Drospirenone, again — but this time produced in a surprisingly different way

Case No. S2015_002 ¦ Decision of 20 August 2015 ¦ “Abweisung vorsorgliche Massnahmen; Verletzungshandlung nicht glaubhaft gemacht”

This is yet another case relating to the contraceptive drospirenone. See this Blog here, here and here for details on an earlier case (with different parties) and relevant background information.

Drospirenone
Drospirenone

The plaintiff again sought for preliminary injunctive relief and invoked two European patents: EP 1 149 840 B2, which had already been at stake in the earlier case; and  — for the first time — the only recently granted EP 2 168 974 B1 (a divisional of EP’840). Both patents relate to methods for the production of drospirenone (DRSP), a compound used in contraceptives (birth control pills).

Plaintiff (1) is the registered proprietor of the Swiss part of EP’840, i.e. Bayer Pharma AG. Plaintiff (2) is the registered proprietor of the Swiss part of EP’974, i.e. Bayer Intellectual Property GmbH.

The independent claims of EP’840 and EP’974 only differ slightly. The single claim of EP’974 reads as follows:

Process for preparing drospirenone from [well, let’s call it ‘precursor A’] in isolated form by water elimination.

On the other hand, the single claim of EP’840 reads as follows:

Process for preparing drospirenone by water elimination from [precursor A] through addition of p-toluenesulphonic acid to [precursor A].

EP’974 thus requires [precursor A] in isolated form, but is not limited to a certain catalyst for water elimination. To the contrary, EP’840 explicitly recites p-toluenesulphonic acid as the catalyst, but does not require the isolated form of [precursor A].

From the details given in the decision, it is evident that the defendant is Spirig HealthCare AG. The three products concerned are Sue 20, Sue 30 and Suzanne:

Reasoning presented by the plaintiffs as to why these products are infringing both EP’840 and EP’974 was an intricate issue: From a LOT number imprinted on the blisters, it was concluded that the Spanish company Laboratorios Léon Farma S.A. was the manufacturer. In turn, this company allegedly obtained drospirenone inter alia from the Italian company Industriale Chimica s.r.l.; both companies are parties in opposition proceedings re EP’974 at the EPO (see EPO register). Moreover, it has been alleged based on information from parallel proceedings in Germany, Spain and Switzerland that the method for manufacturing the drospirenone used by Industriale Chimica s.r.l. was as follows:

Allegedly used method of manufacturing drospirenone
Allegedly used method of manufacturing drospirenone

This was a non-starter. The defendant denied that the method outlined above had been used. Rather, defendant argued that a one-step palladium-catalyzed synthesis was used:

Palladium-catalyzed one-step synthesis of drospirenone
Palladium-catalyzed one-step synthesis of drospirenone

The defendant even provided exhaustive evidence in support of this synthesis being used, i.e. purchase orders, declarations of personnel of both Laboratorios Léon Farma S.A. and Industriale Chimica s.r.l., as well as an excerpt from the “Drug Master File Drospirenone D., Module 999: Description of manufacturing process and process controls”.

Plaintiffs did not allege that the one-step palladium-catalyzed synthesis would infringe EP’840 and EP’974. Rather, only the actual use of the palladium-catalyzed synthesis was disputed. Plaintiffs argued that defendant’s documentation had not been approved by an independent third party. Moreover, the palladium-catalyzed synthesis would be too expensive and more difficult to handle, for security reasons.

The FPC held that the documentation provided by the defendant in support of the palladium-catalyzed reaction was credible. Plaintiffs’ suspicion of false testimony was held unfounded, as well as the arguments with respect to the feasibility of the palladium-catalyzed process for cost and security reasons.

Consequently, the plaintiffs have failed to furnish prima facie evidence for a patent infringement. To the contrary, defendant’s documentation was held to credibly establish a case of non-infringement, by prima facie evidence. The plaintiffs’ request for interim injunctive relief was thus dismissed.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. S2015_002 ¦ Decision of 20 August 2015 ¦ “Abweisung vorsorgliche Massnahmen; Verletzungshandlung nicht glaubhaft gemacht”

(1) Bayer Pharma AG
(2) Bayer Intellectual Property GmbH
./.
Spirig HealthCare AG

Subject(s):

  • Infringement
  • Interim injunctions
  • Drospirenon II

Board of Judges:

  • Dr. Dieter BRÄNDLE (President)
  • Dr. Tobias BREMI (Reporting Judge)
  • Dr. Erich WÄCKERLIN

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Gregor KÖNIG (KSVR), assisting in patent matters

Representative(s) of Defendant:

— DECISION IN FULL —

Download (PDF, 214KB)

— BE ON THE KNOW —

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