Bayer’s uphill fight re sorafenib tosylate

Reading time: 6 minutes

Case No. S2021_006 | Hearing of 4 April 2022

Zentiva logo

Bayer HealthCare is seeking preliminary injunctive relief against Sorafenib Zentiva of Helvepharm, the Swiss branch of Zentiva. Bayer’s product is Nexavar® (see Compendium and Bayer’s Nexavar website for more information); the active ingredient (AI) is sorafenib, a kinase inhibitor inter alia for the treatment of primary kidney and liver cancer.

Sorafenib
Bayer logo

The basic patent on sorafenib is EP 1 140 840 B1 which lapsed on 11 January 2020. An SPC had been in force until 28 March 2021; C01140840/01. The present litigation is about alleged infringement (and validity) of EP 2 305 255 B1 (see EPO Register), specifically claiming the tosylate salt of sorafenib. EP 255 will only lapse on 3 December 2022.

As patent protection is fading out, Bayer’s turnover generated with Nexavar® fell sharply in 2021:

Nexavar® package

Patent practitioners might recall Nexavar® and/or sorafenib tosylate for the first compulsory license that had been issued in India already back in 2012, which has been confirmed through all instances.

Lately, EP 255 was held to be invalid both in Germany (Federal Patent Court, judgment of 29 September 2021 in cases 3 Ni 12/20 and 3 Ni 13/21) and the U.K. (judgment of 8 October 2021 in case [2021] EWHC 2690 (Pat); the Court of Appeal decided on 1 April 2022 to hear the appeal).

Helvepharm logo

From the announcement of the hearing, it had been known that Helvepharm asserts invalidity of EP 255 in view of unallowable amendments, lack of novelty over WO 00/42012 A1 and obviousness in view of Lyons et al. (the acronym BAY 43-9006 refers to sorafenib as such, i.e. the free base; not sorafenib tosylate).

In the hearing, it became clear that the judge-rapporteur‘s expert opinion held that the claimed subject-matter was obvious, in line with the judgments in Germany and the U.K.

Plaintiff urged the court to independently assess the matter, in particular in view of the many expert declarations on file in the present proceedings which the foreign courts had not at hand. Plaintiff emphasized that the skilled person had not been in a position at the priority date to reliably determine the dissolution rate of sorafenib tosylate; the experimental setup previously known in the art had not been suitable. Further, a tosylate had not been a promising candidate for a weak base such sorafenib in any event.

However, the inventors had a moment of genius:

Die Erfinder hatten einen genialen Moment.

With its concluding remarks of the first pleadings, Bayer essentially held that if ever a salt form of a pharmaceutical compound was patentable, then sorafenib tosylate is it.

Expenses for the assistance of a patent attorney were orally indicated (and detailled to some extent) as kCHF 52, but no evidence was handed over.

After a break, the President gave the floor to Zentiva‘s counsel, indicating that the judges had a lively discussion during the break, and that they are now eagerly awaiting Zentiva‘s pleadings:

Die Diskussionen im Spruchkörper in der Pause waren heftig! Wir sind gespannt auf Ihre Ausführungen.

Defendant focused its pleadings on non-obviousness only.

In defendant‘s view, Lyons does not teach that the free base has been used in the clinical trials. Lyons is just silent about this (in my understanding, contrary to what had been held in the judge-rapporteur‘s expert opinion). In any event, the first step would be a salt screening in order to assess the bioavailability of sorafenib — and tosylate would have been included in such a salt screening, essentially as outlined in Bastin. A salt screening involves not only the assessment of solubility, but also the dissolution rate. The skilled person would not have disregarded the tosylate in view of its low solubility. Further, defendant argued that it had well been possible for the skilled person to determine the dissolution rate, actually with reference to an experimental setup that had been known in the art and which is similar to the one used by plaintiff.

Defendant handed over a cost note for assistance of the patent attorney. Further, defendant objected to plaintiff‘s asserted costs of kCHF 52 as somewhat high for summary proceedings („etwas hoch“), and not evidenced anyway.

An entertaining aspect of the second round of pleadings circled around the (lack of) plaintiff‘s cost note for patent attorney expenses. Plaintiff was seemingly taken by surprise that the expenses were not accepted by defendant, and asked for a break to come up with written evidence of the expenses in the amount as indicated earlier. The judges were noticeably perplexed (instructions for the hearing typically remind the parties that cost notes shall be provided in the first round of pleadings). Still, the President interrupted the proceedings for ten minutes, for the plaintiff to gather the written evidence of expenses, and defendant to prepare the rebuttal to plaintiff‘s pleadings. Worse comes to worst: Plaintiff apparently had a letter in its electronic dockets that set forth the costs incurred, but could not provide any printout. Defendant did not consent to an on-the-spot visual inspection of the electronic file.

The parties did not engage in settlement discussions.

/MW

BIBLIOGRAPHY

Case No. S2021_006 | Hearing of 4 April 2022

Bayer HealthCare LLC
./.
Helvepharm AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Andreas SCHÖLLHORN

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

    • Dr. Simon HOLZER (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant:

ANNOUNCEMENT

PATENT IN SUIT

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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 666Pemetrexed 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

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

ORDER IN FULL

JUDGMENT IN FULL

PATENTS IN SUIT

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Ex parte interim injunctive relief granted and confirmed after hearing the Defendant

Reading time: 3 minutes

Case No. S2021_003 | Decision of 15 September 2021 | ‘Baugerüst’

DISCLOSURE NOTICE
Hepp Wenger Ryffel is involved in this matter on behalf of the Plaintiff / Tobler AG.

The patent at stake is EP 2 881 521 B1; cf. EPO Register and Swissreg for further bibliographic information. Tobler AG had requested interim injunctive relief for Vijator Schweiz GmbH‘s scaffolds of the “WAS-M” type with a diagonal strut of rectangular, oval or pentagonal shape (cf. claim 1 of EP 521):

Notably, Vijator Schweiz had admitted that EP 521 was valid and infringed by its WAS-M scaffolds; cf. ¶16.  Nevertheless, Vijator Schweiz had indicated to Tobler after having been served with the request for interim injuntive relief that it would export the remaining WAS-M scaffold as soon as possible. This gave rise to ex parte interim injunctive relief by order of 16 June 2021, prohibiting such export. Further, Vijator Schweiz did not submit an unconditional cease and desist declaration, but rather only declared that it would do so in case the FPC would order interim injunctive relief. The threat of (further) infringing acts and of not easily reparable harm was thus established; cf. ¶17, 20.

Tobler logo

Urgency was given, too: Tobler had undisputedly become aware of the infringing acts only in April 2021, i.e. the request for interim injunctive relief was filed soon thereafter (25 May 2021) and well before the 14 months bar for ‘relative urgency’; ¶21.

Commensurability of interim injunctive relief was a non-issue since Vijator had declared that it would provide a cease and desist declaration when the FPC would order interim injunctive relief; cf. ¶24.

