Tag: Mepha

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It’s official now: The effect of email newsletter fizzles out quickly

Reading time: 6 minutes
DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of the defendant, Mepha Pharma AG.

Case No. S2022_006 | Order of 12 October 2022 | ‘Fingolimod / Unfair competition’

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WHAT YOU NEED TO KNOW

The FPC applies a broad understanding of its concurrent competency with cantonal courts. It suffices that patent law is touched as a preliminary question (‘vorfrageweise’). →

Legal interest for a complaint based on the UCA requires a showing that one is actually better off when the complaint is allowed. →

Novartis’ request for interim measures against Mepha’s mailing re fingolimod was not considered, for lack of legal interest. Main proceedings based on the UCA are stayed until an indication of validity of EP 894 is available; S2020_002. →

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Background

As mentioned earlier on this Blog here, Novartis is seeking injunctive relief for Mepha’s generic version of Gilenya®, i.e. Fingolimod Mepha®.

Fingolimod (aka FTY720) is an immunosuppressant for the treatment of relapsing multiple sclerosis (MS). It’s a structural analogue of sphingosine; grab/ rotate the molecule here or below to get a better idea:

Gilenya was Novartis’ third-best selling drug in 2021. It is still a blockbuster, but sales have been declining since 2018 when it was Novartis’ best selling drug (2021: USD 2.8m, -7%; 2020: USD 3.0m, -7%; 2019: USD 3.2m, -4%; 2018: USD 3.3, +5%).

The patent at stake

The patent at stake is EP 2 959 894 B1 (see EPO Register and Swissreg for bibliographic details), with a priority date of as early as 27 June 2006. It’s a grandchild patent: The grandparent application is EP 2 037 906 (regional phase of WO 2008/000419 A1 at the EPO, actively withdrawn in April 2015 after a negative office action), and the parent application is EP 2 698 154 (filed Sept 2013, notification of deemed withdrawal in May 2016 for failure to reply to an office action). Yet another divisional application is pending; EP 3 797 765 (filed Nov 2020).

EP 894 had initially been refused by the ED in November 2020. Novartis appealed in December 2020 and requested expedited processing since it intended to lodge infringement proceedings in Turkey; see the Notice of Appeal, p. 1 and 32 et seqq. The Board of Appeal indeed accelerated the case, overruled the ED and ordered in oral proceedings of 8 February 2022 that a patent be granted; T 0108/21. See also Novartis’ press release of 15 February 2022. Novartis subsequently filed an amended description, with some reservations (cf. p. 2), and withdrew the designation of the U.K. shortly before grant. EP 894 was issued on 12 October 2022, i.e. about 15.5y after the filing date and on the day of issuance of the FPC’s order.

Five oppositions have been filed with the EPO on the day of grant(!).

What happened?
Fingolimod-Mepha

It’s all about Mepha’s letter entitled «Wichtige Mitteilung zur Patentanmeldung von Novartis betreffend Fingolimod-Mepha® 0.5mg» dated 27 April 2022 that had been sent to customers; it had also been available on Mepha’s website until 15 June 2022.

Novartis asserted that the letter contained confusing / misleading information about the exemptions under Art. 9 para. 1 lit. g PatA. Novartis argued that Mepha encouraged physicists and pharmacists to stock-pile Fingolimod-Mepha® for use after the grant of EP 894 and/or when interim injunctive relief in parallel infringement proceedings has been granted. Mepha disagreed that the information was misleading.

Competency of the FPC

Novartis sought to obtain a list of all addressees of the letter, and requested that Mepha be obliged to send a follow-up letter correcting the allegedly confusing / misleading information. The patent had not yet been granted when Novartis brought the suit. Accordingly, Novartis invoked Art. 2 UCA only.

Now, is the FPC competent to hear such a case?

The FPC applied a broad understanding of its concurrent jurisdiction with cantonal courts under Art. 26(2) PatCA, i.e. that it is competent even if patent law is touched only as a preliminary question (‘vorfrageweise’), as it is the case here:

This concurrent competency also covers summary proceedings.

Lack of legal interest

Novartis had argued that the sales numbers of Gilenya and the generic Fingolimod-Mepha establish that Mepha’s letter of April 27 has actually raised Fingolimod-Mepha’s market share from about 17% to about 20-23%:

Monthly sales

Novartis further argued that physicists and pharmacists would docket the letter and consult it again when placing new orders of fingolimod. The President did not buy into this and notes that systematic docketing and re-assessment of such mailings contravenes experience of life. The increased market share of the generic can rather be attributed to the fact that physicists and pharmacists have been made aware or reminded of the mere existence of the generic. This effect, however, is to be accepted by Novartis, at least for the time being while infringement proceedings with the nullity plea in defense are pending.

