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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Riendeau ./. Zehnder: Heat exchanged?

Case No. 4A_277/2018 ¦ Decision of 01 October 2018 (Supreme Court) on appeal against O2015_009 ¦ Decision of 21 March 2018 ¦ ‘Wärmeaustauschelement: Feststellung der gemeinsamen Berechtigung an der Anmeldung’

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff / appellant.

Please see this Blog here for a discussion of the underlying decision of the FPC. In brief, it is all about an assignment action of Marcel Riendeau against Zehnder Group International AG, concerning two European patent applications, i.e.:

Both EP2 and EP3 had been filed in Zehnder’s name only; the plaintiff had been designated as inventor. The plaintiff had partially suceeded in first instance when the FPC held that the parties are jointly entitled to both patent applications.

On appeal, the plaintiff objected that the facts had been wrongly established in the first instance decision in various aspects, that the burden of proof had been incorrectly allocated and that the FPC had not dealt with the plaintiff’s entitlement to a transfer of the patent applications based on a contractual undertaking.

To cut a long(er) story short: The Supreme Court did not agree and dismissed the appeal. The FPC’s decision is thus final now, and it remains to be seen how the parties get along with their joint entitlement to both EP2 and EP3.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_009 ¦ Decision of 21 March 2018 ¦ ‘Wärmeaustauschelement: Feststellung der gemeinsamen Berechtigung an der Anmeldung’

Marcel Riendeau
./.
Zehnder Group International AG

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Nicolas CURCHOD

Representative(s) of Plaintiff:

Representative(s) of Defendant:

SUPREME COURT DECISION

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FPC DECISION

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EP 2 829 834 A1
(referred to as EP2 in the decisions)

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EP 2 829 836 A1
(referred to as EP3 in the decisions)

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Supreme Court confirms FPC’s decision O2015_008 — Omega’s appeal dismissed

Case No. 4A_282/2018 ¦ Decision of 4 October 2018 (Supreme Court) on appeal against O2015_008 ¦ Decision of 14 March 2018 (FPC)¦ ‘Balancier de montre’

Reading time: 4 minutes

As to the background of this matter, please see the report about the main hearing on this Blog here and the discussion of the first instance decision of the FPC on this Blog here.

In brief, Omega had alleged infringement of its EP 1 837 719 B1; see the EPO Register and Swissreg for further bibliographic details of the patent in suit. With decision of 14 March 2018, the FPC had rejected Omega’s claim for infringement while Tudor’s / Detech’s counterclaim for invalidity had been allowed; EP(CH) 1 837 719 B1 had been declared invalid.

The Supreme Court now dismissed Omega’s appeal, i.e. confirmed the FPC’s decision. EP(CH) 1 837 719 B1 is thus finally declared invalid.

The issues dealt with by the Supreme Court in the decision, in brief:

  1. Age of a prior art document 

On appeal, Omega has argued that the FPC took an unrealistic piece of prior art into account in the assessment of inventive step. Indeed, the FPC had considered a document that was published already about a century ago, i.e. US 759,914. In view of the evolution of watchmaking since then, Omega considered it unrealistic that such a document was actually considered as a starting point in the assessment of inventive step. Consequently, Omega alleged a violation of Art. 56 EPC.

The Supreme Court did not buy this argument. It is held in no uncertain terms that everything that had been made publicly available — including old documents — forms part of the prior art. One cannot exclude a document from consideration in the assessment of inventive step just because of its age; see ¶3.1.3.

Écarter un document de ceux que consulterait l’homme de métier en raison de son ancienneté reviendrait à priver les brevets ayant dépasé un certain âge de toute valeur dans le cadre de l’analyse de l’effet invenif. Un telle pratique ne saurait être déduite de l’art. 65 CBE.

Reference to some case-law of the Boards of Appeal of the EPO did not help either: The mere age of a document has not been decisive in T 479/00, T 366/89, T 1000/92 and T 334/92. The Supreme Court notes that the obsolescence or outdatedness of a technology had been the key issue in these decisions, which excluded the respective documents from consideration by the skilled person. Apparently, no such case had been established by the appellant in the present matter.

  1. Incompatibility of technical teachings

The balance wheel of US 759,914 has inertia blocks that must have been placed from the inside, as claimed by the patent in suit; see the screw head on the inner side of the felloe in the figures below.

But what is still missing here is the stud (‘plot’) according according to the patent in suit. Omega argued that the skilled person would not have added studs to the balance of US 759,914 in view of the risk to impair the automatic adjustment of its temperature dependent moment of inertia, which is the sole purpose of this invention. However, the Supreme Court holds that this is not in agreement with the fact findings of the FPC, and thus did not consider this argument any further.

  1. Choice of the closest prior art

The FPC had not explicitly motivated its choice of US 759,914 as the closest prior art in the assessment of inventive step in accordance with the problem-and-solution approach.

Kind reminder …

And the Supreme Court indeed acknowledges that it would have been desirable if it had done so.

Ainsi, il eût été souhaitable que la juridiction précédente détaille la première étape de l’approche problème-solution comme elle l’a fait pour les autres étapes de son examen.

But still, in view of the FPC’s detailed discussion of how the skilled person had arrived at the invention starting from US 759,914 without inventive merit, it became sufficiently clear how close both inventions actually are, and why US’914 thus is a reasonably chosen closest prior art.

  1. Late filed auxiliary requests / claim limitations

Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. The FPC had not admitted this request into the proceedings anymore, with reference to O2015_012.

Omega had challenged this on appeal. But while this appeal has been pending, the Supreme Court ruled on the appeal against O2015_012 — and backed the practice of the FPC in this respect; decision 4A_543/2017 of 08 May 2018, see this Blog here. Accordingly, Omega did not succeed with this argument, either.

In sum, Omega’s appeal was dismissed and EP(CH) 1 837 719 B1 is now finally declared invalid.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_282/2018 ¦ Decision of 4 October 2018 (Supreme Court) on appeal against O2015_008 ¦ Decision of 14 March 2018 (FPC) ¦ ‘Balancier de montre’

Omega S.A.

./.

  1. Montres Tudor S.A.
  2. Detech S.A.

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Nicolas CURCHOD

Representative(s) of appellant / plaintiff:

Representative(s) of defendants / respondents:

SUPREME COURT DECISION 

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FPC DECISION 

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PATENT IN SUIT

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