The EPO has reversed its preliminary opinion in the case of another Novo Nordisk patent and revoked it. Generic drug manufacturers could enter the market several years earlier, possibly as early as 2031.
9 October 2026 by Christina Schulze
Six years’ more or less market exclusivity makes a huge difference to originator manufacturers of blockbuster medicines. And, of course, to generic drug companies too. Consequently, the decision by EPO Board of Appeal 3.3.04 on Thursday afternoon is likely to have far-reaching consequences. Contrary to the assessment in the preliminary opinion, the board revoked Novo Nordisk’s EP 3 448 416.
According to JUVE Patent sources, the hearing focused primarily on formal grounds. The discussion centred mainly on comparing the invention with the formulation described in the patent and on the assessment of the publication of a study prior to the patent application.
The revocation of EP 416 is a setback for Novo Nordisk, as there are no divisional applications within this patent family and the patent could have guaranteed protection until 2037. Under the patents that remain valid, market exclusivity for products containing semaglutide could expire as early as 2031.
Novo Nordisk works with various law firms in its various patent disputes concerning its top-selling blockbuster products. In this case, Antony Proctor, Philip Thomas Potter, and Helen Bartlett of Potter Clarkson led the negotiations.
Malte von Seebach of Hamm&Wittkopp led the team of opponents on behalf of client Stada. Marco Fachini of Kraus & Lederer represented Teva.
Veronica Müller of Ter Meer Steinmeister & Partner represented Generics. Sandoz, as the opponent, relied on Paul Brookes of Elkington + Fife. Adalvo worked with Emma Battell of Brand Murray Fuller. Christoph Schön and Rudolf Schön of Dr Schoen, Neymeyr & Partner Patentanwälte acted as frontmen.
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