The United Patent Court in Milan is hearing a dispute that puts the so-called “divisional game” under close scrutiny. The case involves a patent on semaglutide, the active ingredient in several high-profile weight-loss and diabetes medicines.
Revocation action against a key semaglutide patent
Sandoz filed a revocation request for European patent EP 3 689 365 this summer, marking the first UPC proceeding that targets a semaglutide-based invention. The filing, identified as UPC-CFI-0002221/2026, challenges the patent on grounds of added matter and lack of inventive step.
The generics maker also seeks an order preventing Novo Nordisk from withdrawing the patent text before the court reaches a decision on validity, whether that decision comes from the EPO or the UPC.
Patent claims and related litigation
EP 3 689 365 claims an improved therapeutic use of GLP-1 peptides, focusing on specific dosage regimens that allegedly enhance clinical effect. The claim is part of a family that includes the parent application EP 2 866 825, which the Boards of Appeal revoked in an opposition in April last year.
Other semaglutide-related patents were revoked by the EPO in 2024, highlighting ongoing challenges to the protection surrounding the molecule. EP 3 689 365 also has a divisional counterpart, EP 4 406 593, currently under examination.
EPO oppositions and procedural acceleration
The patent faces 18 oppositions at the European Patent Office. Opponents include well-known generics firms such as Teva, Zentiva and Synthon, alongside Sandoz. The Opposition Division has informed the parties that, because of the pending UPC case, it will speed up its proceedings.
In the opposition filings, it asks the UPC to issue an order that “the approval to the text of the patent must not be withdrawn to avoid a decision on the merits.” This request mirrors concerns about a practice where owners pull applications to sidestep a final validity ruling, a tactic critics label the “divisional game.”
Judicial panel and legal arguments
The Milan panel consists of a presiding judge, judge rapporteur Andrea Postiglione, legally qualified judge Anna-Lena Klein and technically qualified judge Rudi Goedeweeck. Their first task is to determine whether the UPC has the authority to issue the kind of injunction Sandoz seeks.
If the court grants the order, it would function similarly to an “Arrow declaration” used in the United Kingdom, which pre-emptively declares a claim lacking novelty or inventive step on a specific date.
Legal representation and procedural tactics in the semaglutide dispute
Sandoz has engaged Bird & Bird, an international law firm, to handle its case. The team includes Milan-based partner Giovanni Galimberti alongside German partners Oliver Jüngst and Jan van Dieck from the Düsseldorf and Munich offices. The firm has prior experience representing generic drug manufacturers like Zentiva and Teva/Ratiopharm, as well as advising Sandoz in past litigation, including a dispute against Biogen involving the drug Tyruko.
The generics company has also requested that the European Patent Office accelerate its proceedings due to the ongoing UPC case. This follows a preliminary objection from Novo Nordisk, which opposes Sandoz’s demand that the patent remain in force until a final decision on validity is reached. The court’s ruling on this issue could establish a precedent affecting future pharmaceutical patent disputes.
At the EPO, Sandoz is represented by patent attorney Lee Mullen of Elkington + Fife, who is managing the opposition work. Meanwhile, Novo Nordisk’s defense is led by Bristows, with Claire Phipps-Jones heading the litigation team. The firm collaborates with Novo Nordisk’s internal legal team, including associate general counsel Michal Porubsky and principal patent attorney Michaela Melcher. Forresters is handling the parallel EPO opposition for the Danish company.
