Intellectual property

CJEU confirms that prior authorisation for a drug-incorporating device is not an MA under the SPC Regulation

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

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

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

Federal Circuit upholds finding that Broad Institute CRISPR patents in plant and animal cells do not overlap with UC Berkeley patents

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

Dutch government survey: “Are the supplementary protection mechanisms for pharmaceutical products fit for their purpose?”

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