Amlodipine / Valsartan: Controlling blood pressure while assessing obviousness

Case No. S2018_002 | Decision of 07 June 2018 | ‘Abweisung vorsorgliche Massnahme; Fachrichtervotum im parallelen Nichtigkeitsverfahren kein Grund für die Abänderung einer Massnahme; fehlende relative Dringlichkeit’

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the defendant.

The patent in suit is EP 2 322 174 B1; see EPO Register and Swissreg for further details. It relates to a fixed dose combined unit dose form of two active ingredients for effective control of blood pressure, i.e. amlodipine and valsartan. The former is a dihydropyridine calcium-channel blocker, the latter is an angiotensin II antagonist.

Déjà-vu, you think? Indeed!

A first request for interim injunctive relief had been dismissed with decision of June 1, 2017; see S2017_001. At that time, the claimed subject-matter had been held obvious over Corea in further view of the skilled person’s knowledge. Separately, nullity proceedings had been pending at that time — and they are still pending now; O2016_006. The main hearing is scheduled for August 21, 2018; see here.

What has changed since then is that the patent has been maintained by an Opposition Division of the EPO in first instance at the end of a hearing on December 6-7, 2017. The reasoned decision has been issued on February 8, 2018; see here. Appeal proceedings are still pending at the EPO.

Wind of change?

In the aftermath of the EPO’s first instance decision, the wind has somewhat changed: While the Düsseldorf Regional Court had initially dismissed the request for injunctive relief (decision 4c O 6/17 of April 10, 2017, the Higher Regional Court overturned the decision of the Regional Court and granted interim injunctive relief (decision I - 2 U 18/17 of December 14, 2017), in consideration of the decision of the EPO’s OD. But it is not only that the wind has changed in Düsseldorf from the first to the second instance. Even the judge-rapporteur in both the first summary proceedings and the nullity proceedings at the FPC has changed his mind and gave an expert opinion in parallel nullity proceedings that the claimed subject-matter was non-obvious. The prior art and the arguments on file are still essentially the same, and it remains to be seen how the panel of five judges will actually decide.4.3

In view of the above, Novartis again requested interim injunctive relief. The FPC noted that a second request for interim injunctive relief is possible in general, but only when the circumstances have changed. And even though this is the case here in view of the parallel decisions elsewhere, the FPC still denied the request. It did so because the facts (i.e. the relevant prior art documents) have not changed, but rather only the legal assessment thereof; ¶4.3.

Vorliegend ist […] zu berücksichtigen, dass die von den Klägerinnen genannten Parallelurteile nicht neuen Stand der Technik behandeln, sondern den schon im ersten Massnahmeverfahren bekannten Stand der Technik anders würdigen.

The FPC held that assessment of validity of the patent in suit apparently is a borderline case which requires in-depth assessment in main proceedings; ¶4.4.

Vielmehr bedarf die Klärung der Frage der Rechtsbeständigkeit des Klagepatents einer eingehenderen Prüfung im ordentlichen Verfahren.

Moreover, the FPC held that there was no urgency anymore. A decision in the present summary proceedings could not be expected substantially earlier than a decision in parallel nullity proceedings, if earlier at all.


Further, the FPC noted that Novartis could have well initiated main proceedings for infringement at any time since defendant’s product launch in January 2017, and now has to live with the consequences of not having done so.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2018_002 | Decision of 07 June 2018 | ‘Abweisung vorsorgliche Massnahme; Fachrichtervotum im parallelen Nichtigkeitsverfahren kein Grund für die Abänderung einer Massnahme; fehlende relative Dringlichkeit’

  1. Novartis Pharma AG
  2. Novartis Pharma Schweiz AG

./.

Mepha Pharma AG

Panel of Judges:

  • Dr. Daniel KRAUS
  • Dr. Tobias BREMI
  • Prisca VON BALLMOOS

Reporting Judge:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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PATENT IN SUIT

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