Georgetown University, Washington, DC, USA v. Octrooicentrum Nederland (Dutch Patent Office), Administrative Law division of the District Court The Hague, the Netherlands, referral judgement of 12 October 2012, case no. AWB 10/4769
*** Now including a translation in English with thanks to Hoyng Monegier ***
Georgetown University (“GU”) held the EP0647140 patent for ‘Papillomavirus vaccines’ and filed an application for an SPC on 14 December 2007 (application no. 300321) for recombinant L1 protein of human papillomavirus (HPV) type 16, which application was denied by the Dutch Patent Office (“DPO”) by decision of 19 May 2010. GU filed objections against this refusal on 30 June 2010. Parties agreed to directly appeal to the District Court of The Hague and they have filed their views regarding the decisions of the ECJ of 24 and 25 November 2011 in C-322/10 (Medeva), C-422/10 (Georgetown University) and C-630-10 (Queensland).
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The DPO based its refusal on the ground that the Market Authorisation saw to a product combining HPV 6, 11, 16 and 18, and not merely type 16, so that in its view the application did not meet the requirements for obtaining an SPC. After the Medeva decision by the ECJ, GU also filed separate SPC applications for HPV 16, HPV 18, HPV 6, HPV 11 and HPV 18, which applications have not been decided upon by the DPO. Influenced by the Medeva decision, the Parties agreed that the original decision to refuse the application was incorrect. The DPO amended its grounds and now took the position that, in view of consideration 41 in the Medeva decision and consideration 34 of the Georgetown decision, that it proposed to refuse the application because GU had already obtained two SPCs on the basis of the same patent. Since the ECJ explicitly ruled that only one SPC can be granted per base patent, the SPC must be denied.
GU argued against this position, taking the view that (1) these grounds were not the original grounds of the decision under appeal, so that the decision should be annulled and the DPO forced to take a new decision, (2) it is willing to renounce the two existing SPCs with retroactive effect and (3) that at the date of the application, there were no granted SPCs in place as yet. Additionally, GU disputes the DPO’s reading
After extensive reasoning, the District Court sees grounds in this case to refer the following questions to the ECJ:
Question 1
Should the SPC Regulation 469/2009, especially Article 3, be understood to mean that in the situation where one base patent protects several products, the patentee cannot be granted an SPC for each of the protected products?
Question 2
If question 1 is answered in the affirmative, how then should Article 3 be interpreted in the situation where one base patent protects several products and where on the filing date for the SPC application for one such product (A), no SPCs had been granted for two other products (B, C) covered by the same base patent, but where SPCs were granted for B and C before a decision had been taken regarding the application for A?
Question 3
Does it make any difference to the answer to the previous question if the SPC application for (A) was filed on the same date as the applications for products B and C, protected by the same base patent?
Question 4
If question 1 is answered in the affirmative, can an SPC then be granted for a product covered by a base patent, if an earlier SPC was already granted for another product covered by the same base patent, if the applicant is willing to renounce the earlier SPC with the goal of getting a new SPC for the same base patent?
Question 5
If it is relevant to the answer to the previous question, whether the renouncing of the earlier SPC has retro-active effect, should the question whether it has such retroactive effect then be ruled by Article 14 of the Regulation or by national law? If the question whether the renouncing of the earlier SPC has such retroactive effect should be ruled by Article 14 of the Regulation, should that Article then be interpreted as meaning that renouncing has retroactive effect?
Read the decision (in Dutch) here.
Read the decision (in English) here.
Headnote: Maurits Westerik
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