In one of Europe's biggest pharmaceutical disputes, Novartis has won an important victory against the generic drug industry over MS drug fingolimod. By means of a preliminary injunction, the Düsseldorf Regional Court has prohibited eight companies from selling the drug in Germany. Now all eyes are on the opposition proceedings at the European Patent Office, with 16 companies having filed oppositions against the second medical use patent.
31 January 2023 by Mathieu Klos
In a dispute spanning numerous European countries, Novartis is fighting to enforce EP 29 59 894. Earlier in January, the Regional Court Düsseldorf ruled that AbZ Pharma, Accord, Glenmark, Heumann, Ratiopharm, Viatris, Vivanta and Zentiva may no longer sell their generic drugs which cover the second medical use of fingolimod in Germany (case IDs: 4a O 79 to 86/22).
Novartis’ second medical use patent EP 894 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.
The German judges also ruled that the generics manufacturers must hand over all corresponding products to Novartis. However, the eight companies can now appeal to Düsseldorf Higher Regional Court. Novartis has not yet initiated proceedings on the merits against the companies concerning the patent.
Multiple generic drug companies already selling, and now withdrawing, their fingolimod products from the market is unusual. However, it can be attributed to the granting process for the second medical use patent.
The extended market exclusivity for the original drug Gilenya ended in March 2022. At that time, the EPO had not officially granted EP 894 since its Examining Division refused to grant the underlying EP 894 application as a patent. Then in February 2022, the EPO’s Technical Board of Appeal gave the green light, but it took the EPO until October 2022 to make this step official.
Consequently, numerous generics manufacturers in Europe took advantage of the gap between the end of market exclusivity and the official granting of the second medical use patent to sell their own copycat products in various markets.
Last year, Novartis started taking action against generic drug companies, including Mylan, Zentiva and Biogaran. The company filed suits in multiple countries, including the UK, the Netherlands, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal and Switzerland.
Then, last September, Novartis requested a PI against Ratiopharm, AbZ Pharma and Puren Pharma at the Regional Court Düsseldorf (case IDs: 4a O 27/22, 4a O 28/22 and 4a O 44/22). 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.
Five months later, and with EP 894 now officially registered, Novartis has had more success. The generic drug companies will likely have difficulty appealing successfully against the Regional Court’s preliminary injunction, as Düsseldorf Higher Regional Court very rarely overturns these for existing patents. JUVE Patent cannot confirm whether the generics manufacturers intend to appeal.
However, the generics companies are now attacking the patent itself, with 15 companies and Munich law firm Dr. Schön Neymeyr & Partner as strawman filing oppositions with the EPO against the granting of EP 894. The EPO has not yet scheduled an oral hearing.
Among the opponents are parties from the Düsseldorf case, namely Accord, Glenmark, Heumann, Vivanta and Zentiva. Parent company Teva represents AbZ Pharma and Ratiopharm in the opposition proceedings, while Viatris is not directly present. However, the latter company has apparently filed an objection through its UK subsidiary Generics (UK) Ltd.
A-med, Bausch Health, Biogaran, Elpen Pharmaceuticals, Genepharm, Pharmathen, Rapharm and Stada comprise the remaining opponents.
Like in the Dutch proceedings, Novartis relied on its go-to law firm Freshfields Bruckhaus Deringer in the German dispute. 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 also rely on their regular advisors. 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. In the EPO opposition against EP 894, Teva relies on UK patent attorney firm D Young & Co.
In the UK, Teva once again turned to regular advisors Pinsent Masons. The firm is strongly positioned in Europe with the generics industry. It also represented Accord in the German proceedings and Zentiva in France.
In the September proceedings, Hamburg-based IP boutique Harmsen Utescher represented Puren Pharma, together with patent attorneys from Hamm & Wittkopp.
Indian life sciences company Aurobindo owns Puren Pharma, which was not involved in the latest proceedings. Instead, Harmsen Utescher and Hamm & Wittkopp represented two other generics companies with strong Indian ties: Heumann Pharma, which belongs to Indian company Torent Pharma, and Vivanta, which is part of the MSN Group from India.
Hamm & Wittkopp’s patent attorneys are well-known for their litigation work on the generics side. The firm is also representing Heumann and Vivanta, as well as Stada, in the EPO opposition.
For many years, Wildanger partner Eva Geschke has litigated for Mylan and Viatris. UK patent attorney firm Gill Jennings & Every provides support, also filing an opposition against EP 894 on behalf of the Viatris subsidiary Generics (UK) Ltd. Viatris and Mylan respectively rely on BarentsKrans in the Netherlands, and on Schertenlieb Advocats in France.
Arnold Ruess partner Cordula Schumacher and df-mp partner Elisabeth Greiner frequently work for Zentiva. Greiner is also responsible for the EPO appeal. In the UK, Zentiva relies on Mishcon de Reya. Taylor Wessing is present for Glenmark in the UK as well as in the German proceedings, while UK patent attorney firm Venner Shipley represents the Indian company in the EPO opposition.
With 16 opponents, the proceedings against EP 894 are currently one of the largest in the EPO. In addition to the generics manufacturers now affected by the German PI, well-known patent attorney firms are representing most of the other opponents.
For example, df-mp represents A-med, Maiwald represents Bausch Health, Casalonga advises Biogaran, and Kilburn & Strode is acting for Pharmathen. Rapharm has instructed Becker Kurig & Partner, while Elpen Pharmaceuticals and Genepharm have retained Munich-based sole practitioner Dimitrios Roukounas.
Freshfields Bruckhaus Deringer (Düsseldorf/Munich): Frank-Erich Hufnagel (partner); associates: Kilian Seidel, Fabian Schubach, Elena Henneke
Ter Meer Steinmeister & Partner (Munich): Bernd Aechter (partner); associate: Markus Ackermann (both patent attorneys)
For Ratiopharm and AbZ Pharma (case ID 4a O 80 and 81/22)
Bird & Bird (Düsseldorf/Munich/Hamburg): Oliver Jüngst, Michael Alt (patent attorney, both partner); associates: Lucas Brons, Anne Halbach (patent attorney)
For Heumann Pharma and Vivanta (case ID 4a O 82 and 86/22)
Harmsen Utescher (Hamburg): Karsten Königer (partner); associate: Marisa Bruckmann
Hamm & Wittkopp (Hamburg): Alexander Wittkopp (partner), Heike Lackmann (both patent attorneys)
For Viatris (case ID 4a O 79/22)
Wildanger Kehrwald Graf v. Schwerin & Partner (Düsseldorf): Eva Geschke (partner); counsel: Alexander Wiese
For Accord (case ID 4a O 83/22)
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 4a O 84/22)
Taylor Wessing (Düsseldorf): Alexander Rubusch, Roland Küppers (both partners); associate: Eugen Reismann
Dompatent (Cologne): Eva Bock, Anke Krebs (both partners and patent attorney)
For Zentiva (case ID 4a O 85/22)
Arnold Ruess (Düsseldorf): Cordula Schumacher (partner); accociates: Lisa Rieth, Marius Klötzer
df-mp (Munich): Elisabeth Greiner (partner); associate: Holger Schimmel (both patent attorneys)
Düsseldorf Regional Court, 4a Civil Chamber
Bérénice Thom (presiding judge), judge Hengemühle, judge Hammans