SPC waiver: good intentions, but not the right deal?


SPC waiver: good intentions, but not the right deal?

KittisakJirasittichai / iStockphoto.com

The European Commission’s proposed export waiver for supplementary protection certificates has exposed a number of likely flaws which have not gone down well with patent owners. LSIPR reports.

Striking the perfect balance between incentivising innovation in drug development and widening access to medicines through generic competition is perhaps an unobtainable aim, but it’s an ideal that legislators and regulators must strive towards.

In 2016, in its “Resolution in the Single Market Strategy”, the European Parliament urged the European Commission to boost competition in the generic and biosimilar drugs market—without undermining the market exclusivity granted to IP owners—by 2019.

In response, in May this year, the Commission announced its plan to introduce a manufacturing waiver in relation to Regulation 469/2009, which governs the grant and scope of supplementary protection certificates (SPCs).

European Commission, supplementary protection certificate, patent, waiver, safeguard, market exclusivity, generic manufacturing, drug competition