The President held that Novartis lacks a legal interest because it would not actually be better off when it succeeded with the complaint. On the contrary, the requested follow-up correction letter would likely even worsen Novartis’ position because it would again remind customers of the existence of the generic; p. 9, first para.

What’s next?

Main proceedings in this matter are still pending; O2022_008. The President decided that these proceedings are stayed until a decision in co-pending summary proceedings re infringment / validity of EP 894 is available; S2022_002. If the patent is held presumably invalid, this would also impact the assessment of Mepha’s letter under the UCA:

Gilenya capsule

Oral proceedings in the case S2020_002 are scheduled for 9 November 2022. Stay tuned.

Btw, for the trademark aficionados: Novartis’ two stripes trademark application for the Gilenya capsule has been refused in 2016, for lack of distinctiveness.

✍ MW

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BIBLIOGRAPHY

Case No. S2022_006 | Order of 12 October 2022 | ‘Fingolimod / Unfair competition’

Novartis AG
./.
Mepha Pharma AG

Single judge:

    • Dr. Mark SCHWEIZER

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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ORDER

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PATENT IN SUIT

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T 0108/21 — 3.3.01

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Equivalency in case of numerical ranges

Reading time: 9 minutes

Case No. S2021_005:
Order of 19 August 2021 | ‘Deferasirox-Mepha’
Decision of 15 December 2021 | ‘Deferasirox-Mepha’

DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of Defendant.
deferasirox

This case is about deferasirox, an iron chelating agent. It is mainly used to reduce iron overload in patients who are receiving long-term blood transfusions in the treatment of chronic anemias.

Novartis held a compound patent that already expired in June 2017; EP 914 118 B1 (EPO Register and Swissreg). A subsequent SPC expired in May 2021; C00914118/01.

Exjade

Initially, Novartis had sold deferasirox as dispersible tablets under the trademark Exjade®. However, the dispersible tablets have been taken off the market in October 2019. They were replaced by Novartis’ Jadenu®, i.e. swallowable tablets of deferasirox.

Mepha’s Deferasirox-Mepha had been approved by Swissmedic on 24 August 2020, and Mepha lodged nullity proceedings against EP 2 964 202 B1 (EPO Register and Swissreg) and EP 3 124 018 B1 (EPO Register and Swissreg) on 19 April 2021 (case no. O2021_004). The patents in suit are currently also challenged in opposition/appeal proceedings at the EPO; both patents were maintained in limited form in first instance, with their respective main claims as follows:

In response to the nullity attack, Novartis counter-claimed for infringement on 29 June 2021 (case no. O2021_005).

Novartis logo

Shortly thereafter, Novartis requested a preliminary injunction against Deferasirox-Mepha on 11 August 2021, based on EP 202 and EP 018. A request for ex parte preliminary injunctive relief was dismissed with order of 19 August 2021, for lack of particular urgency.

The summary judgment after hearing the defendant holds that both patents do not suffer from unallowable amendments, cf. ¶¶25-27. Novelty had not been challenged, and inventive step over WO 2004/035026 A1, WO 2007/045445 A1, WO 2009/067557 A1 and WO 2010/035282 A1 is acknowledged in the summary judgment, cf. ¶¶29 et seqq..

Mepha logo

With respect to infringement, it is important to recall that both patents require deferasirox to be present in an amount «from 45% to 60% by weight»; the allegedly infringing embodiment contained 64.3% by weight of deferasirox.

Novartis essentially argued that numerical values are not sacrosanct but need to be construed like any other feature, and that in particular in view of typical tolerances a value of 64.5% by weight would still be literally covered by the range of from 45% to 60% by weight. The FPC did not buy into that, in no uncertain terms:

Now, moving on to the assesement of infringement under the DoE, here is the current Swiss three-step questionnaire (as a reminder), i.e. assessment of i) same effect(s); ii) accessibility; iii) equality / equal value:

Q1: Same effect?

The judgment first elaborates on two essential issues in the assessment of Q1, i.e. the effect(s) of what; and just one, some or all effect(s)?

As to the first issue, the Supreme Court has caused some confusion amongst practitioners with a remark in BGE 143 III 666 — Pemetrexed that, at least at the face of it, might suggest that the effect of the whole claimed subject-matter is decisive, not only the effect of the replaced feature (r. 5.3.3, emphasis added):

Vielmehr muss die abgewandelte Ausführungsform alle diejenigen Wirkungen erzielen, die nach dem Verständnis des Fachmanns mit den einzelnen technischen Merkmalen des Patentanspruchs für sich und in ihrem Zusammenwirken erzielt werden sollen.

