As was reported in our Life Sciences Updates of December 2011 and March 2012, several important decisions regarding Supplementary Protection Certificates (SPCs) have recently been handed down by the Court of Justice of the EU (CJEU). Some of these decisions, however, do not provide full clarity as to all aspects of SPC protection under consideration and leave room for further interpretation by the national courts or referral questions to the CJEU.
One of the issues yet to be clarified is whether the observation in the Medeva (C-322/10) and Georgetown (C-422/10) decisions, at  and  respectively, that “where a patent protects a product … only one [SPC] may be granted for that basic patent”, means that in cases where several products are protected by the same patent only one SPC per patent can be obtained, rather than one SPC per product per patent. This is at the core of a set of questions raised by the District Court of The Hague in its referral to the CJEU in yet another Georgetown case. The English High Court of Justice has also referred this question to the CJEU.
The SPC at hand: refusal by the Dutch Patent Office
On 14 December 2007, Georgetown University (GU) applied to the Dutch Patent Office for a series of SPCs for (combinations of) several types of recombinant L1 protein of Human Papilloma Virus (HPV), one of which related to HPV type 16 (SPC 321).
For each of these applications, GU referred to marketing authorisations for either the drug Gardasil (aka Silgard) or the drug Cervarix, both of which were also at stake in the UK proceedings which led to the Georgetown decision of the CJEU. Gardasil comprises a combination of the virus-like particles of the recombinant L1-protein of HPV 6, 11, 16 and 18, whilst Cervarix only comprises HPV 16 and 18. The basic patent to which GU referred in the Dutch applications was EP ‘140, which covers Papilloma virus vaccines, and which again was also at stake in the UK case that led to the CJEU reference. The patent claims proteins of various HPV types, among which HPV 16.
The Dutch Patent Office, and likewise the Comptroller in the UK, granted only the SPCs that were applied for the combination of all types of HPV comprised in Gardasil or Cervarix respectively. The applications for single types of HPV, including SPC 321, were denied on the basis that the underlying marketing authorisations did not pertain to these single types of HPV, and hence the SPC applications did not comply with the requirement as stipulated in article 3(b) of the SPC Regulation, i.e. that a valid marketing authorisation to place the product on the market as a medicinal product had been granted.
The appeal before the District Court of The Hague
GU lodged an appeal before the District Court of The Hague regarding the refusal of SPC 321. Pending this appeal, the CJEU rendered its decisions in Medeva and Georgetown, which made clear that SPC 321 should not have been refused on the basis of article 3(b) of the SPC Regulation. After all, in these decisions the CJEU applied a broad approach in respect of article 3(b), holding that a marketing authorisation for a combination product with two or more actives should also be regarded as a marketing authorisation for a product comprising one or only some of these actives. In light of this broad approach, the parties agreed that the appeal of GU was justified in as far as it was based on application of article 3(b).
However, as a further ground for refusal, the Dutch Patent Office asserted that SPC 321 should be denied on the basis of article 3(c) of the Regulation, stipulating that an SPC cannot be granted for a product for which an SPC has already been granted. The Dutch Patent Office, referring to the Medeva and Georgetown decisions, decided that only one SPC could be granted per basic patent. Since GU already possessed two SPCs based on basic patent 140, one for the actives in Gardasil and the other for the actives in Cervarix, the Dutch Patent Office held that SPC 321 should be denied.
GU raised a formal objection based on the change of ground for refusal from 3(b) to 3(c). Furthermore, GU expressed their willingness to voluntarily surrender the two SPCs which had already been granted with retrospective effect so that the debate on article 3(c) would be redundant. Moreover, GU argued that, since the granted SPCs were applied for on the same date as SPC 321 and granted only later, article 3(c) based on the wording thereof would not be applicable at all. Finally, GU pointed out that the relevant observations in Medeva and Georgetown referred to the Biogen decision of the CJEU (C-181/95), which dealt with a different situation than the underlying: in Biogen the product was protected by several basic patents, while the underlying case pertains to the situation in which one basic patent protects several products. GU therefore implied that the one SPC per patent rule does not apply when the patent protects multiple products.
The considerations of the District Court
The District Court of The Hague stated that it did not consider this an acte clair and that preliminary questions should be referred to the CJEU. In respect of the main issue, i.e. the question of whether or not, where several products are protected by the same patent, article 3(c) precludes the grant of an SPC for each product, the District Court summarised some of the arguments in favour of each approach. It follows that arguments based on the case law of the CJEU seem to be more in favour of ‘one SPC per patent’, whilst legislation and legislative history do not seem to preclude ‘one SPC per product per patent’. The District Court added that if the ‘one SPC per patent’ approach is to be followed, this would lead to the remarkable situation where a patentee would be able to easily circumvent this by applying for several patents protecting separate products, instead of one patent protecting all products.
