Even though the Court of Justice of the European Union (CJEU) has handed down in the last two years a considerable number of landmark decisions concerning various aspects of Regulation 469/2009/EC (i.e. the SPC regulation), the rulings have apparently still left numerous issues of the legislation unresolved. Courts in Great Britain, Germany, and the Netherlands have now referred numerous further questions to the CJEU, which might be wondering whether there is some pan-European conspiracy to deluge it with SPC-related references. Two interesting referrals will be illustrated below.

1. Case C-484/12 (Georgetown University)

On October 12, 2012 the District Court of The Hague referred questions relating to Article 3(c) of the SPC Regulation to the CJEU in proceedings between the Dutch Patent Office and Georgetown University.

Georgetown University is the proprietor of a basic patent that protects four active ingredients (i.e. HPV6, HPV11, HPV16, and HPV18) and was also granted a marketing authorization for the combination of these substances. Based thereon, the university applied in 2007 for an SPC for each of the active ingredients individually. The application for HPV 16 was refused by the Dutch Patent Office; the other applications are still pending. The applicant subsequently appealed to the District Court.

The Dutch Patent Office stated that the application for an SPC for HPV16 is to be refused under Article 3(c) of the Regulation because of two SPCs previously been granted based on the same basic patent, namely one for the combination of HPV16 and 1HPV8, and one for the combination of all four active ingredients.

The District Court considered that in the Medeva case (C-322/10; cf. Newsletter issues of August 2011 and May 2012), the CJEU, of its own accord, explicitly stated in the context of Article 3(c) of the Regulation:

  • “[…] in a situation such as in the main proceedings […] where the patent protects a product, in accordance with Article 3(c) of Regulation 469/2009/EC, only one certificate may be granted for that basic patent.”

This could be read as a “one certificate per patent” rule. However, the Court noted that, if the rule should be interpreted as prescribing only one certificate per basic patent, a patentee could simply circumvent this by applying simultaneously for several patents, each protecting a single product, instead of protecting several products in one patent. The patent holder would thus still be able to receive SPCs for each product. In addition, the Court wondered, if only one SPC per patent could be granted, how to deal with the situation that several applications are pending simultaneously, and one application is decided on before the other applications.

Another issue in this case related to the surrender of SPCs. Georgetown University stated that it were willing to abandon its SPCs for the combinations of two and four active ingredients, respectively, if that would mean that it would be able to obtain an SPC for HPV 16. Georgetown argued that surrendering a certificate had retrospective effect and that, therefore, after abandonment, the SPCs thus should be deemed to have never been granted, and the SPC for HPV 16 applied for would be the first certificate for the product.

The Court held that Article 14 of the Regulation provides the right to surrender but does not mention retrospective effect. In addition, it appeared that the definition of the term ‘surrender’ must be considered to be a matter of EU community law.

Furthermore, the Court held that the provision of Article 3(c) of the Regulation did not clearly imply that a surrendered certificate would or would preclude a new certificate for the product being granted.

In order to address these issues the District Court referred the following five questions to the CJEU.

  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 an SPC 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 an SPC in respect of one of the products (A) protected by the basic patent, no SPCs had in fact yet been granted in respect of other products (B, C) protected by the same basic patent, but where SPCs were nevertheless granted in respect of those applications in respect of the products (B, C) before a decision was made with regard to the application for an SPC 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 an SPC be granted for a product protected by a basic patent which is in force if an SPC had already been granted earlier for another product protected by the same basic patent, but where the applicant surrenders the latter SPC 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?

2. AstraZeneca v Comptroller General of Patents

On October 19, 2012 the UK High Court of Justice in London referred questions relating to the interpretation of Article 13(1) of the SPC Regulation to the CJEU (no case number assigned yet). In particular, the referral relates to the duration of an SPC.

The case involved an SPC for AstraZeneca’s medicinal product IRESSA® which is used for the treatment of non-small-cell lung cancer. AstraZeneca owns European patent 0 832 900 B1 protecting gefitinib, the active ingredient in IRESSA. The patent will expire in April 2016. AstraZeneca applied for an SPC for gefitinib at the end of 2009. The SPC was duly granted with an expiry date in March 2019. The duration of the SPC was calculated by reference to a marketing authorization (MA) granted by the Swiss regulatory authority in March 2004.

However, Switzerland is neither member of the EU nor of the European Economic Area (EEA) and thus not bound by the relevant EU Directives (i.e. Directive 2001/83/EC for human medicines) which are referred to in the SPC Regulation. However, due to the longstanding customs union between Switzerland and Liechtenstein, this Swiss authorization was also automatically valid in Liechtenstein (member of the EEA).

The Swiss MA applied less stringent criteria than would have been required by the EU authorities, under the relevant Directives. The Swiss authorities granted a limited-duration MA and required that better clinical data be supplied to them, within a time limit, in order for a longer-term MA to be granted. Since the applicant did not provide further data, the Swiss MA was withdrawn, thus also terminating its effect in Liechtenstein. Following the submission of more clinical trials, AstraZeneca was ultimately granted a European MA by the European Medicines Agency in 2009 and a new Swiss MA in 2010.

AstraZeneca contended that the European MA should be used as the basis for the grant of an SPC, giving an expiry date in April 2021. However, the UK Patent Office decided that the SPC should be granted based on the first Swiss MA. AstraZeneca appealed to the High Court.

In an earlier decision on this point (Novartis) the CJEU reasoned that such a Swiss MA did count as the first MA for the purposes of calculating SPC term pursuant to Article 13(1) of the Regulation, due to its effect in Liechtenstein. However, more recent CJEU decisions have appeared to contradict this and to imply that the relevant MA must be one, which complies with the requirements of the relevant EU Directives.

Due to this apparent inconsistency the UK High Court decided to refer the following questions to the CJEU, for clarification of the position.

  1. Is a Swiss MA not granted pursuant to the administrative procedure laid down in Directive 2001/83/EC, but automatically recognized by Liechtenstein, capable of constituting the ‘first authorization to place the product on the market’ for the purposes of Article 13(1) of the 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 MA was considered by the European Medicines Agency as not satisfying the conditions for the grant of a MA pursuant to Regulation 726/2004/EC; and/or
(b) the Swiss MA was suspended after grant and was only reinstated following the submission of additional data?
  3. If Article 13(1) of the Regulation refers solely to MAs granted pursuant to the administrative authorization 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 MA automatically recognized in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of an SPC pursuant to Article 2 of the Regulation?

It remains to be seen whether the upcoming rulings (to be expected in fall 2013) of the CJEU will finally clarify at least theses aspects of the SPC Regulations.