However, the Supreme Court has also explicity referred to the case-law of the German Supreme Court in the Pemetrexed case, and the German case-law undoubtedly focusses on the effect(s) of the replaced feature only. In sum, the FPC holds that it cannot see a clear deviation of the Supreme Court from the generally applied focus on the effect(s) of the replaced feature. (I hope the Supreme Court will clarify its position at the next possible occasion.)

On the second issue, i.e. which / how many effects of the replaced feature one has to look at, the judgment holds that only the desired effects of the replaced features matter (referred to as ‘erfindungsgewollte’ or ‘patentgewollte’ effects) — but that all these desired effects have to be considered (see emphasis in the above citation).

The judgment holds hat the same effect in terms of bioequivalency and swallowability suffices in the case at hand. The mere fact that plaintiff failed to establish the further desired effects of the replaced feature which are outlined in the patents in suit is held to be irrelevant because defendant could not prove that the challenged embodiments do not achieve the corresponding effects either.

Accordingly, Q1 is answered in the affirmative (same effect(s) given).

Q2: Accessibility?

Note that Q2 asks for ‘accessiblity’ of the same effect in retrospect, i.e. when the skilled person is confronted with both the claimed feature and the variant with the replacing feature: In knowledge of both, is the same effect ‘accessible’ for the skilled person?

This approach is in line with e.g. the UK Supreme Court in [2017] UKSC 48 (cf. ¶62), but markedly different to the approach of the German Supreme Court which excludes non-obvious variants from infringement under the DoE, i.e. variants that can only be found with inventive activity.

The FPC notes that, again, the Supreme Court judgment Pemetrexed (BGE 143 III 666) is not fully clear.  While the earlier Supreme Court judgment BGE 142 III 772 — Urinalventil explicitly held that an inventive variant (where exactly the replacing feature is inventive over the replaced one) can constitute an infringement under the DoE (cf. r. 6.4), the exact opposite is held in the Pemetrexed case (cf. r. 5.4.1):

The skilled person must, on the basis of his general knowledge, be stimulated by the patented invention to make the variation; if the variation is itself based on an inventive step, accessibility is ruled out.

Notably however, the Supreme Court in Pemetrexed did not refer to the Urinalventil case anymore, but rather to a pretty old case that still applied a ‘gist of the invention’ approach — which is rightly considered overcome today. (Again, I do hope that the Supreme Court will clarify its position at the next possible occasion.)

Finally, the FPC holds that the current wording of Q2 may be criticized with good cause (sic!), but that it surely is not totally off-beat since it is also used by the UK Supreme Court. The FPC did not consider it appropriate to deviate from the current wording of Q2 in summary proceedings; this shall be subject to main proceedings at the FPC — and ultimately the Supreme Court (again).

In application of the current (retrospective) wording of Q2 (cf. p. 52, last para.), the judgment holds that Q2 is to be answered in the affirmative (accessibility given). However, I’m afraid the way the conclusion (and the analysis two paragraphs earlier) is phrased might well add to the confusion:

Q2 as it stands is not about accessibility of the replaced feature per se, but rather about accessibility of the same effect of the replaced feature. (‘Accessibility’ (Auffindbarkeit) is a very misleading term in the context of Q2 anyway, in my perception; ‘recognisability’ (Erkennbarkeit) would make more sense to me.)

Q3: Equal value?

The judgment holds that tolerances beyond a claimed range which are generally accepted in a certain field are covered by the claimed range, under the DoE:

In view of the evidence on file (a meanwhile replaced EMEA ‘Note for Guidance on Manufacture of the finished dosage form‘ (1995) and European Pharmacopoiea 10.0, 2.9.5), the judgment holds that an amount of 64.4% by weight of the active ingredient is well within the generally accepted tolerance (66% by weight); cf. ¶¶59-61. Q3 was thus answered in the negative.

Accordingly, the summary judgment holds that the patents in suit are infringed under the DoE. Interim injunctive relief was thus granted, but not to the extent of storage (‘Lagern’) and possession (‘Besitzen’); cf. p 60 (don’t be misled by the wrong marginal numbers). Further, defendant was ordered to recall the product from commercial customers within three days of receipt of the judgment; 24 hours as requested were considered too short.

