On 19 July, the Court of Justice of the European Union (CJEU) handed down its judgment in the Neurim Pharmaceuticals v. Comptroller General of Patents in relation to the interpretation of Articles 3 and 13 of 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 SPC Regulation).

The widely anticipated decision has paved the way for supplementary protection certificates to be granted in respect of (patented) second medical uses of the active ingredients. Previously, the CJEU's wide interpretation of the term "Product" meant that an Supplementary Protection Certificate (SPC) application could only be made on the basis of the first marketing authorisation for the active ingredient, which in effect meant that for most second medical use patents no useful SPC was available.

The Judgment of the CJEU in Neurim has shed new light on the interpretation of the SPC Regulation, holding that a 'marketing authorisation' in the context of the SPC Regulation must be interpreted as meaning a marketing authorisation for a product which comes within the limits of protection conferred by the basic patent. The effect of the decision is that an earlier marketing authorisation will not be relevant to the grant of an SPC unless what it authorises falls within the protection conferred by the basic patent. Accordingly, an earlier authorisation for an active ingredient will not preclude the grant of an SPC in relation to a new patented use of the same active ingredient.

The operative part of the Judgment is as follows:

"1. Articles 3 and 4 of 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 must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

2. Article 13(1) of Regulation (EC) No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

3. The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant."

Background

The decision concerned Neurim's product Circadin, a formulation of the naturally occurring hormone melatonin for use in the treatment of insomnia. Neurim obtained a European Patent for the use of its formulation in the treatment of insomnia in humans. On obtaining itsmarketing authorisation for Circadin, Neurim applied for a SPC basing its application on its marketing authorisation for Circadin.

The United Kingdom Intellectual Property Office (UKIPO) rejected Neurim's SPC application on the basis of Article 3(d) of the SPC Regulation because it had identified an earlier marketing authorisation for melatonin for a product called Regulin. Accordingly the Circadin marketing authorisation was not the first to place the "product" on the market. Regulin is a veterinary medicinal product authorised to regulate the reproductive cycle in sheep. Neurim appealed the UKIPO's decision first to the High Court and then to the Court of Appeal where five questions were referred to the CJEU.

  1. In interpreting Article 3 of [the SPC Regulation], when [a marketing authorisation] (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later [marketing authorisation] (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier marketing authorisation on the market within the meaning of Article 4?
  2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, "the first [ marketing authorisation] in the Community" needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?
  3. Are the answers to the above questions different if the earlier [marketing authorisation] has been granted for a veterinary medicinal product for a particular indication and the later [ marketing authorisation] has been granted for a medicinal product for human use for a different indication?
  4. Are the answers to the above questions different if the later [marketing authorisation] required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)?
  5. Are the answers to the above questions different if the product covered by the authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?"

The Advocate General gave her opinion on 3 May 2012, answering the first and second questions in the affirmative and the third to fifth questions in the negative.

CJEU Judgment

The CJEU judgment in all material respects followed the Attorney General's opinion albeit without the in depth analysis of possible literal, schematic and purposive constructions of the SPC Regulation. The judgment begins by referring to the fundamental objective of the SPC regime: "to ensure sufficient protection to encourage pharmaceutical research", and explains that where "the period of effective protection under the patent is insufficient to cover the investment put into pharmaceutical research" the SPC regime remedies that insufficiency by creating supplementary protection for products meeting certain conditions. The judgment then refers to paragraph 29 of the explanatory memorandum to the SPC Regulation, which expressly states that a patent for protecting a new application of a new or known product may be the subject of a SPC. The judgment continues to use the terminology of the explanatory memorandum, sometimes confusingly, referring to the "application" of a product rather than its "use".

The Court answers questions 1 and 3 together in paragraphs 25 - 27.

25 Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.

26 In such a situation, only the marketing authorisation of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first marketing authorisation of 'that product' as a medicinal product exploiting that new use within the meaning of Article 3(d) of the SPC Regulation.

27 In the light of all the above considerations, the answer to the first and third questions is that Articles 3 and 4 of the SPC Regulation are to be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.

Paragraph 25 explains that scope of a SPC granted for a second medical use would only cover that use and not the Product (active ingredient) per se. Paragraph 26 then takes the reasoning of paragraph 25 a step further, and in doing so answers the first question, finding that only a marketing authorisation for a medicinal product the use of which is protected by the basic patent can be considered to be the first marketing authorisation for that product for the purposes of Article 3(d) of the SPC Regulation. Paragraph 27 applies the principle set out in paragraph 26, and expressly answers the third question, stating that the existence of an earlier veterinary marketing authorisation for the same product (active ingredient) does not preclude the grant of an SPC for a different application (use) of the same product (active ingredient).

The Court then turns to the second question, its answer to which is set out in paragraphs 30 - 31.

"30 However, although those two provisions of the SPC Regulation thus refer to the two different territorial areas of the authorisations in question in defining the duration of the protection conferred by the SPC in a particular situation, there is no reason why, as regards the assessment of the very nature of those authorisations, it is necessary to use different criteria according to which the article is applicable. Therefore, the marketing authorisation referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.

31 It follows from the above that the answer to the second question is that Article 13(1) of the SPC Regulation is to be interpreted as meaning that it refers to the marketing authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC."

In Paragraph 30 the Court says that the first marketing authorisation referred to in both Articles 3 and 13 of the SPC Regulation should be determined using the same criteria (i.e. those set out in the answer to the first question) and accordingly, the marketing authorisation referred to Article 13(1) of the SPC Regulation is the marketing authorisation of a medicinal product which is within the limits of the protection conferred by the basic patent.

In answering the fourth and fifth questions, the Court asked whether the fact a full marketing authorisation application was required by the EMEA, or whether the medicinal product covered by an earlier marketing authorisation was protected by a different basic patent owned by a different proprietor, were relevant to the answers to questions 1, 2 and 3. The Court found that such facts and circumstances where "wholly distinct" from the considerations relevant to first, second and third questions and therefore the answers would not be different.

While this is a welcome judgment from all parties investigating further uses of previously marketed drugs, the judgment (as is increasingly often the case) also leaves a number of questions open. In anticipation of this judgment, several commentators raised a concern that if the CJEU's judgment followed the Attorney General's opinion (which it now has) 'ever-greening' would be more facilitated by the 'relevant marketing authorisation' qualification i.e. the same proprietor can now obtain multiple SPCs for the same active ingredient? Questions also remain in relation to the exclusion of matter specified in earlier marketing authorisations from later patent applications, and whether excluding such matter would, following the Neurim judgment, permit the grant of a SPC. No doubt in time the CJEU will be called on again to clarify these questions.