28th May 2018

Pharmaceuticals: Commission refines intellectual property rules

The European Commission proposes the so-called 'export manufacturing waiver' to Supplementary Protection Certificates.

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 proposal amends Regulation 469/2009 on the supplementary protection certificate for medicinal products. 

>> Read full press release.


Members of the American Chamber of Commerce in the Czech Republic