Tag: SPC

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Spirig’s sitagliptin / metformin fixed-dose combination: Launch failure

Reading time: 6 minutes

Case No. S2022_010 | ‘Sitagliptin Metformin’
👉 Order of 16 January 2023
👉 Judgment of 27 March 2023

MSD logo

Sitagliptin is one of the best selling treatments for type II diabetes; it is sold by MSD as Januvia® (Swissmedic market authorization no. 57863). Sitagliptin is often used in combination with Metformin, a first line anti-diabetic medication. The fixed-dose combination is sold by MSD as Janumet® (Swissmedic market authorization no. 58450).

Putting it simple, metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and improves the use of sugar in the body. Sitagliptin helps to make the pancreas release more insulin. It also signals the liver to stop producing sugar when there is too much sugar in the blood.

MSD’s full year 2022 financial report acknowledges «lower sales of Januvia and Janumet, primarily reflecting lower demand in Europe as a result of generic competition.» Combined sales dropped by 15%, from USD 5,288 bn (2021) to 4,513 bn (2022).

MSD held two SPCs in Switzerland, i.e.

    • C01412357/01 for the fixed-dose combination of sitagliptin and metformin (granted 31 December 2009, lapsed 7 April 2023); and  
    • C01412357/02 for sitagliptin as such (granted 23 November 2021 as a paediatric extension, lapsed on 4 January 2023).

Both SPCs were based on EP 1 412 357 B1 (lapsed 5 July 2022; see EPO Register and Swissreg).

Spirig logo

Helvepharm, Sandoz and Mepha chose to enter the market with the fixed dose combination only in April 2023, while Spirig (member of the Stada group of companies) apparently took that step already in January 2023 when C01412357/01 was still in place ; see Compendium.

Here’s what happened:

When Spirig had obtained the Swiss market approval for the fixed-dose combination, MSD requested them to confirm that they will respect the two SPCs. Spirig confirmed that it would respect the one for sitagliptin as such, but refused to confirm the same for the SPC on the fixed-dose combination, because the latter was invalid, in their view.

On that basis, MSD sought preliminary injunctive relief on 23 December 2022. The President acting as single judge dismissed MSD’s request for an ex parte PI with order of 3 January 2022 (unpublished). Essentially, it had been held that mere refusal to confirm that one respects an SPC does not mean that infringing acts are imminent:

This could have been it. But it wasn’t. Shortly thereafter, on 12 January 2023 when the inter partes PI proceedings were still ongoing, MSD informed the FPC and provided evidence that Spirig meanwhile had entered the market — and again requested an ex parte PI. This time, indeed, the President issued an ex parte PI on 16 January 2023, yet without reasons. On Spirig’s request, reasons for the ex parte PI were subsequently provided. Spirig did not dispute but rather even confirmed with their request for a reasoned decision that they had taken up commercialization of the fixed-dose combination:

Apparently, Spirig took from certain subsidiary considerations in the President’s (unpublished) order of 3 January 2023 that MSD’s right to an ex parte PI would be forfeited. But it wasn’t: New facts (infringing acts) gave rise to a new assessment by the President.

Turning now to the alleged invalidity of the fixed-dose SPC, the judgment holds that the (meanwhile overcome) ‘infringement test’ still applies to C01412357/01, in view of a Swiss Supreme Court decision of 2018; see this Blog here. What is more, the fixed-dose SPC was the first one to be granted in Switzerland. Accordingly, the President held that the Swiss fixed-dose SPC was prima facie valid.

The situation is different in some other countries, e.g. in Germany where the Federal Patent Court had revoked the fixed-dose SPC because it lacked a further ‘inventive advance’; see 3 Ni 2/20. Note, however, that the fixed-dose SPC was the second one to be granted in Germany. MSD’s appeal is currently pending at the German Supreme Court, with case no. X ZR 64/21.

My reading between the lines is that the Swiss Federal Patent Court does have a different understanding of the ECJ rulings on combination SPCs than the German Federal Patent Court. The FPC explicitly disagrees with Spirig’s pleadings to this effect:

But, hey, the ECJ rulings on SPCs are somewhat cryptic indeed, aren’t they? Accordingly, it comes as no surprise that the Markkinaoikeus of Finland in corresponding proceedings between MSD and Teva asked the ECJ for a preliminary ruling (case no. C-119/22); see the questions here. Maybe, we will soon get some clarification about ‘core inventive advance’, ‘central inventive step’ and/or ‘subject matter of the invention’ from the ECJ (hopefully, it’ll not be a ruling that raises more questions than it answers).

The ex parte PI that had been issued by the President was confirmed by a panel of three judges after Spirig has been heard, with judgment of 27 March 2023.

What is interesting on the precedural side is that MSD was not set a time limit for initiating main proceedings. The SPC lapsed earlier than the 30 days time limit, which is why the excercise was meaningless:

The judgment has not been appealed / is final.