The parties were far apart with their respective estimates of the value in dispute: Tobler assumed CHF 100’000,–, while Vijator Schweiz submitted that it had only made a profit of CHF 1’000,– with the infringing scaffolds. The judgment holds that in case of such discrepancy the higher value is typically to be taken — and it is Plaintiff’s commercial interest which is relevant for the value in dispute, not Defendant’s profits; ¶30.

In a nutshell, interim injunctive relief was ordered as requested, including a prohibition to export.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2021_003 | Decision of 15 September 2021 | ‘Baugerüst’

Tobler AG
./.
Vijator Schweiz GmbH

Single Judge (President):

    • Dr. Mark SCHWEIZER

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

    • n/a
    • n/a, assisting in patent matters

DECISION IN FULL

EX PARTE INTERIM INJUNCTION

PATENT IN SUIT

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Inspection on site on the day of the main hearing

Reading time: 2 minutes

I have recently attended a main hearing at the FPC that began only in the afternoon because a site visit took place on the same day immediately before the hearing, at the premises of the defendant.

Note that this site visit was not for the purpose of a precise description in accordance with Art. 77(1) lit. b PatA (see e.g. this Blog here), but rather an inspection in accordance with Art. 181, 182 CPC. To the best of my knowledge, this was the first time that the FPC actually conducted such an inspection «in order to see the facts for itself or for a better understanding of the case.»

The judges did not bring any measuring instruments or analytical equipment — but both parties did, and I feel that the judges appreciated the demonstrations and measurements being made on the object of inspection during operation. The results of the measurements (showcased in the header image) have later on been discussed at the hearing .

Getting to the bottom of things is a good thing to do. In my perception, the inspection went smoothly and could (should?) set a precedent.

Reported by Martin WILMING

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The first enforcement decision of the FPC — but there is nothing to enforce (yet)

Reading time: 7 minutes

Case No. S2020_001 | Decision of 25 August 2020 | ‘Enforcement request’

HEADNOTE

Art. 26(2) PatCA, Art. 339 CPC; jurisdiction for execution.

The Federal Patent Court is competent for the enforcement of its judgments rendered in concurrent jurisdiction.

We have reported about this matter on this Blog already here and here.

The parties had come to a settlement in their patent ownership dispute in proceedings O2017_026 at the FPC. But, clearly, the parties do not get along well with each other. The former plaintiff now tried to enforce the settlement decision.

Competency of the FPC

This is what the hn is all about. Art. 339(1) CPC provides for mandatory jurisdiction to order measures of enforcement. For disputes falling under the exclusive subject-matter jurisdiction of the FPC (Art. 26(1) PatCA), enforcement is explicitly reserved exclusively to the Federal Patent Court because of the primacy of the PatCA (Art. 27 PatCA) for such disputes.

For disputes falling under concurrent subject-matter jurisdiction (Art. 26(2) PatCA), the place of jurisdiction for enforcement is not governed by Art. 339(1) CPC, insofar as the FPC has ruled on the merits of the case; the FPC is competent to enforce its decisions for the whole of Switzerland also in this concurrent subject-matter jurisdiction. The place of jurisdiction is determined by Art. 339(1) CPC only to the extent that a competent cantonal court has ruled on the case in disputes falling under the concurrent jurisdiction of the FPC (Art. 26(2) PatCA).

A request for enforcement of a decision concerning the entitlement to patent applications is a civil action within the meaning of Art. 26(2) PatCA. If the underlying judgment is patent-related, which always applies to substantive judgments rendered by the FPC, then the enforcement of that judgment is also patent-related. The Federal Patent Court is therefore competent to enforce such judgments.

No manifest abuse

The FPC held that the defendant’s position is erroneous that, in enforcement proceedings, the court is not competent to interpret the judgment to be enforced. The mere fact that the judgment contains language that requires interpretation does not make a motion for enforcement abusive.

But it’s a different topic whether the alleged obligations of the defendant actually flow from the judgment. This question must be addressed when assessing the merits of the motion for enforcement. It is possible that the plaintiff’s motion may not succeed because the obligations to be enforced do not in fact arise from the judgment, as the defendant claims. But not every unsuccessful motion is in itself abusive.

In substance, the defendant essentially argued that the request for execution was abusive because it would be unsuccessful — which is insufficient.

time is not yet ripe

The defendant had argued that all of its obligations to pay a share of the license fees received under the license agreements for the assigned patents are subject to the plaintiff’s obligation to take all necessary steps to assign the patent applications to the plaintiff. On the contrary, the applicant argued that there is no subordination between its obligation to take all necessary steps to assign the patent applications and the payment of a share of the license royalties generated.

Apparently, there is a license contract in place between ROCK dental and Sulzer Mixpac AG, dated 23 January 2017. I have not been able to spot a corresponding product on the market, though. But Sulzer Mixpac is pursuing a related patent application, WO 2020/083841 A1.

Anyway, according to the plain language of the settlement, there is an exchange between the transfer of the applicant’s share in the patents and the compensation due under Art. 3 of the settlement:

The compensation under Art. 3 of the settlement is therefore effectively subject to the obligation of the applicant to take all necessary steps for the transfer of his share in the patents (or patent applications). However, it is not necessary that the applicant’s share in the patents (or patent applications) be actually transferred. All that is required under Art. 2 of the settlement is that the applicant takes all necessary steps for the transfer of his share in the patents / patent applications. If the effective transfer fails, for example because the defendant does not take the necessary steps, the claimant has fulfilled his obligations as the performance has been duly offered within the meaning of Art. 342 CPC.

It was undisputed that the patent application US 2017/325923 filed by the applicant and specifically mentioned in Art. 2 of the settlement has not been formally transferred to the defendant, i.e. the defendant is not yet registered as the sole owner of this application in the US Patent Register (and no assignment has been recorded to date).

The parties did not agree on the reasons why the transfer of this patent application has not been made. The applicant argued that he had undertaken all that was necessary for a transfer, namely that he has signed all the required documents. According to him, the non-registration of the transfer was attributable to the defendant, who refused to cooperate with the assignment. On the other hand, the defendant argued that the plaintiff did not sign all the required documents and that he himself diligently and fully complied with his obligations, in particular the various requests made by the plaintiff’s patent attorneys, who systematically answered all enquiries with considerable delay and in an incomplete or incomprehensible manner.

The FPC held that the applicant failed to show that the fault for the non-assignment of the patent(s) lies with the defendant. The file revealed that the applicant’s patent attorneys had often acted with a considerable delay and demanded documents that were not necessary for a transfer of patent applications. It therefore appears that the failure to register the transfer of the US patent application US 2017/325923 to the defendant is the responsibility of either the plaintiff or the plaintiff’s patent attorneys (acting as plaintiff’s associate), who was in possession of the documents necessary to execute the registration of the transfer on 14 August 2019. As the applicant is liable for the acts and omissions of his associate (Art. 101 CO), the failure to get the transfer registered must be considered a fault of the applicant.

