28 June 2019
This article was updated on 26 July 2019, to reflect the SPC manufacturing waiver coming into force
The legislation amending the SPC Regulation EC/469/2009 to introduce a manufacturing and stockpiling waiver for EU-based generic and biosimilar manufacturers entered into force on 1 July 2019. A copy of the new legislation can be found here.
The original manufacturing waiver stems from a proposal from the EU Commission to allow EU-based manufacturers of generics and biosimilars to manufacture a product, protected by an SPC, in the EU for the purpose of exporting it to non-EU markets.
The need for this waiver was said to be the competitive disadvantage EU-based companies face as a result of the SPC system preventing them from manufacturing during the period of SPC protection. During this period, their non-EU competitors will often be free to manufacture and stockpile products, as any equivalent patent protection outside the EU will normally have expired.
When the Commission's proposal was considered by the European Parliament during the legislative process, it was amended to include a stockpiling waiver to enable EU-based manufacturers to be ready to launch in the EU on the first day of SPC expiry.
Subject to complying with certain safeguards discussed below, the proposed waiver will mean that:
Three months before starting any manufacture or associated activity, the generic or biosimilar manufacturer must notify the national patent office who granted the SPC, and the SPC holder, with details of:
For export to countries outside the EU, a new "EU export" logo must also be applied to the packaging of the product.
The manufacturer must also inform anyone in its supply chain with whom it has a contractual relationship that the placing on the market, import or re-import of the product into the EU will be an infringement of the SPC.
The waiver entered into force on 1 July 2019: