Late last year the Court of Justice of the European Union (CJEU) released three judgements that provide additional assistance interpreting the European Union’s Supplementary Protection Certificate (SPC) Regulation (Regulation (EC) No 469/2009).
The judgements all concern Article 3 of the Regulation -‘Conditions for obtaining a certificate’- and generally serve to increase opportunities for obtaining SPCs.
European SPCs are available for medical or veterinary active ingredients that are protected by a basic patent and are subject to a new marketing authorisation (regulatory approval). They provide a patent term extension of up to five years, calculated based on the date of grant of the first marketing authorisation. SPCs are intended to compensate patentees for delays in obtaining marketing authorisations that can effectively result in reduced patent terms for regulated products.
Separate SPCs must be applied for in each European country in which a patent is in force.
The cases were referred to the CJEU by national courts seeking clarification on European Union law. The judgements, known as preliminary rulings, are binding on the originating courts, as member countries are obliged to enforce their laws consistent with the European Community Regulations. The three cases have now been referred back to the respective originating courts in the United Kingdom and the Netherlands.
Functional claims satisfy the ‘specified or identified’ criteria
Eli Lilly and Company Ltd v Human Genome Sciences Inc  concerns Article 3(a) of the SPC Regulation, which requires that “the product is protected by a basic patent in force”.
Prior to the present decision, the test for this requirement has been based on the ‘Medeva rule’ from a 2011 decision of the CJEU. The Medeva rule requires that in order to be “protected by a basic patent in force” the product must be “specified (or identified) in the wording of the claims of the basic patent”. There has been debate as to how the test ought to be applied, particularly with regard to the meaning of the term “specified”.
Human Genome Science’s (HGS) patent claims all (therapeutic) antibodies that specifically bind to a certain new protein that HGS found to be linked with autoimmune disorders. The claims are functional; they do not identify individual antibodies. Eli Lilly was developing a specific antibody that would fall within the scope of the claims and sought to prevent HGS from obtaining an SPC.
The issue before the CJEU was whether HGS’ patent claim sufficiently “specified” the product that Eli Lilly was developing, such that HGS may be able to obtain an SPC for Eli Lilly’s product. The CJEU ruled that a functional description can be sufficient, stating,
“it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula … [provided that] the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.”
This decision serves to broaden the Medeva test, and introduces new opportunities for obtaining SPCs for products protected by functional claims. However it may still be advisable to include both broad and narrow claims in a patent application, the former to capture infringers, and the latter to avoid doubt as to whether the claims “relate implicitly but necessarily and specifically” to the product. Alternatively divisional applications directed to various products may be filed.
Interestingly, in Eli Lilly the CJEU opined on the possible outcome if a patentee applied for an SPC on the basis of a marketing authorisation obtained by a third party. The SPC Regulation itself is silent on this point. The CJEU suggested that such an SPC could be refused if the patentee had not invested in the specific development of the product, on the grounds of being contrary to the purpose of granting SPCs to encourage research and compensate patentees for their investment in that research.
One SPC per product per patent
Actavis v Sanofi concerns Article 3(c) of the SPC Regulation, which requires that “the product has not already been the subject of a certificate”. Earlier decisions of the CJEU had not clarified whether this provision prevents the grant of multiple SPCs per patent.
Sanofi had two SPCs, one for a tablet containing the antihypertensive irbesartan and a second SPC for irbesartan combined with the diuretic HCTZ. Sanofi’s patent claimed irbesartan alone and in combination with a non-specified diuretic. The first SPC expired in August 2012 and the second in October 2013. Actavis wished to manufacture a generic version of both tablets and thus sought to have the second SPC declared invalid.
In deciding this case the CJEU noted that there is no new therapeutic effect when the two drugs are administered in a combined tablet, compared to taking them as two separate tablets. The referring UK court had already established that the “core inventive advance” of the patent was irbesartan. The CJEU held that the first SPC, for irbesartan alone, enabled Sanofi to enforce their patent against a combination product and thus the second SPC, directed to the combination of irbesartan and HCTZ, should not be allowed.
The decision in Actavis appears to turn on the fact that the first SPC was for the active ingredient alone, rather than in combination with another (non-protected) active ingredient as,
“[the first] supplementary protection certificate for that active ingredient [entitles the patentee] to oppose the use of that active ingredient, either alone or in combination with other active ingredients.”
The court also expressed concern that the second SPC (for the combination product) would, as an indirect consequence, further extend the exclusivity period for the single ingredient product, contrary to the stated objectives of the SPC regulation. It is therefore pertinent to consider the order in which SPCs are obtained for patents which protect more than one product.
Like Actavis, the third and final case, Georgetown University v Octrooicentrum Nederland (the Dutch Patent Office), concerns Article 3(c). In this case the products in question were vaccines for human papillomavirus (HPV) infection. Georgetown also had two SPC applications. One of the SPC applications claimed a single active ingredient, while the other claimed a combination of active ingredients including the single active ingredient of the first product. Both the single and combined vaccines were claimed in the patent. The second application, for the single active ingredient, was refused by the Dutch Patent Office. The CJEU held that as the basic patent protected both the single and combination products, it was possible for Georgetown to obtain two SPCs.
In addition to the potential influence of the order in which SPCs are applied for, the difference in the decisions in Actavis and Georgetown also appears to depend on the concept of the “core inventive advance” protected by the patent, and more particularly whether a combination product is part of this advance. These two cases appear to have been distinguished based on the inventiveness of the combination product and the order of the applications for regulatory approval.
It will be interesting to see how the originating courts in the United Kingdom and the Netherlands apply the decisions of the CJEU, which are binding on the referring courts, particularly in Eli Lilly where the court will have to consider whether the claim relates to the antibody in question “implicitly but necessarily and specifically”.
Furthermore, the CJEU will shortly consider, on referral from the UK, a case regarding SPCs involving post-grant amendments and products containing multiple active ingredients. Further developments in this area of the law will be of interest to the pharmaceutical industry globally.
If you would like to discuss your options for protecting or enforcing your intellectual property in Europe or elsewhere, please contact us.
This article is intended to summarise potentially complicated legal issues, and is not intended to be a substitute for legal advice. Please contact a Baldwins attorney or other IP professional before acting on any information contained in this publication.
 Case C-493/12 Eli Lilly and Company Ltd v Human Genome Sciences Inc 
 Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks 
Case C‑443/12Actavis Group PTC EHF, Actavis UK Ltd v Sanofi, Sanofi Pharma Bristol-Myers Squibb SNC intervening 
 Case C-484/12 Georgetown University v Octrooicentrum Nederland