CJEU backs Warner-Lambert in marketing authorisation dispute
The Court of Justice of the European Union has issued a judgment in favour of Warner-Lambert amid a dispute between the American pharmaceutical company and an administrative body in the Netherlands.
In a judgment issued on Thursday, February 14, the court said that a request by a generic drug producer to remove references to patented indications or dosage forms from a medicinal product leaflet is “a request to limit the scope of marketing authorisation of generic drugs”.
Warner-Lambert brought the action against the Netherland’s Medicinal Product Evaluation Board (MPEB) at the District Court of the Hague for publishing full product leaflets and characteristics of the drug Lyrica (pregabalin) on its website, instead of edited versions.
Warner-Lambert, which is owned by Pfizer, holds marketing authorisation for the drug Lyrica which can be used in the treatment of epilepsy, anxiety disorders and neuropathic pain.
Up until July 2017, Warner-Lambert owned EU patent number 0934061B3 for the use of pregabalin to treat neuropathic pain.
Warner-Lambert had argued that the board should publish an edited version of the leaflets which did not disclose patented indications or dosage forms when granting marketing authorisations to generic producers of the drug.
During 2015, generic producer Aurobindo obtained market authorisation for pregabalin.
Aurobindo asked the MPEB if it could omit patented indications from the package leaflet of the drug and the summary of the product characteristics relating to the treatment of neuropathic pain, but the board refused permission.
Warner-Lambert said the MPEB’s refusal to omit this information constituted a direct infringement because “it offers pregabalin for sale for a patented indication”. The Pfizer subsidiary also said it was “an indirect infringement of its patent as it encourages third parties to engage in infringement”.
The CJEU said that while, in general, the summary of product characteristics accompanying a generic drug “cannot cover indications or dosage forms which are not consistent with those covered” by the marketing authorisation of the reference product, exceptions can be made when indications or dosages in the reference product are protected by a patent.
It added that it was up to the board to ensure that the marketing authorisation and the summary of product characteristics reflected each other.
In a statement to WIPR, Pfizer welcomed the decision which it said "helps to safeguard an important form of intellectual property protection, which is essential in encouraging continued innovation in the life sciences sector".
Following the CJEU’s decision, the case will now go back to the District Court of The Hague.
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