Dutch MEB held to have acted unlawfully towards patent holder by publishing the patented indication for generic medicinal products

After expiry of regulatory data protection for Lyrica, marketing authorisations for generic pregabalin were obtained. In the Netherlands, medicinal products are mainly prescribed using the name of the active substance. The indication for which the substance is prescribed is not included on the prescription.

Currently (since 2009) the policy of the Dutch Medicines Evaluation Board (hereinafter: "MEB") is to publish the full label instead of the carve-out version of the Summary of Product Characteristics (hereinafter: "SmPC") and patient information leaflet (hereinafter: "PIL") in the Medicines Information database ('geneesmiddeleninformatiebank') on its website. The MEB requires that when marketing the generic product, the holder of that marketing authorisation should remove the patented indication from the printed SmPC and PIL and insert the following standard phrase: "<product name> comprises as active substance <active substance>, which has also been approved for other disorders which are not mentioned in this this patient information leaflet. Please ask your physician or pharmacist if you have further questions." Also, a reference to the website of the Dutch MEB needs to be included.

WLC: MEB infringes the patent by publishing full label SmPC and PIL on its website

WLC alleged that the MEB directly infringed the patent by offering pregabalin for sale, bringing it onto the market or otherwise trading pregabalin for a patented indication. Further or alternatively, the MEB infringed indirectly as it made available an essential part of the patent to third parties. Finally, WLC alleged that the MEB acted unlawfully vis-à-vis WLC as it played a key role in inducing, facilitating and inciting patent infringement by wholesalers, physicians and pharmacists by publishing a full label version of the SmPC and PIL on its website and by requiring the reference to the MEB's website in the printed PIL (in which a carve-out had been incorporated in accordance with the MEB's requirements described above). WLC alleged that attempts of generic manufacturers to prevent patent infringement by means of a carve-out were being frustrated by this policy of the MEB.

MEB: Carve-outs jeopardise patient safety

MEB argued that its policy is in the interest of public health: from the viewpoint of public health and patient safety, patients should be fully informed. The marketing authorisation was being granted for all indications and incomplete information would jeopardise patient safety. Furthermore, the MEB stated that it was not infringing WLC's patent as it did not manufacture or trade in pregabalin products.

Moreover, the MEB argued that if patients received generic pregabalin for the patented indication, they would not find the indication in their PIL, which would be perceived as confusing.

Preliminary judgment: MEB does not (in-)directly infringe the patent, but acts unlawfully vis-à-vis WLC

The judge considered that publication in the Medicines Information Database on the MEB's website could not be considered as a reserved act within the meaning of the Dutch Patent Act ("DPA"), thus there was no direct infringement. Also, there was no indirect infringement. The knowledge that pregabalin may be used for neuropathic pain could not be considered as a means concerning an essential part pursuant to the DPA, as it did not concern a physical object. Moreover, WLC did not make any plausible argument that the protected invention – the use of pregabalin for manufacture of a medicinal product for the treatment of neuropathic pain – was occurring downstream of MEB's actions.   

As to the unlawful act, the judge held that MEB was not required by law (or denied by law) to publish the full label SmPC and PIL for generic versions of a drug. The MEB had some degree of discretionary power as to its policies, but this power was limited where the MEB could not have reasonably arrived at such a policy. The judge had to assess on the one hand the grounds for MEB's policy, and on the other hand the (alleged) consequences of such policy for (the patent rights of) WLC.

The judge was not convinced by the argument that the policy of the MEB reduces confusion with patients. Patients who are prescribed pregabalin in a patent-respecting fashion obtain a suitable PIL. If generic pregabalin was prescribed for the patented indication, the standard phrase as mentioned above was adequate to remedy possible confusion with the patient.

Furthermore, by publishing a full label SmPC (which is aimed at medical professionals), the MEB actively informed medical professionals that generic pregabalin may be prescribed for the patented indication. In this case, it was sufficiently plausible that the pharmacists (and pharmacists' organisations) relied on the information on the website of the MEB. Providing this information lowered the threshold for prescribing and dispensing pregabalin for the patented indication, and it was plausible that this caused, or was likely to cause, damage to WLC.

In conclusion, the MEB acted in violation of the standard of due care by mentioning the patented indication without warning or at least indicating that it concerned a patented indication.

The MEB therefore acted unlawfully vis-à-vis WLC and the MEB was (inter alia) ordered to replace the full label SmPC and PIL for generic pregabalin with carve-out versions.

In response to this judgment, the MEB has published its intention to change its policy with respect to patented indications and started a public consultation. Unexpectedly, the MEB still intends to publish the patented indication in the SmPC and PIL in the Medicines Information database, but in a marked fashion (e.g. the patented indication will be shaded or mentioned between brackets or arrows). The MEB further intends that text should be inserted stating that (1) the active substance in the medicinal product has been approved for this indication and (2) that the MEB has been informed that the application of this active substance for this indication is being protected by a patent of a third party.

The MEB has appealed from the judgment against it.

Impact of this decision in practice

It remains to be seen whether this decision in summary proceedings will be upheld on appeal. If so, it is anticipated that more patent holders with second medical use claims will summon the MEB to remove the full label SmPC and PIL from its website and - if they are capable of adequate substantiation - claim damages.

By way of final thought, this case seems to clarify that at some point in time, physicians and/or pharmacists may be at risk of being found to infringe patents containing second medical use claims. This would not apply in the case of Swiss type claims, as these medical professionals are not manufacturing, but could possibly apply in the case of second medical use claims under EPC 2000. 

This article is part of the International Life Sciences Update for April 2016