The ECJ confirms no preferential ranking in obtaining SPCs

The ECJ has accepted that the holder of a basic patent is entitled to one SPC regardless of whether other SPCs have already been granted to other holders of one or more other basic patents.

Legislative framework

Regulation 1768/92 (and Regulation 1610/961) sets out the regime for granting SPCs in respect of medicinal products. SPCs provide the holder of a basic patent with an additional protection for medicinal products of up to a maximum of five years after patent expiry. The objective of SPCs is to compensate the patentee for th e lost period of effective patent protection of 20 years caused by the time taken during the life time of a patent for necessary safety and efficacy testing to be carried out to obtain marketing authorisation.

In this case, the principal question related to the interpretation of Article 3(c) of Regulation 1768/92 in conjunction with Article 3(2) of Regulation 1610/96. Article 3(c) of Regulation 1768/92 lays down the basic rule that only one SPC per patent holder per product. Article 3(2) of Regulation 1610/96 provides that, where more applications concerning the same product and emanating from two or more holders of different basic patents are pending, one SPC for this product may be issued to each of these holders.

Background of the case

A European marketing authorisation was granted for the medicinal product "Enbrel" for the first time on 3 February 2000.

On 4 and 6 October 2000 and 30 January 2001, three SPCs were granted to three different patent holders. A further basic patent was subsequently granted to Hoffmann-La Roche, published on 2 April 2003. On 2 July 2003, Hoffmann lodged an application for an SPC for Enbrel. The Dutch patent office refused the application. On the basis of a strict interpretation of Article 3(2) of Regulation 1610/96, and the express reference therein to permitting a grant only where the SPC applications emanating from the different patent holders are pending, Hoffmann’s application for an SPC was refused. The Dutch patent office found that since other SPCs for the same product had already been granted, other applications were no longer pending within the meaning of Article 3(2) of Regulation 1610/96. The appeal court in The Hague decided to refer the issue to the ECJ for a preliminary ruling.

ECJ Ruling

The ECJ considered that the mere fact that SPCs have already been granted to other patent holders does not preclude the grant of an SPC to the holder of a basic patent for a product for which, at the time the SPC application is submitted, one or more SPCs have already been granted to one or more holders of one or more other basic patents.

Whilst the Dutch patent office ruled that more than one SPC applications for different patent holders could only be granted when other applications are still pending, the ECJ considered that such simultaneity of the applications could not be considered an essential condition for the grant referred to in the second sentence of Article 3(2) of Regulation 1610/96.

The ECJ considered that the strict textual interpretation of the word "pending", as had been applied by the Dutch patent office construing it as a strict condition for granting an application for an SPC to a subsequent patent holder, would effectively deprive the later applicant of the benefit provided for by SPCs. This would run contrary to the objective of the SPC Regulation. Moreover, the ECJ considered that if such a condition existed, the grant of an SPC could depend on an uncertain event which was outside the control of the applicant. As the Regulations do not contain any time limits to be taken into account by the national patent offices to reach a decision on an application, an applicant would be left solely at the discretion of national patent offices in obtaining his right to an SPC.

Clearly, the sooner a decision on an SPC application is taken by national patent offices, the less likely it is that two or more SPC applications are still pending. In other words, such condition would effectively deprive applicants of their right to an SPC in Member States where the decisionmaking process was efficient and would lead to disparities within the internal market. The ECJ considered that such a development would be contrary to the aim of the SPC Regulation, which was adopted to establish a uniform solution at Community level by creating a right to be obtained under the same conditions in each Member State.

The ECJ also referred to Case C-181/95 Biogen in which it had already been decided that the SPC Regulation did not seek to institute any preferential ranking amongst holders of national or European patents. Biogen had established that where a product is protected by a number of basic patents in force, which may belong to a number of patent holders, each of those patents may be designated for the purpose of the procedure for the grant of an SPC, although only one SPC may be granted for each basic patent. In Biogen, various patent holders had applied for SPCs simultaneously and therefore all applications would have been pending within the meaning of Article 3(2) of Regulation 1610/96, whereas in the current case, the application was filed later, whilst the earlier application was no longer pending.

The outcome of this ECJ judgment is in line with the decision of the UK's IPO in its judgment of 16 November 2004 ([2004] RPC 24). However the reasoning was slightly different. The UK's IPO recognised that Article 3(2) of Regulation 1610/96 only addresses the situation where two or more applications are pending together and that this Article is merely a further interpretation of Article 3(c) of Regulation 1768/92. Therefore Article 3(2) is not applicable to the situation of successive applications for SPCs by different patent holders referring to the same product. On the basis of Article 3(c), the IPO found that where there are a number of patents in different hands, but protecting the same product, all holders of basic patents may be granted only one SPC. It should not be possible for one and the same patent holder to multiply the extent of protection under SPCs by obtaining successive SPCs.

The ECJ provides an interpretation of Article 3(2) in relation to successive SPC applications. The ECJ considers that the second sentence of Article 3(2) does not require that the applications be pending at the same time, hence there is no preferential ranking regardless of whether the applications are simultaneous or successive.