In respect of the other arguments brought forward by GU, the District Court held that neither argument stood in the way of referring questions to the CJEU. The formal objection was dismissed on the basis that the District Court was of the opinion that it must assess whether the current ground for refusal was valid in light of final dispute resolution. With respect to GU’s proposed voluntary surrender of the two granted SPCs, the District Court was of the opinion that it was a matter of EU law whether or not such surrender has retrospective effect and, if so, whether or not this would preclude application of article 3(c). The argument based on the wording of article 3(c), i.e. non-applicability now that the product was not yet subject of another (granted) SPC at the date of application for SPC 321, was not without merit according to the District Court in as far as it relates to a literal reading of article 3(c). However, the District Court also stated that this would go against the ratio of article 3(c), which it considered to be avoidance of multiple SPCs for one and the same product (or patent, dependent of the CJEU’s view on the main issue at hand). The District Court held that these additional issues should also be decided by the CJEU.
The questions referred to the CJEU
Therefore, the District Court of The Hague referred the following questions to the CJEU:
In the situation wherein a basic patent in force protects several products, does 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, more in particular article 3 heading and under 'c', oppose the grant of a certificate in respect of each of the protected products to the holder of the basic patent?
In the event that question 1 is to be answered affirmative, how should article 3 heading and under 'c' of the Regulation be explained in the situation wherein a basic patent in force protects several products and on the application date of a certificate for one of the products (A) protected by the basic patent no certificates had been granted yet for the other products (B, C) protected by the same basic patent, but certificates were granted on the basis of these applications for the products (B, C) before the application for the certificate for the first-mentioned product (A) is decided upon?
When answering the previous question, is it relevant whether or not the application for one of the products (A) protected by the basic patent has been filed on the same date as the applications for the other products (B, C), which are protected by the same basic patent?
In the event that question 1 is to be answered affirmative, can a certificate be granted for a product protected by a basic patent in force, if a certificate had already been granted for another product protected by the same basic patent, but the latter certificate is surrendered by the applicant with the intention of obtaining a new certificate based on the same basic patent?
In the event that it would be relevant for answering the previous question whether or not the surrender has retrospective effect, is the question of whether or not the surrender has retrospective effect governed by article 14 heading and under 'b' of the Regulation or by national law? In the event that the question of whether or not the surrender has retrospective effect is governed by article 14 heading and under 'b' of the Regulation, should this provision be explained such that surrender has retroactive effect?
In the article ‘Initial attempts to apply the recent CJEU case law on SPCs’ in our Life Sciences Update of March 2012, the main issue at hand was discussed from a UK perspective. It was explained that the view of the UK Intellectual Property Office is that the CJEU in its Medeva and Georgetown decisions was not intending to change the law, its understanding of which was that there could be only one SPC per product per patent. Therefore, it was concluded that it seemed unlikely that an opportunity would arise for the English courts to refer this particular question to the CJEU for clarification.
Given the fact that the Dutch Patent Office’s views are different from those of their UK counterpart, the opportunity has now arisen for the District Court of The Hague to refer the above questions to the CJEU. Furthermore, given the fact that the Dutch Patent Office took the view that it did, the English High Court in a case between Sanofi and Teva (irbesartan) has now held that indeed the CJEU should decide on the first question raised in the Dutch case and has referred a similar question to the CJEU.
With regard to the interpretation favoured by the Dutch courts, it is noted that, based on the judgment of the District Court of The Hague alone, it is rather difficult to predict which position the District Court is likely to take. The questions are formulated neutrally and in the judgment arguments have been discussed in favour of both approaches.
However, it should also be noted that the PI Judge of the Court of The Hague recently did have to show colours on this issue in the Dutch proceedings between Sanofi and Teva regarding irbesartan. In this PI action, albeit under different circumstances, one of the questions raised was whether article 3(c) of the Regulation precludes the grant of two SPCs for two products protected by the same basic patent (being irbesartan and a combination of irbesartan/HCTZ). Even though the final questions to the CJEU cited above had not been formulated yet by the District Court, the PI Judge did make reference to the District Court’s intention to ask questions, which had already been announced.
The PI Judge considered the fact that the CJEU’s answer to these questions could be important to the outcome of the PI action, but concluded that the urgency of the case meant that it should not be delayed to wait for the answer. Instead, the PI Judge made her own assessment and held that the mere reference to the Biogen decision in the Medeva decision is not an indication that the CJEU wanted to put an end to the consistent practice of granting one SPC per product per patent. Therefore, the PI Judge rejected the defence that the SPC for the combination product was invalid due to the prior SPC for the mono product.
In light of the position taken by the PI Judge, as of yet, there is no pressing reason for owners of separate SPCs for different products protected by the same basic patent to hold off from seeking preliminary relief in the Netherlands on account of the questions asked in the new Georgetown referral. Needless to say, this may change once the CJEU has given an answer to these questions. In any case, further clarification of the Medeva and Georgetown decisions is to be welcomed.
This article was written by:
Hanneke Later-Nijland Lars Huisman
Other articles in the Life Sciences newletter for December 2012:
> Pan-European declaration of non-infringement can be brought before the English Courts
> Germany: No imminent threat of patent infringement upon obtaining a marketing authorisation
> Czech Republic: New restrictions on advertising of pharmaceuticals
> Spain: Supreme Court ruling on reference pricing system
> CJEU dismisses appeals by AstraZeneca and upholds General Court Judgement