Pregabalin - CJEU

On Feb 14, 2019, Court of Justice of European Union (CJEU) handed down answers to the question related to carve-out or skinny labeling in case of protected indication.

Background:

Warner-Lambert Company (WLC) / Pfizer market the medicinal product Lyrica, whose active ingredient is pregabalin. That medicinal product is intended for the treatment of epilepsy, generalised anxiety disorder and neuropathic pain. WLC was the holder of European Patent EP 0934061 B3, which covered the used of pregabalin for the treatment of, inter alia, neuropathic pain. That patent expired on 17 July 2017. In the Netherlands, the College ter Beoordeling van Geneesmiddelen (Medicinal Product Evaluation Board, ‘the CBG’) is the autonomous administrative body responsible for monitoring and assessing the efficacy, risks and quality of medicinal products. The CBG publishes on its website, inter alia, the terms of the marketing authorisation, the package leaflet and the summary of product characteristics for each medicinal product. During 2015, several producers of generic medicinal products obtained marketing authorisation for pregabalin from the CBG under the decentralised procedure. One of those producers, Aurobindo, informed the CBG, before placing its medicinal product on the market that it intended not to include the package leaflet and the summary of product characteristics in the information relating to the treatment of neuropathic pain. That company asked if it could publish only part of the package leaflet and of the summary of product characteristics, but the CBG refused. WLC brought an action before the rechtbank Den Haag (District Court, The Hague, Netherlands) seeking, in essence, an order that CBG abandon its practice of publishing in full on its website package leaflets and summaries of product characteristics of generic medicinal products and instead publish the edited version of those documents. By judgment of 15 January 2016, the Hague district court upheld WLC’s action concerning pregabalin. On 11 February 2017, the Netherlands State filed an appeal against that judgment with the referring court. WLC also lodged a cross-appeal with that court. Court of appeal then referred the following questions to the CJEU.

1.  Must Article 11 of Directive 2001/83 (1) or any other provision of European Union law be interpreted as meaning that a communication whereby the marketing authorisation applicant or holder for a generic medicine, within the meaning of Article 10 of Directive 2001/83, notifies the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party, should be considered as a request to limit the marketing authorisation which must result in the marketing authorisation not applying, or no longer applying, to the patented indications or dosage forms?

2. If the answer to question 1 is in the negative, do Articles 11 and 21(3) of Directive 2001/83 or any other provisions of EU law preclude the competent authority from making public, by means of an authorisation granted under Article 6 in conjunction with Article 10 of Directive 2001/83, the Summary of Product Characteristics and the package leaflet, including those parts which refer to indications or dosage forms which fall under the patent rights of a third party, in a situation where the marketing authorisation applicant or holder has notified the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party?

3. Does it make any difference to the answer to question 2 that the competent authority requires the authorisation holder to include in the package leaflet which the authorisation holder must insert in the packaging of the medicine a reference to the authority’s website on which the Summary of Product Characteristics is published, including the parts which refer to indications or dosage forms covered by the patent rights of a third party, whereas those parts, pursuant to Article 11 of Directive 2001/83, are not included in the package leaflet?

CJEU answered the 1^st question as affirmative. CJEU said that as an exception to that principle that the marketing authorisation of a generic medicinal product and that of a reference product must tally, the second paragraph of Article 11 of Directive 2001/83 provides, as regards applications for marketing authorisation of generic medicinal products, that ‘those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included’. The rationale behind this exception is not to delay entry on the market of generic medicinal products until expiry of all patents which may include several indications or dosage forms of the reference medicinal product, without any relaxation of the requirements of safety and efficacy which must be met by generic medicinal products (see, to that effect, judgment of 23 October 2014, Olainfarm, C‑104/13, EU:C:2014:2316, paragraphs 27 and 28).

It is clear from a combined reading of Article 8(3)(j) and the second paragraph of Article 11 of Directive 2001/83 that failure to include in the summary of product characteristics of a generic medicinal product certain indications or dosage forms of the marketing authorisation for the reference medicinal product means that those indications or dosage forms are not covered by the marketing authorisation application. By making use of the option given by the second paragraph of Article 11, the marketing authorisation applicant thus limits the scope of his application and the competent national authority does not have any discretion in that respect, as the Advocate General stated in point 57 of her Opinion.

CJEU also held that having regard to the positive answer given to the first question, there is no need to answer the second & third questions.