EU regulatory data protection - UK court considers generics' challenges to prior EC decisions authorising reference product

In an important recent UK case concerning regulatory data protection (“RDP”), the High Court has rejected a challenge by Teva to an assessment underlying the RDP for Tecfidera (dimethyl funarate), a multiple sclerosis treatment approved in the EU in 2014.  Teva sought a judicial review of a decision by the MHRA refusing to accept Teva’s application for a generic of Tecfidera on the basis that Teva’s application was made during Tecfidera’s period of RDP.  Mr Justice Jay held that, in considering Teva’s generic MA application, the MHRA and the UK court were bound by a decision of the EC that Tecfidera and a previously authorised product, Fumaderm, did not fall within the same global marketing authorisation. The consequence being that Tecfidera benefits from its own independent period of RDP.

An application by Mylan for permission to challenge a similar MHRA decision of the MHRA refusing an application for its generic of Tecfidera was also rejected at the beginning of the month by the High Court.  In his decision on permission, Mr Justice Supperstone decided that Mylan had alternative remedies for challenging the EC’s decision.

Further background regarding the RDP issues concerning Tecfidera and comment on the High Court’s decision in Teva’s challenge can be found in a Practice Note on EU Regulatory Data Protection for Life Sciences Companies by Marjan Noor and Rafi Allos recently published on Practical Law. This Practice Note provides a timely and comprehensive overview of the regulatory regime and tackles some of the other difficult areas which have given rise to disputes before the courts. The Practice Note also discusses the relationship between regulatory protection and the protection afforded by patents and SPCs.

The Practice Note has been published at a time when the RDP framework and other EU incentives for pharmaceutical innovation are under scrutiny as part of the EU pharmaceutical incentives review. An important aspect of that review, an economic impact study by Copenhagen Economics of regulatory incentives,  as well as a legal study of the SPC system by the Max Planck Institute have just been published by the European Commission.  It remains to be seen whether in light of these studies the EU legislature will seek to amend the EU pharmaceutical incentives framework separate to the introduction of the SPC export manufacturing waiver.