The new ECJ decision about article 3a of the Supplementary Protection Certificate (SPC) regulation

by | Jul 25, 2018

European Court of Justice (ECJ) ; Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as ‘Mylan’ v Gilead Sciences Inc, C 121/17 (Darts-ip reference : darts-378-846-F-en) – 25 July 2018

The European Court of Justice (ECJ) published today its answer to the preliminary ruling filed by the High Court of Justice (England and Wales), Chancery Division (Patents Court) (United Kingdom) related to the article 3(a) 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 request for a preliminary ruling affords the ECJ a further opportunity to rule on the thorny issue of the criteria for determining whether an active ingredient or combination of active ingredients of a medicinal product is ‘protected by a basic patent in force’ within the meaning of the article 3(a) of Regulation No 469/2009.

According to the Court, said article must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination.

For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent :

  • the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
  • each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

This decision supplements the ECJ’s numerous case-law on Article 3a, including the Medeva and Eli Lilly / HGS  cases.

In the Medeva case in 2011, the Court concluded that the article 3a must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

Two year after, the ECJ added in Eli Lilly / HGS that when the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of SPC regulation does not, in principle, preclude the grant of a SPC for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

The main contribution of this case law relates to the products composed of several active ingredients with a combined effect. According to the ECJ, each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

Notes:

  • ECJ, Medeva, C 322/10 – 24 november 2011 (darts-ip reference : darts-515-654-A-en)
  • ECJ, Eli Lilly v Human Genome Science, C 493/12 – 12 december 2013 (darts-ip reference : darts-478-130-B-en)
  • Interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision.

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