✍ MW

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BIBLIOGRAPHY

Case No. S2022_010 | ‘Sitagliptin Metformin’
👉 Order of 16 January 2023
👉 Judgment of 27 March 2023

Merck Sharp & Dohme LLC
./.
Spirig Healthcare AG

Single Judge (Order of 16 January 2023):

    • Dr. Mark SCHWEIZER

Panel of Judges (Judgment of 27 March 2023):

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Prof. Dr. Daniel KRAUS

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

Representative(s) of Defendant:

    • Dr. Christian HILTI (Rentsch)
    • Dr. Andrea CARREIRA (Rentsch), assisting in patent matters

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JUDGMENT

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EX PARTE PI

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BASIC PATENT

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The final curtain: The salt form identified in an SPC doesn’t matter (much)

Reading time: 4 minutes

Case No. 4A_274/2019 (Supreme Court) | Decision of 26 November 2019, on appeal against O2017_023  (FPC) | Decision of 3 May 2019 | ‘SPC, salt form’

DISCLOSURE NOTICE

Hepp Wenger Ryffel is involved in this case on behalf of the appellant / defendant.

Readers of this Blog will recall the infringement case of Gilead’s SPC C00915894; the basic patent is EP 0 915 894 B1 (see EPO Register and Swissreg). Gilead’s products are Truvada® and Atripla® which are pharmaceuticals for the treatment of HIV-1 infection.

Gilead’s Truvada®
Gilead’s Atripla®

The dispute is all about whether or not the scope of an SPC that specifically refers to a unique salt form does extend to other salts. The SPC concerns ‘tenofovir disoproxil fumarat + emtricitabin’ (emphasis added). Mepha’s attacked generics (Swissmedic MAs No. 66181 and 66217) instead comprise tenofovir disoproxil phosphate.

Tenofovir disoproxil fumarate
CAS no. 202138-50-9
Tenofovir disoproxil phosphate
CAS no. 1453166-76-1

Now, is that still the same ‘product’ in the sense of Art. 140d PatA?

The FPC had issued a PI in summary proceeding S2017_006; see this Blog here. Validity of the SPC was not an issue anymore, this had already been affirmed by the Supreme Court; see this Blog here. Later, the finding of infringement had been confirmed in main proccedings O2017_023; see this Blog here.

Mepha appealed. But with reference to the ECJ’s reasons given in C-392/97 — Farmitalia (¶¶ 17-22), the Supreme Court has confirmed the FPC’s finding of infringement in late 2019:

If derivatives are covered by the scope of protection of a patent which have the same pharmacological effect as the product listed in the marketing authorisation, they are also protected by the SPC.

Accordingly, the Supreme Court dismissed the appeal.

This could have been it. But the Supreme Court also expanded on the FPC’s secondary line of reasons with respect to infringement of the SPC under the DoE. And this is where things went somewhat astray, in my opinion.

Loosely translated (third to fifth and last sentence of the above citation):

The complaint is based on the assumption that combinations of active substances are not covered by the basic patent. As mentioned, however, it was bindingly established by the lower court that combinations were covered by the scope of the basic patent. Since submissions with reference to facts that differ from those established in the contested decision cannot be taken into account, the complaint made by the appellant cannot be considered. […] Here, too, the appellant fails to recognise that the fumarate salt of the active substance tenofovir-disoproxil is covered by the basic patent according to the binding findings of the lower court.

Clearly, it was not in dispute that the scope of the basic patent covered the attacked embodiment — what I hope is the reason why the Supreme Court holds that this has been ‘bindingly established’ by the FPC. Else, the Supreme Court surely reviews issues of scope; see e.g. 4A_131/2016 — Urinalventil and 4A_208/2017 — Pemetrexed.

But coverage by the scope of the basic patent is only one of many aspects in the assessment of infringement of an SPC under the DoE; see O2017_023, ¶¶ 35 et seqq. I have the vague feeling that the Supreme Court missed the point here. But be this as it may, this obiter dictum is irrelevant for the outcome of the matter.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. 4A_274/2019 (Supreme Court) | Decision of 26 November 2019, on appeal against O2017_023  (FPC) | Decision of 3 May 2019 | ‘SPC, salt form’

Mepha Pharma AG (Appellant / Defendant)
./.
Gilead Sciences Inc. (Respondent / Plaintiff)

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Kathrin KLETT
      • Dr. Fabienne HOHL
      • Dr. Martha NIQUILLE
      • Marie-Chantal MAY CANELLAS

Court Clerk:

    •  Nicolas CURCHOD

Representative(s) of Plaintiff / Respondent:

    • Dr. Simon HOLZER (MLL)
    • Dr. Kilian SCHÄRLI (MLL)
    • Dr. Michael RITSCHER (MLL)

Representative(s) of Defendant:

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SUPREME COURT DECISION

on appeal against decision O2017_023 of 3 May 2019:
4A_274/2019 26 November 2019

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SECOND FPC DECISION

in main proceedings, following up on decision S2017_006 of 12 October 2017:
O2017_023 3 May 2019

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FIRST FPC DECISION

in summary proceedings:
S2017_006 12 October 2017

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Generic Kivexa®: Supreme Court confirms interim injunctive relief

Reading time: 7 minutes

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

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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:

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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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Generic Kivexa®: Interim injunctive relief granted, appeal pending

Reading time: 10 minutes

Case No. S2018_004 | Decision of 22 October 2018

As to the background of this case, please see the report about the hearing of 10 September 2018 on this Blog here.

