Oxycodone / Naloxone II, III, … and counting(?)

Reading time: 7 minutes

Case No. O2017_009 | Decision of 7 November 2019 | ‘Oxycodon und Naloxon II und III’

The patents at stake in this nullity case are MundiPharma‘s EP 2 425 821 B1 (see EPO Register and Swissreg) and EP 2 425 824 B1 (see EPO Register and Swissreg). The same parties have already litigated over EP 2 425 825 B9 in separate proceedings O2016_016; see this Blog here — and so did yet another plaintiff in O2016_017; see this Blog here.

Wondering about the color code? It is adopted from the decision itself (¶ 16), to help getting the ducks (pardon me, divisional applications) in line:

Patents in suit: EP’821 and EP’824

Yet again, it’s all about a combination of oxycodone hydrochloride and naloxone hydrochloride, in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma.

Develco sought annulment of both EP(CH)’821 and EP(CH)’824 inter alia for undue extension of subject-matter, in violation of Art. 76 and Art. 123 EPC. Note that both patents had been filed as divisional applications, without any claims in first place. However, the claims of WO’520 had been recited in the specification in ¶ [0127] of EP 821 A1 and ¶ [0131] of EP 824 A1, respectively.

As to EP 824, the decision holds that claim 1 as granted does not comply with Art. 76 and Art. 123 EPC; see the following mark-up over the first claim-like clause  in ¶ [0131] of EP 824 A1:

EP 824 as granted; mark-up over ¶ [0131] of EP 824 A1
Likewise, the first auxiliary request (AR 1) — wherein only feature 1.7 had been amended over the claims as granted — failed  for essentially the same reasons:

AR 1, mark-up over the claims as granted

Both claim 1 as granted and claim 1 of the AR 1 had also been held by an Opposition Division of the EPO to not comply with Art. 123 EPC; see the decision of 11 September 2019, ¶¶ 2.4-2.9, 6 and 8.

Finally, also AR 2 failed for essentially (some of) the same reasons as the claims as granted, and in line with the ratio decidendi of the EPO’s Opposition Division:

AR 2, mark-up over the claims as granted

As to EP 821, the decision is pretty straight forward because the specification is the same as in EP 824. Claim 1 as granted does not comply with Art. 123 EPC:

EP 821 as granted; mark-up over ¶ [0127] of EP 821 A1
The FPC comes to the same conclusion for claim 1 of AR 1:

AR 1, mark-up over the claims as granted

This finding of the FPC is in line with the decision of an Opposition Division in parallel proceedings at the EPO; see the decision of 11 September 2019 (AR 1 corresponds to AR IX in EPO opposition proceedings).

On the merits, I feel that this case is nothing out of the ordinary in terms of assessment of undue extension of subject-matter. Still, there are two statements that I find noteworthy.

First, the decision holds in ¶ 25 that, as a rule, when reading a patent application or a patent, the person skilled in the art assumes that features, if they are expressly mentioned in an independent claim, are important and not just superfluous — unless there are clear indications to the contrary. Thus, for a feature to be omitted, it is therefore not sufficient to show that it is not highlighted anywhere as important. Rather, it must be shown that the skilled person recognizes that the feature does not make a technical contribution or can be omitted. It must therefore be established that the skilled person, using common general knowledge, would regard the claimed subject-matter even without the specific feature  as — explicitly or implicitly — directly and unambiguously disclosed in the application as filed.

Grundsätzlich geht der Fachmann beim Lesen einer Patentanmeldung oder einer Patentschrift a priori zunächst einmal davon aus, dass Merkmale, wenn sie ausdrücklich in unabhängigen Patentansprüchen genannt werden, auch wichtig und nicht einfach überflüssig sind, sofern es nicht klare Hinweise für das Gegenteil gibt.

Damit ein Merkmal weggelassen werden kann, genügt es also nicht, zu zeigen, dass es nirgends als wichtig hervorgehoben wird, sondern es muss gezeigt werden, dass für den Fachmann zweifelsfrei erkennbar ist, dass das Merkmal keinen technischen Beitrag leistet oder auch weggelassen werden kann. Mithin muss gezeigt werden, dass der Fachmann unter Heranziehung des allgemeinen Fachwissens den beanspruchten Gegenstand auch ohne das Merkmal als – explizit oder implizit – unmittelbar und eindeutig in der ursprünglichen Fassung der Anmeldung offenbart ansehen würde.

In my perception, this is essentially the approach of the EPO, even though the decision does not make any reference to the EPO Guidelines or case-law of the Boards of Appeal in this respect.