Joh 8:7

In summary, the FPC held that the applicant had failed to prove that it has taken all necessary steps to assign the U.S. patent application to the defendant. Notably, the FPC held that it may well be that the defendant has also failed to take certain steps. However, until plaintiff has taken all necessary steps to transfer his rights, plaintiff is prohibited from seeking performance of defendant’s outstanding obligations.

Well,

[h]e who is without sin among you, let him throw the first stone at her.

UPDATE 6 November 2020:

The decision has not been appealed / is final now.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2020_001 | Decision of 25 August 2020 | ‘Enforcement request’

Dr. David BENSOUSSAN
./.
ROCK dental AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Lara DORIGO

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

SETTLEMENT

PATENT FAMILY IN SUIT

See the consolidated patent family in the European Patent Register.

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Low dosage form of tadalafil held obvious, preliminary injunction denied

Reading time: 13 minutes

Case No. S2019_007 | Decision of 1 October 2019

DISCLOSURE NOTICE

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

The patent in suit is CH/EP 1 173 181 H1, after partial surrender of EP 1 173 181 B3 which itself came out of central limitation proceedings concerning EP 1 173 181 B1 before the EPO; see EPO Register and Swissreg for further information.

EP’181 is meant to protect Lilly‘s low dosage forms of tadalafil, i.e. Cialis® 2.5 mg and Cialis® 5 mg, for the treatment of erectile dysfunction. Cialis at these low dosages is sometimes referred to as the ‘weekend pill’ because it can not only be taken on demand but also once daily, without regard to timing of sexual activity. See drugs.com and Lilly’s prescribing information.

Lilly sought for a preliminary injunction against Sandoz‘s generics Tadalafil Sandoz® 2.5 mg and Tadalafil Sandoz® 5 mg.

The feature analysis of claim 1 of CH/EP’181 H1 reads as follows:

1.1 Pharmaceutical unit dosage composition
1.2 comprising a compound having the structural formula [tadalafil]
1.3 comprising 1 to 5 mg of this compound
1.4 said unit dosage form suitable for oral administration
1.5 up to a maximum total dose of 5 mg per day
1.6 for use in treating a condition where inhibition of PDE5 is desirable
1.7 wherein the condition is sexual dysfunction.

No dosage regime

Note that the claim does not address the frequency of taking of tadalafil. In accordance with feature 1.5, tadalafil could be taken once or several times per day (prophylactic or on demand, as long as the dose of 5 mg per day is not exceeded), and it is not defined that tadalafil is taken each day. Similar to the German FPC (¶ II.1), the decision holds that the claim lacks an essential element of a dosage regime, i.e. the frequency of taking tadalafil.

Claim to priority presumably valid

EP’181 is based on a national phase application of WO 00/66099 and claims priority of US 60/312,036.

The decision holds that the claim to priority is presumably valid, both formally (¶ 19) and on the merits (¶¶ 20-22).

Presumably no undue extension of subject-matter

The range of ‘1 to 20 mg’ in EP’181 B1 — with ‘5 to 20 mg’ being preferred — had been limited to ‘1 to 5 mg’ in EP’181 B3.

The decision holds that the plea in defense with respect to an undue extension of subject-matter is presumably unfounded (¶¶ 23-24), because the skilled person would still have seriously contemplated the range of 1 to 5 mg in view of dependent claim 4 (2.5 mg) and example 7 (2 mg).

Novelty acknowleged …

Since the priority claim was held presumably valid, the only remaining document to be considered with respect to novelty was WO 97/03675 A1 (Daugan). The relevant disclosure therein reads as follows (p 5, l 1-11):

For administration to man in the curative or prophylactic treatment of the disorders identified above, oral dosages of [tadalafil] will generally be in the range of from 0.5-800 mg daily for an average adult patient (70kg). Thus for a typical adult patient, individual tablets or capsules contain from 0.2 – 400 mg of active compound, in a suitable pharmaceutically acceptable vehicle or carrier, for administration in single or multiple doses, once or several times per day. […] In practice the physician will determine the actual dosing regimen which will be most suitable for an individual patient and it will wary with the age, weight and response of the particular patient.

Specific examples in Daugan make use of 50 mg of active compound in a tablet (p 12 ff).

Now, is the range of 1-5 mg novel over the broad range disclosed in Daugan?

According to the EPO Guidelines (G-VI, 8, ed. 2018), a sub-range selected from a broader numerical range of the prior art is considered novel, if each of the following three criteria is satisfied (emphasis added):

    1. the selected sub-range is narrow compared to the known range;
    2. the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art and from the end-points of the known range;
    3. the selected range is not an arbitrary specimen of the prior art, i.e. not a mere embodiment of the prior art, but another invention (purposive selection, new technical teaching).

The decision only applies criteria a. and b. for novelty, while the requirement of a purposive selection / new technical teaching (c.) is said to be related to obviousness only. Note that this criterion is also abolished with in the 2019 edition of the EPO Guidelines, entering into force on 1 November 2019.

Clearly, 1-5 mg is a narrow range compared to 0.2 – 800 mg; criterion a. is thus fulfilled.

But is the range sufficiently removed from the working example of 50 mg in Daugan? The decision holds that even though the absolute difference is only 45 mg, the absolute amounts still differ by a factor of 10. Thus, criterion b. is also considered fulfilled.

On a personal note, I doubt that time was already ripe for changing the Guidelines. The recent 2019 edition of the book ‘Case Law of the Boards of Appeal’ in chapter I.C.6.3.1 correctly holds that there are several decsions that disregard criterion c., but still there are even recent decisions that do apply criterion c. There have been constant rumors for quite a while that this might be sth for the EBoA to finally decide. I would have preferred to await final clarification on BoA level over the uncertainty of an early change in first instance proceedings that might perhaps need to be reversed again in a worst-case scenario. In my view, criterion c. when correctly applied is a test whether there is a ‘new technical teaching’ (not just a formally new numerical value); see emphasis above. I cannot see any fundamental misconception in doing so under the title of novelty. A new technical teaching must not be confused with a non-obvious technical teaching. But be this as it may, I am still hopeful that the EBoA might finally have its say.

… but the low dosage form is obvious

Actually, obviousness is at the heart of this multi-national dispute. Lilly argued that courts in strict application of the problem-solution approach had found that EP’181 B3 was valid (e.g. in DK and FI), whereas only courts that applied a somewhat different approach concluded that EP’181 B3 was invalid (e.g. in the U.K., DE and NL):

Accordingly, Lilly pushed for a strict application of the problem-solution approach in the present proceedings. The FPC indeed applied the problem-solution approach, but still concluded that EP’181 H1 was invalid.

The parties agreed on WO 97/03675 A1 (Daugan) as the closest prior art.

