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

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.