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NL – Warner-Lambert v. Dutch Medicines Evaluation Board

26 Jan 2016

Warner-Lambert Company LLC v. the State of The Netherlands (Dutch Medicines Evaluation Board), District Court of The Hague, The Netherlands, 15 January 2016, Case file number: C/09/498943 / KG ZA 15-1656

Warner-Lambert Company LLC is part of the Pfizer group of companies (hereinafter: “WLC”). Pfizer brings a medicine on the market (including The Netherlands) under the brand name LYRICA for treatment of three separate indication, i.e. epilepsy, generalized anxiety disorders and nerve pain. The active ingredient of Lyrica is pregabalin.
WLC is the holder of a European patent EP 0 934 061 which relates to “isobutylgaba and its derivatives for the treatment of pain”. During central limitation proceedings at the EPO the Markush claims of the patent were limited to the active ingredient of the preferred embodiment. This claims of the patent cover a second medical use. The patent which cover pregabalin and its use for the indication epilepsy and anxiety is already expired. Only the treatment for pain is therefore covered by the patent of WLC.

To obtain a market permit an applicant has to submit inter alia a Summary of product Characteristics (SPC) and the package leaflet. The SPC contains information on the name of the drug, the therapeutic indications, the dosage and the way of administration as well as information on the holder of the market permit. Until 2009 the Dutch Medicines Evaluation Board always published the SPC and package leaflet, applying a carve out of certain patented indications. However, in 2009 the Board amended its policies by publishing a full label, without carving out patented uses.

Also the full label (including the still patented indication) of pregabalin was published. WLC objected to this policy and claimed that the Board (and therefore the State of The Netherlands, since the Board has no legal identity of its own) infringed upon the patent by offering for sale, selling or otherwise trading pregabalin for a patented indication. The claim for infringement is however dismissed by the Court. The Board is not actually trading in pregabalin and merely providing information without any commercial gain. The court however is of the opinion that providing this information is unlawful against WLC. The court’s preliminary view is that there is no valid reason to switch the policy from publishing SPC’s with a carve out, to SPC with a full label.

Read the decision (in Dutch) here.

Head note: Wim Maas, Taylor Wessing