The SPC Manufacturing Waiver: Strategic Implications for Originators and Market Entrants | Kisaco Research

This roundtable will examine the legal and strategic implications of the EU SPC manufacturing waiver, focusing on its “safe harbour” role in enabling export and day-one EU market entry while reshaping originator exclusivity planning in the final phase of IP protection. Participants will assess notification requirements, stockpiling constraints and enforcement exposure, considering how originators and generics are adapting to core challenges and shifting strategies in response to new legislation and case law.

Speaker(s): 

Author:

Laila Beynon

Director, Dispute Resolution
Regeneron

Laila Beynon is Director, Dispute Resolution at Regeneron, responsible for the strategic co-ordination of ex-US patent litigation. She has a PhD in Biochemistry/Molecular Biology, 10 years’ private practice experience in life sciences patent litigation at Herbert Smith Freehills LLP, and prior to her role at Regeneron headed up the Patent Litigation team at BAT. 

Laila Beynon

Director, Dispute Resolution
Regeneron

Laila Beynon is Director, Dispute Resolution at Regeneron, responsible for the strategic co-ordination of ex-US patent litigation. She has a PhD in Biochemistry/Molecular Biology, 10 years’ private practice experience in life sciences patent litigation at Herbert Smith Freehills LLP, and prior to her role at Regeneron headed up the Patent Litigation team at BAT. 

Author:

Aled Richards-Jones

Partner
Mewburn Ellis

Aled Richards-Jones

Partner
Mewburn Ellis
Agenda Track No.: 
Track 3
Session Type: 
General Session (Presentation)
Force Inline Description: 
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