Intellectual property
06 November 2018 - Posted by: Michael Krenz
The Court of Justice of the European Union (CJEU) has ruled that a supplementary protection certificate (SPC) cannot be granted for a medical device comprising an active ingredient because the EU authorisation procedure for devices does not result in a marketing authorisation (MA). The request was made in proceedings brought by Boston Scientific Ltd. and › Read More
French Courts also want the CJEU to clarify the criteria laid down in the Neurim landmark decision
24 October 2018 - Posted by: Charles Tuffreau
While Article 3(d) of the SPC Regulation (No. 469/2009) was thought to prevent the grant of an SPC covering a new therapeutic application of a product which had already received a MA for a medicinal product, the CJEU ruled in its Neurim decision (C-130/11) of 19 June 2012 that “the mere existence of an earlier › Read More
European Commission opens public consultation on Orphan and Paediatric Regulations
22 October 2018 - Posted by: Jacqueline Bore
The European Commission has embarked on the latest round of evidence gathering to support its review of pharmaceutical incentives, launched in response to the Council Conclusions of June 2016. The Health and Food Safety Directorate opened a public consultation on the Orphan and Paediatric Regulations on 18 October 2018. This joint evaluation will assess whether › Read More
19 September 2018 - Posted by: Jacqueline Bore
CRISPR-Cas9 is a remarkable gene editing technology which has the potential to revolutionise the development of medicines, particularly those for genetic diseases and cancer. Pharmaceutical companies have been quick to partner with innovators who have begun to find ways to commercialize CRISPR-Cas9, both as a research tool and as a route to the development of › Read More
08 August 2018 - Posted by: Anna-Maria Withagen
Supplementary protection mechanisms have succeeded in achieving most of their aimed objectives, according to a study by the Technopolis Group that was commissioned by the Dutch government. However, another conclusion of the study is that the mechanisms seem to have various unintended effects as well. These effects still have to be further investigated. Below is › Read More