EU

European Commission adopts revised definition of “similar medicinal product”

Eveline Van Keymeulen

Yesterday, the European Commission adopted Regulation 2018/781 amending Regulation (EC) No 847/2000 as regards the definition of the concept “similar medicinal product” in the context of the Orphan Medicines Regulation.  The Regulation extends the definition of “similar active substance”, by clarifying that “[i]f the principal molecular structural features cannot be fully established, the similarity between Read More

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

Rafi Allos

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 Read More

European Commission proposes export manufacturing waiver for SPCs

Eveline Van Keymeulen

The European Commission has published today a proposal for a Regulation amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products. The proposal introduces a so-called “export manufacturing waiver”, an exception to the SPC system in relation to exports to third countries (outside the EU). Due to the waiver, EU-based companies will be entitled Read More

Resisting parallel imports of trade marked goods – pre- and post-Brexit

Natasha Rao

On 17 May 2018, the CJEU confirmed that trade mark owners cannot oppose a parallel importer’s further commercialisation of a medical device in its original packaging if additional labelling added by the importer does not threaten the medical device’s guarantee of origin. By way of background, Lohmann & Rauscher International argued that by re-selling its Read More

Commission closes infringement proceedings against Poland, Romania and Slovakia relating to parallel trade of medicines

Juraj Gyarfas

On 17 May 2018, the European Commission announced that it had decided to close its infringement procedures and the treatment of complaints related to parallel trade of medicines for human use against Poland, Romania and Slovakia. By way of background, parallel trade has long been a major concern for both governments and pharmaceutical companies in Read More