It’s no more than a sideshow for the outcome of the decision, but an interesting one:

The decision holds in ¶ 33 that the skilled person would understand the broad ranges in Daugan as ‘boiler plates’ which are aimed at claiming the broadest possible protection. This implies quite some knowledge of a patent practitioner. The discussion of the broad ranges is in the specification, not in the claims. What is more, the skilled person is defined earlier in the decision as follows (¶ 14):

[A] team consisting of a clinical pharmacologist (with knowledge of the pharmacokinetics of conventional medicines and biological preparations) and a clinician (with knowledge of urology, and in particular of sexual dysfunctions or erectile dysfunctions and available medicinal treatments such as sildenafil).

I wonder where any knowledge of a patent practitioner stems from in this team. When discussing patent literature in litigation, it is constantly assumed that the ‘skilled person’ just knows how to read patents, and that he is even able to understand what the drafting attorney might have had in mind and intended in legal terms when drafting the specification. This is anything but realistic, in my perception. On the contrary, the typical pharmacologist and clinician will be used to read scientific publications, and without any additional training in patent matters he will approach a patent document just like any other piece of scientific literature.

In view of WO 97/03675 A1 (Daugan) as closest prior art, the FPC defined the objective technical problem as to provide a clinically effective and safe dosage of tadalafil for the treatment of sexual dysfunction.

The decision holds that it is credible that the skilled person would always aim to find the lowest possible effective dosage of an active substance, for various reasons. First, because the skilled person knows that a lower dosage will have fewer side effects, and the avoidance of side effects is always a goal in drug research. Second, the skilled person will strive to find the lowest possible effective dosage, because it may well be that the regulatory authority asks for it. Although it is not certain that the approval authority will require this information, it is still reasonably possible. Even this possibility is a sufficient incentive to identify the lowest possible dosage: If the necessary studies would only be done at the request of the authority later on, the market authorisation would be considerably delayed.

Interestingly, the decision also expands on the ‘reasonable expectation of success’ (see this Blog here) — and its irrelevance for the case at hand. A ‘reasonable expectation of success’ is not necessary if the skilled person has an incentive for any other reason (e.g. a potential inquiry from the approval authority to specify the lowest effective dosage in the present case). The skilled person will then just take the necessary steps towards the invention unless he has to assume that this is hopeless right from the outset (¶36):

[E]ine Erfindung [ist] naheliegend, wenn der Stand der Technik […] dem Fachmann einen Anlass (“Motivation”) bietet, den nächstliegenden Stand der Technik so abzuwandeln, dass er zum beanspruchten Gegenstand gelangt. Oft wird den Fachmann eine begründete Erfolgserwartung zu der Weiterentwicklung veranlassen, d.h. wenn er aufgrund wissenschaftlicher Erwägungen annimmt, dass die Abwandung des Standes der Technik mit hoher Wahrscheinlichkeit zur Lösung der Aufgabe führt, wird er diese Abwandlung naheliegenderweise vornehmen. Eine begründete Erfolgserwartung in diesem Sinne ist aber nicht notwendig, wenn der Fachmann bereits aus anderen Gründen einen Anlass hat, den nächstliegenden Stand der Technik zum Gegenstand des geltend gemachten Anspruchs weiterzuentwickeln. Er wird diese Entwicklung dann vornehmen, wenn er nicht geradezu annehmen muss, dass sie aussichtslos ist.

The decision holds that the skilled person would  have routinely included a dose of 5 mg of tadalafil in the phase IIb clinical study to determine the dose-response curve, in particular in view of Goldstein et al. (1997) where quite some efficacy of the sildenafil, the first-in-class drug, had been reported for a dosage of as low as 5 mg.

Excerpt from Goldstein et al. (1997)

The skilled person would then inevitably have realised that tadalafil at a dose of 5 mg was still clinically effective. Thus, the decision holds that the subject-matter of EP’181 H1 was prima facie obvious.

  • The decision can still be appealed to the Supreme Court.

Reported by Martin WILMING

The ‘two bathtubs’ header image is a screenshot taken from one of Lilly’s Cialis® commercials at about 0:40 min.

BIBLIOGRAPHY

Case No. S2019_007 | Decision of 1 October 2019

(1) ICOS Corporation
(2) Eli Lilly (Suisse) SA
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Martin SPERRLE
    • Marco ZARDI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of ICOS / Eli Lilly:

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

Representative(s) of Sandoz:

DECISION IN FULL

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PATENT IN SUIT

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PI request against Edwards’ TMVr device PASCAL granted based on EP’850

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Case No. S2019_002 | Decision of 15 August 2019 | ‘PASCAL’

DISCLOSURE NOTICE

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

This infringement case is about EP 1 624 810 B1 and EP 1 408 850 B1; see EPO Register (here and here) and Swissreg (here and here) for further bibliographic information. Plaintiffs (Abbott et al.) asserted that defendants  (Edwards et al.) are infringing the Swiss parts of EP’810 and EP’850 with their PASCAL Transcatheter Mitral Valve repair (TMVr) device.

See Edward’s PASCAL website for further information on this product.

For comparison, plaintiffs’ own product is MitraClip:

See Abbott’s MitraClip website for further information on this product.

The main hearing had taken place on 3 July 2019.

The decision holds that PASCAL infringes claim 1 of EP’850 (¶¶ 62-70), and that this claim is valid over the prior art referred to by defendants as a plea in defense, i.e. US 3,874,388 (E5), WO 96/32882 A1 (E6) and CN 1 142 351 A (E7); ¶¶ 48-61. Preliminary injunctive relief was thus granted, based on EP’850.

As to EP’810, the decision holds that claim 1 is not infringed; ¶¶ 31-34.

Not easily reparable harm

Defendants contested that MitraClip itself is covered by the patents in suit; plaintiffs disagreed. The decision holds that this is irrelevant in any event. The irreparable harm of plaintiffs 1 and 3 depends on whether their own product is competing, since experience has shown that this leads to a loss of turnover, the extent of which is difficult to prove. Mere reference to potential financial compensation does not eliminate the irreparable harm; ¶ 77.

Proportionality

Precautionary measures must be proportionate in the sense that the content of the ordered measure must be suitable to avert the asserted disadvantage and must not go further than is absolutely necessary to avert the disadvantage (‘proportionality in the narrower sense’). Whether the adoption of precautionary measures may also be made dependent on the fact that the precautionary measure applied for does not encroach disproportionately heavily on the legal sphere of the defendant (‘proportionality in the broader sense’) is controversial.

In the present case, the FPC could leave this issue undecided because the defendants did not claim that the precautionary measure applied for has a disproportionate impact on their legal sphere, but that it is in the public interest that the marketing of the PASCAL device in Switzerland should not be prohibited as a precautionary measure.