Appeal pending

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.

Loosely translated:

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?

ViiV corporate tree (section), as illustrated by respondent

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.

UPDATE 10 April 2019:

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

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BIBLIOGRAPHY

Case No. S2018_004 | Decision of 22 October 2018

ViiV Healthcare UK Ltd.
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

  • Dr. Christoph GASSER
  • Dr. Tobias BREMI
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

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DECISION IN FULL

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PATENT IN SUIT

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ViiV seeking injunctive relief against Sandoz’s generic Kivexa®

Reading time: 9 minutes

Case No. S2018_004 | Hearing of 10 September 2018

ViiV logo

Infringement of ViiV‘s SPC based on EP 0 817 637 B1 is at stake. See EPO Register and Swissreg for bibliographic details of the patent; and Swissreg for further bibliographic details of the SPC C00817637/01.

Claim 1 of EP’637 is straight forward — at least when the IUPAC names of the compouds are replaced with the respective INNs:

A combination comprising [abacavir; ABC] or a physiologically functional derivative thereof and [lamivudine; 3TC] or a physiologically functional derivative thereof.

For the chemists out there, these are the molecules:

Abacavir; aka ABC
Lamivudine; aka 3TC

Both these compounds are nucleoside reverse-transcriptase inhibitors (NRTIs). Both compounds alone and the fixed-dose combination thereof are included in the WHO Model List of Essential Medicines.

ViiV’s Kivexa®

ViiV‘s own product is Kivexa® (aka Epzicom® in the U.S.); see compendium.ch.

The European public assessment report (EPAR) of the European Medicines Agency (EMA) provides a wealth of further information about this antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

Sandoz‘s generic version ‘Abacavir Lamivudine Sandoz®’ had obtained market approval on December 15, 2017, and it has been listed since April 1, 2018; see compendium.ch.

Sandoz logo

Sandoz contests infringement of the SPC solely on the ground that EP’637 and the SPC are null and void. A lack of novelty and inventive step is alleged, and that the priority claim was not valid. Sandoz had refused to undertake not to put the product on the market before the expiry of the SPC (October 30, 2020); Sandoz rather informed ViiV that it would start marketing in calendar week 21 — and has consequently been sued by ViiV.

I have attended the hearing yesterday; see the official announcement and some live notes below.

The following issues have been discussed:

  1. Is EP’637 entitled to the priorities claimed?

The parties dissent about whether or not EP’637 is actually entitled to the priorities claimed; see a compilation of the two priority documents here. Respondent argued that the whole disclosure of the priority documents is about a combination of three active substances, compared to a combination of only ABC and 3TC finally claimed in the patent in suit; plaintiff disagreed.

If priority was not validly claimed, D1 (WO 96/06844) would be pre-published prior art, i.e. relevant for both novelty and inventive step assessment.

  1. Has D1 (WO 96/06844) to be considered in the assessment of novelty?

From the pleadings, I conclude that in the exchange of briefs the plaintiff himself had submitted that D1 (WO 96/06844) forms prior art that is (only) relevant for the assessment of novelty. Respondent had agreed. Only later, in my understanding in the judge-rapporteur’s expert opinion, it has been held that D1 does not form part of the prior art under Art. 54(3) and (4) EPC 1973 or Art. 7(3) lit. a old PatA, respectively. Respondent disagrees on the merits, and further argued that the principle of party disposition was violated.

  1. Is D1 (WO 96/06844) novelty destroying?

From the pleadings it could be concluded that the expert opinion established by the judge-rapporteur was advantageous for the plaintiff, i.e. that novelty of EP’637 over D1 was given. The EPO’s approach of how to deal with selections from two or more lists of a certain length will be decisive.

Respondent argued that the German Federal Patent Court and a Stockholm court had denied novelty. I could not yet spot any such decision; maybe these were only interim assessments of the courts before the respective parties settled(?).

If you know more, I would be grateful if you would let me know.

UPDATE 12 September 2018:

I have meanwhile been informed of the decision issued in Sweden (Case PMÖ 3565-17 of the Svea Hovrätt), briefly reviewed on EPLAW Blog.

  1. An ‘optional’ disclaimer in summary infringement proceedings?

In a secondary line of defense, plaintiff offered to limit the patent with a disclaimer, to exclude the disclosure of D1 and to restore novelty if necessary.

Defendant argued that this was not possible and referred to an order of the Zurich Commercial Court (HE070010 of 22 August 2007, issued by Dieter BRÄNDLE, the later President of the FPC) that was upheld by the Zurich Court of Appeal (AA070145/U/Ia of 25 January 2008). At that time, it had been held (emphasis in original; cf ¶3.2):

Im Massnahmeverfahren [kann] sich der Kläger somit nur auf ein Zertifikat bzw. das diesem zugrundeliegende Patent in der aktuellen (d.h. uneingeschränkten) Fassung berufen.

