The UK Intellectual Property Office (UKIPO) is seeking views and evidence on a proposed new exception from infringement of Supplementary Protection Certificates (SPCs), which protect medicines. The European Commission proposes a new exception to permit manufacture of protected medicinal products in the EU for export outside of the EU.
SPCs are national rights provided for by EU regulations. The European Commission published a proposal for a new Regulation on 28 May 2018 to amend Regulation (EC) No469/2009 concerning the SPC for medicinal products. Further details of the proposal can be found at https://ec.europa.eu/docsroom/documents/29462 and the accompanying press release can be found at http://europa.eu/rapid/press-release_IP-18-3907_en.htm .
The rationale behind the proposal is said to be:
Supplementary Protection Certificates (SPCs) extend patent protection for medicinal products which must undergo lengthy testing and clinical trials prior to obtaining regulatory marketing approval. Thanks to the waiver, in the future EU-based companies will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed. The waiver will support Europe’s pioneering role in pharmaceutical research and development.
The waiver will be accompanied by a series of safeguards which are intended to create transparency and prevent IP-infringing products from reaching the market in EU member states.
The UKIPO is seeking views on the draft legislative proposal, for example evidence of the possible impact of the legislation for the UK, views on the draft legal text and comments on the Commission’s impact assessment. Initial views should ideally be received in time to inform expected discussions between EU member states during the summer – more substantive detail can be provided at a later date.
Views should be sent to firstname.lastname@example.org.
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