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UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

AstraZeneca refused interim injunction on SPC for blockbuster diabetes treatment against Glenmark but swiftly obtains permission...

On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more

A new approach to regulation by the MHRA and NICE

On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more

Clinical Trial Regulation: A streamlined reform of the UK Clinical Trials Regulatory Framework - new measures published

The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more

The Windsor Framework: MHRA to have power to licence all types of medicines to be supplied in the United Kingdom in single pack

The European Commission and the United Kingdom government announced on Monday that they have come to agreement on measures to alleviate the remaining practical difficulties in the supply of medicines to Northern Ireland that...more

Thaler v Comptroller General of Patents, Trade Marks and Designs: Court of Appeal Judgment on Machine Inventors

The Court of Appeal (Arnold LJ, Laing LJ and Birss LJ) handed down its judgment in Thaler v Comptroller General of Patents Trade Marks And Designs on 21 September 2021. The court held, with Birss LJ dissenting, that the judge...more

Updated UK Laws on medical devices and clinical trials to diverge from EU regulatory framework

We have just witnessed the first moves by the United Kingdom government to diverge from the harmonised laws regulating medicines and medical devices that the UK inherited on leaving the European Union at the end of January...more

10/1/2021  /  Clinical Trials , Medical Devices , Popular , UK

Fibrogen v Akebia Court of Appeal judgment on sufficiency of functional claims

The Court of Appeal (Birss LJ, Floyd LJ and Phillips LJ) handed down its judgment in Fibrogen v Akebia on 24 August 2021, overturning Arnold LJ (another Court of Appeal judge) on his judgment on insufficiency when sitting at...more

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