Loosely translated:

In summary proceedings the plaintiff may thus only rely on the SPC or the basic patent, respectively, in its current (i.e. unamended) version.

  1. Risk of a not easily reparable harm for the plaintiff?

Further, the requirement of a ‘not easily reparable harm’ for interim injunctive relief to be granted has been addressed at length by the parties. Is the plaintiff actually at risk of a ‘not easily reparable harm’ as required by Art. 261(1) lit. b CPC?

ViiV corporate tree (section), as illustrated by respondent

Respondent firmly insisted 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.

Respondent argued that none of the boilerplate arguments like confusion of the market, price erosion, etc can apply here, since this does not affect the plaintiff / SPC holder. Plaintiff inter alia argued in the hearing that the Swiss MA holder has a license under SPC. This was firmly rebutted by the respondent as ‘not true’, or at least not to be a royalty-bearing license — and procedurally belated in any event. In my understanding, it had not been argued in the written exchange of briefs that a license is in place.

Finally, the parties were asked whether they were interested in settlement discussions. I would have loved to hear the answer, but the public has been excluded on request of the plaintiff even before the general (un)willingness to talk settlement has been indicated.

Reported by Martin WILMING

P.S.: After plaintiff’s initial pleadings, the presiding judge asked whether the pleading notes that had obviously at least partially been read out would be handed over to the court (“not necessarily to the other party”), to ease compilation of the minutes. The parties agreed. A pragmatic approach. Still, I strongly feel that whenever pleading notes are handed over to the court, the other party should get a copy, too. Frankly, I would not feel comfortable when the counter-party submits something in writing that I haven’t seen. How would I know that there was no change or omission in the speech vis-à-vis the pleading notes, and how easily might a different message silently sneak into the minds of the judges …

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BIBLIOGRAPHY

Case No. S2018_004 | Hearing of 10 September 2018

ViiV Healthcare UK Ltd.
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

  • Dr. Christoph GASSER
  • Dr. Tobias BREMI
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Benjamin THOMAS (Simmons), assisting in patent matters

Representative(s) of Defendant:

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PATENT IN SUIT

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ANNOUNCEMENT

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The CJEU’s judgment on Gilead’s SPC for Truvada® is out now

Case No. C-121/17 (CJEU) | Decision of 25 July 2018

Note that Hepp Wenger Ryffel has been involved in parallel proceedings in Switzerland on behalf of Teva.

It’s showtime again for the SPC community — but don’t expect big surprises:

The CJEU handed down its judgment in the matter Teva et al. ./. Gilead (C-121/17) earlier today, concerning an SPC for the combination of tenofovir disoproxil (TD) and emtricitabine, i.e. Gilead’s Truvada®.

For ease of reference, the opinion of the Advocate General and Judge Arnold’s referral are also included hereinbelow.

Be remembered that Arnold J had referred the same question from the Actavis ./. Sanofi (C-443/12) case again, i.e.:

What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?

Now, in case of a combination product, the CJEU’s answer is as follows (emphasis added):

Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent; and

each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

It will now be on the referring court to decide how this will play out in the matter at hand. However, there is a quite clear message from the CJEU in ¶56:

Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent.

Reported by Martin WILMING

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DECISION C-121/17

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ADVOCATE GENERAL’S OPINION

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REFERRAL

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The Supreme Court sets the ‘infringement test’ aside — but with a ‘Swiss touch’

Supreme Court
Case No. 4A_576/2017 | Decision of 11 June 2018 | Appeal against decision O2017_001 of 3 October 2017

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.
Gilead's Truvada
Gilead’s Truvada®

Please see this Blog here for a summary of the first instance decision of the FPC.

Nullity of the supplementary protection certificate C00915894 has been at stake. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg. On a more general level, this case was all about what it needs for a product to be protected by a basic patent, which is a prerequisite for an SPC both in the EU (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

It was beyond dispute between the parties that the subject-matter of the SPC (tenofovir disoproxilfumarat + emtricitabin) is covered by the basic patent EP’894. The so-called ‘infringement test’ that had been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met. However, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and the plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland, either.

The FPC had held that it is not appropriate to change the practice. On the contrary, the Supreme Court did now exactly that.

In first place, the Supreme Court reviewed the practice of the CJEU which initially left it to the national courts to decide on what it meant to be protected by a basic patent. Essentially two lines of jurisprudence developed thereafter, i.e. the disclosure theory (‘Offenbarungstheorie’) and the infringement test (‘Verletzungstest’). Only later, the CJEU disapproved the ‘infringement test’; CJEU C-322/10 – Medeva.

