On 15 January 2016, the Provisions Judge in The Hague rendered a decision which confirms that the Dutch Medicines Evaluation Board (MEB) should take second medical use patents into account in its policies. The Judge decided that, in this case, the policy of the MEB to publish on its website the full Summary of Product Characteristics (SmPC) and package insert of generic products, including any indications from the paper versions of these labels, was unlawful towards the patentee. The Provisions Judge ordered the MEB to remove the full labels of certain generic medicinal products from its website and to replace these with the carved out versions.

The case

Warner-Lambert owns a second medical use patent protecting pregabalin for the treatment of neuropathic pain. Several other companies market a generic product for which the labels are limited to unpatented indications. The MEB, however, continued to publish on its website the full label versions of the SmPCs and package inserts mentioning all indications including the patented one. Both Warner-Lambert and a generic company requested the MEB to replace the labels but the MEB refused. Warner-Lambert brought interim relief proceedings against the MEB claiming an order against the MEB to replace the labels on the basis of patent infringement and unlawful act (tort). The Provisions Judge rejected Warner-Lambert’s claims based on patent infringement, but granted the claims on the basis of unlawful act (tort).

The MEB defended its policy by pointing to the importance of fully informing patients from the perspective of public health and patient safety. At the hearing, the MEB acknowledged that the background of its policy had to do with the changed reality that physicians nowadays prescribe medicines by their generic names and the pharmacist may substitute the patented product for a generic one. According to the MEB, a patient receiving a generic product with a carved out label could be confused as to whether the correct medicine was provided if the patient’s ailment/condition is not mentioned in the label.

The Provisions Judge rejects this argumentation. The Judge considers that patients receiving the generic product for unpatented indications would be informed of such indications in the carved out label and that patients receiving the patented product would also read the patented indication on the full label.

The Judge further considers that if the undesirable situation would occur that a patient receives the generic product for the patented indication, the standard wording in the carved out label specifying that the substance is also approved for other indications not mentioned on the label is sufficient for preventing confusion. The Judge holds that by publishing the full SmPC the MEB actively informs healthcare professionals that the generic product can be prescribed and dispensed for the patented indication, which could lower the threshold for healthcare professionals to prescribe and dispense the generic product for the patented indication.

The Judge concludes that the MEB acted unlawfully by publishing the full labels without indicating that the labels comprise a patented indication, as informing the public and practitioners is one of the duties of the MEB. The Judge orders the MEB to remove the full label SmPCs and package inserts for generic pregabalin products from its website and to replace these with the carved-out versions. The MEB was also ordered to place a rectification message on its website.