Second, the decision makes a clear distinction in ¶ 44, with extensive reference to case-law of the Boards of Appeal, between mere deletion of some elements from lists of a certain length on the one hand (which may well be admissible), and so-called singling out of specific elements from a lists (which is typically not permissible).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_009 | Decision of 7 November 2019 | ‘Oxycodon und Naloxon II und III’

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

    • Dr. Daniel M. ALDER
    • Dr. Tobias BREMI
    • Dr. Hannes SPILLMANN

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Develco:

    • Andrea MONDINI (TIMES)
    • Dr. Cornelia HOFFMANN (SBMP), assisting in patent matters

Representative(s) of Mundipharma:

    • Dr. Simon HOLZER (MLL)
    • Renato BUCHER (MLL)
    • Dr. Dirk BÜHLER (Maiwald), assisting in patent matters
    • Dr. Andreas LEDL (Maiwald), assisting in patent matters

DECISION IN FULL

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PATENTS IN SUIT

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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

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)

SUPREME COURT DECISION

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FPC DECISION

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EP 2 266 573 B1

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Lilly’s EP 1 313 508 on combination of pemetrexed and vitamin B12 held valid

Case No. O2018_003 | Decision of 15 October 2019 | “Patentnichtigkeit; Pemetrexed”

The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. In a nutshell, EP’508 relates to combination of pemetrexed disodium and vitamin B12. See this Blog here for a discussion about earlier infringement proceedings concerning the same patent.

Now, nullity is at stake.

An Opposition Division of the EPO had maintained the patent as granted with decision of 27 December 2010; an appeal had initially been lodged but withdrawn later. Related decisions in civil proceedings elsewhere had also addressed the validity of EP’508, e.g. in

Thus, it was an uphill fight for the plaintiff. And even though the FPC took the parallel decision of the German FPC into account, it explicitly disagreed. It is held on p 19 (penultimate and lastparagraph), that the German FPC erred with the finding that

[…] bei einer Pemetrexedgabe durch die Blockierung der drei Schlüsselenzyme Thymidylatsynthase (= TS), Dihydrofolatreduktase (= DHFR) und Glycinamidribonukleotidformyltransferase (= GARFT) im «DNA- Zyklus» nicht nur dieser Zyklus, sondern auch der «Methylierungszyklus» blockiert wird.

Consequently, the FPC did not put much weight (if any) on the parallel decision in Germany.

On the contrary, the decision holds that the claimed subject-matter was novel over Worzalla et al. since mere reference to a diet ‘Purina Chow #5001’ did not implicitly, yet clearly and unambiguously, disclose the presence of vitamin B12 (or folic acid).

Further, the decision rejects plaintiff’s argument re obviousness over Niyikiza et al. (abstract 609P bridging pages 126/127), Niyikiza et al. (abstract 2139 on the top right, referred to as act. 7_10 in the decision), the IBIS Guide to Drug-Herb and Drug Nutrient Interactions, Jackman and Calvert (which had been considered as closest prior art in EPO opposition proceedings).

The decision can still be appealed to the Supreme Court.

A discussion of this decision is also available on the EPLAW Blog, provided by defendant’s counsel

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_003 | Decision of 15 October 2019 | “Patentnichtigkeit; Pemetrexed”

Sandoz Pharmaceuticals AG

./.

Eli Lilly & Company

Panel of Judges:

    • Dr. Daniel ALDER
      • Dr. Roland DUX
      • Marco ZARDI

Court Clerk:

    •  Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Markus WANG (Bär & Karrer)
    • Christoph FRAEFEL (SBMP), assisting in patent matters

Representative(s) of Defendant:

DECISION IN FULL

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Non-official English translation (first published on the EPLAW Blog):

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PATENT IN SUIT

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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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The public may be excluded from settlement discussions — but maybe not from the instruction hearing in general?

Reading time: 3 minutes

As discussed a while ago on this Blog here, the settlement discussion at the occasion of a main hearing is non-public at the FPC. I trust that this will not change any time soon, in view of a decision of the Supreme Court that has been published earlier this week (4A_179/2019 of 24 September 2019). In that case, an accredited court reporter of the Republik had been asked to leave the room for the settlement discussion at the end of a main hearing in proceedings at the Zurich labor court. Ultimately, the Supreme Court has now endorsed this exclusion of the public from the settlement discussion:

Die Bemühungen des Gerichts, zwischen den Parteien zu vermitteln, gelten nicht als Gerichtsverhandlung respektive Verhandlung und unterstehen nicht dem Grundsatz der Justizöffentlichkeit.

