Generics companies score a win against Novartis in battle over fingolimod

For over a year, a fierce battle has raged across many European countries over Novartis’ EP 2 959 894. The second medical use patent covers a 0.5mg per day dosage of active ingredient fingolimod, which forms the basis of Novartis’ drug Gilenya. The product is used to treat relapsing-remitting multiple sclerosis.

All over Europe

In January, Düsseldorf Regional Court issued a preliminary injunction which prevented generic drug companies from entering the German market with their own fingolimod products.

Now seven generics manufacturers, including Viatris, Zentiva, and Ratiopharm, have won an important victory. Last week, the Düsseldorf Higher Regional Court overturned the PI judgement in the second instance.

This opens up the possibility for generic drug manufacturers to enter the German market. A certain risk remains for the generics companies if Novartis files a main action for infringement – but it is not yet known whether the patent holder will take this step. 

Frank-Erich Hufnagel

Novartis started taking action against generic drug companies last year. The company filed suits in multiple countries, including the UK, the Netherlands, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal, and Switzerland.

First attempt failed

Novartis attracted particular attention last summer with its first application for a preliminary injunction.

The extended market exclusivity for Gilenya had ended on 22 March 2022. At that time, the EPO had not yet officially granted EP 894. The EPO had, however, given the green light for the granting of the fingolimod dosage patent in the spring.

Shortly after, Novartis requested an initial PI against Ratiopharm, AbZ Pharma, and Puren Pharma at the Regional Court Düsseldorf, but in September this was unsuccessful. The originator argued that it is immoral to sell generics that infringe a patent when it is considered certain that the EPO will grant the patent in question. However, the court did not follow this view, confirming that injunctive relief exists only for a granted patent.

In other countries, such as France and the Netherlands, Novartis also failed in its attempt to protect the not-yet-granted patent through a PI.

Novartis tries again in Germany

Subsequently, after the EPO granted EP 894 in October 2022, Novartis requested a second PI at Düsseldorf Regional Court and this time the company was successful. However, the PI has now been overturned in the second instance. Nevertheless, Novartis managed to keep the generic fingolimod products off the market for another seven months.

Oliver Jüngst

In parallel to the PI proceedings, a total of 23 opponents are taking action against EP 894 in one of the largest opposition proceedings at the EPO. These are represented by the who’s who of European patent attorney firms.

Reliable representation

Novartis relied on its go-to law firm Freshfields Bruckhaus Deringer in the German dispute as well as in the Netherlands. The originator has close ties with Freshfields’ patent teams in Düsseldorf, Munich and Amsterdam. Additionally, the patent attorneys of Ter Meer Steinmeister assisted in technical questions. The firm is also handling the appeal proceedings at the EPO.

In France, Novartis relies on the Paris team of Allen & Overy, and in London on Bristows.

Most of the generics companies have also retained their regular advisors for the fingolimod case. For example, Teva Group and Bird & Bird have a long-standing cooperation. Patent litigator Oliver Jüngst and patent attorney Michael Alt led a team which represented Teva subsidaries Ratiopharm and AbZ in the first PI proceedings in September.

Extensive advisors

Eva Geschke

Many of the patent attorney firms advising on technical issues in the German fingolimod proceedings are also involved in the EPO opposition against EP 894. However, Teva works with UK patent attorney firm D Young & Co, while Glenmark works with Venner Shipley.

For Novartis
Freshfields Bruckhaus Deringer (Düsseldorf/Munich): Frank-Erich Hufnagel, Nina Bayerl (both partners); associates: Kilian Seidel, Fabian Schubach, Elena Hennecke
Ter Meer Steinmeister & Partner (Munich): Bernd Aechter (partner); associate: Markus Ackermann (both patent attorneys)

For Ratiopharm and AbZ Pharma (case IDs: I-2U46/23 and I-2U48/23)
Bird & Bird (Düsseldorf/Munich/Hamburg): Oliver Jüngst, Michael Alt (patent attorney, both partners); associates: Lucas Brons, Anne Halbach (patent attorney)

For Vivanta (case ID: 1-2 U 47/23)
Harmsen Utescher (Hamburg): Karsten Königer (partner); associate: Marisa Bruckmann
Hamm & Wittkopp (Hamburg): Alexander Wittkopp (partner), Heike Lackmann (both patent attorneys)

For Viatris (case ID: 1-2 U 45/23)
Wildanger Kehrwald Graf v. Schwerin & Partner (Düsseldorf): Eva Geschke (partner); counsel: Alexander Wiese

For Accord (case ID: I-2 U 43/23)
Pinsent Masons (Munich): Marc Holtorf (partner); legal director: Julia Traumann
Hoffmann Eitle (Munich): Joachim Renken, Boris Tchitchanov (both partners and patent attorneys)

For Glenmark (case ID: 1-2 U 49/23)
Taylor Wessing (Düsseldorf): Alexander Rubusch, Roland Küppers (both partners); associate: Eugen Reismann
Dompatent (Cologne): Eva Bock, Anke Krebs (both partners and patent attorney)

Cordula Schumacher

For Zentiva (case ID: 1-2 U 42/23)
Arnold Ruess (Düsseldorf): Cordula Schumacher (partner); accociates: Lisa Rieth, Marius Klötzer
df-mp (Munich): Elisabeth Greiner (partner); associate: Holger Schimmel (both patent attorneys)

Düsseldorf Higher Regional Court, 2nd Civil Senate
Thomas Kühnen (presiding judge)