C-322/10 and C-422/10 Medeva: beyond the words

The Court of Justice has recently been submitted a serious of cases concerning the legislation on supplementary protection certificates for medicinal products (see also C-518/10 Yeda Research and Development Company and Aventis Holdings, C-630/10 University of Queensland and CSL, C-6/11 Daiichi Sankyo, C-130/11 Neurim Pharmaceuticals).
A unique opportunity for the Court of Justice to sort out the field, apparently marked with differences in interpretation and application throughout the Union.

Legal backround

The key piece of legislation is 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*.
The logic behind the legislation is quite simple: as it takes time for a patented medicinal product to be put on the market (the time was estimated at average 12 years in the original Commission proposal**), the patent protection of the medicinal products is dramatically reduced (from 20 to 8 years). Since this would have a negative effect on R&D in the field, the inventors should be compensated by allowing them to prolong the patent protection so that they can benefit from it effectively for the full period (starting from the marketing authorisation). This is to be done through the grant of the so-called supplementary protection certificates (SPC).
The (cumulative) conditions for obtaining an SPC are set out in Article 3 of the Regulation. It reads as follows:
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:
(a) the product is protected by a basic patent in force;
(b) 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;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.

The issue

In Medeva, as in the other cases, the questions arise from the reality of things. It's quite simple, in the real world, the patented medicinal product (or active substance) is rarely put on the market (years later) as such, but in a modified version, many times in combination with other (active) substances. One thing is the requirements to be fulfilled to obtain a patent, another thing is the reality of the market. Can an SPC be granted in a situation like this? That is the fundamental question behind the preliminary questions submitted to the Court.

Solution offered by GA Trstenjak


GA Trstenjak, in her opinion published on 13 July 2011, started by examining the wording of the Regulation and found that as a general rule, on a literal interpretation of Regulation No 469/2009, there can be no question of a supplementary protection certificate being granted for a multi‑disease vaccine in which the combination of active ingredients is only partly patented (paragraph 74).

She derived this (provisional) conclusion in particular from the wording of Article 1(b) of the Regulation (the definition of the term "product"): Viewed in terms of the wording, ‘an’ active ingredient, which together with other active ingredients is only part of the combination of active ingredients of a medicinal product, therefore does not constitute a product within the meaning of Article 1(b) of Regulation No 469/2009 ... It actually means that, in the case of a multi‑disease vaccine, only the combination of all the active ingredients constitutes the product within the meaning of Regulation No 469/2009. According to the wording of Article 1(b), on the other hand, a single active ingredient of a multi‑disease vaccine cannot be subsumed under the concept of product in Regulation No 469/2009 (paragraphs 61 and 62).

GA Trstenjak was, however, quick to conclude that such an interpretation would not be compatible with the objectives of the Regulation***. If no supplementary protection certificates could be granted in respect of medicinal products with multiple active ingredients only part of which is the subject‑matter of a patent, that would actually have the result that, in all spheres in which the manufacturers of medicinal products found themselves obliged, for legal or practical reasons, to place patented active ingredients on the market in combination with other active ingredients in one medicinal product, an extension of the term of protection of the patented active ingredients in accordance with the requirements of Regulation No 469/2009 would not be possible (paragraph 80).

Therefore it appears (...) to be necessary to interpret the definition of ‘product’ in Article 1(b) of Regulation No 469/2009 teleologically to the effect that the product within the meaning of the regulation includes not only ‘the’ active ingredient or ‘the’ combination of active ingredients, but also ‘an’ active ingredient or ‘a’ combination of active ingredients of a medicinal product. Such an interpretation also brings within the scope of Regulation No 469/2009 medicinal products in which the combination of active ingredients is only partly the subject‑matter of a patent. (paragraphs 89 and 90).

Here, GA Trstenjak deals with the risk that a manufacturer of medicinal products could develop a number of medicinal products with different combinations of active ingredients on the basis of one patented active ingredient or combination of active ingredients and place those products on the market with a time lag in some cases, for the purpose of optimising the protection under the certificate (paragraph 96) and offers the following solution: In order to prevent such an undermining of the system of limitation of the duration of the protection conferred by a certificate provided for in Regulation No 469/2009, Article 3(a) must be interpreted as meaning that the product within the meaning of that provision is the same as the product which forms the subject‑matter of the basic patent within the meaning of Article 1(c).**** In fact, having particular regard to Article 3(c) of Regulation No 469/2009, according to which only one supplementary protection certificate per product may be granted in the Member State in which the application is submitted, that interpretation of Article 3(a) has the effect, on the other hand, that, for each active ingredient or combination of active ingredients which is the subject‑matter of a patent, only one supplementary protection certificate for the extension of that patent’s term of protection may be granted, regardless of the number of combinations of active ingredients in which the patented active ingredient or combination of active ingredients has been used. This makes it impossible for manufacturers of medicinal products to optimise the term of protection under the patent and certificate in relation to an active ingredient by placing the patented active ingredient on the market in a number of combinations of active ingredients as different medicinal products, with a time lag in some cases (paragraph 100).