Now, what about instruction hearings according to Art. 226(2) CPC?

Maybe, the Supreme Court telegraphed a message by explicitly saying nothing (emphasis added):

Demgegenüber ist hier nicht zu beurteilen, ob es zulässig wäre, die Öffentlichkeit über die Vergleichsgespräche hinaus generell von Instruktionsverhandlungen auszuschliessen, zumal an solchen nach Art. 226 Abs. 2 ZPO unter anderem auch der Sachverhalt ergänzt und die Hauptverhandlung vorbereitet werden kann ([…]).

In English (emphasis added):

On the other hand, it is not necessary here to assess whether it would be permissible to generally exclude the public from instruction hearings beyond the settlement discussions, especially since, according to Art. 226 para. 2 CPC, the facts of the case can be supplemented and the main hearing can be prepared in the instruction hearings ([…]).

The FPC took note. Here is the FPC’s tweet of earlier today:

Indeed, the Supreme Court did leave it undecided whether the public could also be excluded from the formal part of an instruction hearing. Still, the Supreme Court made it crystal clear that it does not want to see its judgement being read on instruction hearings in general, in view of what is (or maybe) going on in (the formal part of) an instruction hearing — contrary to mere settlement discussions, be it during a main hearing or an instruction hearing.

In my perception, that’s a somewhat deafening silence on this issue, isn’t it?

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_179/2019 (Supreme Court) |  Decision of 24 September 2019, on appeal against RA190002-O/U (High Court, Zurich) | Decision of 6 March 2019 (unpublished)

[accredited court reporter, Republik] (Appellant)
./.
Labour Court, Zurich (Respondent)

Panel of Judges:

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

Court Clerk:

    •  Dr. Christian KÖLZ

Representative(s) of Appellant:

    • Marin FARNER (FWE)

Representative of Respondent:

    • n/a

SUPREME COURT DECISION

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

Reading time: 5 minutes

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.

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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Clarification on clarity

Case No. O2016_010 | Decision of 15 May 2019 | ‘Klarheitsprüfung bei Änderung der Patentansprüche’
Case No. O2016_011 | Decision of 15 May 2019 | ‘Klarheitsprüfung bei Änderung der Patentansprüche’

Reading time: 15 minutes

HEADNOTE in O2016_010

Art. 26, 27 PatA: Clarity on amendment of patent claims.

Lack of clarity is not a ground for invalidity. However, in order for a prayer for relief for limitation of claims in a patent nullity suit to be admissible, it must also be sufficiently determined. Therefore, the limitation of claims must be clearly formulated. The waiver of a granted independent claim constitutes a limitation of the patent, but this waiver cannot raise a question of clarity if, apart from the waiver of a granted independent claim, a mere reformulation of a granted dependent claim is made as an independent claim (¶34).

Loepfe logo

Loepfe had sued Uster Technologies AG for nullity of EP 2 347 250 (see EPO Register and Swissreg) and a divisional thereof, i.e. EP 2 352 018 (see EPO Register and Swissreg). The inventions are all about the capacitive testing of yarns or fabric, wherein the dielectric property of a capacitor arrangement is determined.

The case was split into two separate proceedings (O2016_010 for EP’250 and O2016_011 for EP’018). We have reported about the main hearing in both cases on this Blog here.

O2016_010 re EP’250

Uster logo

Uster did not defend the patent as granted but rather filed a main request (MR) and six auxiliary requests (AR1 to AR6) to maintain EP’250 in limited form. In response, Loepfe argued that all requests contained subject matter that went beyond the application as originally filed, and that all claims lacked an inventive step over several combinations of prior art documents. Novelty, however, was not at issue.

Added Matter

Loepfe alleged that several features of the MR were not disclosed in the application as originally filed. The FPC disagreed to large extent, except with regard to the feature of symmetric balancing without a reference capacitor. Briefly, the decision holds that the application as filed only disclosed symmetric balancing w a reference capacitor, and does not provide any teaching related to how symmetric balancing could be done w/o a reference capacitor. Thus, the MR failed because of added matter.

AR1 and AR2 failed for the very same reason.

AR3, however, had a reference capacitor included and could thus be considered further on the merits. Here is the structured feature analysis of AR3:

  • Claim 1 of AR3

In German language only; I’m sorry. Markup over claim 1 as initially granted (additions and deletions) for the changes made already in the MR; additional markup for AR3 in italic. Mere changes of the order of the features are not marked-up. Identifiers of the features are as used in the decision.

