EU

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

Getting ready for the EU MDR: New guidance documents available for manufacturers

Eveline Van Keymeulen

During the summer months of July and August, the European Commission has published five documents aimed at guiding manufacturers and other economic operators through the changes implemented by the EU Medical Devices Regulation (MDR) and the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR). Both regimes will be fully applicable on 26 May 2020 and on 26 Read More

UK government publishes plans for the Life Sciences sector in the event of a no-deal Brexit

Jacqueline Bore

The UK government has published a series of guidance documents setting out how it plans to regulate the Life Sciences sector if the UK leaves the European Union on 29 March 2019 without an agreement with the remaining EU-27 Member States. The UK government emphasizes that significant progress has been made in negotiations with the Read More

Getting ready for the EU MDR: Requirements for identification and traceability of medical devices

Eveline Van Keymeulen

In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that will be imposed on manufacturers and other economic operators placing medical devices on the EU market. MedTech Europe, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices 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