Fulvestrant, again

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Case No. O2017_014 | Decision of 10 March 2020 | ‘Fulvestrant use’

When you have read the report about the main hearing of 20 January 2020 on this Blog here, you probably won’t be overly surprised by the outcome: AZ’s complaint has been dismissed.

In brief, AstraZeneca asserted that EP(CH) 1 272 195 (see EPO Register and Swissreg for further information) is infringed by Sandoz’s generic version of AZ’s Faslodex®, i.e. Fulvestrant Sandoz 250 mg/5ml (Swissmedic approval no. 56778). The patent has been partially waived after closure of the file, in accordance with Art. 24 PatA (newly added features marked-up):

Additional features in claim 1, by way of a partial waiver

Here are my take-away messages from the decision:

Expert opinion

The decision clarifies in no uncertain terms the nature of the judge-rapporteur’s expert opinion (EO):

... is a legal assessment of the facts as pleaded before closure of the file.

Loose translation to English:

The [EO] is established after closure of the file, and it is the judge-rapporteur’s legal assessment of the facts put forward by the parties. It provides a contribution to the discussion for the purpose of rendering a judgment. The [EO] can therefore only deal with questions of law, but not with questions of fact. Accordingly, [an EO] cannot entitle the submission of new facts from the outset. Certainly, a party cannot use [the EO] as a trigger to remedy incomplete factual allegations.

Admissibility of partial waiver

Nosy? Me too. But it’s not yet time. Admissibility of the partial waiver after closure of the file is left undecided, in view of the appeal in case O2016_012 that is currently still pending at the Supreme Court. Irrespective of the answer to this highly interesting question, the complaint had to be dismissed for other reasons; see below.

Belated and insufficient factual allegations re infringement of the partially waived patent

A partial waiver after closure of the file per se cannot carry the day.

The decision holds that AZ’s pleadings re infringement of the partially waived patent — for the first time at the hearing — were belated and insufficiently substantiated:

... and insufficiently substantiated pleadings re infringement of the partially waived patent.

Accordingly, the complaint was dismissed.

How to (formally correctly) introduce a partially waived patent into the proceedings

AZ had submitted the partially waived patent to the court with letter of 8 August 2019, and Sandoz had been given the opportunity to comment thereon. The decision holds:

... and how it had been introduced into the proceedings.

Loose translation to English:

In this respect, it is not clear to the Court what the defendant means when asserting that the partially waived patent has not yet been asserted or formally correctly introduced into the proceedings.

Frankly, I am confused. My understanding from what had been pleaded at the hearing was that AZ had indeed submitted the partially waived patent — but merely as an annex, i.e. without asserting the substance of the partially waived patent in the submission itself. That could have been an interesting issue, somewhat similar to the situation that gave rise to the order of 3 May 2012 in O2012_022; see ¶¶ 10.4 et seqq. But, maybe, I just got it wrong. Anyway, that’s not the decisive issue here.

UPDATE 27 May 2020:

According to an update on the FPC’s website earlier today, the decision has not been appealed / is final.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_014 | Decision of 10 March 2020 | ‘Fulvestrant use’

AstraZeneca AB
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

    • Prof. Dr. Daniel KRAUS
    • Prisca VON BALLMOOS
    • Marco ZARDI

Judge-rapporteur:

    • Prisca VON BALLMOOS

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Michael RITSCHER (MLL)
    • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters

Representative(s) of Defendant / Patentee:

DECISION IN FULL

PATENT IN SUIT

EP 195 as granted by the EPO:

 

EP 195 after partial waiver in Switzerland:

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