1A
Verfahren für den Symmetrieabgleich einer Vorrichtung (1)
1B
zur kapazitiven Untersuchung eines bewegten länglichen textilen Prüfgutes (9) wie Kardenband, Vorgarn, Garn oder Gewebe
1C mittels einer Kondensatoranordnung (21),
1E’ welche Vorrichtung (1) eine Auswerteschaltung (6) zur Auswertung mindestens einer elektrischen Messgrösse eines an einer die der Kondensatoranordnung (21) beinhaltenden Messschaltung (2) abgegriffenen elektrischen Signals,
1Ea einen Referenzkondensator (22), welcher in Serie zur  Kondensatoranordnung (21) geschaltet ist,
1D’
mindestens einen Wechselsignalgenerator (3) zum Anlegen eines elektrischen Wechselsignals von zwei elektrischen Wechselspannungen mit entgegengesetzten Phasen an die Kondensatoranordnung (21) bzw. an den Referenzkondensator,
1Da’
wobei die Kondensatoranordnung (21) vom Wechselsignalgenerator (3) durch eine Filter- und/oder Verstärkerstufe (5) zur Filterung und/oder Verstärkung des vom Wechselsignalgenerator (3) erzeugten Wechselsignals derart abgekoppelt ist, dass sie Parameter des vom Wechselsignalgenerator (3) erzeugten Wechselsignals nicht beein- flusst,
1F
Abgleichmittel (4),
1G”
die in einem elektrischen Pfad zwischen dem Wechselsignalgenerator (3) und der Messschaltung (2) Filter- und/oder Verstärkerstufe (5) angeordnet sind und mittels derer mindestens ein Parameter des elektrischen Wechselsignals derart veränderbar ist,
1H
dass ein Ausgangssignal der Auswerteschaltung (6) bei definierten, konstanten Bedingungen einen bestimmten Wert, vorzugsweise Null, annimmt, und
1I
Steuermittel (7) zur Abgabe eines elektrischen Steuersignals an die Abgleichmittel (4), mittels dessen die Veränderung des mindestens einen Parameters steuerbar ist,
beinhaltet
1J
wobei die Kondensatoranordnung (21) ohne Prüfgut (9) im Wesentlichen zeitlich unverändert belassen wird,
1K’
ein elektrisches Wechselsignal von dem mindestens einen Wechselsignalgenerator (3) erzeugt und an die  Kondensatoranordnung (21) angelegt wird
1L’
ein elektrisches Ausgangssignal der Messschaltung (2) Kondensatoranordnung (21) abgegriffen wird,
1M’
mindestens eine elektrische Messgrösse des an der Messschaltung (2) Kondensatoranordnung (21) abgegriffenen elektrischen Ausgangssignals durch die Auswerteschaltung (6) ausgewertet wird,
1N”
mindestens ein Parameter des elektrischen Wechselsignals in dem elektrischen Pfad zwischen dem mindestens einen Wechselsignalgenerator (3) und der Messschaltung (2) Filter- und/oder Verstärkerstufe (5) derart durch die Abgleichmittel (4) verändert wird,
1O
dass ein Ausgangssignal der Auswertung bei definierten, konstanten Bedingungen einen bestimmten Wert, vorzugsweise Null, annimmt,
1P
die Veränderung des mindestens einen Parameters mit dem elektrischen Steuersignal durch die Steuermittel (7) gesteuert wird, und
1Q
das elektrische Steuersignal durch das Ausgangssignal beeinflusst wird.

Inventive Step of AR3

Plaintiff alleged a lack of inventive step over EP 1 124 134 (D2) in view of WO 01/31351 (D11), DE 195 35 177 (D5), US 4,843,879 (D1, referred to in EP’250, ¶[0007]), US 3,757,211 (D6), US 2007/0146019 (D4), a publication by Huang (D3) which is unfortunately not specified any further, and further in view of general knowledge.

In addition, plaintiff also alleged a lack of inventive step over D1 since the differentiating feature (arrangement of the means for balancing before the filter/amplifier) had no technical effect and could not render the claimed subject-matter inventive.

The FPC did not agree. In particular, the decision holds that the skilled person would not have considered D4, D11, D5, D6, or D3 to solve the objective technical problem which was defined as enhancing the quality of the measurement results. Note that D2 had already been cited in the patent in suit, as a result of which the objective technical problem was taken from the patent itself.

Finally, the FPC also rejected the argument that general knowledge would have led a skilled person to control the balancing means automatically. While the skilled person could arguably have done so, the decision holds that there was no teaching in D2 that would have led the skilled person to actually do it.