As mentioned above, main proceedings are already pending.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. S2021_005:
Order of 19 August 2021 | ‘Deferasirox-Mepha’
Decision of 15 December 2021 | ‘Deferasirox-Mepha’

Novartis AG
./.
Mepha Pharma AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Marco ZARDI

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

    • Andrea MONDINI (TIMES)
    • Dr. Andreas WELCH (Hepp Wenger Ryffel), assisting in patent matters

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ORDER IN FULL

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JUDGMENT IN FULL

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PATENTS IN SUIT

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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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The Supreme Court will not have its say on O2018_009 re Fulvestrant

Case No. 4A_332/2019 (Supreme Court) | Order of 13 November 2019, on appeal against O2018_009  (FPC) | Decision of 27 May 2019 | ‘Patentnichtigkeit Fulvestrant’

Reading time: 3 minutes

A quick recap: Actavis had challenged validity of AZ’s Swiss part of EP 2 266 573 back in 2015, and the FPC had indeed held in 2017 that EP 573 was invalid for lack of inventive step; see this Blog here. However, the Supreme Court overruled that decision and remitted the case back to the FPC for re-assessment of obviousness; see this Blog here. In the second round, the FPC held that the subject-matter of EP 573 did involve an iventive step; see the decision O2018_009 of 27 May 2019. In brief, the FPC held that neither

rendered the claimed subject-matter obvious. That decision was again appealed to the Supreme Court, and I have been eagerly awaiting a good read. But nothing like that. The Supreme Court only published a dismissal order. The parties have apparently reached an amicable settlement; court fees are shared.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. 4A_332/2019 (Supreme Court) | Order of 13 November 2019, on appeal against O2018_009  (FPC) | Decision of 27 May 2019 | ‘Patentnichtigkeit Fulvestrant’

Mepha Schweiz AG
(formerly Actavis Switzerland AG)		 (Appellant / Plaintiff)
./.
AstraZeneca AB (Respondent / Defendant)

Single Judge:

    • Dr. Kathrin KLETT

Court Clerk:

    •  Dr. Thomas WIDMER

Representative(s) of Appellant / Plaintiff:

Representative(s) of Respondent / Defendant:

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

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SUPREME COURT DECISION

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FPC DECISION

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EP 2 266 573 B1

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Fumarate and phosphate: Same same, but different?

Reading time: 6 minutes

Case No. O2017_023 | Decision of 3 May 2019

DISCLOSURE NOTICE

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

This case is about an alleged infringement 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 present main proceedings are following-up on summary proceedings S2017_006 when the FPC granted interim injunctive relief; 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.

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; we had reported about the main hearing in this matter on this Blog here. 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 ‘product’ in the sense of Art. 140d PatA?

The decision holds in ¶26-27 that in order to not frustrate the objective of an SPC the understanding of the term ‘product’ in the context of an SPC must be aligned with the understanding of the same term in the context of the Therapeutic Products Act (TPA). Thus, the scope of protection is not strictly limited to what is named in the MA or in the SPC, but rather extends to derivatives, salt forms, etc. which do not differ significantly in their properties with regard to safety and/or efficacy. In other words, the decision holds that the scope of protection extends to everything for which a simplified approval according to the TPA can be obtained (see Swissmedic Guidelines, ¶1.1.1).

Thus, the decision holds that the ‘product’ in the sense of Art. 140d PatA is (¶28):

Emtricitabine plus tenofovirdisoproxil fumarate and all derivatives (i.e. in particular all salt forms) thereof, provided that they have the same pharmacological effects.

Since the attacked embodiments had been approved by Swissmedic by way of a simplified approval, the decision holds that they are presumed to have the same pharmacological effects and are thus the same ‘product’ in the sense of Art. 140d PatA.

For the sake of completeness, the decision also analyses the alleged infringement under the DoE (¶33 et seqq.). As proposed by some scholars, the scope of protection of an SPC is determined by the content of the claims of the basic patent, whereby the description and the drawings are to be used for interpretation, and the Protocol on the Interpretation of Art. 69 EPC is also to be observed. Since the SPC is only product-related and purpose-related, the patent claim of the basic patent is to be defined artificially as if only the active substance designated in the certificate were mentioned, for the approved use of the active substance as a pharmaceutical. The description and drawings of the basic patent shall be used for the interpretation of the claim so formulated.

