• Professional News
  • 18 October 2017

SPC Protection and the Bolar Exemption up for Review

The EU Commission considers creating a centrally issued EU SPC, limiting the rights granted under patents and SPCs and introducing an SPC manufacturing waiver. Submit your input directly to the Commission before 4 January 2018 if you would like to impact future legislation on this matter.

In October 2015, the EU Commission announced its plan to consult, consider and propose further measures, as appropriate, to improve the patent system in Europe. Key elements for consideration comprise:

  • the creation of a centrally issued EU SPC;
  • limits to the rights granted under patents and SPCs (“bolar”); and
  • the introduction of an SPC manufacturing waiver.

From 12 October 2017 to 4 January 2018, the EU Commission welcomes input from all stakeholders, including manufacturers of innovative, generic and biosimilar products, innovative sectors subject to pre-market regulatory authorisation but not eligible for an SPC, national authorities and the general public.

Now is therefore the time if you would like to impact your regulatory framework. Submit input online using the EU Survey.

For a quick brush-up on SPCs and the bolar exemption continue reading below.

Supplementary Protection Certificates
Supplementary Protection Certificates (SPCs) grant up to five years extension to the term of a patent right to offset loss of effective protection due to the compulsory and lengthy testing and clinical trials that medicinal products require prior to obtaining regulatory marketing approval.

The Bolar Patent Exemption
Aimed at speeding up entry of especially generics, the bolar patent exemption provides that certain pre-market activities are not regarded as an infringement of a patent right or an SPC.

Concerns to be addressed
SPCs and bolar exemptions are, however, implemented and enforced differently, leading to considerable uncertainty across the EU. Accordingly, SPCs are granted and enforced at national level. In some cases, applicants have obtained an SPC in one country, while similar applications have been refused or granted with a different scope in another.

Further, in some Member States, the bolar exemption does not allow the supply of active pharmaceutical ingredients to EU-based generic manufacturers for the purpose of seeking marketing authorisation. In other Member States, it is not certain whether testing in the EU by originators and biosimilar manufacturers may benefit from these exemptions for the purpose of seeking marketing authorisation in the EU and in non-EU countries, or for meeting emerging regulatory requirements such as those related to health technology assessment.

Finally, it is suggested that the bolar exemption puts EU-based manufacturers at a disadvantage because they are not allowed to manufacture for export to non-EU markets during the patent or SPC term. As a result, non-EU based manufacturers may launch medicinal products outside the EU several years earlier than EU-based manufacturers.

Comments by Bech-Bruun
Bech-Bruun is excited to see the EU Commission’s efforts to clarify the highly complex legal area involving all parties concerned. Many years’ uncertainty across the EU has unreasonably enhanced the business risk of the pharmaceutical industry. Hopefully, the thorough analysis – supported by insights from the consultation process – will lead to an improvement of the patent and SPC regimes to the benefit of life sciences businesses and the health of EU citizens.

For more information please do not hesitate to get in touch.

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