The decision holds that — while it is controversial whether the adoption of a precautionary measure can be refused if it disproportionately affects the interests of the defendant — it is clear that public interests are not to be taken into account when it comes to weighing of interests: The PatA provides for a system of compulsory licences which, in principle, closes the gap in order to protect public interests from being jeopardised by the enforcement of patents. In particular, Art. 40 PatA provides for a compulsory licence in the public interest. In passing, the decision notes that it has not yet been decided in Switzerland whether the claim to a compulsory license can also be invoked in summary proceedings. Note that this has been answered in the affirmative in Germany recently; BGH X ZB 2/17 — Raltegravir.

Anyway, defendants did not claim that they should be granted a compulsory license in order to protect public interests. In particular, defendants had not submitted a license offer to the patentee at reasonable market conditions which the patentee has not accepted within a reasonable period (cf. Art. 40 in conjunction with Art. 40e (1) PatA). Accordingly, the objection that the requested measures were disproportionate has been rejected.

These considerations in ¶¶ 80-82 are what the FPC referred to in the following Tweet:

An appeal is currently pending at the Supreme Court.

UPDATE 7 May 2020:

The appeal has been dismissed; the Supreme Court decision 4A_453/2019 has been published earlier today.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2019_002 | Decision of 15 August 2019 | ‘PASCAL’

(1) Evalve, Inc.
(2) Abbott Cardiovascular Systems, Inc.
(3) Abbott Medical (Schweiz) AG
./.
(1) Edwards Lifesciences AG
(2) Edwards Lifesciences Technology Sàrl
(3) Edwards Lifesciences IPRM AG
(4) Mitral Valve Technologies Sàrl

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • André ROLAND
    • Dr. Michael STÖRZBACH

Judge-rapporteur:

    • André ROLAND

Court Clerk:

    • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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ANNOUNCEMENT OF THE HEARING

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EP 1 624 810 B1

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EP 1 408 850 B1

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Register ban ordered, but only after hearing the defendants

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Case No. S2019_003 | Decision of 6 February 2019
Case No. S2019_003 | Decision of 11 July 2019

These two decisions in summary proceedings are heavily redacted — which is an exception to the rule. Obviously, the overall conflict between the parties also involves some criminal allegations against a natural person (Art. 146 CC; fraud).

In view of the criminal allegations I am not going to engage in any de-anonymisation exercise here; and this post is not open for comments, either.
Canton of Fribourg

A register ban for six Swiss patent applications had been issued by the public prosecutor of the Canton of Fribourg on 22 May 2017, in view of the criminal charge. The public prosecutor informed the plainfiff on 21 November 2018 of the deadline for finally lodging civil proceedings, i.e. 31 January 2019, and indicated that sequestration of the six patent applications would be lifted at that date (however, this apparently had not happened).

The plaintiff indeed initiated civil proceedings, but only on the very last day of the time limit,  and only in summary proceedings. In particular, issuance of a register ban had been requested without hearing the defendant beforehand.

While the President acting as single judge appreciated the risk that the six patent applications might be transferred to defendant (3) in view of some prior conduct of the defendant(s), and even though particular urgency was acknowledged, he did not order a register ban ex parte. The President held that the urgency is exclusively due to the late submission of the request by the plaintiff who should have taken action swiftly after the public prosecutor’s notification of 21 November 2108. If the plaintiff had filed the request in a timely manner, i.e. in early December 2018, the defendants would have had sufficient time to take a position on the request. The President held that the defendants cannot be deprived of their constitutional right to be heard because of the plaintiff’s belated action. The decision refers in passing to S2018_002, ¶7, for that a delay of two months results in the rejection of the request in any event.

The request for issuance of interim measures without hearing the defendant beforehand was thus denied with decision of 6 February 2019.

However, the register ban had still been issued with decision of 11 July 2019. In balancing the potential disadvantages suffered by the plaintiff and the defendants, the President (again acting as single judge) concluded that there was a much greater potential damage that the plaintiff would suffer if the register ban would not be issued, compared with the defendants potential damage if the register ban was granted. Nevertheless, the decision clearly notes that it is highly doubtful that the six patent applications had been contractually assigned to the plaintiff. Still, the fact that defendants (1) and (2) had previously attempted to assign the patent application to defendant (3), which is a mailbox company in Luxembourg, played out to the plaintiffs advantage, for the time being.

UPDATE 22 August 2019:

The decision of 11 July 2019 has not been appealed / is now final.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2019_003 | Decision of 6 February 2019
Case No. S2019_003 | Decision of 11 July 2019

A. Sàrl
./.
(1) B.
(2) C.
(3) D. S.A.

Single judge:

  • Dr. Mark SCHWEIZER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of A.:

  • Stefano FABBRO (FLD)

Representative(s) of B.:

FIRST DECISION OF THE FPC
→ register ban denied without hearing the defendant
Case no.: S2019_003
Decision of: 6 February 2019
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SECOND DECISION OF THE FPC
→ register ban granted after hearing the defendant
Case no.: S2019_003
Decision of: 11 July 2019
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The expert opinion of the judge-rapporteur is not the end of the line

Reading time: 8 minutes

Case No. S2018_007 | Decision of 2 May 2019

Fein’s logo

The patent at stake is EP 3 027 362 B1 which is jointly owned by C&E Fein GmbH and Robert Bosch GmbH; see the EPO Register and Swissreg for further information.

We had reported about the main hearing in this matter on this Blog here.

The patent in suit

Bosch’s logo

The invention is about a tool which is intended to be used with a machine tool, in particular a hand guided machine tool. The machine tool has a rotational drive, e.g. an oscillating drive.

In simple terms, it’s all about a somewhat special attachment device that transfers a torque from the driving device to the machine tool. It’s a 3D fitting; see e.g. Fein’s various Starlock® tools:

Fein’s Starlock tools

Bosch has the same attachment system in place in the Professional Multitool series:

Bosch’s GOP 12 V-28 Professional Multitool

Plaintiffs referred to it as ‘Gugelhupf’ or ‘Napfkuchen’. The claim language is a bit more complicated and less culinary, though.


Claim 1 of EP'362

1.1 A tool device (1, 1b) which is suitable for use with a machine tool (22), and in particular suitable for use with a hand guided machine tool, which has a driving device moving around a driving axis, and in particular oscillating around the driving axis,
1.2 and which has an attachment device (12) by means of which it can be fastened to a machine tool (22) in such a manner that the driving axis and a tool axis of rotation (5) are substantially coincident,
1.3 wherein, for receiving a driving force, the attachment device (12) comprises at least two driving area regions (2, 2a, 2b) each having a plurality of surface points (3) and which are spaced from this tool axis of rotation (5),
1.4 characterized in that tangent planes (4) at these surface points (3) are inclined relative to an axial plane (7), which includes the tool axis of rotation (5),
1.5 wherein the tangent planes (4) are inclined relative to a radial plane (6), which extends perpendicular to the tool axis of rotation (5),
1.6 wherein the attachment device (12) comprises a side wall,
1.7 wherein the side wall extends spaced radially from the tool axis of rotation (5),
1.8 wherein the side wall extends between a first, upper boundary plane (8a) and a second, lower boundary plane (8b), and
1.9 wherein the side wall comprises the driving area regions (2, 2a, 2b),
1.10 wherein a substantially hollow conical section is formed in the region of the attachment device by means of the side wall, which section has a cross section with a variable spacing of the side wall to the tool axis of rotation in a plane orthogonal to the tool axis of rotation.