Consequently, the FPC concluded that AR3 was inventive over the prior art.

Clarity

An aspect of the decision that is of interest beyond the specific case is related to clarity. Plaintiff alleged that defendant’s requests for maintenance of the patent in limited form were unclear.

A Europen patent cannot be revoked for lack of clarity; the lists in Art. 138 EPC and Art. 26 PatA are closed. However, the decision holds that this must not be mixed up with requests in civil proceedings which must be clearly worded in order to be allowable. The decision holds that this is not only the case with prayers for injunctive relief (BGE 131 III 70), but also with requests for limitation of the patent in nullity proceedings. The decision goes on with a somewhat complicated derivation  with reference to BGE 92 II 280 (¶3a), 120 II 357 (¶2), 4C.108/1997 (¶3a), the corresponding practice at the EPO (G 3/14) and an analogy to Art. 97 PatR. I feel this was necessary since there is no explicit rule in the Swiss PatA that requires the amended claims to fulfil all requirements of the PatA (unlike e.g. Art. 101(3) lit. a EPC — “meet the requirements of this Convention”, what includes clarity, Art. 84 EPC).

Ein Rechtsbegehren, das einen […] unabhängigen Anspruch durch die Aufnahme eines […] abhängigen Anspruchs beschränkt, stellt keine materielle Einschränkung des erteilten abhängigen Anspruchs dar. Damit wird auf den erteilten unabhängigen Anspruch  verzichtet und der entsprechende abhängige erteilte Anspruch wird im eingeschränkten Patent als unabhängiger Anspruch weitergeführt. Der Verzicht auf den erteilten unabhängigen Anspruch bildet zwar eine Einschränkung des Patents gemäss Art. 27 Abs. 1 PatG. Dieser Verzicht kann jedoch keine Klarheitsfrage aufwerfen, denn die blosse Umformulierung des erteilten abhängigen Anspruches als unabhängiger Anspruch bildet keine weitere Einschränkung des Patents im Sinne von Art. 27 Abs. 1 PatG und kann entsprechend auch nicht auf Klarheit geprüft werden.

The bottom line is that mere combination of an independent claim with one or more dependent claims in nullity proceedings cannot be challenged with respect to clarity.


In the case at hand, the court did not see any problem re clarity. The plaintiff had basically objected to the term ‘parameter’ being unclear and that the limited claims would contradict the description. The former argument was rejected by the court because the term was already included in the claims as granted, while the latter was deemed resolved by a declaration according to Art. 97(2) PatR.

Costs

In view of the mixed outcome, the costs were split between the parties. The fact that the patent was limited by incorparation of a feature taken from the specification did not change anything in this respect since revocation of the patent had been requested in entirety.

The FPC did not follow defendant’s argument that costs incurred for the assisting patent attorney are no ‘necessary expenses’ (Art. 3 lit. a and Art. 9(2) CostR-PatC), on top of the costs for legal representation according to the tariff, if the patent attorney could have done the whole case on her/his own; Art. 29(1) PatCA. Even if the patent attorney could have run the case on his own, there is no obligation to do so. Complex legal issues may come up in the further course of the proceeding, and/or a counterclaim for infringement.

Aus der Tatsache, dass einer Partei die Möglichkeit gegeben wird, sich durch einen Patentanwalt in Nichtigkeitsprozessen vertreten zu lassen (Art. 29 PatGG),  kann weder eine Pflicht abgeleitet werden, keinen Rechtsanwalt beizuziehen, noch kann sie es rechtfertigen, wenn eine Partei von einem Rechtsanwalt vertreten wird, keine notwendigen Auslagen für den Patentanwalt mehr zuzusprechen.

Now, what is interesting is the split of costs awarded for legal representation on the one hand, and assistance of the patent attorney on the other hand. Even though the actual expenses for the patent attorney were not awarded in full, they were still awarded to an extent that is on the upper end of the tariff (CHF 44’841.20 requested, CHF 30’000,– awarded). However, compensation for legal representation was only considered on the lower end of the tariff according to Art. 4 CostR-PatC, based on a value in dispute of CHF 125’000,–.

The decision has not been appealed and has thus become final meanwhile.

O2016_011 re EP’018

Defendant filed a MR and five ARs to maintain the patent in limited form. With respect to the main request, plaintiff alleged that new matter was introduced and that the independent claim was not inventive.

Main Request: Added matter?

Plaintiff alleged that the newly introduced feature of a ‘reference capacitor different from the balancing means’ did not have sufficient basis in the application as originally filed, and that it amounts to a disclaimer.