In brief, the decision holds that the three questions of the Swiss test for infringement under the DoE are to be answered in the affirmative, i.e. that the ‘same effect’ (Gleichwirkung), ‘obviousness’ (Auffindbarkeit) and ‘same value’ (Gleichwertigkeit) are given. Noteworthy, the decision holds that one cannot assume that the SPC holder made a purposive selection in favor of one salt over other salts mentioned in the specification. If one were to see this differently, equivalence for SPCs in different salt forms would in fact be excluded if only one specific salt had been used for the MA and the wording of the SPC. On the contrary, on the basis of an objective reading of the patent specification and in the knowledge that such an artificial claim is to be interpreted for the scope of protection of an SPC, the skilled person will readily assume that other salts,  because they are mentioned in the description, are not excluded from the scope of protection (¶43):

Im Gegenteil wird der fachkundige Dritte bei objektiver Lektüre der Patentschrift und im Wissen darum, dass ein solcher fiktiver Anspruch für den Schutzbereich eines ESZ auszulegen ist, in einer solchen Situation gerade davon ausgehen, dass natürlich diese anderen Salzformen, weil sie in der Beschreibung genannt werden, nicht vom Schutzumfang ausgeschlossen sind.

In any event, the decision holds that there was no specific, individualized disclosure of tenofovir disoproxil phosphate in the specification of the basic patent.

LDCs

Injunctive relief was thus granted. However, Mepha shall be permitted to export products that it had on stock when interim injunctive relief had been granted to any of the least developed countries, LDCs, according to the list of the the United Nations.

The decision is still open to appeal.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2017_023 | Decision of 3 May 2019

Gilead Sciences Inc.
./.
Mepha Pharma 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)
  • Dr. Michael RITSCHER (MLL)
  • Dr. Andreas SCHÖLLHORN (LSP), assisting in patent matters

Representative(s) of Defendant:

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DECISION IN FULL

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Truvada®: PrEPared for a decision on the scope of an SPC

Reading time: 5 minutes

Case No. O2017_023 | Hearing of 4 April 2019

Note that Hepp Wenger Ryffel is involved in this case on behalf of the defendant.
Gilead’s Truvada®

This case is about an alleged infringement of Gilead’s SPC C00915894; the basic patent is EP 0 915 894 B1 (see EPO Register and Swissreg). Gilead’s product is Truvada®, a pharmaceutical for the treatment of HIV-1 infection. The present main proceedings are following-up on summary proceedings S2017_006 when the FPC granted interim injunctive relief; see this Blog here.

Validity of the SPC is not an issue anymore, it has already been affirmed by the Supreme Court; see this Blog here.

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.

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 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?

The parties agreed to disagree on this issue in the hearing. Gilead insisted that the ‘typical product definition’ has to be applied, in a sense that the fumarate is only to be understood as a ‘reference’ for the assessment of whether or not yet another salt form has the same pharmacological effect. If it had, then it should be considered ‘the same product’.

On the other hand, Mepha argued that the term ‘product’ is defined in Art. 140a(2) PatA, and it is to be construed within the context of the PatA; the Therapeutic Products Act (TPA) was not relevant in this respect. Thus, infringement has to be assessed as it is routinely done, i.e. deciding on whether there is literal infringment or infringement under the DoE. Mepha argued that the SPC is neither literally infringed, nor under the DoE.

The expert opinion of the judge-rapporteur held that the SPC was infringed, apparently essentially along the line of Gilead’s arguments. Still, in case the court followed the expert opinion, Mepha requested the court to provide a full assessment of infringement in the judgment, also including an assessment of literal infringement and infringement under the DoE. The Supreme Court would then be in a position to review the whole matter at once and in a timely manner, without the need to remit the case back to the FPC to carry out yet another assessment.

As mentioned above, Truvada® is a pharmaceutical for the treatment of HIV-1 infection. But Mepha recently obtained the market authorization of its Emtricitabin-Tenofovir-Mepha® in Switzerland also for PrEP – which is short for Pre-Exposure Prophylaxis; see Swissmedic Journal 02/19. More information on PrEP can be found on Gilead’s website here. However, Gilead currrently has no MA for PrEP in Switzerland; Mepha’s MA is the only one in Switzerland for this indication.

PrEP likely is the reason why this case attracted quite some public attention. There has even been an organised Facebook event in St. Gallen; and flyer have been distributed, see here and here.

‘Groupe sida‘ activists

On a sidenote, when a member of the audience wore a shirt with one of these slogans on it, the presiding judge held that this was an attempt to influence the judges, and thus ordered him to either hide the slogan / change clothes; or to leave the court room.

The NZZ reported on the matter, as well as the ‘Tagesschau‘:

 
Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2017_023 | Hearing of 4 April 2019

Gilead Sciences Inc.
./.
Mepha Pharma 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. Andreas SCHÖLLHORN (LSP), assisting in patent matters

Representative(s) of Defendant:

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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 ‘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

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