The alleged infringement

Coram’s logo

The plaintiffs asserted that EP’362 (more precisely, the independent claim 1 and dependent claims 2-9, 11, 13 and 14) is infringed by Coram’s saw blades ‘B-Cut’ with ‘Quick Fixture’, and requested interim injunctive relief.

And indeed, the attachment device of Coram’s saw blades appears somewhat ‘gugelhupfig’:

But infringement was not the major issue here. Apparently, it had not even been explicitly disputed.

The bone of contention was the validity of EP’362.

The expert opinion was not yet it

What …?!

It was clear from the pleadings at the main hearing that the judge-rapporteur’s expert opinion had held that EP’362 was valid.

Some still say that the expert-opinion of the judge-rapporteur is effectively the end of the line. And, indeed, the handwriting on the wall bodes poorly when the judge-rapporteur does not follow your arguments. But there are exceptions to the rule, and the present case apparently is a prime example.

Novelty / claim construction

The decision holds that EP’362 is invalid.

Even though novelty over DE 2 120 669 has been acknowledged (because the ‘Gugelhupf’ structure in Fig. 5 of DE'669 is not the attachment device of the tool towards the driving means, but rather only an inner part of the tool itself) , the decision holds that claim 1 is not novel over EP 0 596 831 A1:

Fig. 2 of EP’831 (annotations by the FPC to show the sidewalls, i.e. the cone-shaped surfaces 8c and 8d). Note that the figure is erroneously referred to as Fig. 4 in the decision.

The critical issue here was claim construction. The decision again expands on a key aspect of claim construction, as follows (r. 14):

Claims are to be construed functionally, i.e. a feature is to be construed in such a way that it can fulfil the intended purpose. The claim should be read in such a way that the embodiments disclosed in the patent are literally covered; on the other hand, the wording of the claim should not be restricted to the embodiments if it covers further embodiments. When case-law refers to ‘broadest interpretation’ of claim features, the feature must still be capable of fulfilling its purpose in the context of the invention. This means that the claim must not be interpreted under its wording, but also not in such a way that embodiments are covered which do not achieve the inventive effect.

It is the second time that this paragraph is verbatim included in a decision in a short time; r. 14 of the present decision corresponds literally to r. 25 of O2016_009 (see this Blog here). For the time being, it is pretty clear what to expect at the FPC when it comes to claim construction.

By the way, you would not notice from the decision itself that the expert opinion of the judge-rapporteur has been reversed. It is just noted that the judge-rapporteur had provided his opinion on 25 March 2019, but the decision is silent about its content. Some earlier decision of the FPC gave at least some indication in this respect (e.g. O2015_011, r. 4: “On the question of validity [the judge-rapporteur] gave his expert opinion. The panel agrees with this opinion, with certain additions, as will be explained below. ), but the more recent decisions don’t give this insight anymore. What a bummer.

With the independent claim 1 being held likely invalid, the whole patent was held to be likely invalid. Thus, the request for interim injunctive relief was dismissed.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2018_007 | Decision of 2 May 2019

(1) C&E Fein GmbH
(2) Robert Bosch GmbH
./.
Coram Tools GmbH

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Markus A. MÜLLER
  • Dr. Stefan KOHLER

Judge-rapporteur:

  • Dr. Markus A. MÜLLER

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Andri HESS (Homburger)
  • Hans Rudolf GACHNANG (Gachnang), assisting in patent matters

FULL TEXT DECISION 
Case no.: S2018_007
Decision of: 2 May 2019
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PATENT IN SUIT

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Premature database entry infringes SPC

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Case No. S2019_006 | Decision of 1 May 2019
Case No. S2019_006 | Decision of 21 March 2019

Lilly / ICOS

The SPC in suit is ICOS’ C00740668/01, the basic patent of which is EP 740 668 B1; see EPO Register and Swissreg for further information.

The SPC protects tadalafil (which is also referred to in claim 10 of the basic patent), a phosphodiesterase type 5 (PDE5) inhibitor. Lilly‘s products are Cialis® (for the treatment of erectile dysfunction) and Adcirca® (for the treatment of pulmonary arterial hypertension).

Lilly’s Cialis and its active ingredient tadalafil

The basic EP’668 had lapsed already back in 2015; and the SPC has also lapsed meanwhile, on 4 May 2019. But the present decisions relate to an apparent mishap shortly before the SPC finally lapsed.

Sandoz’s logo

Sandoz had Swissmedic’s market authorization for its generic ‘Tadalafil Sandoz’ since 7 November 2017, but did not yet put it on the market. Still, the plaintiffs came across database entries for ‘Tadalafil Sandoz’ in HCI SolutionsmedINDEX (for physicists) and pharmINDEX (for pharmacists). These databases are used by practitioners to order pharmaceuticals. Even though ‘Tadalafil Sandoz’ could not be ordered at that time, the President held that the effect of the database entries was essentially comparable to an inquiry of future needs (see S2014_001). Potential customers are made aware that the launch of a generic is imminent. This may tempt them to postpone orders for the original product and to order the cheaper generic once it becomes available. The generic manufacturer benefits from this advertising effect to the detriment of the supplier of the original product. During the term of the SPC, such advertising constitutes a violation of the exclusive rights of the owner of the SPC.

At the face of it, the situation was apparently so clear that the President granted interim injunctive relief without hearing Sandoz beforehand, and obliged Sandoz to immediately request the database provider to delete the entries.

After hearing the defendant, it turned out that Sandoz’ had not made the entries in the databases. The entries had been made the database provider, an independent third party, without Sandoz’s knowledge and intervention. The database entries had meanwhile been deleted on Sandoz’s request, and thus there was no basis anymore for interim injunctive relief. The request was thus denied.

Now, what about the costs?

As a rule, the costs are clapped on the unsuccessful party; Art. 106(1) CPC. But the court may diverge from the general principles and allocate the costs at its own discretion when a party was caused to litigate in good faith; Art. 107(1) lit. b.

The President held that even though the plaintiff’s course of action may be understandable under the given circumstances, this still does not justify that the defendant bears the costs incurred in view of the unlawful conduct of an unrelated third party:

The plaintiffs have refrained from issuing a warning to the defendant before submitting the request for action. The applicants’ action may be understandable in the circumstances, but it does not justify the defendant having to bear the costs of the proceedings. As the defendant credibly demonstrates, it had nothing to do with the unlawful conduct of a third party; it is to be regarded neither as an instigator nor as an accomplice nor as a collaborator. Nor does it exercise any control over the third party. Since the defendant is not responsible for the unlawful conduct and has not created the appearance of being responsible for it, it cannot be ordered to pay the costs.