Such a conclusion may seem to be particularly harsh in cases where a patent relates to several active ingredients and also to one or more combinations of those active ingredients, because according to the Court’s case-law, only one supplementary protection certificate may be granted for each basic patent (C‑181/95 Biogen). According to GA Trstenjak, the proprietor of such a patent will have to make a choice: he must decide in respect of which active ingredient or combination of active ingredients he is going to apply for a supplementary protection certificate on the basis of the basic patent. The grant of a first supplementary protection certificate in respect of one active ingredient or combination of active ingredients in reliance on that patent then precludes the grant of further supplementary protection certificates in reliance on the same basic patent (paragraph 103). The advice of GA Trstenjak is to obtain an SPC for the "central" active ingredient or combination of active ingredients: By relating his SPC application to the central active ingredient or combination of active ingredients which is also contained in the medicinal products to be placed on the market in the future, the proprietor of a patent covering a number of active ingredients and also one or more combinations of those active ingredients can therefore ensure that those subsequent medicinal products also enjoy – within the limits of the basic patent and during the term of the supplementary protection certificate – protection against unauthorised production and distribution (paragraph 109).*****

Summary

An example could be the appropriate way to summarise the solution offered by GA Trstenjak. This is how it works (or should work):
1/ A basic patent is obtained for A, B and C (separately, not in combination).
2/ A marketing authorisation is granted for a medicinal product containing A and F.
3/ An SPC can be granted (its scope will be limited to A, but /normally, it will depend on the legislation in the particular Member State/ the marketed medicinal product will also be protected /indirectly, by way of the so-called contributory infringement/).
4/ No other SPC can be granted on the basis of the basic patent.
It is as simple as that.
Good solution, I think, that the Court should certainly follow.

* The Regulation codified the preceeding Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products
** COM(90) 101 final – SYN 255, 11 April 1990
*** The objectives of the Regulation (and the reality of things) are exhaustively described in paragraphs 75 to 87. Paragraph 77 warrant a closer attention: Those rules are intended to achieve a balance between the various interests at stake in the pharmaceutical sector. Those interests include, on the one hand, the interests of the undertakings and institutions, some of which pursue very cost‑intensive research in the pharmaceutical sector and therefore favour an extension of the term of protection for their inventions in order to be able to recoup the investment costs. On the other hand, there are the interests of the producers of generic medicines who, as a consequence of the extension of the term of protection of the active ingredients under patent protection, are precluded from producing and marketing generic medicines. It is also relevant in this connection that, in general, the marketing of generic medicinal products has the effect of lowering the prices of the relevant medicinal products. Against that background, the interests of patients lie between the interests of the undertakings and institutions conducting research and those of the producers of generic medicines. That is because patients have an interest, on the one hand, in the development of new active ingredients for medicinal products, but, on the other, they also have an interest in those products then being offered for sale as cheaply as possible. The same applies to State public health systems in general which, in addition, have a particular interest in preventing old active ingredients from being brought onto the market in slightly modified form under the protection of certificates but without genuine innovation and thereby artificially driving up expenditure in the health sector.
**** This is another fundamental question in the cases at hand: shall a product be deemed to be protected by the basic patent also where it is not a subject-matter of the patent itself, but is protected indirectly (by way of the notion of contributory infringement of the patent)? GA Trstenjak's answer is clear: NO!
***** Frankly, I'm not sure of this. If the basic patent covers active ingredients A, B and C (separately, not in combination), what exactly is the "central" active ingredient here? In my view, whatever choice you make, you "lose" some of the scope of the basic patent for the purposes of an SPC. An example: if an SPC is granted on the basis of a market authorisation for A+F (for instance), how can any protection be derived from such an SPC in relation to B and C? But that is the price to pay, I guess, as there is no better solution to this (to say that an SPC prolongs the validity of the patent as a whole would stretch things to the opposite extreme). See inter alia paragraphs 106 a 107 on the issue of the scope of an SPC (articles 4 and 5 of the Regulation).