Bayer and Elanco may not sell the veterinary drug BayCox Iron in injection form in Germany. In mid-July Düsseldorf Regional Court ruled the product infringes a patent held by Ceva Santé Animale. Now Ceva has enforced the ruling, thus increasing the pressure on Bayer and Elanco.
20 August 2021 by Mathieu Klos
The French animal health company Ceva Santé Animale is currently enforcing a judgment from Düsseldorf Regional Court against Bayer and Elanco. The court had ruled in mid-July that Bayer and Elanco infringed Ceva’s EP 2928454 B1 with the veterinary product BayCox Iron, and ordered a halt to sales (case ID: 4b O 40/20). Ceva did not take long to enforce the ruling, although Bayer and Elanco have already appealed the decision.
EP 2928454 B1 was not granted until early 2020. It protects a triazine compound to combat protozoan diseases in animals. Other patents also protect similar combinations of active ingredients. However, these are usually administered orally to animals and not as an injection into the neck or behind the ear of the animals, as protected by the Ceva patent.
Ceva regarded it as infringed because BayCox Iron uses a combination of an iron compound with toltrazuril. This has now been confirmed by the Düsseldorf judges. However, the sales stop for BayCox Iron refers only to the administration via injection and with a certain dosage in suspension form.
In the proceedings, Bayer and Elanco had invoked a private right of prior use and referred to the development of the product, which started seven years before approval.
The judges did not agree, nor did they grant the request for a stay of proceedings. Bayer and Elanco had both filed an opposition against the granting of the patent at the European Patent Office and this is still pending. Elanco became embroiled in the dispute after it acquired Bayer Animal Health in August 2020.
The global dispute between Bayer and Ceva started a year earlier after both companies launched products in quick succession to treat anaemia and infections, particularly in piglets. Bayer launched BayCox Iron first. Ceva’s Forceris entered the market a little later.
In 2019, Bayer accused Ceva of infringing European patent EP 21 64 496 across several European countries. As a result, proceedings commenced in 16 European jurisdictions.
However, over the past few years courts have handed down various national decisions, with no consistent approach. Bayer enforced preliminary injunctions in Belgium, Denmark, Greece, Hungary, Spain, Sweden and Germany. Other European courts denied Bayer a preliminary injunction against Ceva, such as France, the Netherlands, Finland, Romania, Bulgaria and Portugal.
In Germany, Bayer successfully obtained a preliminary injunction before the Regional Court Hamburg. But after an unfavourable appeal hearing at the Higher Regional Court at the end of August 2019, Bayer withdrew the claim.
A turning point in the dispute was the decision by the Boards of Appeal at the European Patent Office revoking Bayer’s EP 21 64 496 in September 2020. Now, the markets where Bayer had enforced injunctions may go into damages proceedings.
Following this decision, Ceva went on the offensive and sued Bayer over its own patent at the Regional Court Düsseldorf. Shortly after, Ceva extended the suit to include Elanco.
By enforcing the ruling, Ceva is now increasing the pressure on Bayer and Elanco to settle the dispute. However, it is still possible that the Ceva patent will face a similar fate as Bayer’s at the EPO.
Düsseldorf boutique Rospatt Osten Pross already led the appeal against Bayer’s preliminary injunction claim before Hamburg Higher Regional Court. Partner Thomas Musmann, with the technical support of the Amsterdam-based patent attorneys of Hoyng ROKH Monegier, then also counter-attacked in the infringement proceedings in Düsseldorf.
International boutique Hoyng ROKH Monegier has acted for Ceva since the beginning of the dispute in various jurisdictions, led by Paris managing partner Benoît Strowel. The relationship between Hoyng ROKH and Ceva is a relatively recent one. Strowel gained Ceva as a client in 2017.
Initially, Hoyng ROKH Monegier’s German practice also represented Ceva in Bayer’s German lawsuits. However, after the first round of PI proceedings was unsuccessful, the French group switched to Rospatt Osten Pross.
Dutch Hoyng ROKH Monegier lawyer Peter Van Schijndel and patent attorney Jeroen den Hartog represent CEVA Santé Animale in the Netherlands. The firm is also leading the defence against Bayer’s and Elanco’s attacks on EP 2928454 B1.
Hoyng ROKH Monegier had already been active for CEVA Santé Animale in the opposition proceedings against Bayer’s EP 21 64 496. Here the firm worked alongside German patent attorney firm df-mp Dörries Frank-Molnia & Pohlman, which opposed the patent independently for Ceva subsidiary Ceva Animal Health.
Allen & Overy acted for Bayer right from the beginning of the dispute. The international law firm led the cases in Germany, France, and the Netherlands. Furthermore, the firm co-ordinated or led parallel proceedings in various other jurisdictions. Munich Allen & Overy partner Joachim Feldges led the case for Bayer, alongside senior consultant Stephan van der Vlugt who is a former Bayer in-house counsel. The firm also represented Elanco.
However, in Germany the litigation team relied on patent attorney Dorothea von Renesse from Düsseldorf outfit König Szynka Tilmann von Renesse. The firm has an established relationship with Bayer. It also represents Bayer in the opposition proceedings at the EPO against Ceva’s patent. UK firm Potter Clarkson represents Elanco.
For CEVA Santé Animale
Rospatt Osten Pross (Düsseldorf): Thomas Musmann
Allen & Overy (Munich): Joachim Feldges (lead); senior consultant: Stephan van der Vlugt; associates: Antje Brambrink, Eda Zhuleku (life science regulatory),
König Szynka Tilmann von Renesse (Düsseldorf): Dorothea von Renesse (patent attorney)
Regional Court Düsseldorf, 4b Chamber
Daniel Voß (presiding judge), Antje Gruneberg, Tobias Schmitz