Generic version of Faslodex®, with a procedural twist

Case No. S2016_007 ¦ Decision of 10 August 2016 ¦ “Abweisung superprovisorische Massnahme; Interessenabwägung; Pflicht der klagenden Partei, den relevanten Sachverhalt vollständig darzulegen”

Case No. S2016_008 ¦ Decision of 08 August 2016 ¦ “Vorsorgliche Massnahme; Abweisung mangels Aktivlegitimation”

sandoz-logoBoth decisions are anonymised, but the patent in suit clearly is AstraZeneca‘s EP 1 250 138 B2 (see EP Register and Swissreg).

The defendant is Sandoz: They had launched a generic version of AZ’s Faslodex® in Switzerland on 26 July 2016, i.e. FULVESTRANT Sandoz 250 mg/5ml (Swissmedic approval no. 56778).

Corresponding litigation on generic Faslodex® has recently been settled in the U.S. on 12 July 2016 between AZ and Sandoz, but this settlement does obviously not cover Switzerland: The present request for interim injunctive relief has been filed on 03 August 2016.

Fulvestrant
Fulvestrant

EP’138 pertains to a second medical use of fulvestrant, the active ingredient of Faslodex®. Fulvestrant is an estrogen receptor antagonist indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. It has been approved by Swissmedic on 19 March 2004.

Sales figures (worldwide) are significant (according to AZ’s Annual Report 2015; see p. 151):

2012 2013 2014 2015
USD 654m USD 681m USD 720m USD 704m

AZ had requested interim injunctive relief without hearing the defendant beforehand; Art. 265 CPC. That is exactly what a potential defendant aims to prevent with a protective letter (Art. 270 CPC). And, indeed: The defendant had filed a protective letter in anticipation of the case on 15 July 2016. Later on, the defendant had also submitted an interim assessment of the German Federal Patent Court in nullity proceedings on 21 July 2016 (case no. 3Ni17/15(EP); see the German Patent Register), as a supplement to the protective letter already on file. Plaintiff in nullity proceedings in Germany is Hexal AG, a connected undertaking of the defendant in the Novartis group of companies.

AZ argued that the patent in suit had been maintained (in amended form) in opposition / appeal proceedings at the EPO, and that all involved courts held the patent valid and infringed:

  • Rechtsbank Den Daag, decision of 27 July 2016 in case no. C/09/513437 / KG ZA 16-779
  • Higher Regional Court of Dusseldorf, decision of 19 February 2016 in case no. I-2 U 54/15
  • Juzgado Mercantil No 4 of Barcelona, decision of 28 July 2016

Note that all these decisions were issued in summary proceedings. The decision of the Dusseldorf court pertained to Hexal’s product in Germany:

Apparently, the plaintiff did not mention the interim assessment in nullity proceedings at the German Federal Patent Court.

The President was not amused.

First, the President notes that the final decision of the EPO in opposition / appeal proceedings has been rendered ex officio; the only opponent Gedeon Richter Ltd. had withdrawn the opposition before the finally maintained claims had been put on file. Thus, the German Federal Patent Court is actually the first court that has assessed the validity of the patent in adversarial main proceedings and with technically trained judges. Evidently, the interim assessment of the German Federal Patent Court is highly relevant. And the President had no doubt that AZ had the interim assessment at hand. He notes in passing that the assisting patent attorney in the present matter is involved in the nullity case in Germany.

The President expressly holds that it is an abuse of ex-parte proceedings when those facts are not disclosed which the plaintiff knows or should reasonably assume that they could be interpreted to his disadvantage. Credibility of the plaintiff is damaged and sanctions apply when this duty is disregarded:

Es ist ein Missbrauch des superprovisorischen Verfahrens, Tatsachen nicht offenzulegen, von denen die Gesuchstellerin weiss oder annehmen muss, dass sie zu ihren Ungunsten gewertet werden könnten. Die Verletzung dieser Pflicht schadet der Glaubwürdigkeit der Gesuchstellerin und zieht Sanktionen nach sich.

It is not clear at present whether this conduct is sanctionable under Art. 128 CPC. It remains to be seen in the further course of the proceedings who actually was aware of the interim assessment of the German Federal Patent Court, and why it has not been brought to the FPC’s attention. The plaintiff has been ordered to provide this information by 25 August 2016.

The President dismissed the request for ex-parte interim injunctive relief, giving due consideration to the interests of both parties. In view of the foregoing, the President held that AZ is skating on thin ice with respect to validity of the patent in suit. The defendant would have to face severe consequences if the requested ex-parte injunction would be granted (including withdrawal of the already launched product). On the other hand, the President notes that the plaintiff was only concerned about difficulties concerning the calculation of damages.

The plaintiff had requested that the parties be summoned to a hearing within two weeks time if the injunction was not granted ex-parte. Moreover, the reporting judge should provide the interim assessment at the occasion of this hearing. The President notes that lengthy submissions of the parties were to be expected at this stage, and that a hearing does not appear feasible. The President further notes that an interim assessment of the reporting judge in a hearing (either prepared in advance without having heard the defendant or provided ad hoc) is obviously inappropriate. Consequently, the defendant has been invited to reply by 25 August 2016, i.e. within 14 days. That is a typical timeline in summary proceedings. The plaintiff had requested that the time limit shall be non-extendable right from the outset; the President did not see any reason for this.

Now, why are there two decisions?

Proceedings had been initiated jointly by AstraZeneca AB (the patentee) and AstraZeneca AG. The President has separated both cases and continued the patentee’s case as S2016_007. However, the President dismissed AstraZeneca AG‘s case for a lack of right to sue; S2016_008. It had been submitted that AstraZeneca AG is the marketing authorisation holder in Switzerland for AZ’s Faslodex®, and a licensee under EP’138 in Switzerland. However, it is not that any licensee has the right to sue, and AZ did not provide any further information in this respect. Note that the holder of an exclusive license is entitled to bring an action (Art. 75 PatA), but expressly only if this is not excluded by the license agreement. In the absence of any information in this respect, the President dismissed AstraZeneca AG‘s request.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2016_007 ¦ Decision of 10 August 2016 ¦ “Abweisung superprovisorische Massnahme; Interessenabwägung; Pflicht der klagenden Partei, den relevanten Sachverhalt vollständig darzulegen”

Case No. S2016_008 ¦ Decision of 08 August 2016 ¦ “Vorsorgliche Massnahme; Abweisung mangels Aktivlegitimation”

(1) AstraZeneca AB (S2016_007 only)
(2) AstraZeneca AG (S2016_008 only)

./.

Sandoz Pharmaceuticals AG

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE

Court Clerk

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISIONS IN FULL 

S2016_007 ¦ Decision of 10 August 2016:

Download (PDF, 88KB)

S2016_008 ¦ Decision of 08 August 2016 :

Download (PDF, 64KB)

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