The court fee and a compensation for legal representation of the defendant are thus to be borne by the plaintiffs.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2019_006 | Decision of 1 May 2019
Case No. S2019_006 | Decision of 21 March 2019

(1) ICOS Corporation
(2) Eli Lilly (Suisse) SA
./.
Sandoz Pharmaceuticals AG

Single judge:

  • Dr. Mark SCHWEIZER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of ICOS / Eli Lilly:

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

Representative(s) of Sandoz:

  • Dr. Markus WANG (Bär & Karrer)

FIRST DECISION OF THE FPC
→ injunctive relief granted without hearing the defendant
Case no.: S2019_006
Decision of: 21 March 2019
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SECOND DECISION OF THE FPC
→ injunctive relief denied after hearing the defendant
Case no.: S2019_006
Decision of: 1 May 2019
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PATENT IN SUIT

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Fulvestrant, revisited: Is it still urgent? Views are divergent …

Reading time: 9 minutes

Case No. S2019_004 | Decision of 9 April 2019
Case No. S2019_004 | Decision of 20 February 2019

Sandoz’s logo

With request of 12 February 2019, AstraZeneca asserted EP(CH) 2 266 573 B1 (see EPO Register and Swissreg for further information) against Sandoz’s generic version of AZ’s Faslodex®, i.e. Fulvestrant Sandoz 250 mg/5ml (Swissmedic approval no. 56778). Note that Sandoz’s generic has been on the market in Switzerland since 26 July 2016.

AZ’s request for interim injunctive relief w/o hearing the defendant beforehand was dismissed with decision of 20 February 2019. Hearing the defendant didn’t change the outcome; the request was also dismissed with decision of 9 April 2019. Both requests failed for lack of urgency, given the fact that Sandoz’s generic has been on the market since 2.5 years.

At the face of it, this appears to be pretty straight forward, in particular in view of the most recent decisions S2018_006 (¶13) and S2019_001 (¶6) emphasizing the 14 months time bar in no uncertain terms.

But the devil is in the detail. Maybe.

AZ’s logo

This is not the first time that the FPC had to deal with EP’573. The patent had been revoked for lack of inventive step over Howell in view of McLeskey; see this Blog here. But AZ appealed and essentially argued that the FPC erroneously assumed a (concrete) pharmaceutical formulation in Howell, thus incorrectly defined the distinguishing features and the (objective) technical problem, and then wrongly concluded for lack of inventive step.

Fulvestrant (aka ICI 182,780), the active ingredient of AZ's Faslodex®
Fulvestrant (aka ICI 182,780), the active ingredient of AZ’s Faslodex® and Sandoz’s generic

And, indeed, the Supreme Court agreed and remitted the case for re-assessment of inventive step; see this Blog here. From the reasons of the present decisions, we can now catch a glimpse of what is currently going on in the remitted proceedings (formerly O2015_011, now O2018_009): The judge-rapporteur held on 23 November 2018 that the patent was valid. But it is not only that the wind has changed at the FPC. The Gerechtshof Den Haag also held that the patent was valid, in second instance proceedings. Likewise, a Board of Appeal at the EPO overruled the first instance revocation of an opposition division and finally ruled on 24 January 2019 that the patent was valid.

On the other hand, this is also not the first time that AZ sought injunctive relief for Sandoz’s generic. AZ had asserted a different patent against the same generic already in summary proceedings S2016_007, i.e. EP'138. It becomes clear from the present decisions that these earlier proceedings had been terminated because AZ had withdrawn the requests.

Now, here is a timeline events which is colored to reflect my very personal view on the prima facie validity of EP’573 over time:

17 Jun 2015 Grant of EP’573
29 Oct 2015 1st opposition filed (Hexal)
16 Feb 2016 2nd opposition filed (Actavis)
8 Mar 2016 3rd opposition filed (Fresenius Kabi)
16 Mar 2016 4th opposition filed (Intas)
17 Mar 2016 5th opposition filed (Teva)
17 Mar 2016 End of EPO opposition period
21 Mar 2016 Acceleration request by FPC in opposition proceedings
26 Jul 2016 Sandoz’s market entry
3 Aug 2016 AZ seeks interim injunctive relief based on another patent, i.e. EP'138; S2016_007, see this Blog here
30 Nov 2016 Summons (EPO) issued with ED’s preliminary opinion that patent is invalid
… Mar 2017 Request for interim injunctive relief in case S2016_007 withdrawn
8 May 2017 EPO first instance decision to revoke EP’573
29 Aug 2017 FPC’s first instance decision to revoke EP(CH)’573; O2015_011, see this Blog here
8 May 2018 On appeal re O2015_011, Supreme Court remits the case for re-assessment of obviousness; 4A_541/2017, see this Blog here
15 Oct 2018 Preparatory notes of EPO BoA indicating that obviousness is tbd in the hearing
23 Nov 2018 Judge-rapporteur’s expert opinion in O2018_009 (which is the remitted case O2015_011) that EP(CH)’573 is valid
27 Nov 2018 Gerechtsbank Den Haag holds that EP(NL)'573 is valid and infringed
24 Jan 2019 EPO BoA pronounces the decision to reject the oppositions / maintain EP’573 at the end of the hearing
12 Feb 2019 AZ files requests for interim injunctive relief in the present proceedings
15 Mar 2019 EPO BoA issues reasoned decision

One may conclude from the above timeline that there had been some red(-ish) flags concerning the validity of EP’573 for quite a long time.

The decisions note in passing that main infringement proceedings with case no. O2017_014 concerning Sandoz’s generic are pending in parallel, but based on a different patent (EP'195); from the case no. it is clear that this suit has been brought in 2017, but no further information is available to date.

Further, the decision indicates that in some proceedings with case no. O2018_010 the very same EP’573 is at stake as in the present matter, but the defendant is not revealed.

AZ essentially argued that it had been prevented from bringing the request for interim injunctive relief earlier because of the previously negative assessment of validity EP’573 by the EPO, the FPC (O2015_011) and the district court of The Hague (NL), and that the wind has changed only very recently; see timeline above.

The single judge did not buy into that and emphasized that AZ had undoubtedly been aware of Sandoz’s generic since 26 July 2016; AZ could have lodged main proceedings at any time since then. The decision further holds (¶22; inofficial translation):

[T]he decision of the Board of Appeal of the EPO of 24 January 2019 […] may substantiate the claim to which the plaintiff is entitled with regard to the validity of the patent in suit, but in no way justifies urgency. […]

Ultimately, however, all parallel proceedings have no influence on the purely procedural question of urgency in the present summary proceedings. […]

The tactical awaiting of a foreign parallel decision on the patent in suit before an action is lodged does not belong to the subjective but rather to the subjective circumstances.

