No damages for Glenmark in battle over Mundipharma’s Targin

Mundipharma does not have to pay Glenmark damages for the cancelled launch of a generic painkiller. Düsseldorf Higher Regional Court has upheld last year's first-instance decision, rejecting Glenmark's claim in the dispute over Targin.

For years, Frankfurt-based Mundipharma defended market exclusivity for its painkiller Targin against various generic drug manufacturers. The product combines two active ingredients, oxycodone and naloxone. The drug has long been one of the pharmaceutical innovator’s top-selling products.

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

Success in PI

Although Mundipharma’s key patent EP 1 492 505 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 asserted some of these patents against various generics manufacturers.

Based on EP 825, Munich Regional Court granted Mundipharma a preliminary injunction against Hexal, 1A Pharma, Krka and TAD Pharma in summer 2017 (case ID: 21 O 8130/17).

Glenmark had 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. Glenmark agreed not to sell its generic version of the painkiller 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.

By the end of 2019, the EPO had indeed revoked all three patents-in-suit due to inadmissible extension. Subsequently, Glenmark claimed damages from Mundipharma, as the generics manufacturer had been unable to launch its products on the German market after Targin’s market exclusivity expired.

Duty of care maintained

Among other arguments, Glenmark accused Mundipharma of acting negligently with the warning letter. The generics manufacturer argued that a patent holder should not rely on the validity of its patents if this has been challenged.

In their argumentation, the plaintiff also referred 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 an injunction, as well as the destruction of goods.

However, early last year Düsseldorf Regional Court’s 4c Chamber dismissed Glenmark’s damages claim (case ID: 4c O 6/23). The Higher Regional Court Düsseldorf has now confirmed the first instance decision on appeal, equally dismissing the claim for damages.

The panel of judges, consisting of presiding judge Stephan Fricke, judge Michels and judge Lena Gräwe, took the same view. They found that Mundipharma was entitled to rely on the validity of its patents, especially given that the Munich Regional Court had already issued preliminary injunctions in the patent holder’s favour. Accordingly, the originator had not breached its duty of care and had not acted negligently with the warning letter.