New SPC manufacturing waiver will favour generic pharmaceutical producers

We are now well into the European election season, and pending legislation that did not make it through in the final days of activity will have to wait for the new EU Parliament and Commission. One of the planned laws that got over the line was the regulation to create an SPC manufacturing waiver. You can see the final text here.

Supplementary Protection Certificates, or SPCs, provide an important form of protection for innovative pharmaceutical companies. Applied for under SPC Regulation 469/2009, they can extend patent protection for up to five years for medicines that have been held up in the regulatory process, giving back lost years of market exclusivity.

But the new law means that, in future, manufacture of an SPC protected product will not amount to infringement in the following contexts:

  • manufacture within the EU for the purpose of export to non-EU countries, and
  • manufacture and storage within the EU in the six months before expiry of the SPC, to enable generic or biosimilar launch on day one after expiry.

Strictly necessary related acts are also exempt.

A manufacturer making use of the exemption will have to inform the relevant authorities and the SPC holder, and affix export labels where appropriate.

The research-based pharmaceutical industry is strongly opposed, arguing that the new law will water down Europe’s strong protection for innovative products. So why the change? The EU considers that its own generics and biosimilars industries are suffering. Non-EU manufacturers are able to produce medicines for supply to non-patented markets and to be ready for launch post-expiry in the EU, putting businesses within the EU’s home markets at a disadvantage.

Lobbying for changes to reduce the effect on R&D based companies (discussed here) has had some impact. The exemption for stockpiling in preparation for day one launch remains, although this has been reduced from two years to six months. Notification and labelling requirements should help to counter unauthorised reimportation to the EU market.  

The changes will be introduced by amendments to the existing SPC Regulation. Initially only new SPC applications will be affected – expected to be those filed on or after made after 1 July 2019.  Pending applications for SPCs that are granted after 1 July will also be affected after 1 July 2022.

The impact of the manufacturing waiver will be up for review after five years.

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