message of the judgment for drafting patents seems to be that it would appear advisable or preferable, if possible, to list examples at least in the specification.