Background

In the beginning of May 2019 the Swedish Patent and Market Court of Appeal, requested a preliminary ruling from the Court of Justice of the European Union (”CJEU”) regarding the interpretation of Article 3(c) of the Regulation No 469/2009 and the condition described therein for obtaining a supplementary protection certificate (“SPC”) (case no. PMÖÄ 9354-17). A SPC constitutes an extension of the term of protection for a patent where the patentee has obtained a marketing authorisation (“MA”) to place a medicinal product covered by the patent on the market. Article 3 of the Regulation sets forth the general conditions for obtaining a certificate.

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

  1. the product is protected by a basic patent in force;
  2. a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
  3. the product has not already been the subject of a certificate;
  4. the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.”

The question referred by the Swedish Patents and Market Court of Appeal specifically relates to Article 3(c) and how this shall be interpreted in the light of earlier decisions by the CJEU.

The facts of the case before the Patent and Market Court of Appeal

The medicinal company Novartis AG (“Novartis”) applied in December 2013 for a SPC regarding the product “canakinumab” based on the basic patent EP 1 940 465 and a MA from 2013. The basic patent and the MA relates to the use of canakinumab for a certain therapeutic indication (systemic juvenile idiophatic arthritis).

The Swedish Patent and Registration Office rejected the application due to the fact that Novartis already had been granted a SPC for the product canakinumab. The earlier SPC was based on a different basic patent, EP 1 313 769, as well as a previous MA from 2009 regarding a different therapeutic indication (cryopyrin periodic syndromes). Novartis appealed the patent office’s decision to the Swedish Patent and Market Court. The Patent and Market Court also rejected Novartis’ application and stated that the “product” specified in Article 3(c) of the Regulation No 469/2009 shall be interpreted as the active substance (with reference to Glaxosmithkline Biologicals, C 210/13) and that the meaning of “product” had not changed through the Neurim decision, Neurim, C-130/11 (with reference to MIT, C-431/04 and Forsgren, C-631/13) (see below more regarding the Neurim decision). Accordingly, the court concluded that the earlier SPC for canakinumab therefore prevents the grant of an additional SPC for the same product.

Patent and Market Court of Appeal

Novartis further appealed the decision to the Patent and Market Court of Appeal. The court initially confirmed the lower instances statements in that the CJEU in previous cases has stated that “product” should be interpreted as “active substance”.

The Patent and Market Court of Appeal stated that the original purpose with Regulation No 469/2009 is to stimulate research that leads to the discovery of new products. According to the CJEU the development of pharmaceutical research has a decisive role in the continuing improvement in public health (Farmitalia, C-392/97 and Forsgren, C-631/13). However, there must be a balance between the interest of research, the public health and the pharmaceutical companies´ interests (Sanofi, C-443/12).

Furthermore, the CJEU has in a previous case, Neurim Pharmaceuticals (Neurim, C-130/11) examined whether an older MA for use of a certain product prevents the grant of an SPC for a new use of the same known product protected by a basic patent. In this case the CJEU stated that a SPC may be granted on the basis of a new basic patent protecting a new therapeutic use of an already known product, regardless of an earlier MA covering another use of the known product. The CJEU has further also stated that in the event that the same product is protected by multiple basic patents which belong to multiple holders, all of these may be granted a SPC, without any of these being given priority (Biogen, C-181/95). According to the Patent and Market Court of Appeal, the interpretation of the regulation in these cases does not directly correspond with the purpose of the regulation, which is to stimulate pharmaceutical research that will lead to the discovery of new products. These cases rather correspond with a wider purpose than the original purpose of the regulation, i.e. research relating to new therapeutic uses.  

The Patent and Market Court of Appeal also discuss Article 3.2 of Regulation No 1610/96 regarding SPC for plant protection products. This regulation is relevant for the interpretation of the purpose of the regulation at issue and thus how the issue regarding SPCs for new uses of known products shall be interpreted. The article states that it is not possible for one holder of several patents protecting a certain product to be granted more than one SPC. However, according to the article two separate applications from two different holders of different patents may each be granted a SPC, even though the applications concern the same product, provided that the applications are pending at the same time. The CJEU has later clarified that the requirement that the applications shall be pending at the same time cannot be upheld and the fact that a SPC has been granted (i.e. the applications are not pending at the same time) shall not hinder two patent holders from being granted separate SPCs for the same product (AHP Manufacturing, C-482/07). According to the Patent and Market Court of Appeal, an application of Article 3.2 of Regulation No 1610/96 which entails that a SPC may be granted by several holders of basic patents, without a requirement that the applications should be pending, is also an application which does not directly correspond with the purpose to stimulate research that will lead to discovery of new products. This case thus also rather supports a purpose which stimulates research for a new therapeutic use of already known products, with the effects this will have on public health.

Request for a preliminary ruling

In the light of this potentially wider purpose of the SPC regulations recognised by the Patent and Market Court of Appeal, the court wants to clarify the purpose of the regulation and the interpretation of article 3(c). The court therefore requested a preliminary ruling from the CJEU in relation to the following question.

In view of the fundamental objective that a SPC is intended to fulfil, which is to encourage pharmaceutical research, does Article 3(c) in Regulation No 469/2009 regarding SPC for medicinal products – with reference to Article 3.2 in Regulation No 1610/96 regarding SPC for plant protection products – prevent an applicant which previously has been granted a SPC for a product protected by a valid basic patent for that product per se, from being granted a SPC for a new use of the product in a case where the new use constitutes a new therapeutic indication which is specifically protected by a new basic patent.

Summary

The referral is very interesting since the Swedish Patent and Market Court seems to acknowledge the widened scope of application of the SPC regulations which inter alia the Neurim decision has opened for. The Neurim decision has given rise to considerable discussion and the exact extent of the widened scope is yet unclear. The CJEU has been busy with referrals the last few years, which also have been reported in earlier Lexology articles. In a recent preliminary ruling (Abraxis, C-443/17) the court ruled in a response to Justice Arnold’s referral that new formulations of an old active substance cannot be regarded as being the first MA since the earlier active substance already was covered by an earlier MA. The ruling has been argued to show that the CJEU took a restrictive approach to the application of the principle set forth in the Neurim judgement. However, it can be noted that the court stated that the Neurim decision applies to new therapeutic uses, not new formulations, and that the Neurim decision therefore could not be relied upon in the Abraxis case. This means that the restrictive approach taken in Abraxis does not necessarily close the door that the CJEU opened in the Neurim decision in relation to new therapeutic uses. We look forward to the CJEU’s further guidance.