The Supreme Court noted that the Swiss SPC legislation had been enacted with the explicit aim to make it materially the same as in the European Union. The ‘infringement test’ cannot achieve this aim anymore, and it thus cannot be maintained; ¶2.2.5-2.2.6:

Die Auslegung […] weicht konzeptionell ab von der Auslegung durch den EuGH. […] Das vom schweizerischen Gesetzgeber angestrebte Zeil, das Schutzniveau für das Institut der ergänzenden Schutzzertifikate  mit demjenigen im benachbarten Ausland in Einklang zu bringen, wird damit verfehlt. […] An  BGE 124 III 375 kann nicht festgehalten werden.


Noteworthy, the Supreme Court also briefly touched the IPI’s prior initiative to amend its SPC granting practice in light of the CJEU’s Medeva case law, and the positive feedback that had been received from (at least some of) the interested circles. The Supreme Court notes that this was a strong indication that the Swiss practice should indeed be changed, and the IPI’s initiative thus paid off. Still, it was good that the IPI’s initiative had been put on hold in view of the present proceedings. In my humble opinion, any change of practice while BGE 124 III 375 – Fosinopril was still formally applicable would have been premature. Just imagine the consequences if the granting practice had been changed and the Supreme Court later did not abstain from the ‘infringement test'(!), for any reason whatsoever. Dreadful.

Now, what is the test instead? Practitioners are familiar with the subtle twists in the various decisions of the CJEU. This is not further clarified in the present decision. Unsurprisingly, the Swiss Supreme Court essentially only summarizes the criteria of these decisions, ¶2.2.6:

Bezeichnet ein Grundpatent nur einen von zwei Wirkstoffen, kann ein Erzeugnis […] nicht als ergänzendes Schutzzertifikat beanspruch werden, wenn es aus zwei Wirkstoffen zusammengesetzt ist. Art. 140b PatG ist vielmehr […] so auszulegen, dass die Wirkstoffe des Erzeugnisses im Grundpatent beansprucht werden müssen, indem sie in den Patentansprüchen benannt werden, oder indem sich die Patentansprüche – im Lichte der Beschreibung ([…]) ausgelegt – zumindest stillschweigend, aber notwendigerweise auf diese Wirkstoffe beziehen, und zwar in spezifischer Art und Weise.

The ‘Swiss touch’

But the Supreme Court did not just change the practice. It did so with a smooth ‘Swiss touch’: Already granted SPCs shall not be affected by the change of practice. The Supreme Court held that, as a rule, formally final administrative decisions cannot be reconsidered or reversed on the basis of a change in case law. In the Supreme Court’s view, the public interest in equal treatment hardly exists in the context of an SPC, contrary to e.g. in social insurance issues. Apart from the fact that the number of SPCs — irrespective of their economic importance — is rather small, the purpose of granting them is precisely to grant privileges to their owners. If a change of the case law now restricts the conditions for granting SPCs in certain cases, the interests of the other market participants are given a higher weighting and the interests — including public interests in health care — are weighed up differently. However, this change in valuation and consideration of the interests involved does not justify the withdrawal of acquired legal positions, in the Supreme Court’s view; see ¶3.6. No national court in the European Union took this approach when the ‘infringement test’ had been abandoned, to the best of my knowledge.

Now, what is next? Respondent’s counsel already noted on Kluwer Patent Blog that it remains unclear how pending SPC applications shall be dealt with, but they suggested that the infringement test should also apply in these cases. I feel this could well be handled differently. No subjective right has yet been granted in these cases, and I cannot readily see an overriding interest of the applicants to still get SPCs granted contrary to the changed practice. To strike a balance, one might as well just give applicants a chance to amend their pending applications in view of the changed practice instead.

Reported by Martin WILMING

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BIBLIOGRAPHY

Supreme Court
Case No. 4A_576/2017 | Decision of 11 June 2018 | Appeal against decision O2017_001 of 3 October 2017

Mepha Pharma AG
./.
Gilead Sciences Inc.

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL
    • Dr. Martha NIQUILLE
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Plaintiff / Appellant:

Representative(s) of Defendant / Respondent:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Michael RITSCHER (MLL)

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SUPREME COURT DECISION

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Inofficial English translation, as provided by Defendant’s Counsel on EPLAW Blog:

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FIRST INSTANCE DECISION

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THE BASIC PATENT

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The wording of a Swiss SPC does not (really) matter … (?)

Case No. S2017_006 ¦ Decision of 12 October 2017 ¦ “Gutheissung vorsorgliche Massnahme, ESZ Kombinationspräparat”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the defendant.

Infringement of a supplementary protection certificate (SPC) is at stake again. The FPC had granted ex parte interim injunctive relief; see this Blog here. Interim injunctive relief has now been confirmed.

The SPC concerns (emphasis added)

SD.-fumarat + T.

On the contrary, defendant’s attacked embodiment comprises SD.-phosphate and T.

The FPC held that this is still ‘the product’ in the sense of Art. 140d PatA, with reasons essentially as follows:

The codified definition of ‘product’ is ‘active ingredient or combinations of active ingredients’; Art. 140a(2) PatA. According to the Federal Council Dispatch (p. 729), this refers to the active ingredient or combination of active ingredients that is used in the medicament.