The court did not agree that new matter was introduced. Rather, the reference capacitor and the balancing means were indeed separate entities in all embodiments of the patent. Therefore, the feature in question was directly and unambiguously derivable for the skilled person from the application as originally filed, and the main request did not contain added matter and the disclaimer argument was moot.

… but is it inventive?

No, it is not. The decision holds that the subject matter of the main request was obvious to the skilled person from EP 1 124 134 (D2) in view of the skilled person general knowledge. Plaintiff’s other arguments / combinations of prior art failed to render the subject-matter of the MR obvious.

Plan B

The FPC then moved on to AR1:

  • Claim 1 of AR1

In German language only; I’m sorry. Markup over claim 1 as initially granted (additions and deletions) for the changes made already in the MR; additional markup for AR1 in italic. 

1A’ Vorrichtung (1) zur Bestimmung mindestens einer dielektrischen Eigenschaft kapazitiven Untersuchung eines bewegten länglichen textilen Prüfgutes (9) wie Kardenband, Vorgarn, Garn oder Gewebe mittels
1B’ einer Kondensatoranordnung (21) mit zwei voneinander beabstandeten Platten, zwischen denen sich Luft befindet und zwischen die das längliche textile Prüfgut (9) einführbar ist,
1C beinhaltend eine Auswerteschaltung (6) zur Auswertung mindestens einer elektrischen Messgrösse eines an der Kondensatoranordnung (21) abgegriffenen elektrischen Signals,
1D einen Referenzkondensator (22), welcher in Serie zur Kondensatoranordnung (21) geschaltet ist,
1E’ mindestens einen Wechselsignalgenerator (3) zum Anlegen von zwei elektrischen Wechselspannungen mit entgegengesetzten Phasen an die Kondensatoranordnung (21) bzw. an den Referenzkondensator (22),
1Ea’ wobei die Kondensatoranordnung (21) vom Wechselsignalgenerator (3) durch eine Filter- und/oder Verstärkerstufe (5) zur Filterung und/oder Verstärkung des vom Wechselsignalgenerator (3) erzeugten Wechselsignals derart abgekoppelt ist, dass sie Parameter des vom Wechselsignalgenerator (3) erzeugten Wechselsignals nicht beeinflusst,
1F Abgleichmittel (4),
1G”’ die in einem elektrischen Pfad zwischen dem mindestens einen Wechselsignalgenerator (3) und der Filter- und/oder Verstärkerstufe (5) Kondensatoranordnung (21) angeordnet sind und mittels derer mindestens ein Parameter des elektrischen Wechselsignals derart veränderbar ist,
1H dass ein Ausgangssignal der Auswerteschaltung (6) bei definierten, konstanten Bedingungen den Wert Null annimmt,
1I Steuermittel (7) zur Abgabe eines elektrischen Steuersignals an die Abgleichmittel (4), mittels dessen die Veränderung des mindestens einen Parameters steuerbar ist.

Contrary to plaintiff’s allegation, the court found that no new matter was introduced.

In terms of obviousness, AR1 was based on the MR, but more narrow in scope. Thus, any combination of prior art that did not render the MR obvious could consequently not render AR1 obvious. As such, the court only discussed obviousness over D2 in view of the skilled person’s general knowledge. Here, the court did rule that an inventive step was given.

EP ‘018 was thus maintained in limited form according to AR1.

Clarity and costs

No surprises here; the reasoning is essentially the same as in O2016_010, see above.

Like O2016_010, this decision has also not been appealed and has thus become final meanwhile.

Reported by Philippe KNÜSEL and Martin WILMING

BIBLIOGRAPHY

Case No. O2016_010 | Decision of 15 May 2019 | ‘Klarheitsprüfung bei Änderung der Patentansprüche’
Case No. O2016_011 | Decision of 15 May 2019 | ‘Klarheitsprüfung bei Änderung der Patentansprüche’

Gebr. Loepfe AG
./.
Uster Technologies AG

Panel of Judges:

  • Frank SCHNYDER
  • Dr. Tobias BREMI
  • Christoph MÜLLER

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Kurt SUTTER (Blum), assisting in patent matters

Representative(s) of Defendant:

  • Dr. Andri HESS (Homburger)
  • Dr. Pavel PLISKA (inhouse @ Uster Technologies)

CASE NO. O2016_010
EP’250 maintained as amended
Decision of: 15 May  2019
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EP 2 347 250 B1:

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CASE NO. O2016_011
EP’018 maintained as amended
Decision of: 15 May 2019
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EP 2 352 018 B1

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Be specific!

