New SPC referral to the CJEU regarding medical drug and device combinations

The referral C-527/17 raises the question if an SPC may be obtained for a combination of a drug and a medical device

Summary

Currently the question whether medical devices and/or combinations of medical drug/device fall within the Regulation (EC) No. 469/2009 is regarded as being a controversial topic taking the legislator’s goal with the Regulation into consideration on one hand and at the same time considering the literal requirements of the regulation referring to authorization procedures according to Directive 2001/83/EC.

The German Federal Patent Court (hereinafter ‘the German Court´) has referred a case to the CJEU to clarify if:

  • 1) An authorization according to Directive 93/42/EEC (EC-mark) can be considered as equivalent to an authorization according to Directive 2001/83/EC and
  • 2) An authorization according to Directive 93/42/EEC can be considered as an administrative sales authorisation procedure.

Based on the current pending case at the German Court, the German Court considers that an authorization according to Directive 93/42/EEC for a drug-device-combination is equivalent to a marketing authorization according to Directive 2001/83/EC for the purposes of Art. 2 of Regulation (EC) No. 469/2009.

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// Gyde Balzer Carstensen