The European Commission proposed an amendment to its IP rules that will allow EU companies to manufacture generic or biosimilar versions of patent-protected medicinal products for export to non-EU markets where their protection has expired or never existed.
The “export manufacturing waiver” will apply to drugs carrying supplementary protection certificates (SPCs), which extend EU patent protections for a period equal to the time between the date of patent application filing and marketing authorization, reduced by five years. Under the current law, EU drug manufacturers are barred from producing generics or biosimilars of SPC-protected drugs for any purposes during the protection period. The certificates, which carry average terms of 3.5 years, are intended to offset the effective patent protection lost due to clinical testing. According to the EC, 86% of approved drugs have an SPC in at least one EU member state.
The commission said the amendment will correct the competitive disadvantage for EU companies caused by restricting manufacture of SPC-protected drug generics or biosimilars for export. The agency also noted that because companies will have set up manufacturing for exportation they will also be able to manufacture drugs for the EU market immediately following SPC expiration.