EPO revokes Novartis’s everolimus patent in major victory for generics companies

In the long-running dispute with Novartis over breast cancer drug Afinitor, generic drug manufacturers have now scored a major victory. The EPO Boards of Appeal have revoked a patent covering active ingredient everolimus. Further oppositions against patents of the same family are still pending.

EP 3 351 246protects the use of everolimus (a rapamycin derivative) in combination with an aromatase inhibitor. It forms the basis of Novartis’s drug Afinitor, a treatment for breast cancer.

The EPO granted the patent in spring 2019. Shortly afterwards, Stada filed the first opposition, with other opponents joining the suit. In total, nine generic drug manufacturers filed oppositions against the patent.

In spring 2022, the EPO’s Opposition Division rejected the opposition. The opponents then appealed the decision at the Boards of Appeal. Now the Boards of Appeal have reversed the first-instance decision and revoked the patent in its entirety due to lack of inventive step (case ID:TB o814/22-3.3.07) .

Civil courts confirm infringement

In parallel with the EPO opposition case, infringement proceedings were pending in various countries. In 2019 the District Court of The Hague issued a preliminary injunction against Teva in the Netherlands. At the end of 2020,Düsseldorf Regional Court found Novartis’ EP 246 to be infringedand prohibited generics manufacturers Zentiva and Aliud Pharma from marketing their imitation products in Germany. The Higher Regional Court had scheduled an oral hearing in the appeal for 10 August 2023, but cancelled the hearing in light of the Boards of Appeal’s decision.

Although the current ruling puts an end to the disputes concerning EP 246, parallel appeals against other patents of the same family are still pending at the EPO. This includesEP 3 342 411, which covers a treatment for pancreatic cancer, andEP 3 143 995, which protects a treatment for lung cancer.

Everolimus still under fire

Furthermore, there are currently opposition proceedings at the Boards of Appeal concerningEP 1 983 984, which does not belong to the same patent family but protects the use of everolimus in treating tuberous sclerosis complex (TSC) and brain cancer. The same applies toEP 3 345 602, granted at the beginning of 2022, which can be used for various cancer therapies.

Many opponents in the EP 246 case are also involved in some or even all of the proceedings against other everolimus patents. Many of these successfully opposed another everolimus patent,EP 2 269 603, which the EPO revoked in November 2019.