Generic drug companies attack Novo Nordisk’s diabetes and weight-loss drug

The Danish pharmaceutical manufacturer Novo Nordisk originally developed the active ingredient semaglutide for the treatment of type 2 diabetes. However, market participants know it more commonly 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. But regardless of whether they are used for weight-loss or diabetes, Wegovy and Ozempic are blockbusters. Both markets are extremely lucrative.

Now, generic drug manufacturers are attacking the granting of various Novo Nordisk patents at the European Patent Office. This could be part of a strategy to clear the way for their own products.

Success for generics

Recently, various companies succeeded in destroying two Novo Nordisk patents relating to the administration of semaglutide in tablet form. Novo Nordisk markets the medication for type 2 diabetes in tablet form under the trade name Rybelsus.

EP 2 827 845 would have protected a “composition comprising a delivery agent and preparation thereof”. This makes it relevant for the tablet formulation of Rybelsus. The Boards of Appeal have now declared the patent invalid, with Novo Nordisk having previously withdrawn its appeal (case ID: T2044/21-3.3.0). In 2021, the Opposition Division did not grant the patent after Teva, Galenicum, Generics Ltd, Hexal, and CMS Cameron McKenna Nabarro Olswang (acting as a straw man) mounted a challenge.

Generic drug manufacturers Teva, Galenicum, Generics Ltd., and Hexal also filed oppositions against the granting of Novo Nordisk’s EP 2 827 885. The patent would have protected a “composition of GLP-1 peptides and preparation thereof” and thus also have been relevant for oral formulations of semaglutide. Again, the Opposition Division did not grant the patent. The Boards of Appeal under Chairperson M. Pregetter upheld the decision, consequently revoking the patent (case ID: T0291/22-3.3.04.).

According to JUVE Patent information, generic drug manufacturers are also attacking other patents from the Novo Nordisk portfolio that cover solid formulations of semaglutide.

Novo Nordisk unruffled

Despite the two setbacks to EP 845 and EP 885, Novo Nordisk does not believe the tablet formulation relevant to Rybelsus is in danger. When asked by JUVE Patent, the company stated via its lawyers at D Young & Co, “There are granted European divisional patents in both patent families which remain in force, as well as pending European divisional applications in both patent families.”

The company adds, “The revocation of the two patents EP 845 and EP 885 does not mean that semaglutide in tablet form is no longer protected. In fact, it is quite the contrary. Novo Nordisk has an extensive IP portfolio containing a series of other patents and patent applications covering inter alia semaglutide in tablet form.”

The decisions do not affect the administration of Wegovy and Ozempic via syringe.

D Young takes over

During the appeal, D Young & Co took over the representation of Novo Nordisk from its London competitor JA Kemp. The D Young team comprises partners Charles Harding, Jennifer O’Farrell, and Antony Latham. The firm has a long-standing relationship with Novo Nordisk and has represented the company in other disputes.

Teva and Galenicum handled the oppositions with in-house teams and without external support from patent attorneys. Bernd Aechter and Veronika Müller of Ter Meer Steinmeister & Partner represented Generics Ltd.

Hexal relied on Nils Braun of Maiwald. Several of the firm’s partners are active in oppositions and nullity proceedings against patents of various manufacturers.

Straw man CMS Cameron McKenna, however, was only active in the opposition against EP 845. London partner Jane Evenson and senior associate Lianne Leith led the proceedings.