Pharmaceuticals : the European Commission Refines Intellectual Property Rules
The European Commission made a proposal for a new Regulation amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (COM / 2018/317 final). The proposal aims to adjust intellectual property rights framework, which sustains the pharmaceutical industry’s world-class innovation capacity. To improve the current system and remove a major competitive disadvantage of EU manufacturers, the Commission proposed a targeted amendment called ‘export manufacturing waiver’ to Supplementary Protection Certificates. SPCs extend to patent protection for medicinal products which must undergo lengthy testing and clinical trials prior to obtaining regulatory marketing approval. Due to the waiver, EU-based countries 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 includes a series of safeguards to create transparency and prevent IP-infringing products from entering Member State markets. Furthermore, this proposal amends Regulation 469/2009 on the supplementary protection certificate for medicinal products. Once adopted by the European Parliament and Council, the new regulation will be directly applicable in all EU countries.
