Marketing authorisation: the right to challenge

Since the EU regime of data exclusivity for pharmaceuticals was amended in late 2005, in large part to reflect Court of Justice of the EU (CJEU) case law in the 1990s and early 2000s, there has been little case law on the interpretation of the new legislation. This situation is now starting to change.

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk

More on this story

Big Pharma

Novo Nordisk and OpenAI strike AI deal to boost drug discovery

15 April 2026 The Danish pharma giant is turning to artificial intelligence as it faces patent expiry, falling shares and intensifying competition from Eli Lilly.

Big Pharma

Part II: The race to replace semaglutide heats up

23 March 2026 With Novo Nordisk's core semaglutide patent expired in India last week, the company that built one of the most successful drugs in pharmaceutical history is already fighting on a new front. So what comes next?

Big Pharma

Sandoz strikes fresh biosimilar deal with South Korean biotech

19 March 2026 The Swiss generics giant secures global commercialisation rights as partnership targets multi-billion-dollar loss-of-exclusivity opportunity.

More features

EU court under pressure to define SPC limits in patent row

Amneal acquires biopharma ahead of $300bn patent wave

Squires refuses to resurrect HydraFacial patent review

INTA 2026: In-house tips on what to do in London

Baker McKenzie strengthens IP bench with new German lead

Novo Nordisk and OpenAI strike AI deal to boost drug discovery

IP finance gap risks startup exodus, EUIPO warns

Patent office fee increases: What applicants must know

Marketing authorisation: the right to challenge

More on this story

Editor's picks

Editor's picks

More features