Novo Nordisk and D Young defend crucial patent for tablet form of semaglutide

Novo Nordisk’s EP 3 746 111 B1 protects a new formulation that leads to better bioavailability of the active ingredient in the tablet form of the drug.  Several opponents had challenged the patent due to lack of inventive step. However, the panel, chaired by Stefanie Schüle and comprising first examiner Josep Gimenez Miralles and second examiner Heidi van den Bulcke, came to a different conclusion and upheld EP 111.

With the Boards of Appeal revoking several Novo Nordisk patents relating to the active ingredient semaglutide in recent months, this represents a success for the patent holder. Nevertheless, the parties may still lodge an appeal against the first-instance judgment.

The Danish pharmaceutical manufacturer Novo Nordisk originally developed semaglutide for the treatment of type 2 diabetes. However, the drug is more commonly known in a higher dosage as the weight-loss injection Wegovy. Novo Nordisk markets the diabetes drug under the brand name Ozempic. Medical professionals administer both drugs via injection. The oral medication for type 2 diabetes is marketed under the brand name Rybelsus.

Now, generic drug manufacturers are challenging the granting of various Novo Nordisk patents at the European Patent Office, likely to clear the way for their own products. In October 2024, the Boards of Appeal revoked Novo Nordisk’s EP 2 827 845 and EP 2 827 885 relating to the administration of semaglutide in tablet form. The revocation of EP 2 866 825, a patent which covers the use of long-acting GLP-1 peptides, followed in May.

In June, the Opposition Division upheld EP 3 870 213, protecting a composition of a liquid injectable of semaglutide. Two opponents have appealed this decision.

Straw men oppositions

As with the previous EPO proceedings, British firm D Young & Co represented Novo Nordisk. The firm has a long-standing relationship with the Danish pharma company and has represented the client in other disputes. Patent attorneys Antony Latham and Charles Harding took over the representation in the current case. Jennifer O’Farell was involved in the written proceedings. The team worked closely with Birgit Petersen, principal patent attorney at Novo Nordisk.

Straw men filed hree of the four oppositions against EP 111. One of the straw men was Kraus & Lederer. The Munich-based patent attorney firm emerged from the merger of Lederer & Keller and Kraus & Weisert in early 2024.

Partner Marco Fachini has extensive experience in pharmaceutical patents, having worked as in-house patent attorney for Sandoz before joining what was then Lederer & Keller in 2019. He represented Teva in other oppositions against Novo Nordisk’s patents.

The Oslo-based IP advisory firm Acapo Onsagers and patent attorneys Michael Westendorf and Renate Decker of Hoefer & Partner also acted as straw men for unknown opponents.

Hexal relied on a team from Maiwald. The mixed firm has respresented the generics company in oppositions in the past. Matthias Hoffmann and Derk Vos acted for the generic manufacturer in the recent proceedings. Partner Nils Braun represented the client at the Boards of Appeal in the case of EP 845 and EP 885.