Generic Kivexa®: Supreme Court confirms interim injunctive relief

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Case No. 4A_575/2018 (Supreme Court) | Decision of 12 March 2019 on appeal against S2018_004 (FPC) | Decision of 22 October 2018 | ‘Abacavir / Lamivudine’

Please see this Blog here for a detailed review of the first instance decision S2018_004 of the FPC in this matter, granting interim injunctive relief against Sandoz’s generic Kivexa®.

An appeal against a decision in summary proceedings is not so easy anymore as it used to be. In former times, a not easily repairable harm had routinely be assumed on appeal against decisions concerning interim injunctive relief (see BGE 134 I 83, ¶3.1, with further reference). However, the more recent case law requires that the appellant is threatened by a not easily repairable harm (in legal terms) in the specific case at hand; see BGE 144 III 475, ¶1.2, with further reference). In the case at hand, the Supreme Court left it undecided whether the loss of the first mover advantage or reputational damages would be sufficient to meet the threshold. But the Supreme Court noted that the interim injunctive relief also prohibited possession and storage, and the defendant would thus have to destroy all products on stock. The Supreme Court held that this constitutes a not easily repairable harm in the sense of Art. 93(1) lit. a SCA, and the appeal was admissible already for this reason. This surely is lawyer’s playground; but I am wondering why the loss of stock was considered a not easily repairable harm? It surely is a harm. But wouldn’t it be one of the kind that is quite easy to repair?

Further, Sandoz had argued that the plaintiff was not actually at risk of a ‘not easily repairable harm’ as required by Art. 261(1) lit. b CPC.

ViiV corporate tree (section), as illustrated by respondent

In brief, plaintiff ViiV Healthcare UK Ltd is the holder of the Swiss SPC, and is fully owned by ViiV Healthcare Ltd; cf the right branch of the illustration. Likewise, ViiV Healthcare GmbH (holder of the Swiss MA for Kivexa® according to the ‘Spezialitätenliste‘) is fully owned by ViiV Healthcare Overseas Ltd, which in turn is fully owned by ViiV Healthcare Ltd; cf the left branch of the illustration.

The FPC had held that a not easily repairable harm was sufficiently credible; it was ‘obvious and notorious’ that in such group structures of pharmaceutical companies a disadvantage that cannot be easily repaired arises for the group and thus at least indirectly also for the formal holder of the SPC. The FPC failed to see why / to what extent this should not be the case in the present setup.

Es ist offensichtlich und notorisch, dass in derartigen Gruppenkonstellationen von pharmazeutischen Konzernen ein nicht leicht wiedergutzumachender Nachteil bei der Gruppe anfällt und damit wenigstens indirekt auch bei der formellen Inhaberin des Schutzrechts. Inwiefern dies in der vorliegenden Konstellation nicht der Fall sein sollte, ist nicht ersichtlich.

The Supreme Court essentially confirmed this reasoning.

The decision also discusses the dispatch of the Federal Council on the Civil Procedure Code and holds that any impairment of the execution of absolute rights constitutes a not easily repairable harm; BBl 2006, ¶5.19, p. 7354:

[…], wird in der Botschaft zur ZPO ausgeführt, jede Beeinträchtigung in der Ausübung absoluter Rechte bedeute einen nicht leicht wieder gutzumachenden Nachteil ([…]).

Frankly, I don’t see that in the dispatch. In my reading, the dispatch only holds that any impairment of the execution of absolute rights constitutes a harm, but it does not say that this harm is automatically not easily repairable:

Als Nachteil gilt beispielsweise eine Beeinträchtigung der Ausübung absoluter Rechte (z.B. Störung des Eigentums).

As to the alleged lack of novelty over D1 (WO 96/06844), the Supreme Court held that the FPC did not arbitrarily acknowledge novelty based on multiple selections from lists.  In my perception, the Supreme Court suggests that the standard established by the case law of the Boards of Appeal of the EPO in relation to selections from multiple lists of certain length shall be applicable:

Die Beschwerdeführerin stellt zu Recht nicht in Frage, dass auf die Praxis der Beschwerdekammern des EPA abgestellt werden kann.

Thus, let’s do it. Here is the critical paragraph of D1:

[Abacavir] may be administered alone or in combination with […] Nucleoside Reverse Transcriptase Inhibitors (NRTIs) for example zidovudine, zalcitabine, lamivudine, didanosine, stavudine, 5-chloro-2′,3′-dideoxy-3′-fluorouridine and (2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine; non-NRTIs for example nevirapine and α-APA; HIV protease inhibitors for example saquinavir; other anti-HIV agents for example soluble CD4; immune modulators for example interleukin II, erythyropoetin, tucaresol; and interferons for example a-interferon.

Now, does it require a multiple selection from two lists of certain lengths to arrive at the combination of abacavir and lamivudine, in accordance with the established case-law of the Boards of Appeal of the EPO? Does one have to first choose a generic class (NRTIs) and then lamivudine within that class — or does one just have to pick one compound from a single (structured) list of compounds? A decision on that question could have been a very interesting read. But the Supreme Court merely held that the FPC could well assume, without becoming arbitrary, that it would still require a twofold choice and thus a multiple selection from D1.

Selbst wenn daher die Rüge der Beschwerdeführerin begründet wäre (was offen bleiben kann), dass die im angefochtenen Entscheid genannte erste Auswahl keine relevante Wahl im Sinne der Rechtsprechung sein sollte [Anm.: Mono- bzw. Kombinationstherapie], konnte die Vorinstanz ohne in Willkür zu verfallen davon ausgehen, es erfordere immer noch eine zweifache Wahl und damit eine Mehrfachauswahl aus [D1], um zum Gegenstand des Patents der Beschwerdegegnerin zu gelangen.

Now, what? Does any ‘twofold selection’ whatsoever create novelty? I don’t think so. What about the requirement of the Boards of Appeal that the lists have a ‘certain length’? And what about the argument that the above is only a single, yet structured list? While the FPC clearly intended to follow the EPO’s approach, I am not so sure about the Supreme Court’s view on this. Anyway, time will tell …

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_575/2018 (Supreme Court) | Decision of 12 March 2019 on appeal against S2018_004 (FPC) | Decision of 22 October 2018 | ‘Abacavir / Lamivudine’

ViiV Healthcare UK Ltd. (respondent / plaintiff)
./.
Sandoz Pharmaceuticals AG (appellant / defendant)

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Martha NIQUILLE

Court Clerk:

  • Linus HUG

Representative(s) of ViiV:

  • Dr. Simon HOLZER (MLL)
  • Louisa Galbraith (MLL)

Representative(s) of Sandoz:

SUPREME COURT
on appeal against S2018_004 (FPC) | Decision of 22 October 2018
Case no.: 4A_575/2018
Decision of: 12 March 2019
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PATENT COURT
Case no.: S2018_004
Decision of: 22 October 2018
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PATENT IN SUIT

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