The ECJ on market exclusivity for orphan drugs

(An Italian version is published on Diritto24 – Il Sole 24 Ore)

On 3 March 2016, the European Court of Justice (ECJ) issued its decision in C-138/15 P, Teva v. European Medicines Agency (EMA) dealing with orphan drugst (of which we already talked here on this blog). The Court dismissed Teva’s appeal against the European General Court decision in T-140/12, which had upheld the EMA’s decision rejecting their application to place the generic version of the orphan medicinal product Glivec (imatinib mesylate) on the market, insofar as concerned the therapeutic indications for the treatment of chronic myeloid leukaemia (CML).

Here is the background to the dispute. In 2001, Glivec was granted a marketing authorisation for the treatment of CML under Regulation (EC) no. 141/2000 on orphan medicinal products. Pursuant to art. 8(1) of the Regulation, it then enjoyed a market exclusivity period of ten years, during which no marketing authorisation could be granted to a similar product for the same therapeutic indications, unless one of the derogations under art. 8(3) be met, namely: (a) the holder of the marketing authorisation for the original orphan product consents; or (b) is unable to supply sufficient quantities of the medicinal product; or (c) the second applicant can establish that their product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.

Pursuant to art. 8(3)(a) above, in 2007 the same holder of the marketing authorisation for Glivec was granted with a marketing authorisation for another medicinal product for the treatment of CML called Tasigna (nilotimib), which was similar to Glivec and for the same therapeutic indications. The holder in fact consented to authorisation being granted for the marketing of that similar medicinal product for the same therapeutic indications as those covered by Glivec.

In 2012 Teva applied for a marketing authorisation for a generic version of Glivec, as its ten-year market exclusivity period had expired; but Teva’s application was rejected due to the market exclusivity period for Tasigna. Teva maintained that this was not in line with Regulation 141/2001, for three main reasons:
1) similar orphan drugs authorised under art. 8(3) could not enjoy the same exclusivity period as the first drug since that provision contains an exception to the general rule established in art. 8(1) and must be construed narrowly;
2) should a similar orphan drug authorised under art. 8(3) enjoy a ten-year exclusivity period, this might make the first orphan drug enjoy up to twenty years of market exclusivity, if the second drug were authorised around the expiry date of the first drug’s exclusivity; this would create ‘perverse’ incentives for undertakings to develop a series of slightly different, but nevertheless similar, orphan products, thereby benefiting from an extension of the market exclusivity period;
3) even if a similar orphan medicinal product authorised under art. 8(3) may benefit from an independent ten-year period of market exclusivity, that second period of exclusivity would preclude only authorisation for the marketing of products that are similar to the second orphan product, and could not prevent marketing authorisation being granted for medicinal products that are similar to the first authorised orphan product, in particular generic versions of that product, after the expiry of the period of market exclusivity attaching to the first orphan product.

In the decision under review, the Court dismissed the three grounds of appeal, confirming the GC decision, based on the following.

First, “Regulation no. 141/2000 does not contain any provision under which it is possible not to apply the ten-year period of market exclusivity to orphan medicinal products that have been granted marketing authorisation for certain therapeutic indications, with the exception of the situations set out in Article 8(2) of the regulation. As a consequence, where a similar medicinal product that has been granted marketing authorisation under Article 8(3) of Regulation no. 141/2000 is an orphan product, it enjoys the market exclusivity provided in Article 8(1) of the Regulation”.

Second, “the ten-year period of market exclusivity with which an orphan medicinal product is endowed by virtue of Article 8(1) of Regulation no. 141/2000 cannot be curtailed as a result of the fact that there exists an orphan medicinal product which has received marketing authorisation for the same therapeutic indications and which benefits from market exclusivity for those indications”.

Third, the GC was correct in finding that “under Article 8(1) of Regulation no. 141/2000, marketing authorisation may be refused for a ‘similar’ medicinal product only in respect of the therapeutic indications for which the marketing of an orphan medicinal product has been authorised and in respect of which that orphan product enjoys market exclusivity. By virtue of that provision, market exclusivity attaches to that medicinal product for all those therapeutic indications, irrespective of the fact that the medicinal product in question, which is itself similar to another orphan product which has been granted marketing authorisation, relied on one of the derogations laid down in Article 8(3) of the regulation at the time of that authorisation. Thus, 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 by virtue of Article 8(1) of that regulation for those therapeutic indications” (GC in T-140/12, p. 79).