[Bei Erzeugnissen] handelt es sich […] nicht um das (Human- oder Tier-)Arzneimittel, so wie es als pharmazeutische Spezialität genehmigt wird, sondern um den Wirkstoff oder die Wirkstoffzusammensetzung, welche(r) in einem solchen Arzneimittel Anwendung findet.

IPI
IPI

The FPC holds that the term ‘product’ shall be construed consistently in the registration process and when it comes to assessment of the scope of protection. The FPC then refered to the Guidenlines on Examination of the IPI. The Guidelines hold that different salts or esters of an active ingredient are regarded as one and the same chemical substance / product, unless the specific salt or ester has an influence on the pharmacological effect (which would then need to be derivable from the patent).

Liegen für einen Wirkstoff mehrere Genehmigungen für jeweils unterschiedliche Salzformen oder Ester vor, so werden diese grundsätzlich als ein und dieselbe chemische Verbindung respektive als ein und dasselbe Erzeugnis betrachtet. Diese Salze bzw. Ester dienen der Handhabung bei der Herstellung, Verarbeitung oder Verabreichung (z.B. Verbesserung der Löslichkeit) oder Stabilisierung des Wirkstoffs. Ist beispielsweise eine Carbonsäure je separat als freie Säure, als Natrium- und Kaliumsalz zugelassen worden, so ist die früheste dieser drei Genehmigungen massgebend.

Hat jedoch die Salzform (bzw. das Gegenion) oder die Estergruppe einen Einfluss auf die pharmakologische Wirkung im Körper, handelt es sich um eine neue Erfindung. Die durch die spezielle Salz- oder Esterform veränderte Wirkung muss aus dem Patent hervorgehen.

The FPC thus concluded that a proper construction of the wording of the SPC in the case at hand is

T. plus SD.-Fumarat incl. all derivatives therof (i.e. in particular all other salts), provided that they have the same pharmacological effect and are protected by the basic patent

The FPC in particular noted that the specific wording of the SPC (‘fumarate’) is not a differentiation over the prior art, but rather is dictated by the wording of the underlying market authorisation. In the FPC’s assesement, it would not have been possible for the plaintiff to obtain a SPC that did not mention the fumarate. The wording of the SPC shall thus not limit the scope of protection, provided that the pharmacological effect of the ‘phosphate’ is the same (and the attacked embodiment is covered by the basic patent).

Die spezifische Formulierung des ESZ ist damit keine Abgrenzung vom Stand der Technik durch die Schutzrechtsinhaberin, sondern vielmehr bestimmt durch den Wortlaut der arzneimittelrechtlichen Zulassung. Damit ist glaubhaft, dass die Klägerin gar kein Schutzzertifikat gestützt auf die Zulassung […] hätte erhalten können, bei welchem […] und nicht […] Fumarat genannt wird. Eine Beschränkung des patentrechtlichen Schutzbereichs kann daraus deshalb auch nicht abgeleitet werden, vorausgesetzt dass, wie hier unbestritten, die gleiche pharmakologische Wirkung beim anderen Salz als Fumarat gegeben ist.

Swissmedic
Swissmedic

The FPC then took the fact that the attacked embodiment had been registered by Swissmedic essentially based on the plaintiff’s prior market authorisation as prima facie evidence of the same pharmacological effect of the fumarate and the phosphate.

It was beyond dispute that the attacked embodiment was covered by the basic patent, and that the attacked embodiment had a market authorisation by Swissmedic. Thus, the FPC held that all elements of an infringement of the SPC had been fulfilled.

The decision is not yet final.

UPDATE 01 December 2017:

The decision has not been appealed.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. S2017_006 ¦ Decision of 12 October 2017 ¦ “Gutheissung vorsorgliche Massnahme, ESZ Kombinationspräparat”

n/a  ./.  n/a

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

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DECISION IN FULL

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The ‘infringement test’ is (still) alive in Switzerland, surrounded by post-Medeva EU

Case No. O2017_001 ¦ Decision of 3 October 2017 ¦ “Nichtigkeit eines ESZ; Überprüfung der bisherigen Rechtsprechung zu Kombinationspräparaten; Klageabweisung”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.
Gilead's Truvada
Gilead’s Truvada®

Nullity of the supplementary protection certificate C00915894 has been at stake; see this Blog here and here for some background information. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

It was beyond dispute between the parties that the subject-matter of the SPC (Tenofovir Disoproxilfumarat + Emtricitabin) is protected by the basic patent EP’894. The so-called ‘infringement test’ that has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met.

On the contrary, the CJEU disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland either.

The FPC held that it is not appropriate to change the practice, and affirmed the ‘infringement test’ – at least for the time being.

The FPC’s reasons are as follows:

  1. The law is clear

It is (only) required by the law that the product is protected by a patent; Art. 140b(1) lit. a PatA. The Supreme Court had held in the Fosinopril decision that it is not necessary that the product be explicitly named and described in the patent (‘ausdrücklich genannt und beschrieben’). Rather, it is decisive whether the product is covered by the scope of the basic patent. Well, that’s the ‘infringement test’.

The FPC notes in passing that the Introduction of further criteria might require a change to the law.

