Supplementary Protection Certificates (SPCs) have been the hot topic in the pharmaceutical patent sector in recent years, and towards the end of last year it appeared as though many of the queries regarding interpretation of the SPC Regulation (469/2009) had been clarified. Surely now it would be possible to simply apply the decisions of the CJEU and know, with some certainty, whether an SPC would be granted. Unfortunately this has not been the case, and the decisions of 2011 and 2012 appear to have given rise to further uncertainty, and provided a new series of questions for the CJEU to consider as we enter 2013.
The currently pending referrals cover topics including the criteria for deciding whether a product is protected by a basic patent in force, particularly in relation to combination products (Actavis & Eli Lily); the permissibility of multiple SPCs covering different products arising from one basic patent, and whether surrendering one SPC can allow a later SPC to be granted based on the same basic patent (Actavis & Georgetown); and the validity of a Liechtensteinian marketing authorisation, arising from a Swiss marketing authorisation, as the basis for an SPC (Astrazeneca).
We hope that 2013 will see greater clarification of the regulation governing SPCs. However, since many of the questions currently pending before the CJEU are based on questions similar to those considered in 2011 and 2012, we may be disappointed.
C-443/12 – Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC
It was hoped that the decisions of Medeva (C-322/10) and Georgetown (C-422/10) issued in 2011 would clarify once and for all the requirements for obtaining an SPC for a combination product. However in these decisions the CJEU opted to leave the issue open to interpretation, and stated that the phrase “protected by a basic patent in force”, as used in Article 3(a) of the Regulation, “must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application.” The CJEU provided no guidance as to how the requirement “specified in the wording of the claims” was to be interpreted, and several national courts have indicated that they believe this to be an unsatisfactory answer to the questions posed.
Mr Justice Arnold has now requested further clarification of this important point, and has sent the following direct question 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 469/2009/EC (“the Regulation”)?
It remains to be seen whether the CJEU will answer this question given that they only recently decided similarly worded questions in Medeva and Georgetown.
At the same time, Mr Justice Arnold requested clarification of whether it is possible to obtain more than one SPC per patent when multiple products are protected by the claims of a single basic patent. This question also arose from the Medeva decision, where it was stated that “where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent”. This is contrary to the previous indication in Biogen that “one SPC per patent per product” may be granted. On this point, the following question was referred to the CJEU:
2. In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?
Again, it remains to be seen whether the CJEU will answer this question for a second time or whether it will simply refer Arnold to the answer given in Medeva.
C493/12 Eli Lilly v HGS
Shortly after the Actavis referral, Mr Justice Warren referred three questions to the CJEU from the Eli Lilly v HGS case which has been continuing, in various guises, for several years. Here the questions were:
1. What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of Regulation 469/2009/EC;
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?”.
It is not yet clear whether these questions will be combined with those referred in Actavis, and whether the CJEU will even answer these questions in view of the interpretation recently provided in Medeva and Georgetown. Nevertheless, we are hopeful that greater clarification of Article 3(a) will result from these referrals.
C-484/12 Georgetown University
Following the 2011 decision in relation to the Georgetown referral (C-422/10), the Dutch court has now referred five more questions to the CJEU. This time the questions focus on the “one SPC per patent” requirement, which has also been referred in Actavis.
The following questions arose from Georgetown’s application for an SPC for HPV16, when an SPC for the combination of vaccine HPV16 and HPV18, and an SPC for the combination of HPV6, HPV11, HPV16 and HPV18 had already been granted from the same basic patent. Georgetown offered to surrender these earlier SPCs in favour of the later application for HPV16 alone, but the Dutch court considered it unclear whether this surrender would have retroactive effect. The questions referred here are as follows:
1. Does Article 3(c) of the Regulation preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?
2. If so, how should Article 3(c) be interpreted in the situation where there is one basic patent in force which protects several products, and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had in fact yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless later granted in respect of those applications in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?
3. Is it significant for the answer to the second question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same basic patent?
4. If the answer to question one is in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate had already been granted earlier for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?
5. If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering question four, is the question of whether surrender has retroactive effect governed by Article 14(b) of the Regulation or by national law? If it is governed by Article 14(b), should that provision be interpreted to mean that surrender does have retroactive effect?
We hope that this series of questions will force the CJEU to rescind the comments made in Medeva and revert to the “one SPC per patent per product” ruling made in Biogen.
C617/12 – AstraZeneca AB v Comptroller-General
The final case currently pending before the CJEU relates to a situation which the authors of the regulation could not have foreseen.
In 2004 AstraZeneca obtained a Swiss marketing authorisation which was also automatically valid in Liechtenstein (and therefore the EEA). The Swiss marketing authorisation was for a limited duration and complied with less stringent requirements than would have been necessary to obtain a marketing authorisation in the EU. The Swiss authorities requested that additional data be filed within a time limit in order for the marketing authorisation to remain in force, and the marketing authorisation was subsequently withdrawn due to lack of data, terminating its effect in Liechtenstein also. AstraZeneca was ultimately granted a European marketing authorisation in 2009 and a new Swiss marketing authorisation in 2010, once further data was available. A marketing authorisation was therefore in force in the EEA (Liechenstein only) in 2004-2005 and in the EU since 2009.
Under the SPC regulation the date of the first marketing authorisation, which is used to calculate if an SPC should be granted and for how long it should last, can be that of any authorisation to place the drug on the market in the EU or EEA. However it is not clear in this scenario which is the first marketing authorisation. In an attempt to clarify this issue the following questions were put to the CJEU:
1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of the SPC Regulation?
2. Does it make a difference to the answer to the first question if:
(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or
(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?
3. If Article 13(1) of the SPC Regulation refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of the SPC Regulation?
It can be seen from the four pending referrals discussed above that much uncertainty still surrounds the SPC regulation. We hope that 2013 will see clarification of many of the outstanding issues, but it must be considered likely that still further points of interpretation will come to the fore as we head through 2013.