Webinar Video | Life Sciences Session #4: How to optimise your regulatory exclusivity rights for pharmaceutical products?

Webinar Video | Life Sciences Session #4: How to optimise your regulatory exclusivity rights for pharmaceutical products?
May 25, 2021

In the fourth online Life Sciences Session our experts, Kirian Claeyé and Laura Traest, will be focusing on regulatory exclusivity rights for pharmaceutical products, which will include data exclusivity, orphan exclusivity, SPCs and paediatric rewards. They will navigate the maze of regulatory exclusivity rights, update you on a number of significant recent developments, and discuss what is still to come. Specific topics will include:

  • The SPC manufacturing waiver
  • The CJEU’s latest case-law on SPC rights: Santen and Royalty Pharma
  • The European Commission’s review of Orphan Exclusivity and Paediatric Extensions
  • The General Court’s very recent Polpharma ruling on Data Exclusivity

Contact

  • Kirian Claeyé

    Counsel

Recommended articles

February 09, 2023

New Mdeon rules applicable as from 1 January 2023

Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023.

Read on
January 30, 2023

The Belgian Competition Authority fines Novartis for abuse of collective dominance regarding eye disease medicines

The Belgian Competition Authority fines Novartis for abuse of collective dominance regarding eye disease medicines On 23 January 2018, the European Court of Justice (“ECJ”) handed down its judgment (C-179/16) in relation to Novartis’ Lucentis® and Roche’s Avastin® eye disease medicines, and ruled that disseminating misleading information on the off-label use of a medicine could constitute a restriction of competition ‘by object’. Exactly 5 years later, on 23 January 2023, the Belgian Competition Authority (“BCA”) imposed a fine on Novartis Pharma SA and Novartis AG (together “Novartis”) for abuse of collective dominance resulting from disseminating misleading information regarding risks in relation to the off label use of Roche’s Avastin®.

Read on
January 16, 2023

When are IP holders liable for enforcing a later invalidated IP right?

At this IP Update, our IP specialists, Christophe Ronse and Kirian Claeyé, will discuss under what circumstances IP holders may be held liable for enforcing a later invalidated IP right.

Read on