It surely is a tough exercise to fit the gist of a decision in a single tweet; but the FPC’s tweet on the decision is straight to the point:

A decision of a Board of Appeal of the EPO does not give rise to urgency where the contested product has been on the market for 30 months.


The approach taken in the present decisions in my understanding focuses much more on the total time than on the apparent change of prima facie validity of the patent in suit over time. While the 14 months time bar is comparably generous (German courts typically deny urgency after 1-2 months, in my experience), it seems to be a pretty rigid time bar nowadays.

In an earlier case at the FPC, urgency had still been acknowledged for a request that had been filed five months after a BoA of the EPO had maintained the patent in suit which had been revoked in first instance by an opposition division (S2013_004, decision of 12 May 2014, ¶4.8).

It will be interesting to see how the FPC’s approach in the assessment of urgency will develop.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2019_004 | Decision of 9 April 2019
Case No. S2019_004 | Decision of 20 February 2019

AstraZeneca AB
./.
Sandoz Pharmaceuticals AG

Single judge:

  • Dr. Rudolf RENTSCH

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of AstraZeneca:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters
  • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Sandoz:

FIRST DECISION OF THE FPC
→ no injunctive relief without hearing the defendant
Case no.: S2019_004
Decision of: 20 February 2019
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SECOND DECISION OF THE FPC
→ no injunctive relief at all, after hearing the defendant
Case no.: S2019_004
Decision of: 9 April 2019
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PATENT IN SUIT

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T 1680/17 – Decision of EPO BoA 3.3.01

Chairman: A. Lindner
Member: M. Pregetter
M. Blasi

Decision of 24 January 2019:

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Anything but a quick fix: Coram beavering away at knocking out a patent

Reading time: 7 minutes

Case No. S2018_007 | Hearing of 15 April 2019

C&E Fein’s logo

The patent at stake is EP 3 027 362 B1 which is jointly owned by C&E Fein GmbH and Robert Bosch GmbH; see the EPO Register and Swissreg for further information. The invention is about a tool which is intended to be used with a machine tool, in particular a hand guided machine tool. The machine tool has a rotational drive, e.g. an oscillating drive. Examples include a drill, a grinding disc, a cutting disc or a circular saw. If you are interested in such detailed information, you will easily get the gist of the invention from e.g. Fig. 11 of EP’362 (see header picture) when reading the main claim of the patent.


Claim 1 of EP'362

A tool device (1, 1b) which is suitable for use with a machine tool (22), and in particular suitable for use with a hand guided machine tool, which has a driving device moving around a driving axis, and in particular oscillating around the driving axis,

and which has an attachment device (12) by means of which it can be fastened to a machine tool (22) in such a manner that the driving axis and a tool axis of rotation (5) are substantially coincident,

wherein, for receiving a driving force, the attachment device (12) comprises at least two driving area regions (2, 2a, 2b) each having a plurality of surface points (3) and which are spaced from this tool axis of rotation (5),

characterized in that tangent planes (4) at these surface points (3) are inclined relative to an axial plane (7), which includes the tool axis of rotation (5),

wherein the tangent planes (4) are inclined relative to a radial plane (6), which extends perpendicular to the tool axis of rotation (5),

wherein the attachment device (12) comprises a side wall,

wherein the side wall extends spaced radially from the tool axis of rotation (5),

wherein the side wall extends between a first, upper boundary plane (8a) and a second, lower boundary plane (8b), and

wherein the side wall comprises the driving area regions (2, 2a, 2b),

wherein a substantially hollow conical section is formed in the region of the attachment device by means of the side wall, which section has a cross section with a variable spacing of the side wall to the tool axis of rotation in a plane orthogonal to the tool axis of rotation.



The invention aims at providing a tool device in such a manner that the torque which is effectuated by the driving device of the machine is reliably transferred to the tool device. This is achieved by an attachment device (12) which comprises side walls that comprise driving area regions (2). Those driving areas (2) are spaced apart from the tool axis and inclined with respect to the axial plane. It is the function of the driving areas to receive a driving force.

Bosch’s logo

The plaintiffs asserted that EP’362 is infringed by defendant’s saw blades ‘B-Cut’ with ‘Quick Fixture’, and requested interim injunctive relief. Indeed, at least at first sight there are quite some similarities between Coram’s saw blades with ‘Quick Fixture’ (header image, right hand side) and the figures of the allegedly infringed patent (header image, left hand side). But the question of whether or not the allegedly infringing devices actually read on the claim was not an issue in the hearing. Likewise, it was only a sideshow in the hearing whether the matter was urgent, and whether the alleged violation threatened to cause not easily reparable harm to the plaintiffs (Art. 261(1) lit. b CPC).

An allegedly infringing saw blade with ‘Quick Fixture’
Coram’s logo

However, the defendant argued for nullity as a plea in defense, i.e. asserted a lack of novelty over EP 0 596 831 A1 and DE 2 120 669. The defendant construed EP’362 broadly and, thus, found the claimed subject-matter more readily anticipated in the prior art than the plaintiffs — and apparently also more readily than the judge-rapporteur. Specifically, the defendant argued that a ‘side-wall’ not necessarily implies a 3D-structure but is anticipated already by a 2D-surface (as disclosed in Fig. 4 of EP'831). With regard to DE'669, the defendant argued that a feature having a certain function (‘driving area […] for receiving a driving force’) is anticipated by a feature which might not exclusively have that function but nevertheless supports it (‘carrier with an projecting attachment’ as shown in Figs. 5 and 6 of DE'669).

In order to support views on correct claims construction from a Swiss perspective, O2013_008 (‘Sprühpistole’) was cited repeatedly by the parties. Unless the case was settled by agreement after the public part of the hearing, we might gain more insight on this issue soon.

The defendant further argued that the request for interim injunctive relief was overly broad and covered embodiments of the prior art.

Both representatives requested reimbursement of the necessary expenses for the assisting patent attorney in the same amount as are costs for legal representation according to the tariff (~kCHF 25 each).

On the procedural side, it was good to see that the projector / screen infrastructure was used again by at least one party and the court (connection of Windows® devices apparently is unproblematic). Further 8562532553 who call , plaintiffs’ counsel inquired whether the court wishes to be provided with pleading notes or not (see this Blog here for my very personal view, and the results of a little survey). Obviously, some judges appreciate written pleading notes; and some judges don’t. From a personal note of the president, however, it could be inferred that he liked pleadings in free speech. So, now we know!

Reported by Jolanda MINDER and Martin WILMING

BIBLIOGRAPHY

Case No. S2018_007 | Hearing of 15 April 2019

C&E Fein GmbH
Robert Bosch GmbH
./.
Coram Tools GmbH

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Markus MÜLLER-KÄGI
  • Dr. Stefan KOHLER

Judge-rapporteur:

  • Dr. Markus MÜLLER-KÄGI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

ANNOUNCEMENT

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PATENT IN SUIT

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