CJEU – Staat der Nederlanden v. Warner-Lambert Company LLC, Judgment of the Court, 14 February 2019, Case No. C‑423/17

[I]n a marketing authorisation procedure […], 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.

Summary

“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.

“The referring court notes that producers of generic medicinal products sometimes fail to mention on the package leaflet and in the summary of the product characteristics information on a reference medicinal product relating to indications or dosages which are still covered by a patent. Until 2009, it was the CBG’s practice to publish on its website the package leaflets and summaries of product characteristics not mentioned by marketing authorisation holders or applicants for generic medicinal products.

“During 2009, the CBG abandoned that policy and decided to systematically publish all the information on the reference medicinal product, even when the applicant informed the CBG of its intention to omit certain information.

“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. WLC maintains, inter alia, that the CBG’s policy of full publication constitutes a direct infringement of Patent EP 061 as it offers pregabalin for sale for a patented indication and an indirect infringement in that it encourages third parties to engage in infringements. WLC also claims that the CBG’s policy is contrary to Article 11 of Directive 2001/83.

“By judgment of 15 January 2016, the rechtbank Den Haag (District Court, The Hague) upheld WLC’s action concerning pregabalin and rejected the claims concerning other medicinal products due to insufficient interest. That court found that full publication of the package leaflet and the summary of product characteristics of a medicinal product does not constitute an infringement of Patent EP 061, and is incompatible with the CBG’s duty of care.

“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.

“After delivery of that judgment, the CBG changed its administrative practice. It publishes the full version of the package leaflet and the summary of product characteristics in its medicinal products database. However, when the holder of a marketing authorisation for a generic medicinal product informs the CBG that certain indications have been omitted, the CBG indicates this by means of an asterisk, together with the following text:

‘* This indication is protected by a patent … of another marketing authorisation holder. Further information in this regard may be found on the CBG website, www.cbg-meb.nl.’

“The referring court takes the view that the outcome of the dispute in the main proceedings depends on the interpretation of EU legislation on medicinal products, in particular, that of Article 11 of Directive 2001/83.

“The parties to the main proceedings agree that that provision allows the applicant for marketing authorisation in respect of a generic medicinal product not to mention indications that are still covered by a patent in the package leaflet and the summary of product characteristics. On the other hand, their positions differ as to the consequences for the national authority of a declaration whereby a marketing authorisation applicant indicates that it intends to avail itself of that option and to opt for publication of an edited version.

“In the first place, the parties in the main proceedings are in dispute as to whether notification of the intention to publish an edited version aims to limit the marketing authorisation in so far as it will not cover patented indications or dosage forms. If this is so, then the CBG should limit the marketing authorisation and publish the package leaflet and the summary of product characteristics in accordance with the applicant’s wishes, in their edited version.

“In the second place, WLC maintains that, in any event, notification of the intention to publish an edited version requires the national authority to publish the package leaflet and the summary of product characteristics omitting the redacted information, because their full publication is contrary to the objective of the EU legislature, which is to protect the interests of patent holders. Full publication would encourage general practitioners to prescribe generic versions of medicinal products for indications or dosage forms which are still patented.

“In those circumstances, the Gerechtshof Den Haag (Regional Court of Appeal, The Hague, Netherlands) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Must Article 11 of Directive [2001/83] or any other provision of EU law be interpreted as meaning that a communication whereby the marketing authorisation applicant or holder for a generic medicinal product, within the meaning of Article 10 of [that directive], notifies the competent authority that he does not intend to include in the summary of product characteristics or the package leaflet those parts of the summary of product characteristics of the reference medicinal product which refer to indications or dosage forms covered by the patent of a third party should be regarded 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 [that directive], the summary of product characteristics and the package leaflet, including those parts which refer to indications or dosage forms covered by the patent of a third party, where the marketing authorisation applicant or holder has notified the authority that he does not intend to include in the summary of product characteristics or the package leaflet those parts of the summary of product characteristics of the reference medicinal product which refer to indications or dosage forms covered by the patent 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 medicinal product 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 of a third party, even though, under Article 11 of Directive 2001/83, those parts to not have to be included in the package leaflet?’

In the light of all the foregoing considerations, the answer to the first question is that the second paragraph of Article 11 of Directive 2001/83 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.

Having regard to the positive answer given to the first question, there is no need to answer those questions.

A copy of the original judgment can be accessed here.