European Union: SPCs: Three Important CJEU Decisions

Last Updated: 9 January 2014
Article by Alexander Robinson

On 12 December 2013 the Court of Justice of the European Union (CJEU) handed down three decisions which will be of interest to anyone reliant on Supplementary Protection Certificates (SPCs) to extend protection for pharmaceutical products after expiry of their patents.

Cases C-484/12 (Georgetown University v Octrooicentrum Nederland) and C-443/12 (Actavis v Sanofi) sought to clarify the issue of whether more than one SPC could be obtained based on a single patent, with particular reference to situations where protection was sought both for individual active agents and for "combination products" comprising more than one active.

The questions referred in Case C-493/12 (Eli Lilly v Human Genome Sciences) sought to clarify the criteria for determining whether a product "is protected by a basic patent in force" within the meaning of the SPC Regulation.

While Georgetown and Actavis leave a number of issues to be clarified, these two decisions confirmed that there is no general exclusion in EU law which prevents the grant of more than one SPC per patent.  The decisions handed down in these two cases do, however, appear to impose a restriction that any product in respect of which an SPC is sought must be protected "as such" by the basic patent.

Regrettably, however, the decision in Eli Lilly still leaves a degree of uncertainty with regard to the broader question of what constitutes a determination of whether a product is "protected" by a patent for the purposes of granting SPCs, and it seems that further referrals to the CJEU may be required to resolve this thorny issue.

The individual cases are reviewed in more detail below.  Some of the wider implications of these decisions beyond the particular facts of the individual cases remain to be determined.  Anyone wishing to file new SPC applications, or who wishes to explore the implications of these decisions on their existing SPCs, SPC applications or strategy, is advised to contact Dehns for more specific advice relevant to their own circumstances.

Georgetown University

In this case, Georgetown's patent claims were directed inter alia to a vaccine for the prevention of papillomavirus infection, comprising at least one recombinantly produced human papillomavirus (PV) L1 protein or a fragment thereof.  Georgetown subsequently filed eight SPC applications in total, some of which were directed to individual types of PV L1 protein and others to combinations of different types.  In doing so, Georgetown relied upon two Marketing Authorisations (MAs) directed to particular combinations of PV L1 proteins.  SPCs covering the combination products had been granted, but applications directed to the individual actives had been refused or were still pending.

The CJEU considered the question of whether the existence of an SPC covering a combination product, based on a MA in respect of the combination product, precluded the grant of SPCs directed to the individual actives in the combination product.  The Court concluded that no such rule applies, stating that:

In circumstances such as those in the main proceedings, where, 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 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, 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.

It is important to note here the requirement that each active in respect of which an SPC is sought should be protected "as such" by the patent.  As long as this requirement is met, however, a single MA covering a combination of the actives is sufficient.

Actavis

Here, Sanofi's patent covered compounds including irbesartan, an antihypertensive active agent.  Claim 20 related to a pharmaceutical composition comprising irbesartan in combination with a diuretic.

Sanofi had been granted a first MA for a product ("the mono product") comprising irbesartan as a single active, and a second MA for a product ("the combination product") comprising irbesartan in combination with hydrochlorothiazide ("HCT"), which is a diuretic.  On the basis of the patent and the two MAs, Sanofi had been granted SPCs both for the mono product and the combination product.

In the English courts, Actavis had challenged the SPC directed to the combination product on the grounds that, first, the combination of irbesartan and HCT was not specified or identified in the wording of the claims of the patent; and second, that irbesartan (which Actavis considered to be "the product", HTC per se not being the subject of the patent) had already been the subject of the first SPC.

The High Court referred two questions to the CJEU:

'(1)      What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of ... Regulation No 469/2009?

(2)      In a situation in which multiple products are protected by a basic patent in force, does Regulation [No 469/2009], and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?'

In respect of the second question, the Court held that:

In circumstances such as those in the main proceedings, where, 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 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products 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.

As Sanofi's second SPC was deemed invalid in light of the answer to the second question, the Court declined to answer the first question.  However, a similar question was addressed in the Eli Lilly case.

Eli Lilly

Human Genome Sciences ("HGS") held a European patent relating to a protein, Neutrokine alpha, and to antibodies binding specifically to that protein.  Claim 13 of the patent was directed to such antibodies, defined in terms of their binding function.

Eli Lilly wished to market a pharmaceutical composition comprising as its active ingredient a specific antibody which was not named in HGS's patent, but which would fall within the scope of claim 13 due to its Neutrokine alpha binding capability.

Eli Lilly sought a declaration that any SPC based on HGS's patent and an MA directed to the specific antibody would be invalid.  It argued that the claims of HGS's patent could not serve as the basis for an SPC directed to the specific antibody, as the breadth of the claims did not amount to the antibody being "specified".  HGS, on the other hand, contended that it would be entitled to the grant of an SPC based on the HGS patent and any future MA obtained by Eli Lilly for the specific antibody.

The English High Court referred three questions to the CJEU:

'(1)      What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation [No 469/2009]?

(2)      Are the criteria different where the product is not a combination product, and if so, what are the criteria?

(3)      In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?'

Here, the CJEU suggested that functional definitions such as those in HGS's patent may be sufficient for a product to be deemed "specified", and that a specific structural definition may not be necessary.  The decision did not, however, come to a definitive conclusion on this issue, as the Court held that the claims would need to be interpreted in light of Article 69 EPC and the Protocol on Interpretation of Article 69 EPC.  As the EPC is not EU law, it is outside the jurisdiction of the CJEU to decide on claim interpretation.

The CJEU held that:

Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in order 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.

In the case of Eli Lilly, therefore, it falls to the English courts to determine whether or not HGS's patent would be deemed to "specify" the specific antibody which Eli Lilly wishes to market.

Summary

In view of the differing interpretation and application of Article 69 EPC and the Protocol between different European countries, it is regrettable that the Eli Lilly decision seems to do little to harmonise the approach of different Member States with regard to what might count as adequate language for an active to be deemed identified or specified sufficiently to enable the grant of an SPC.  As we have seen from the Georgetown and Actavis decisions, such considerations are likely to be of crucial importance for the future issue of multiple SPCs based on a single patent.  It therefore seems that Eli Lilly is likely to give rise to still further referrals to the CJEU, not least on the point of how the words "implicitly but necessarily and specifically" are to be interpreted.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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