Novartis v. Mylan (deferasirox) District Court of The Hague (PI judge Brinkman), 29 September 2020, KG ZA 20-605

Facts

The patentee Novartis AG (“Novartis”) is the proprietor of EP 0 914 118 (“EP 118”). EP 118 covers deferasirox, an oral iron chelator that is sold by Novartis under the trademark Exjade.

EP 118 is granted on 23 October 2002 on the basis of an application filed on 24 June 1997. An SPC was granted on the basis of EP 118 which was initially valid until 30 August 2021, but was extended with six months following Exjade’s label extension to also cover paediatric use following on Novartis’ compliance with the requirements set forth Regulation (EC) No 1901/2006 (the “Paediatric Regulation”). As to the regulatory status, Exjade had received an orphan designation from the European Commission in 2002 pursuant to Regulation (EC) No 141/2000 (the “Orphan Regulation”), but this designation was unilaterally revoked by Novartis in 2016.

The defendants in this case are three entities belonging to the Mylan group: Mylan B.V., Mylan N.V. and Mylan SAS (together “Mylan”). The first legal entities are based in the Netherlands and the last is based in France. By decision of 26 September 2019, the EMA granted Mylan SAS a centralized MA for its generic deferasirox. It follows from the SmPC of deferasirox Mylan that Mylan SAS is the MA holder for all European Member States.

On 27 May 2020, Novartis informed Mylan of its intellectual property rights relating to Exjade. On 10 June 2020, Mylan responded that they “do not currently have plans to launch a deferasirox product in the Netherlands prior to 30 August 2021. We do not believe that the paediatric extension to SPC No. 300248 is valid.”. In the present case, Novartis seeks preliminary injunctions against Mylan to essentially stop them from marketing the deferasirox prior to expiry of the Paediatric Extension for Exjade.

Question of validity of the Paediatric Extension

The central question in this matter thus is whether the Paediatric Extension for Exjade had prima facie been validly issued. The issue underlying this central question is that Paediatric Regulation provides for two different rewards for conducting paediatric studies: extension of an SPC for the duration of six months or extension of the market exclusivity for the duration of two years granted under the Orphan Regulation.

Mylan has taken the position that the Paediatric Extension is invalid, arguing that Exjade had previously been designated as an orphan drug in theory entitling it to an extension of the regulatory market exclusivity with two years (pursuant to Regulation (EC) No 141/2000).

Therefore, the exception clause of Articles 36(4) and 37 of the Paediatric Regulation should apply (which essentially stipulate that no Paediatric Extension shall be granted for a product that is designated as an orphan medicinal product). Mylan’s reasoning is that Novartis by the expiration of the orphan designation would enjoy a double reward. To this end, Mylan referred to the preamble of the Paediatric Regulation as well as its legislative history. According to Mylan, Novartis was first relying on paediatric reward in the form of extension of market exclusivity as an orphan drug for a period of two years. That Novartis had not in fact benefited from the extended market exclusivity should be irrelevant as this is caused by Novartis itself. The District Court disagreed with Mylan for the following reasons.

Answer by the PI judge
First, the PI judge establishes that, pursuant to long-standing CJEU case law, a (provision of a) Regulation must be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part.

He then goes on to state that the wording of both Article 36(4) and 37 of the Paediatric Regulation does not give any suggestion that products that had been designated as orphan drugs in the past would not also be eligible for an Paediatric Extension. The wording of the provision read in conjunction with the moment that the reward comes into existence, suggests that the moment of eligibility of the Paediatric Extension is decisive. The PI judge held that the Paediatric Regulation in no way expresses the exclusion of products that have been designated as orphan drugs in the past from the scope of the SPC extension. In this context, the PI judge refers to the fact that on the basis of the system of the Orphan Regulation, an orphan drug whose protection period has expired loses that designation. Moreover, nothing can be deduced from the preamble of the Paediatric Regulation about the status of products that had been designated as orphan drugs in the past.

Finally, the PI judge held that there is no double reward for paediatric studies, since – due to the expiration of orphan drug designation – no market exclusivity extension has been granted (in addition to the Paediatric Extension), so that not both are enjoyed.

Consequently, the PI judge of the District Court of The Hague concludes that there is an impending infringement and grants a cross-border injunction against all Mylan entities to stop them from infringing the Paediatric Extension in all countries where it is valid and facilitating such infringement.

The judgment (in Dutch) can be read here.

Headnote: Jeroen Boelens, NautaDutilh