Is the marketing of a generic medicinal product restricted requested if the generic medicinal product manufacturer does not indicate in the summary of product characteristics and the package leaflet of the medicinal product those indications or dosages of the reference medicinal product which are patent protected at that time? The ECJ today handed-out a new landmark ruling on the national authorisation of generic medicinal products.
Limited applications for indications and dosage forms in the generic drug
A medicinal product may not be placed on the market in a Member State until authorised by the competent national authority. Also all other strengths, pharmaceutical forms, routes and forms of administration as well as all changes and extensions must be authorised or included in the initial marketing authorisation, the ECJ clarified today (judgement of 21 Nov 2018, Novartis Farma, C-29/17 , see also “Off-label use without marketing authorisation allowed ” ).
However, in order to facilitate generic entry, Art. 10 of Directive 2001/83 provides for a shortened marketing authorisation procedure. A generic medicinal product may be exempted from the obligation to provide clinical and pre-clinical trial results if certain conditions are met. Such a generic medicinal product must have the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product and its bioequivalence must be demonstrated with the reference medicinal product. In such an abridged procedure, the indications cited in an application for marketing authorisation for a generic medicinal product must not go beyond the indications covered by the marketing authorisation for the reference medicinal product, but must in principle be limited to those indications, the ECJ ruled.
That is an exception under Article 11(2) of Directive 2001/83 to the principle of correspondence between the marketing authorisation for the generic medicinal product and that for the reference medicinal product. In the interests of public health, it is intended not to delay the market entry of generics until all patents have expired, while maintaining the same level of safety and efficacy.
Background: retrospective carve-out
The generic marketing dispute arose in 2015, when several generic manufacturers, including Aurobindo, applied to the Dutch CBG (College ter Beoordeling van Geneesmiddelen , Institute for the Evaluation of Medicinal Products) for authorisation under the decentralised procedure for a generic medicinal product containing pregabalin as the active substance. In the Netherlands, however, patent protection at that time still consisted of the European patent EP 0 934 061 B3 of Warner-Lambert Company LLC (WLC), part of the Pfizer Group, which markets the drug Lyrica with the active ingredient pregabalin worldwide for the indications epilepsy, generalized anxiety disorder and neuropathic pain.
Aurobindo’s original application in the decentralised approval procedure did not contain a so-called carve-out (spin-off) for the indication neuropathic pain, but a full-label version of the summary of the drug’s characteristics, which also included the still patent-protected indication of WLC. Aurobindo wanted to change this and remove the patented indications from the summary of product characteristics by carve-out after the approval had been granted but before the launch of its generic pregabalin drug. However, the CBG published the full-label version of the summary. Before the Dutch Court Rechtbank Den Haag, WLC wanted to enforce the mandatory replacement of the published full-label version by the carve-out version.
Generic drug applied for in decentralised authoration procedure
Where a generic medicinal product manufacturer makes use, in the context of a decentralised procedure, of the derogation and possibility provided for in Article 11 of Directive 2001/83, the marketing authorisation for that medicinal product covers only the indications and dosages which are not protected by a patent. In today’s judgment, the ECJ clarified that the unincluded features protected by patent law were then not the subject of the application for marketing authorisation without the competent national authority having any discretion in this regard. (see also: Decentralised authorisation procedure in case law of the ECJ ).
The Netherlands Government argued that the decision of the generic holder to make use of the possibility under Article 11(2) of Directive 2001/83 does not affect the scope of the marketing authorisation for the generic.
This was contradicted by the ECJ in its ruling today. Any medicinal product placed on the market must comply with the conditions of the marketing authorisation, which must be reflected in the summary of product characteristics. The national authority must amend the marketing authorisation to ensure its conformity with the summary of product characteristics. A communication of a summary of the product characteristics which does not include certain indications of the marketing authorisation constitutes a deletion of therapeutic indications covered by the minor variations of Type IB (subject to the procedure laid down in Article 9 of Regulation 1234/2008), the ECJ ruled.
If, after the expiry of patent protection, the generic manufacturer wishes to add the indications and dosages previously protected by patent to his summary of product characteristics, he could apply for a Type II variation to the marketing authorisation in accordance with the procedure laid down in Article 10 of Regulation No 1234/2008.
Judgment of the ECJ
“The second paragraph of Article 11 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, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, must be interpreted as meaning that, in a marketing authorisation procedure such as that at issue in the main proceedings, communication to the competent national authority by the applicant or holder of a marketing authorisation for a generic medicinal product of the package leaflet or a summary of the product characteristics of that medicinal product which does not include any reference to indications or dosage forms which were still covered by patent law at the time that medicinal product was placed on the market constitutes a request to limit the scope of the marketing authorisation of the generic medicinal product in question.”
Quoted from the today’s judgment of the ECJ
The Court thus answered the first question referred and clarified an important question concerning the summary of product characteristics, in particular for generic medicinal products, in the context of a decentralised procedure. The second and third questions referred, which concerned the publication of the competent national authority, were not answered by the ECJ, since the answer would have been relevant only if the first question had been answered in the negative.
However, Advocate General Kokott answered the issue of publication by the national competent authority in her opinion of 4 October 2018 ( Opinion C:2018:822 ). It argued, interpreting Articles 11 and 21(3) of Directive 2001/83, that a competent authority is prevented from publishing if the generic manufacturer has informed the authority that it does not indicate patent protected indications or dosages in the summary of product characteristics and the package leaflet.
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