Sanofi prevents Mylan marketing insulin pen

Sanofi sells an injection pen containing the drug insulin glargine under the brand name Lantus, widely used for treating diabetes. Mylan has now developed its own insulin pen, a biosimilar called Semglee and already approved for the European market. Sanofi, however, sees this as a threat to its patent.

Protection for the injection pen runs until 2029. Patent protection expired for the active ingredient glargine in 2015. In principle, Mylan could sell the biosimilar separately. However, only the drug and injection pen combination was issused with market approval.

At the beginning of July 2019, the Higher Regional Court Düsseldorf confirmed the first instance decision and dismissed Mylan’s appeal (case ID I 2U 81/18). Further infringement proceedings are currently pending in France, Poland and Italy.

At the same time, an opposition appeal against patent EP 2 346 552 is still pending at the European Patent Office (case ID T0629/16). The oral hearing is scheduled for 9 October 2019.

Parisian proceedings

In parallel to the German proceedings, there are also cases pending in France. The Tribunal de Grande Instance granted a ‘saisie-contrefaçon.’ This procedure is a means of obtaining evidence of an infringement of intellectual property rights by sending an agent to examine and report on the products in question, or even to physically seize them.

Bernhard Arnold

A team from Parisian law firm Gide Loyrette Nouel, around partner Jean-Hyacinthe de Mitry, is advising Sanofi in this instance. Arnold Ruess recommended the firm for the case. A further case is also pending in Australia. Here, Jones Day represents Sanofi. Minter Ellison represents the Mylan subsidiary, Alphapharm.

Teamwork wins

For the first time, Arnold Ruess advised Sanofi in Germany and recommended partner Bernhard Arnold for the case. The company has relied on Hoffmann Eitle partner Niels Hölder for litigation in Germany for years, for example in the dispute with US company Amgen over compulsory licences. Hölder  was assisted by patent law firm Zwicker Schnappauf & Partner, another long-time advisor to Sanofi.

In the current case, the team advising Sanofi was supported by Michael Dahmen from Keil & Schaafhausen, a patent attorney experienced in medical technology. Market information provided all advisor names.

For Sanofi:
Arnold Ruess (Düsseldorf): Bernhard Arnold (lead), Dörthe Minde, Loni Bredies, Jan Wergin
Keil & Schaafhausen (Frankfurt): Michael Dahmen (patent attorney)
Zwicker Schnappauf & Partner (Munich): Christian Schmidt (patent attorney)

For Mylan:
Taylor Wessing (Munich): Christoph de Coster (lead), Jan Rektorschek
df-mp Dörries, Frank-Molnia & Pohlman (Munich): David Molnia (patent attorney)

Regional Court Düsseldorf, 4b Civil Chamber
Daniel Voß (presiding judge)
Berenice Thom, Felix Terlinden (judges)

Further cases between Sanofi and Mylan

EPO: Opposition filed in March 2016.

France: Tribunal de Grande Instance, Paris (RG-Nr. 18/07140): Saisie Contrefaçon issued

Australia: Federal Court of Australia (NSD 1502/2018): Application for preliminary injunction, oral hearing on 2 November 2018; no ruling yet published