Die Einführung zusätzlicher, über den […] Schutz durch das Basispatent hinausgehende Anforderungen an das Basispatent für die Erteilung von Schutzzertifikaten würden wohl eine entsprechende Regelung durch den Gesetzgeber voraussetzen.

  1. The rationale of Medeva is not applicable for Switzerland

The CJEU aimed to harmonize the SPC practice in the EU in order to preclude ‘obstacles to the free movement of medical prodcuts with the EU that would affect the establishment and functioning of the internal market’; see ¶24 of Medeva.

Switzerland is not part of that internal market, in particular not for medical products with state-regulated prices. Further, the FPC notes that the EU has harmonised the grant of market authorizations by the European Medicines Agency; Regulation (EC) No 726/2004. On the contrary, Switzerland has its own market approval procedure via Swissmedic; Therapeutic Products Act, TPA. The FPC concludes that even if one were to change the Swiss pratice in accordance with Medeva, this would not result in harmonised protection by SPCs with the EU.

  1. Voluntary alignment with Medeva would not improve legal certainty and consistency

The FPC analysed the CJEU’s series of decisions dealing with SPCs, i.e.

The FPC held that the CJEU had been asked to answer essentially the very same question again and again, i.e. what exactly the criteria are to decide whether or not a product is ‘protected’ by the basic patent.

The SPC salad
The SPC salad?

In the FPC’s view, Medeva raised more questions than it answered, and this uncertainty has not yet been resolved by the CJEU’s subsequent decisions. Defendant referred to the different wording used by the CJEU as ‘salad’. The FPC notes that this might well be an oversimplification. But still, the FPC identifies a terminological muddle, or at least a substantial unclarity.

Wenn die Beklagte die Formulierungen des EuGH als ‘Salat’ bezeichnet […], greift das wohl auch zu kurz, aber ein gewisses ‘terminologisches Durcheinander’, wie die Beklagte das auch nennt, oder zumindest eine erhebliche Unklarheit, scheint durchaus vorzuliegen.

The FPC further noted that yet another referral to the CJEU has been made by Arnold J in the co-pending case in the U.K.; see [2017] EWHC 13 (Pat). Undoubtedly, Arnold J has immense knowledge and experience in SPC matters. The FPC took the fact that Arnold J again seeks advice from the CJEU on the question

What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?

as a further indication of the substantial uncertainty even in the EU. In the court’s view, an attempt to harmonise the Swiss practice in alignment with Medeva would not improve legal certainty and consistency.

  1. Application of the Medeva principles in the case at hand would not give a clear result

Finally, the FPC holds that it was unclear whether or not the unspecific reference to ‘optionally other therapeutic ingredients’ in claim 27 of the basic patent would be sufficient to meet the CJEU’s criteria, i.e. ‘specified in the wording of the claim’.

In sum:

The FPC holds that if harmonisation with the CJEU case-law should be made at all, it would be too early: In the court’s view, there is just not yet a comprehensible and practicable case-law to align with.

Sollte überhaupt eine Harmonisierung mit der EuGH-Rechtsprechung in Betracht gezogen werden, scheint deshalb auf jeden Fall der Zeitpunkt, die Schweizer Rechtsprechung anzupassen, verfrüht, solange seitens des EuGH nicht eine nachvollziehbare und eindeutig umsetzbare Rechtsprechung vorliegt. Ein Versuch der Übernahme der Rechtsprechung des EuGH im gegenwärtigen Zeitpunkt würde nur eine Erhöhung der Rechtsunsicherheit nach sich ziehen. […] Deshalb ist, jedenfalls solange keine etablierte und die Rechtssicherheit sowohl für die Antragsteller als auch für die Dritten erhöhende Rechtsprechung des EuGH vorliegt, eine Änderung der Schweizer Rechtsprechung in keiner Weise angezeigt. Die strengen Voraussetzungen für eine Praxisänderung [BGE 138 III 270 , r. 2.2.2] sind eindeutig nicht erfüllt.

Two further aspects of the decision relate to the costs:

First, the parties had agreed on the English language to be used by the parties; Art. 36(3) PatCA. The main hearing, however, was held in German on request of the defendant. This required translation at the main hearing, and the defendant has to bear the costs for the interpreter.

That’s not much …

Second, the FPC did not order any reimbursement of expenses incurred by defendant’s patent attorney. Note that expenses for assisting patent attorneys are not reimbursed  according to a tariff (unlike the compensation for legal representation); see Art. 3 lit. a and Art. 9(2) CostR-PatC.

The requested amount has to be specified and substantiated, preferably by means of a detailed debit note. This has not been done, and the FPC accordingly did not award reimbursement of such unspecified and unsubstantiated expenses for the assisting patent attorney.

The decision is not yet final.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2017_001 ¦ Decision of 3 October 2017 ¦ “Nichtigkeit eines ESZ; Überprüfung der bisherigen Rechtsprechung zu Kombinationspräparaten; Klageabweisung”

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Prof. Dr. Daniel KRAUS
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Michael RITSCHER (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

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DECISION IN FULL

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THE BASIC PATENT

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Does the wording of an SPC matter?

