A Japanese generic drug manufacturer, TOWA, has won a partial injunction from the Munich Regional Court against competitor Accord over the tablet formulation of the blood thinner dabigatran etexilate mesilate. The ruling blocks Accord from selling its version of the drug in tablet form while a final decision on patent validity awaits from Germany’s Federal Patent Court.
The dispute centers on EP 2 817 000, a patent held by TOWA for its oral formulation of dabigatran etexilate—a key ingredient in Boehringer Ingelheim’s original anticoagulant Pradaxa. The patent, developed by researchers at Rubicon Research in Mumbai, covers a specific tablet formulation used to treat and prevent blood clots in both adults and children. Accord had previously marketed the drug in hard capsule form but faced legal action after launching a tablet version.
Munich Regional Court, led by Judge Hubertus Schacht, issued the preliminary injunction during ongoing appeals. The ruling follows a January decision by the European Patent Office’s Technical Board of Appeal, which upheld the patent in a limited form (case ID: T 1179/23). A final verdict from Germany’s Federal Patent Court on the patent’s overall validity remains pending, though earlier opinions leaned in TOWA’s favor.
TOWA has so far been largely absent from patent litigation before European courts, including as an opponent before the EPO, but according to the EPO register, it holds several hundred patents. The company enlisted Clifford Chance for the first time, with lawyers Claudia Milbradt, Adrian Crespo, and Judith Dany leading its case. Patent attorneys Oswin Ridderbusch and Jürgen Meier from Vossius & Partner handled nullity proceedings on behalf of TOWA.
Accord, meanwhile, relied on its usual legal team, including Bonabry partners Sarah Salaschek and Daniel Hoppe, alongside patent attorneys from Hamm&Wittkopp, led by Malte von Seebach. The two firms announced plans to merge early next year. Hamm&Wittkopp has also filed an opposition with the EPO, while Bardehle Pagenberg represents Aera in a separate opposition. Notably, Glenmark Pharmaceuticals withdrew its opposition earlier this year.
The original patent was filed by ABG Intellectual Property Law in Madrid on behalf of TOWA.
Generics firms like TOWA often refine existing drugs to extend patent life or differentiate products, a strategy that has drawn increasing legal scrutiny. The appeal process remains open, with no immediate resolution in sight.
Dabigatran etexilate mesilate is prescribed for conditions like atrial fibrillation and venous thromboembolism, with tablet formulations preferred for ease of use.
