Generics suspect GSK of playing “divisional game” after EPO revocation

At the centre of the current dispute is GlaxoSmithKline’s dosing patent EP 2 400 950. It protects the active ingredient vilanterol in a dosage of 25µg and 50µg daily for the treatment of respiratory diseases such as asthma and COPD. In combination with other active ingredients, vilanterol is included in several of GSK’s best-selling products such as Trelegy Ellipta, Breo Ellipta and Anoro Ellipta. These account for a significant proportion of GSK’s EU sales in respiratory therapies. According to GSK’s annual report, the global turnover for these three drugs in 2025 amounted to £4.5 billion (€5.25 billion) and in Europe £922 million (€1,065 million).

Daily dosage

In auxiliary requests, the patent owner focused primarily on the once-daily administration of vilanterol. After the Boards of Appeal stated in a preliminary opinion that this did not constitute an inventive step, GSK withdrew all applications. The EPO consequently revoked the patent, albeit without a substantiated decision on inventive step.

Several divisional applications exist for EP 950, which were filed sequentially after the grant of earlier IP rights. These also essentially relate to a 25µg formulation of vilanterol — in some cases combined with once-daily administration. The divisional patent EP 3 578 169 is currently in opposition proceedings, while further divisional applications for EP 4 403 231 and EP 4 578 502 are still pending in examination proceedings.

Accusations of “divisional game”

Some of the opponents are now accusing GSK of playing the so-called “divisional game” in order to artificially extend patent protection through a strategic sequence of divisional applications, flanked by procedural measures. Julia Pike, global head of IP at Sandoz, writes in a LinkedIn post on GSK’s withdrawal of the auxiliary applications: “That’s not an accident — that’s a plan. GSK’s examination strategy here has artificially prolonged legal uncertainty and delayed effective judicial review.”

In different case in proceedings against Teva, the European Commission categorised this practice as problematic under competition law. On 31 October 2024, the Commission fined Teva €462.6 million for abusing its dominant position in the market for glatiramer acetate, the active ingredient in its blockbuster multiple sclerosis drug Copaxone, in Belgium, the Czech Republic, Germany, Italy, Poland, Spain, and the Netherlands (case ID: AT.40588).

GSK faces eight opponents

Patent owner GlaxoSmithKline relied on Hoffmann Eitle in the EPO proceedings. Partner and patent attorney Thorsten Bausch led the proceedings, assisted by Timo Pruß. Bausch is also defending GSK’s EP 169 in the opposition.

A total of eight opponents challenged GSK’s patent. Turkish pharma company Arven Pharmaceuticals kicked off the opposition in February 2020 with the help of Thomas Sonnenhauser of Wuesthoff & Wuesthoff. The German patent attorney firm withdrew their representation of the opponent in September 2023. In July 2025, Turkish patent attorney Ekrem Soylu of Soylu Patents took over the representation of Arven.

Teva instructed Richard Gillard of UK-based firm Elkington + Fife for the opposition proceedings.

Maiwald led the opposition for Sandoz. The firm is also active in the parallel opposition proceedings over EP 169, where it is the first of six opponents so far. Martin Huenges leads the proceedings with Derk Vos working with him on the current case.

Further opponents acted as straw men. These include Dutch firm NLO, and UK firms HGF, Dehns and Gill Jennings & Every. Danish IP firm Aera also filed a straw man opposition. Patent attorney Henrik Skødt took the client with him when he moved to the Barcelona office of Bardehle Pagenberg in May 2025.