Will the EU’s SPC manufacturing waiver weaken European pharma’s IP?
The US Chamber of Commerce has published its International IP Index 2020, a map of the IP ecosystems of 53 economies, representing over 90% of global gross domestic product (GDP). The index aims to provide a snapshot of each economy’s overall IP ecosystem by evaluating its IP framework across 50 indicators, selected to represent the most effective IP systems.
Nine categories are scanned: patents, copyright, trademarks, design rights, trade secrets, commercialisation of IP assets, enforcement, systemic efficiency, and membership and ratification of international treaties.
Western European economies dominate the top 10 rankings, with the US (#1) and Japan (#6) the only exceptions. The UK ranks second, with a marginally increased score over last year, despite Brexit and (along with EU countries) a score reduction due to the introduction in July 2019 of the EU supplementary protection certificate (SPC) manufacturing waiver.
The IP Index also reviews trends and developments in the global IP environment. Developments from 2019 which are discussed are the US-China trade talks (culminating in the signing on January 15, 2020, of phase one of the Economic and Trade Agreement); whether IP standards are being undermined in international trade agreements; and the erosion of rights in IP-intensive industries.
Regarding the latter, the EU SPC manufacturing waiver is singled out for criticism. Under SPC Regulation (EC) No. 469/2009 it was not possible to manufacture, stockpile or export an active pharmaceutical ingredient or finished dosage form that fell within the scope of an SPC.
For EU generic and biosimilar manufacturers, this meant it was not possible to manufacture in the EU, either for export to countries where the basic patent had already expired and SPC-type patent extensions were not available or in preparation for “day-one" launch within the EU upon SPC expiry.
Waiver rules
The EU SPC manufacturing waiver ( Regulation [EU] 2019/933) is intended to address these issues, by allowing generic and biosimilar manufacturers to make a medicine without the permission of the SPC holder: a) for export to a country outside the EU; and/or b) within the final six months of the SPC, to store to sell on the EU market once the SPC has expired.
