Biosimilars

Sanofi prevents Mylan marketing insulin pen

Düsseldorf Regional Court has granted French pharmaceutical company Sanofi’s request for a preliminary injunction in the dispute with generics manufacturer Mylan over a syringe for self-administering insulin (case ID: 4b O 66/18). The US defendant may not sell its competing product Semglee on the German market, with the plaintiff considering that Sanofi’s European patent EP 2 346 552 has been infringed.

5 December 2018 by Konstanze Richter

© Olexandr/Adobe Stock

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.

While patent protection for the active ingredient glargine expired in 2015, the injection pen itself is protected until 2029. In principle, Mylan could sell the biosimilar separately, but market approval was only issued for the drug in combination with the injection pen.

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. The firm was recommended for the case by Arnold Ruess. A further case is also pending in Australia, in which the company is represented by Jones Day. The Mylan subsidiary Alphapharm is represented by Minter Ellison.

Teamwork wins

For the first time Arnold Ruess was seen advising Sanofi in Germany, with partner Bernhard Arnold recommended for the case. The company has relied on Hoffmann Eitle partner Nils 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. All advisor names were gained through market information.

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 & Pohlmann (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