Damages

Mundipharma and Allen & Overy prevail after Glenmark damages claim

In a dispute over high-selling painkiller Targin, the Düsseldorf Regional Court has rejected Glenmark's claim for damages against Mundipharma. It decided that the latter company was entitled to rely on the validity of its patents, despite the then-pending oppositions at the European Patent Office.

20 February 2024 by Konstanze Richter

Düsseldorf Regional Court has ruled on a damages dispute between Glenmark and Mundipharma, concerning the latter's painkiller, Targin. ©PhotoAlto/ADOBE STOCK

Damages relating to injunctions have recently attracted attention with, for example, the CJEU publishing a landmark judgment on the topic. Today there were further developments on the issue of damages as the Düsseldorf Regional Court rejected Glenmark’s claims against Mundipharma.

At the centre of the dispute is the latter’s painkiller, Targin. It is based on a combination of two active ingredients, oxycodone and naloxone. The drug has long been one of the top-selling drugs of the pharmaceutical innovator, which is based in Frankfurt.

As such, generics manufacturers were keen to launch their generic products after Targin’s market exclusivity expired at the end of May 2017. Numerous companies applied for marketing authorisations for Germany, including Glenmark.

First PI against generics

However, although Mundipharma’s important patent EP 1 492 505 had expired in 2017, further property rights existed for the combination through its divisional patents EP 2 425 825, EP 2 425 824 and EP 2 425 821. Mundipharma took action against various generics manufacturers on the basis of some patents.

With reference to EP 825, Mundipharma applied to the Munich Regional Court for a preliminary injunction against Hexal, 1A Pharma, Krka and TAD Pharma in summer 2017 (case ID: 21 O 8130/17). The court granted the injunction.

Cease and desist, with a catch

Glenmark had also informed Mundipharma of the marketing authorisation for its generic product, before the latter’s market exclusivity expired. The patent holder responded with a warning letter, whereupon the generics manufacturer issued a cease-and-desist declaration.

In this declaration, Glenmark undertook not to sell its product on the German market until the patents expired. However, the UK-based company reserved the right to claim damages should the EPO revoke the patents.

At the same time, numerous generics manufacturers including Glenmark had filed oppositions against the patents at the EPO. At the end of 2018, the EPO Opposition Division revoked EP 825 due to inadmissible extension. Then, in autumn 2019, the EPO revoked EP 824 and EP 821 on the same grounds.

Recent decisions in contrast

Glenmark then claimed damages from Mundipharma, as the generics manufacturer was unable to launch its products on the German market after market exclusivity for Targin had expired.

The plaintiff referred, among other things, to the 2023 decision of Düsseldorf Higher Regional Court in the case of Teva against Mylan. In one of his final decisions before retiring, judge Thomas Kühnen had awarded Mylan damages for lost profits due to the injunction, as well as the destruction of goods.

Christopher Weber, Kather Augenstein

Christopher Weber

However, the Düsseldorf Regional Court judges did not follow this reasoning, considering the case to be different. Mundipharma was entitled to rely on the validity of its patents, according to the court. The judges reasoned that this was even truer, since the Munich Regional Court had already issued two preliminary injunctions in favour of the patent holder at the time.

For this reason, the 4c Chamber did not consider Mundipharma to be at fault for the damages suffered by Glenmark. It has now dismissed the claim for damages (case ID: 4c O 6/23).

Changing counsel

Plaintiff company Glenmark relied on a team from Kather Augenstein. The IP boutique from Düsseldorf is particularly known for litigation across a broad technical spectrum, especially mobile communications, automotive and medical devices.

But the generics manufacturer does not instruct the law firm exclusively. For example, Taylor Wessing represented Glenmark in the dispute with Novartis over fingolimod. A team led by Munich partner Christoph de Coster also represented Hexal and 1A Pharma in the PI proceedings against Mundipharma in Munich.

Stephan Neuhaus

In the 2018 Munich dispute, the Düsseldorf lawyers from Rospatt Osten Pross represented Mundipharma. The company retained the law firm after a pitch in 2016.

Stephan Neuhaus is now representing Mundipharma in the damages claim. Neuhaus moved from Hogan Lovells to Allen & Overy in spring 2021. The contact came about via the UK corporate practice of Allen & Overy, which has had close relationships to Mundipharma for years.

For Glenmark
Kather Augenstein (Düsseldorf): Christopher Weber (partner); associates: Marco Berlage, Carsten Plaga

For Mundipharma
Allen & Overy (Düsseldorf): Stephan Neuhaus (partner); associate: Jan-Willem Prügel

Düsseldorf Regional Court, Düsseldorf
Sabine Klepsch (presiding judge), Sabine Wimmers, Stephan Janich