Reading time: 9 minutes

Case No. O2016_001 | Decision of 27 June 2019

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

Comadur logo

The patent in suit is CH 707 572 B1; see Swissreg for further bibliographic information. An automated translation can be found here. Harcane had sued Comadur essentially to the effect that CH’572 be declared invalid (based on Art. 261(1) lit. a PatA, not lit. d); or, alternatively, if CH’572 was held valid, that it be transfered to Harcane. On the other hand, Comadur finally defended CH’572 with the claims being limited. Further, Comadur requested that Harcane’s complaint should be held inadmissible.

Parallel proceedings elsewhere

It is a procedural requirement that the case is not the subject of pending proceedings elsewhere or is not already the subject of a legally binding decision; Art. 59(2) lit. d and e CPC.

There had been co-pending proceedings in Neuchâtel where Comadur had sued Harcane and sought for a delaratory judgment based on the Unfair Competition Act that it was the owner of certain manufacturing processes of ceramic injection molding (CIM) material. In turn, Harcane saught a declaratory judgment in proceedings in Neuchâtel that Harcane was the owner of the respective trade secrets relating to the CIM material.

Obviously, these requests differ from the requests in proceedings at the FPC. Thus, the case that has been brought before the FPC had not been the subject of pending proceedings elsewhere. Still, the FPC had stayed its proceedings on 28 May 2018 since certain preliminary questions overlapped with the cantonal proceedings. The stay was lifted on 13 February 2019, i.e. shortly after the Supreme Court had decided on both parties’ appeals against the decision of the Neuchâtel cantonal court; see 4A_584/2017, 4A_590/2017 of 9 January 2019.

The decision holds in ¶21 that the plaintiff well has a legitimate interest in bringing the present complaint since, according to the prior cantonal proceedings, Harcane is only prohibited to use some very specific embodiments of the patent in suit. However, even the limited scope of CH’572 goes far beyond that.

limitation of the patent

The defendant / patentee partially surrendered CH’572 in accordance with Art. 24(1) lit. c PatA and declared the same to the FPC; see O2012_030, ¶17.

Claim 1 as amended reads as follows:

  • Claim 1 as amended
Liant pour composition de moulage par injection comprenant :

    • de 35 à 54% vol. d’une base polymérique
    • de 40 à 55% vol. d’un mélange de cires,
    • et environ 10% vol. d’un surfactant,

dans lequel la base polymérique contient des copolymères d’éthylène et d’acide méthacrylique ou acrylique, ou des copolymères d’éthylène et d’acétate de vinyle, ou des copolymères d’éthylène comprenant un anhydride maléique ou un mélange de ces copolymères, ainsi que du polyéthylène, du polypropylène et une résine acrylique, et dans lequel lesdits copolymères sont des copolymères d’éthylène et d’acide méthacrylique ou acrylique, ou des copolymères d’éthylène comprenant un anhydride maléique ou un mélange de ces copolymères;

à l’exclusion d’un liant pour composition de moulage par injection comprenant de 35 à 50% vol d’une base polymérique, de 40 à 55 % vol d’un mélange de cires, et environ 10% vol d’un surfactant, dans lequel la base polymérique contient des copolymères d’éthylène et d’acide méthacrylique ou acrylique, ou des copolymères d’éthylène et d’acétate de vinyle, ou des copolymères d’éthylène comprenant un anhydride maléique ou un mélange de ces copolymères, ainsi que du polyéthylène, du polypropylène et une résine acrylique.

The underlined / italic part of the claim is a so-called undisclosed disclaimer to exclude the subject-matter of CH 708 097 A2, a prior right that had been filed earlier but published only after the filing date of CH’572. As much as I recall, this is the first time that such an undisclosed disclaimer has been at stake and allowed in proceedings at the FPC. Note, however, that O2012_030 in ¶20.1 already suggested that the FPC would follow the EPO’s precedent G 1/03.

Dependent claims 2-6 remain unchanged. Claims 7-10 have been deleted.

novelty and inventive step

The plaintiff alleged that CH’572 was not novel over US 5,266,264, several PhD theses (Juan M. Adames, 2007; S. Kowalski, 2005; C. Quinard, 2008) and a prior use, i.e. the sale of a certain feedstock to Comadur.

Apparently, the court did not appreciate how the novelty attacks had been presented. The decision holds that, according to common practice, a specific analysis of the features of the claim and a specific reference to the prior art has to be made, for each of the features. It is not the court’s task to establish the facts of its own motion and to seek the information in the references filed as exhibits. On the contrary, the relevant facts must be alleged by providing specific information, in particular by reference to a page or line number, while specifying which feature of the claim is there to be found (see ¶¶28-30).

