EP 3 351 246 protects 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 infringed and 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 includes EP 3 342 411, which covers a treatment for pancreatic cancer, and EP 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 concerning EP 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 to EP 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.
Pan-European opposition
Cameron Marshall
Novartis relied on Carpmaels & Ransford, which regularly acts for the pharma innovator in EPO oppositions. London patent attorney and partner Cameron Marshall has represented Novartis, for example, in various proceedings concerning the anti-inflammatory drug Cosentyx, as well as Lucentis, a drug for the treatment of macular degeneration.
Meanwhile, Freshfields Bruckhaus Deringer represented Novartis in the pending infringement proceedings in Germany and the Netherlands. In France, the pharma innovator relied on Allen & Overy, and in the UK, in the dispute over EP 603, on the litigators of Kirkland & Ellis.
Similarly, many of the opposing generic drug manufacturers also retained their regular representatives. For example, Hamm & Wittkopp also assisted long-standing client Stada in the recent opposition over sunscreen.
Jean-Baptiste Lecoeur
For Biogaran, a team from its regular counsel Casalonga stepped up. The mixed Paris-based firm represents the company in virtually all proceedings – with its lawyers litigating for the company in infringement and nullity proceedings before French courts, and its patent attorneys advising in opposition proceedings.
Zentiva has also worked previously with the mixed team from Bird & Bird. The patent attorneys led by Munich partner Michael Alt represented the generics company not only in the current opposition proceedings at the EPO, but also in the infringement proceedings in Düsseldorf, together with a team of lawyers led by partner Christian Harmsen.
Michael Alt
Another Bird & Bird team led by Oliver Jüngst acted for Stada subsidiary Aliud Pharma. Hamm & Wittkopp’s patent attorneys also advised on technical issues. Zentiva does not work exclusively with Bird & Bird in Germany, but also regularly relies on the IP boutique Arnold Ruess in infringement proceedings.
Changing advisors
French law firm August Debouzy represented Teva from the outset in the French infringement proceedings involving everolimus. It was not until January 2023 that Francois Pochard’s team also took over representation of Teva in the current EPO appeal proceedings. Previously, Nikolai Hartz and Wolfgang Blodig of the Munich patent attorney firm Wächtershäuser & Hartz had represented the company in the opposition proceedings.
They had taken over representation from Jens Schiener, who joined ZSP at the beginning of 2023. Ricardo Dijkstra of Vondst, who represented Teva in the Netherlands proceedings, was also involved.
Francois Pochard
Patent attorney firm Elkington + Fife represented UK Generics, trading as Viatris. The patent attorneys regularly file patents at the EPO on behalf of the company. Also present at the hearing was Denis Schertenleib of Schertenleib Avocats, who represents Viatris in parallel infringement proceedings in France as well as other patent litigation.
For Novartis
Carpmaels & Ransford (London): Cameron Marshall (partner); counsel: Liz McKinley (both patent attorneys)
In-house (Basel): Ewan Nettleton (Principal IP Counsel), Jernej Kristl (Senior Patent Attorney)
For Stada
Hamm & Wittkopp (Hamburg): Alexander Wittkopp (partner); Anne-Katrin Meyer (both patent attorneys)
For Biogaran
Casalonga (Paris): Jean-Baptiste Lecoeur (partner, patent attorney)
For Ethypharm
LLR (Paris): Richard Monni (partner); Myriam Allab (both patent attorneys)
For Accord
Plougmann Vingtoft (Hellerup): Jan Mondrup Pedersen (patent attorney)
For Zentiva
Bird & Bird (Munich): Michael Alt (partner, patent attorney); counsel: Tobias Wilcke; associate: Jonathan Wurth (patent attorney)
In-house (Prague) Kristin Cooklin (Head of IP) Cecile Teles (patent attorney)
For Dr. Reddy’s/Betapharm
Maiwald (Munich): Christian Meyer (partner); associate: Renate Rieder (patent attorney)
In-house Betapharm (Augsburg): Sanchita Agarwal (Manager IP)
For Generics/Viatris
Elkington + Fife (Sevenoaks): Richard Cooke (partner, patent attorney)
In-house (Hatfield): Ben Thomson (Global Litigation Counsel)
For Teva
August Debouzy (Paris): Francois Pochart (partner, patent attorney and litigator)
For Arrow Generiques
Cabinet Tripoz (Lyon): Inès Tripoz (partner, patent attorney)
Board of Appeal 3.3.07, European Patent Office, Haar (Munich)
Ambrogio Usuelli (chairman), Yvonne Podbielski, J. Molina de Alba
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