European Parliament Approves Manufacturing Waiver and Reduces Scope of SPC-Based Patent Rights in Medicines
On 17 April 2019, the European Parliament (“EP”) approved a modification to Regulation No. 469/2009 which governs the supplementary protection certificate (“SPC”) for medicinal products. The modification creates a “manufacturing waiver” that encroaches on the operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. The modification will allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, for the double purpose of either exporting to a non-EU market where protection has expired or never existed, or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market once the SPC has lapsed.
The “stockpiling” exception goes beyond the proposal which the European Commission initially tabled in May 2018 (see, Van Bael & Bellis Life Sciences Newsflash of 28 May 2018) and did not form part of the text which the Member States determined as their negotiating position in January 2019 (see, Van Bael & Bellis Life Sciences Newsflash of 21 January 2019). Still, the Council of the European Union is now expected to endorse the text adopted by the EP following a political agreement reached among the EU institutions in February 2019.
Once published in the Official Journal of the EU, the modification to Regulation No. 469/2009 will enter into force 20 days later and will become directly applicable in all EU Member States. However, the full effects of the SPC waiver will only kick in 3 years after the date of that entry into force, currently expected to be around 1 July 2022.
The creation of a manufacturing waiver is regarded as a major victory for the generic and biosimilar industries. Conversely, EFPIA, the European association of innovative pharmaceutical companies, has labelled the move as a “negative signal to the world that Europe is devaluing its intellectual property framework”. EFPIA therefore hopes that the next European Commission, which will take office following the European elections to be held between 23 and 26 May 2019, will “redress the balance, supporting research, development and innovation more broadly” (EFPIA press release of 17 April 2019).