District Court of the Hague, 11 July 2012, cases AWB 10/4769 (Georgetown University/NL Octrooicentrum) and AWB 10/7362 (The University of Queensland/NL Octrooicentrum)
These rulings of the District Court of the Hague concern sub c of Article 3 of the SPC-regulation (469/2009). They follow on the recent rulings of the ECJ in the Queensland (C-630/10), Georgetown University (C-422/10) and Medeva (C-322/10) cases of 24 and 25 November 2011 (concerning sub a and b of Article 3 of the SPC-Regulation). From those cases it followed that an applicant may base its request for an SPC for a single active substance on a marketing authorization in which this substance is included in a combination with other active substances.
In the present cases, the question is whether sub c of Article 3 precludes the grant of an SPC for more than one product covered by the same base patent. Georgetown University and the University of Queensland both hold patents for vaccines. They had obtained an authorisation for a ‘multi-component’ variant of the vaccine and requested an SPC for this vaccine (the “original application”). This SPC was initially refused with reference to sub b of Article 3 of the Regulation, but parties agree that in light of the decisions cited above the refusal was incorrect. However, the Patent Office now refuses to grant the SPC’s under reference to sub c of Article 3 of the Regulation.
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The universities had filed different SPC applications for other products that were protected by the same base patent. These SPCs were granted pending the original application, the difference being that in the case of Georgetown the applications were (mostly) filed before the original application, and in the case of Queensland after the original application. The Dutch Patent Office argued that it follows from the case law of the ECJ that only one SPC can be granted per base patent, regardless of the number of products which are covered by that patent. In order to overcome this concern, the universities primarily argued that they had abandoned any conflicting SPCs. According to them, abandonment of the earlier SPC’s has retroactive effect, so that they do not prejudice a later application for a new SPC. Moreover, the universities argued that it follows from the wording of Article 3 that it is decisive whether on the date of the application a different SPC had already been granted for that patent.
The Court decides to refer the cases to the ECJ. It calls to mind that in Medeva, the ECJ explicitly stated that only one SPC may be granted for a base patent (§ 41). It also refers to the opinion of the Advocate-General, which according to the Court would imply that it may not be possible to obtain SPC’s for mono products and combination products on the basis of the same base patent. Moreover, the Court is not convinced that the abandonment of the earlier SPC’s has retroactive effect, since Article 14, first sentence sub b makes no mention of this. And even if abandonment would have retroactive effect, it according to the Court would not be clear that this would mean that the later filed SPC’s can be granted. On the other hand, a strict interpretation according to the Court finds no support in the wording of the Regulation, which merely requires that the product has not already been the subject of a certificate. The Court notes that in any case patent holders could easily circumvent the provision if interpreted strictly by applying for separate patents for each of the variants of the invention.
The Court eventually formulates the following draft questions to the CJEU:
1. Does Regulation 469/2009 of the European Parliament and the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, particularly article 3, first sentence sub c, prohibit that, in the situation that multiple products are claimed in (the claims of) a single basic patent, the patent proprietor is granted a supplementary protection certificate for each of the claimed products?
2. If the first question is answered in the affirmative, can a certificate be granted for a product that is claimed in the basic patent, if a certificate was already granted for a different product claimed in the same patent, but the patent proprietor abandons this certificate in order to qualify for a new certificate under the same patent?
3. If it is relevant for the answer to the second question whether the abandonment has retroactive effect, is the matter of retroactivity of the abandonment governed by article 14, first sentence sub b of the Regulation or by national law? If the answer is article 14, first sentence sub b of the Regulation, is this provision to be interpreted to mean that abandonment has retroactive effect?
4. If the first question is answered in the affirmative, then how must article 3, first sentence under c of the Regulation be interpreted in the situation that multiple products are claimed in (the claims of) a single basic patent and on the application date for a certificate for one of the claimed products (A), no certificate had been granted for another product claimed in the same patent (B), but where a certificate for product (B) was granted before a decision had been reached on the application for the other product (A)?
And, in the case of Queensland:
5. Is it relevant for the answer to the fourth question whether the application for product (B), which already led to a certificate, was submitted at a later date than the application for a certificate for product (A), which has not yet led to a certificate?
Finally, the Court allowed the parties a term of 6 weeks to comment on the draft questions to be put to the CJEU.
Read the decisions (in Dutch) here and here.
Head note: Geert Theuws
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