As to the background of this case, please see the report about the hearing of 10 September 2018 on this Blog here.
Making a long(er) story short: The FPC granted interim injunctive relief to prohibit Sandoz from placing its generic version of Kivexa®, i.e. ‘Abacavir Lamivudine Sandoz®’, on the Swiss market. Noteworthy, Sandoz has apparently already lodged an appeal with the Supreme Court — long before the due date.
The decision is pretty straight-forward, at least at first glance. But still, it comes along with some quite pointed conclusions.
The standard of novelty
D1 (WO 96/06844) is not pre-published prior art, but might be relevant for the assessment of novelty under Art. 54(3) EPC 1973. The timeline is a bit tricky. The FPC holds that the priority claims of the patent in suit are valid, with particular reference to GB 9506490.3, claim 16. Still, D1 might be prior art under Art. 54(3) EPC if i) it had been further prosecuted before the EPO, and ii) the designation fees had been validly paid (R. 23a EPC 1973) — what is actually the case (see EPO Register), but had not been argued by the parties. The FPC thus left this issue undecided and did correctly not investigate this of its own motion. Rather, it moved on to the assessment of novelty vis-à-vis D1 as a matter of precaution, and held that novelty is given.
Interestingly, the German Federal Patent Court had apparently held in an interim assessment (which is not publicly available, to the best of my knowledge) that novelty was not given over D1. Now, how does the FPC explain the different outcome? That’s an interesting read, indeed. In a nutshell, the FPC bluntly notes that the standard of novelty is interpreted differently in Germany and at the European Patent Office — and that the FPC follows the approach taken by the EPO. Noteworthy, the FPC holds that the different standard is taken in particular with selection inventions. I am wondering: With all selection inventions, or only some kind of selection inventions? And what does in particular mean here? Is the different standard not even limited to selection inventions?
Dass das deutsche Bundespatentgericht in seiner vorläufigen Stellungnahme zu einem anderen Schluss gekommen ist, hängt damit zusammen, dass der Neuheitsbegriff in Deutschland anders interpretiert wird als vom Europäischen Patentamt, insbesondere [Anm.: Hervorhebung hinzugefügt] bei Auswahlerfindungen. Während beim europäischen Patentamt ein strenger Massstab angelegt wird hinsichtlich dessen, was im geltend gemachten Dokument des Standes der Technik für Neuheitsschädlichkeit offenbart sein muss (gewissermassen streng fotografischer Ansatz), wird gemäss deutscher Rechtsprechung ein grosszügigerer Massstab angelegt.4 D.h. ein Dokument ist gemäss deutscher Rechtsprechung bei Auswahlerfindungen eher neuheitsschädlich als gemäss Auffassung der Rechtsprechung der Beschwerdekammern des europäischen Patentamts.
Das Schweizer Bundespatentgericht folgt dem Ansatz der Beschwerdekammern des europäischen Patentamts, weswegen wie oben dargelegt Neuheit glaubhaft vorliegt.
4 Vgl. z.B. Moufang in Schulte, PatG, 10. Auflage, §3 Anm. 128 und 129.
The fact that the German Federal Patent Court came to a different conclusion in its provisional statement is due to the fact that the concept of novelty is interpreted differently in Germany than by the European Patent Office, in particular [Note: emphasis added] with regard to selection inventions. While the European Patent Office applies a strict standard with regard to what must be disclosed in the asserted prior art document in order to destroy novelty (to a certain extent a strictly photographic approach), according to German case law a more generous standard is applied.4 I.e. according to German case law a document is more harmful to novelty in selection inventions than according to the case law of the Boards of Appeal of the European Patent Office.
The Swiss Federal Patent Court follows the approach of the Boards of Appeal of the European Patent Office, which is why, as explained above, novelty is plausible.
4 See e.g. Moufang in Schulte, PatG, 10th edition, §3 Notes 128 and 129.
Practitioner may or may not share the FPC’s view in this respect. In any event, I feel that I have never seen this in writing, without any sugarcoat. Even Moufang in Schulte (referred to in fn 4 of the decision) only gives examples of decisions of the EPO and in Germany for closed numerical ranges, but does not draw any conclusions beyond that.
About motivation and expectation (of success)
The decision holds that in the assessment of inventive step the question arises whether there was a motivation for the combination of the two active ingredients and a reasonable expectation that this combination would also show the same or at least comparable effectiveness, i.e. that it is effectively a valid alternative; see ¶4.8. But there is no reference in the decision why it should be done this way.
I have mentioned earlier on this Blog here that I do not readily agree with the cumulative application of both the motivation and reasonable expectation of success criteria. And I still don’t. But this issue is not relevant for the outcome of the present matter; the decision denies a motivation and does not deal at all with the issue of a reasonable expectation.
The risk of a not easily repairable harm
Is the plaintiff actually at risk of a ‘not easily repairable harm’ as required by Art. 261(1) lit. b CPC?
Defendant firmly insisted in the hearing of 10 September 2018 that this is not the case, with reference to an illustration similar to the one shown on the right. 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 decision literally recites what has been argued by the defendant in the written reply to plaintiff’s request for injunctive relief (loosely translated below):
Plaintiff has failed to provide prima facie evidence, let alone to state reasons, and to prove that he would suffer any damage which could not easily be remedied if the request for interim injunctive relief was refused. In particular, the defendant contests the allegations in para. 138-141 of the application, namely the allegations (i) that the applicant would suffer damage consisting of a decrease in the number of units sold in Switzerland; (ii) that the applicant would be affected by a price review by the Federal Office of Public Health; (iii) that the applicant would suffer financial losses in the event of a price review; and (iv) that the Federal Office of Public Health would require the applicant either to reduce the ex-works price of Kivexa® or to accept a higher deductible. In any event, the defendant cannot be held liable for any losses resulting from the market entry of a second generic manufacturer (see the allegations in paragraph 1. 139 of the application regarding Art. 38 of the Swiss Care Allowance Ordinance).
Further, defendant had apparently submitted in writing (again, loosely translated):
Paragraph 14 of the request for interim injunctive relief states that ViiV Healthcare GmbH (hereinafter ViiV Switzerland) is a group company and not a subsidiary of the plaintiff. According to the extract from the commercial register (act. 1_5), ViiV Switzerland is 100% owned by ViiV Healthcare Overseas Limited (UK), which is a 100% subsidiary of the parent company of the ViiV Group, ViiV Healthcare Limited. ViiV Healthcare Limited is the sole shareholder of the applicant.
The above had been submitted under the heading ‘Parties’, but apparently not in relation to the (lack of a) not easily repairable harm. The decision holds that the fact that the plaintiff itself does not suffer any damage due to the aforementioned corporate structure, but rather ViiV Switzerland, had not been asserted by the defendant in his written reply to the request for injunctive relief, but only for the first time at the hearing on 10 September 2018 — i.e., after the closure of the file after a single exchange of briefs (see decision 144 III 117 of the Supreme Court, ¶2.2).
But even if these allegations were admitted into the proceedings, the decision holds that a not easily repairable harm would be sufficiently credible. In the FPC’s view, it is ‘obvious and notorious’ that in such group constellations 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.
As noted above, defendant has apparently already appealed the decision.
Defendant’s appeal has been dismissed by the Supreme Court with decision 4A_575/2018 of 12 March 2019; published today.
Reported by Martin WILMING
Panel of Judges:
- Dr. Christoph GASSER
- Dr. Tobias BREMI
- Marco ZARDI
- Dr. Tobias BREMI
- Susanne ANDERHALDEN
Representative(s) of Plaintiff:
Representative(s) of Defendant:
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