20 October 2017
Brussels
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.”

More news
The latest news from IPPro Patents
Join Our Newsletter

Sign up today and never
miss the latest news or an issue again

Subscribe now
Countries should break IP rules to ensure growth, says report
23 February 2018 | London | Reporter: Barney Dixon
Countries such as India and China should break harmonised intellectual property rules to avoid protectionist measures from the US and EU, according to a new report from Gowling WLG
EPO employment proposal halted
22 February 2018 | Munich | Reporter: Barney Dixon
A proposal to scrap permanent employment contracts at the EPO has been halted and a controversial article within it withdrawn, a source close to the Staff Union of the EPO has confirmed
UPC complaint to be heard in 2018
22 February 2018 | Karlsruhe | Reporter: Barney Dixon
The German Federal Constitutional Court will hear the constitutional complaint against the UPC in 2018
Cabinet Plasseraud promotes four to partner
21 February 2018 | Paris | Reporter: Barney Dixon
Cabinet Plasseraud has appointed for intellectual property attorneys to partner
NPE litigation in Europe sees continued growth
20 February 2018 | Brussels | Reporter: Barney Dixon
NPE litigation and enforcement in Europe has increased by an average almost 20 percent year-on-year since 2007, according to a new report from Darts-IP
BakerHostetler hires IP partner
19 February 2018 | Los Angeles | Reporter: Barney Dixon
BakerHostetler has hired Troy Schmelzer as partner in its intellectual property group
Sheppard, Mullin, Richter & Hampton promotes four to partner
16 February 2018 | California | Reporter: Barney Dixon
Sheppard, Mullin, Richter & Hampton has promoted four intellectual property attorneys to partner across its Shanghai, San Diego and San Francisco offices