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Latest From Legal Issues

UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD

AMD patients in the UK can legitimately be given compounded bevacizumab (Roche’s Avastin) after the appeals court said NHS trusts could offer a drug off-label for economic reasons where there were no safety or efficacy concerns. 

United Kingdom Legal Issues

Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Biosimilars Legal Issues

New Patent Litigation Playbook For Products Switching To Biologics

Innovators are losing the protections of ANDA litigation as their products transition from drugs to biologics; both sides in patent disputes will now adopt different strategies.

Biologics Biosimilars

German Ruling Spells More Trouble For Europe’s New Patent System

The annulment of Germany’s ratification of the Unified Patent Court Agreement has dealt the proposed system another serious blow following the UK’s recent decision not to take part because of Brexit. 

Germany United Kingdom

Filing Error Slices Nearly Two Years Off Roche’s UK Lucentis Protection

A ruling by the High Court should act as a warning to companies applying for supplementary protection certificates in the UK that they must make sure that the fees are paid for the full duration of the SPC, otherwise they could get a nasty surprise when it expires earlier than expected.

United Kingdom Intellectual Property

What Might Whistleblower Protections Look Like For UK Pharma Post-Brexit?

In the first of two articles on the whistleblowing landscape, Sean Curran considers how things might change in the UK in the wake of the country's departure from the EU.

Europe Legal Issues
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