Estradiol valerate & Dienogest – Netherlands

Estradiol valerate & Dienogest – Netherlands

On Sep 19, 2018, Administrative Jurisdiction Division denied appeal of Dutch patent office & found Bayers’ Qlaira® eligible for supplementary protection certificate (SPC).
Previously in Sept 2011, patent office rejected Bayer’s application for a supplementary protection certificate. Bayer objected but patent office on Oct 21, 2015 found Bayer’s objections unfounded. Bayer then appealed to District court & on Feb 01, 2017 court upheld Bayer’s appeal, annulled the decision of Oct 21, 2015 and instructed patent office to take a new decision on Bayer’s objection with due observance of this ruling. Patent office appealed this decision to Administrative Jurisdiction Division. The Division dealt with the case at the hearing on 22 November 2017.
Bayer applied for a supplementary protection certificate on 23 March 2009 for the medicinal product ‘Qlaira’, a multi-stage contraceptive. Patent office rejected the application on the grounds of Article 3 as the product concerned, consisting of the active substances estradiol valerate and dienogest, has already received prior marketing authorizations than the license submitted by Bayer. Patent office pointed to the marketing authorization for the drug ‘Ciimodien’, a hormone replacement therapy, which, like Qlaira, contains the active substances estradiol valerate and dienogest.

According to Bayer, patent office failed to recognize in the rejection of the application that the judgment of the Court of Justice of 19 July 2012, Neurim Pharmaceuticals, ECU: EU: C: 2012: 489 which shows that a SPC may be obtained for a patent-protected new therapeutic use of a known active substance which has already been marketed as a medicinal product. And this is not only possible in the situation in that judgment that the previous marketing authorization was obtained for veterinary use of the product and the subsequent marketing authorization for human use as a medicine, but also in the situation that both the earlier and the later marketing authorization refers to human use of the medicine.
The court held that Bayer rightly took this position. It has considered that patent office has not contested that the new therapeutic use of the active substances estradiol valerate and dienogest as a contraceptive in the form of a multiphase preparation is protected by the basic patent on the basis of which Bayer’s application for a supplementary protection certificate has been submitted, nor is it drug Climodien, for which the previous marketing authorization has been granted, does not fall within that protection scope. Based on the Neurim judgment, therefore, the marketing authorization for Climodien cannot be considered as the first or previous authorization of this product as a medicine used for this new therapeutic application & hence Qlaira is eligible for SPC. In the Neurim judgment, the Court of Justice has achieved this balance of interests by interpreting Article 3, preamble and under d of the SPC Regulation in such a way that a SPC for a product protected by a basic patent in force can only be applied.
Thus, Administrative Law Division of the Council of State found appeal unfounded & ordered patent office to pay the costs of the proceedings.

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