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China: Patent Law Amendment brings sea change to pharmaceutical patent regime

Jill Ge

On 17 October 2020, the top legislature in China passed the Fourth Amendment to the PRC Patent Law (“Amendment”) which will take effect on 1 June 2021. The Amendment is significant as it introduces patent linkage and patent term extensions for pharmaceutical patents. The Amendment reflects the commitments China made in the U.S.-China Phase 1 Read More

Covid-19 coronavirus – the UK’s preparation for a vaccine

Megan McMellon

The UK’s vaccine portfolio The UK Government has agreed supply deals for at least 340 million doses of six different vaccines, with most likely to require two doses: AstraZeneca and the University of Oxford (adenoviral vector vaccine, 100m doses); Johnson & Johnson (adenoviral vector vaccine, 30m doses, with an option to acquire an addition 22m Read More

France – Update of national early meetings guide for medicines evaluation

Jeanne Fabre

On 29 April 2020, the French High Health Authority (HAS) updated its guide on national early meetings for medicines evaluation. As part of its action plan for innovative medicines and its work programme presented at the beginning of 2020, the HAS has revised its guide to early meetings which aims to support businesses in the Read More

Evalve v Edwards – Review of competing public interests in grant of final injunctions

Marjan Noor

The issue of whether public interest considerations can be relied upon against the grant of a final injunction, or for a carve out in the injunction, is a very live one in disputes in relation to innovative medical devices and pharmaceuticals. In this decision, Edwards argued that, although its PASCAL product used to treat mitral Read More

EMA takes specific steps to reduce possible impact of Covid-19 on pharmaceutical supply chain in EU

Nieke Vanavermaete

In a recent press release, the EMA announced that problems regarding the supply chain of medicines cannot be disregarded as the novel coronavirus (Covid-19) continues to spread. EMA has not (yet) received reports of current shortages or supply disruptions of medicines marketed in the EU due to the outbreak at this point. However, in a Read More