20 October 2017
Reporter: Barney Dixon

European Commission to discuss SPCs

The European Commission will hear opinions on supplementary protection certificates (SPCs) and patent research exemptions as part of a new consultation that could impact biosimilars in the EU.

SPCs are an intellectual property right that currently offers innovative pharmaceutical and plant protection products the ability to extend the term of their patent rights by up to five years.

This offsets the loss of effective patent protection during compulsory clinical trials that are required before regulatory marketing approval.

The commission explained that the consultation was part of the EU’s Single Market Strategy, adopted in 2015.

In 2015, the commission said it would “consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations”.

The consultation will “explore a recalibration of certain aspects of patent and SPCs”, and could result in the creation of a European SPC title, an update of the scope of EU patent research exemptions and the introduction of an SPC manufacturing waiver.

The commission will also discuss the ‘Bolar’ patent exemption, which is used to speed up entry of generic products to the market by providing exemptions to patent protection, including SPCs.

Commenting on the consultation, Danish law firm Bech-Bruun, stated: “Bech-Bruun is excited to see the EU Commission’s efforts to clarify the highly complex legal area involving all parties concerned.”

It said: “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.”

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