Maiwald and betapharm nullify Novartis fingolimod patent in Munich

Novartis is once again going head-to-head with its competitors in Germany to protect a version of multiple sclerosis drug fingolimod. This time, after a multi-party action in Düsseldorf last year, German pharmaceutical company betapharm Arzneimittel is the defendant in Munich.

At the end of June, the German Federal Patent Court declared a Novartis patent covering Gilenya invalid in its entirety for lack of inventive step. However, the parties also await the result of an appeal to the Higher Regional Court Munich, which betapharm had lodged following a first-instance preliminary injunction against its generic fingolimod product.

Betapharm squares up

Betapharm is headquartered in Augsburg, in the Bavarian region of Germany, and owned by British pharmaceutical company, Dr. Reddy’s. On 22 April 2022, Novartis filed an application for a preliminary injunction based on formulation patent EP 3 143 990 B1 against betapharm at the Munich Regional Court (case ID: 7 O 4716/22). The patent protects a pharmaceutical composition for oral administration comprising the active ingredient fingolimod, which healthcare professionals use to treat patients with relapsing-remitting multiple sclerosis.

In filing the PI, Novartis aimed to prevent betapharm from distributing and manufacturing its generic product named “Fingolimod beta 0.5 mg hard capsule” and to protect Gilenya. In May 2022, judges at the 7th Civil Chamber of the Regional Court Munich issued the PI ex parte and set the dispute at €3 million. However, in June 2022, betapharm filed an unsuccessful objection, with the court confirming the PI in September 2022. Betapharm then appealed to the Munich Higher Regional Court in October 2022 (case ID: 6 U 6200/22).

Novartis stumbles at second instance

Simultaneously, in May 2022, betapharm filed a nullity action against EP 990 B1 at the German Federal Patent Court in Munich (case ID: 3 Ni 13/22). In November, the court expressed doubts about the patent’s validity. Then, in March 2023, parallel infringement appeal proceedings lifted the enforceability of the first instance PI, subject to betapharm providing a security deposit. Later that year, in June, the Federal Patent Court declared EP 990 invalid in its entirety for lack of inventive step, increasing the disputed value from €4.5 million to €30 million.

In parallel PI appeal proceedings, the Munich Higher Regional Court set the date for oral proceedings for 27 July 2023. However, the Federal Patent Court has now declared the patent null and void. The Munich court also stayed the enforcement of the PI, pending the appeal’s outcome.

Germany-wide approach

In 2022, Novartis started taking action against generic drug companies. The company filed suits in multiple countries, including the UK, the Netherlands, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal and Switzerland.

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. In October 2022, the EPO granted EP 2 959 894.

In January 2023, at the Düsseldorf Regional Court, Novartis achieved PIs against eight generic drug companies. Earlier that same month, the Regional Court Düsseldorf ruled that AbZ Pharma, Accord, Glenmark, Heumann, Ratiopharm, Viatris, Vivanta and Zentiva may no longer sell their generic drugs that cover the second medical use of fingolimod in Germany (case IDs: 4a O 79 to 86/22).

At proceedings in Düsseldorf , the judges also ruled that the generics manufacturers must hand over all corresponding products to Novartis. However, the eight companies appealed to Düsseldorf Higher Regional Court, with just one declining to do so. Novartis has not yet initiated proceedings on the merits against the companies concerning the patent. The court will hear the appeal on 25 July 2023.

MS drug on the market

Nina Bayerl

The extended market exclusivity for the original drug Gilenya ended in March 2022. At that time, the EPO had not officially granted EP 894. 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.

The generics companies are now attacking the patent, with 15 companies and Munich law firm Dr. Schön Neymeyr & Partner as strawman filing oppositions with the EPO. The EPO has not yet scheduled an oral hearing.

Pharma expertise up front

Like in the Dutch proceedings, Novartis relies 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. Both firms worked together in the nullity and PI proceedings.

Marco Stief

Freshfields 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.

A mixed team from German IP firm Maiwald, led by partner Marco Stief, represents betapharm. In 2022, the firm also represented betapharm as one of the defendants in a dispute against Bayer over Nexavar.

For Novartis (PI and nullity proceedings)
Freshfields Bruckhaus Deringer (Düsseldorf): Nina Bayerl, Frank-Erich Hufnagel (partners); associate: Fabian Schubach
Ter Meer Steinmeister & Partner (Munich): Bernd Aechter, Ingo Ortel (partners, both patent attorneys);

For betapharm (PU and nullity proceedings)
Maiwald (Munich): Marco Stief, Christian Meyer (patent litigators); Andreas Ledl, Annelie Wünsche, Dirk Bühler, Andreas Ledl (all patent attorney) (all partners)

German Federal Patent Court (3rd Senate), Munich
Walter Schramm (presiding judge)