Evergreening allegations and the orphan medicinal products Regulation: fresh guidance from the GC. A victory for originators in the war against generic manufacturers?

An interesting decision from the General Court (full text here) on the exclusivity regime of orphan medicinal products authorised for marketing under Article 8/3 of EC Regulation 141/2000. As is well known, regardless of their patentability/patent protection, Art. 8/1 provides for 10-year market exclusivity for orphan medicinal products complying with the Regulation requirements. This exclusivity prevents the EU and Member States from granting authorisations “for the same therapeutic indication, in respect of a similar product”. By way of derogation from the said provision, Art. 8/3 permits authorisation for a similar medicinal product with the same therapeutic indication to be granted even during the market exclusivity period, provided that certain conditions (inter alia, the consent of the holder of the marketing authorisation for the original orphan medicinal product: Art. 8/3/a) are met. But does an authorisation granted under Art. 8/3, where the similar medicinal product is also orphan, give rise to market exclusivity? And, if so, is such exclusivity independent of the one already granted to the original orphan medicinal product, even though they concern similar products with the same therapeutic indication?

According to the applicant (giant generic manufacturer Teva), both answers should be negative. Granting market exclusivity to similar medicinal products authorised under Art. 8/3 could lead to evergreening the 10-year market exclusivity of the first orphan medicinal product. All the more so where, as in the case at hand, the holder of the original marketing authorisation is the same company as the one which obtained the “second” marketing authorisation under Art. 8/3/a. The GC did not share the applicant’s view. It stated, on the one hand, that market exclusivity “must be granted in all cases in which an orphan product has been given marketing authorisation”, Art. 8/3 cases included (p. 80); and, on the other, that “the fact that the therapeutic indications for which both orphan medicinal products received marketing authorisation are similar cannot undermine the market exclusivity enjoyed by each of those medicinal products” (p. 79). As a result, the GC dismissed Teva’s action, stressing that the interpretation maintained by the applicant “would jeopardise the objective of the regulation … and run counter to its spirit” (p. 80). Whether this is a real victory for the “spirit” of EC Regulation 141/2000 evoked by the GC, rather than a victory for originators in their war against generic manufacturers, is at least debatable.

Riccardo Perotti

General Court (Sixth Chamber), 22 January 2015, T‑140/12, Teva Pharma BV, Teva Pharmaceutical Europe BV v. European Medicines Agency (EMA), supported by European Commission

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