Amendment of the SPC Regulation as of 1 July 2019

New opportunities in Europe for generics and biosimilar companies

Ulla Klinge reports.

An SPC (Supplementary Protection Certificate) is a right issued on the basis of a patent and a marketing authorisation for a drug,and which extends the period of protection for the patented drug for up to 5 years. Until now the holder of an SPC has been able to prohibit any other company from utilising an SPC-protected drug commercially, i.e. produce, offer for sale, sell, or export, the drug, in the country in which the SPC is in force.

With the introduction of a so-called ”Export Manufacturing Waiver” in the SPC Regulation as of 1 July 2019, generics and biosimilar companies are allowed to manufacture SPC-protected drugs for export and for manufacture for stock-piling. The holder of an SPC can thus no longer prohibit other companies from producing an SPC protected drug, provided the manufacture is meant exclusively for export to third countries outside of the EU. Manufacture for export will be allowed throughout the entire lifetime of the SPC. Furthermore the amendment of the SPC Regulation offers the possibility of manufacture for storage (”stock-piling”) during the last 6 months before SPC expiry so that sale of the drug in question can be started immediately after SPC expiry (”day-1 entry”).

Generic or biosimilar companies intending to benefit from the new possibilities must, however, fulfill a number of requirements, i.e.:

  • Provide information to the patent authority in the country in question of the intended manufacture at least 3 months before start of manufacture. The patent authority is required to publish this information. 
  • Provide information to the holder of the SPC, also at least 3 months before start of manufacture
  • Affix a new ”EU export” logo to the outer packaging.

Although the new rules are a limitation of the rights of the SPC holder, a company wishing to benefit from the new possibilities for manufacture during the SPC lifetime is required to submit a range of information of a somewhat confidential nature. The new opportunities therefore come with a price.

The new rules apply for all SPC applications filed on or after 1 July 2019. Conversely, the new rules will not apply to already issued SPCs. With regard to SPC applications filed before, but not yet issued on the date of entry into force, 1 July 2019, the new rules will apply only for such SPC applications for which the corresponding basic patent expires on or after 1 July 2022.