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.
We propose an adjustment to intellectual property rules to remove a legal barrier preventing EU pharmaceutical companies from competing on equal terms on global markets.— European Commission
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6th October 2021
9th July 2021