Case No. S2107_006 ¦ Hearing of 9 October 2017

Note that Hepp Wenger Ryffel AG is involved in this matter on behalf of the defendant.

The supplementary protection certificate C00915894 is at stake; see the official court information about the hearing. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

It’s not the first time that the parties litigate about this SPC. Nullity proceedings are co-pending; see this Blog here and here. A major issue at stake now is the alleged infringement of the SPC. The FPC had granted ex parte interim injunctive relief; see this Blog here. Note, however, that the SPC concerns (emphasis added):

tenofovir disoproxilfumarat + emtricitabin

Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

Tenofovir disoproxil fumarate
CAS no. 202138-50-9
Tenofovir disoproxil phosphate
CAS no. 1453166-76-1

Now, is that still ‘the product’ in the sense of Art. 140d PatA?

Plaintiff essentially argues that an SPC would always extend to all salts of (a component of) a product, irrespective of its wording. On the contrary, defendant argues that this is a misunderstanding of the ‘Farmitalia’ decision of the ECJ (C-392/97): In that case, the market authorisation related to a specific salt, but the ECJ had allowed the registration of an SPC also for salts and esters. It had been held in ¶27 that

[…] where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent.

The ECJ’s judgment only concerned the requirements for grant of an SPC, but not the scope of protection. The FPC will now have to decide on the scope of an SPC directed to a combination product wherein a first component is identified as a specifically named salt (fumarate) which is not used in the attacked product (using a phosphate instead); and wherein the second component (emtricitabin) is not mentioned at all in the basic patent.

The President noted that no expert opinion of the judge-rapporteur will be established. The parties did not enter into settlement discussions.

Reported by Martin WILMING

Header image reproduced with kind permission and copyright of the Swiss Federal Administrative Court (St. Gallen) where the hearings of the FPC take place.

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BIBLIOGRAPHY

Case No. O2107_001 ¦ Hearing of 9 October 2017

Gilead Sciences Inc. ./. Mepha Pharma AG

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

Representative(s) of Defendant:

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THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

Download (PDF, 20KB)

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Ex parte interim injunctive relief granted based on an SPC

Case No. S2017_006 ¦ Decision of 30 August 2017 ¦ “Gutheissung superprovisorische Massnahme”

The defendant in this matter had notified the SPC holder of the imminent launch of its generic product in Switzerland, before a decision in parallel nullity proceedings was available. The validity of the SPC had been challenged in parallel nullity proceedings based on the SPC case law of the CJEU and an accordingly to be revised Swiss practice.

The plaintiff sought for interim injunctive relief without hearing the defendant beforehand. Since the critical issue had not yet been decided in parallel nullity proceedings, interim injunctive relief has provisionally been granted. The defendant has been invited to file a response.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. S2017_006 ¦ Decision of 30 August 2017 ¦ “Gutheissung superprovisorische Massnahme”

Judge(s):

  • Dr. Dieter BRÄNDLE

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

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DECISION IN FULL

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To be, or not to be … (protected by an SPC)

Case No. O2107_001 ¦ Main hearing of 21 August 2017

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

This case is all about the SPC granting practice in Switzerland, ie whether or not – and if so, how – the granting practice shall be brought in line with the recent case law of the CJEU post-Medeva.

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

Towards this end, the so-called ‘infringement test’ has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998. On the contrary, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva in 2011.

Gilead's Truvada
Gilead’s Truvada®

For more background information see this Blog here and the official court information about the hearing.

The pleadings initially focussed on two issues, ie the relevance of the reasons for harmonization given by the CJEU for Switzerland; and the differently phrased criteria used by the CJEU in its decisions post-Medeva. The court had explicitly invited the parties to extend their pleading to these two issues.

Plaintiff essentially argued that the ratio legis of the Swiss SPC regulation requires that the ‘infringement test’ be set aside, and that this change of practice shall be applicable with immediate effect for SPCs granted under the Fosinopril regime. It has been referred to various other European jurisdictions where this has been the outcome in parallel proceedings.

On the contrary, defendant argued with multiple lines of defense. First, when the legal situation of 2006 was applied, the case should be dismissed. Only if it was now decided in favour of a change of practice, it would still need to be decided whether or not this should have retroactive effect. If one were to accept a retroactive effect, the criteria established by the CJEU would need to assessed. The parties disagreed whether the CJEU has established a sufficiently consistent approach.

All in all, the hearing took very long. The plaintiff’s reply was finished after 2h at about 12am; defendant asked for a break of 2h to adapt his rejoinder which then took about 3h. It remains to be seen whether reply/rejoinder in a hearing in main proceedings is a model for success.

The parties did not enter into settlement discussions.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Prof. Dr. Daniel KRAUS
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

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THE BASIC PATENT

Download (PDF, 1.75MB)

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COURT INFORMATION ABOUT THE HEARING

Download (PDF, 48KB)

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NOTES BEFORE AND FROM THE HEARING

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