Kühnen grapples with Mylan dura vs. Teva damages claim on final day of hearings

Mylan dura is claiming €15 million in damages from competitor Teva in Germany. The case involves a preliminary injunction enforced for 15 months for a patent that the European Patent Office has since declared invalid.EP 2 949 335protected the active ingredient glatiramer acetate, which is used in the MS drug Copaxone. The patent was owned by Yeda, which exclusively licensed it to pharmaceutical company Teva.

Doing it Kühnen’s way

In the first instance, the court found in favour of Mylan dura. However, Düsseldorf Regional Court had reduced the claims for damages so the pharmaceutical company, like Teva, appealed the result. As a result, Thomas Kühnen had to deal with the case again on his last day of hearings before retirement.

Thomas Kühnen

Kühnen has been presiding judge of Düsseldorf Higher Regional Court’s 2nd Civil Senate, which specialises in patent cases, since 2008. In 2017, he topped the JUVE ranking as Germany’s best-known patent judge – in fact, lawyers reverently refer to the senate he leads as “the real Federal Court of Justice.”

Even before he took up the important position at Düsseldorf Higher Regional Court, Kühnen worked intensively on patent case law. For seven years before his move to higher court, he headed the renowned patent litigation chamber 4b at Düsseldorf Regional Court.

Copaxone dispute

Since 2017, Mylan dura and Teva have been fighting over patents for the MS drug before various European courts and at the EPO. Teva sold its drug under the name Copaxone, with a dosage of 40 mg/ml. In 2017, Mylan launched its generic product Clift with the same dosage in the US and Europe.

Teva saw Clift as an infringement of EP 335 and applied for a preliminary injunction against Mylan in Munich. However, both the first and second instance rejected a PI due to doubts about validity.

After an EPO opposition division upheld the patent, Teva again applied for a preliminary injunction at the Regional Court Düsseldorf. In June 2019, the first instance issued a sales ban for Clift in Germany.

From Mylan to Viatris

Teva then enforced the PI, with Mylan appealing the decision in return. In September 2019, the Higher Regional Court’s 2nd Senate – meaning Thomas Kühnen himself – upheld the first-instance decision.

The Boards of Appeal, however, destroyed the patent in parallel opposition proceedings inSeptember 2020, immediately after which Mylan sued Teva for damages for lost income due to the sales ban.

The dispute between the two pharmaceutical companies is complex, in part because Mylan dura restructured under the ‘Viatris’ umbrella during the phase in which Teva enforced the PI.

The key question in the proceedings is therefore whether, and how, this restructuring affects the damages claim.

No negligence at play

The question of fault is also at issue. Is Teva liable for having executed the PI even though the legal status of the patent was still under review by the EPO Boards of Appeal? It is true that a patent holder that enforces a judgment bears a certain risk, so long as the fate of an IP right has not yet been clearly established, said Kühnen. However, he said, this is not negligent. In addition, Mylan also has a duty to keep the enforcement damage as low as possible by taking appropriate measures.

On the other hand, Mylan’s representatives argued that Teva had vigorously enforced the judgment from the beginning and only ended this with the final revocation decision of the Boards of Appeal.

This, they argued, did not allow Mylan to limit the damage through further appeals.

Risking infringement

Teva’s representatives countered that Mylan had entered the German market with its product in 2017, although an EPO opposition division had already confirmed the patent’s validity at that time. As a result, Mylan had taken the risk of patent infringement.

Thomas Kühnen announced a ruling in the dispute for 12 October. As in previous proceedings, the parties relied on their long-standing representatives.