Battle lines drawn in EU SPC battle

Generic drugmakers and research-based pharma companies are used to facing each other in patent rows that can bring lost or gained earnings totaling many millions of dollars, but billions are riding on a European Union (EU) review of laws affecting exclusivity periods for the industry as a whole.

The European Commission is considering implementing a Supplementary Protection Certificate (SPC) manufacturing and export exemption, and has launched a consultation on the issue. The SPC compensates originator drug manufacturers for regulatory approval delays by extending their monopoly for up to five years after patent expiry. During this period, European manufacturers of generic and biosimilar medicines cannot produce their medicines in the EU.

It is felt that the waiver could boost economic growth and job creation within the generics and biosimilars industry, and the trade group representing these drugmakers in Europe is naturally pushing for the reform to go through.