Le Tribunal n’est pas chargé d’établir les faits d’office et il ne lui incombe pas de rechercher lui-même les informations dans les documents de l’art antérieur déposés en tant que pièce jointe. En particulier, une référence globale à un document dans le sens de «l’objet de la revendication 1 est divulgué dans le document X» ne suffit pas pour satisfaire au fardeau de l’allégation. Il faut au contraire alléguer les faits pertinents en fournissant des indications spécifiques, notamment par renvoi à un numéro de page, de ligne, tout en précisant quelle caractéristique de la revendication se retrouve dans le document de l’état de la technique invoqué.

In the absence of any specific allegations, the FPC did not consider the novelty attacks to the extent they were based on prior art documents. What remained was the sale of a certain feedstock to Comadur. However, the decision holds that these sales were governed by an NDA and thus cannot be considered at all. Further sales to third parties had been alleged but remained essentially unsubstantiated.

Accordingly, novelty was acknowledged.

The FPC did not appreciate the way the obviousness attacks had been presented, either. The decision holds that the FPC cannot complete an incomplete factual allegations of the parties. This is in contrast to proceedings at the EPO which shall examine the facts of its own motion and which shall not be restricted in this examination to the facts, evidence and arguments provided by the parties and the relief sought; Art. 114(1) EPC. Determining whether an invention is based on an inventive step is a question of law. However, the general technical knowledge of the skilled person, the closest prior art, the differentiating features, etc. are facts, and it is up to the parties to allege these facts (see ¶37).

In my perception, the considerations with respect to the burden / degree of substantiation are what this decision will likely be cited for in the future.

To the extent the FPC admitted the plaintiff’s arguments and evidence into the proceedings at all, the decision holds that the claimed subject-matter was not obvious over US 5,266,264.

Costs

Even though the plaintiff did not succeed with any request, the defendant was still charged with half of the court fee since the patent was maintained only to a limited extent, i.e. the defendant partially acknowledged the plaintiff’s complaint and both parties win and therefore lose equally.

No compensation for legal represenatation was awarded.

Interestingly, the plaintiff only involved a patent attorney when the expert opinion of the judge-rapporteur had been established. The respective expenses were not considered necessary anymore since the closure of the file had already occured at that time. On the other hand, defendant’s expenses for the assisting patent attorney of ICB, a company within the Swatch group of companies, had not been considered, either: No intra-group expenses are reimbursed; see O2014_009, ¶6.2.

UPDATE 9 September 2019:

The decision has been appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_001 | Decision of 27 June 2019

Harcane Sàrl
./.
Comadur SA

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Tobias BREMI
  • Dr. Michael STÖRZBBACH
  • Dr. Regula RÜEDI
  • Dr. Thomas LEGLER

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

  • Jean-Claude SCHWEIZER (SLB)

Representative(s) of Defendant:

  • Dr. Nathalie TISSOT (Tissot)
  • Marie TISSOT (Tissot)
  • Thierry RAVENEL (ICB), assisting in patent matters

DECISION OF THE FPC
→ patent maintained / partially surrendered; plaintiff’s claims dismissed
Case no.: O2016_001
Decision of: 27 June 2019
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DECISION OF THE SUPREME COURT
→ referred to in ¶13 of the FPC decision
Case nos.: 4A_584/2017
4A_590/2017
Decision of: 9 January 2019
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PATENT IN SUIT

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Register ban ordered, but only after hearing the defendants

Reading time: 4 minutes

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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A Swiss approach to the EPO’s gold standard

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Case No. O2016_016 | Decision of 6 June 2019

The patent at stake is MundiPharma‘s EP 2 425 825 B9; see EPO Register and Swissreg. EP’825 pertains to a combination of oxycodone hydrochloride (in an amount of 10 to 150g) and naloxone hydrochloride (in an amount of 1 to 50g), in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma.

Develco’s logo

Develco sought annulment of EP(CH)’825 for various reasons, i.e. undue extension of subject-matter, non-enablement and invalidity of the priority claim. Please see this Blog here for a brief summary of the main hearing in this matter, and some relevant prior art Develco has asserted against patentability of the claimed subject-matter.

MundiPharma’s logo

Defendant / patentee MundiPharma countersued for infringement. MundiPharma not only countersued the plaintiff, but rather also attempted to involve the German branch of Develco as well as Konapharma. This attempt failed.

It was evident from the pleadings at the main hearing that the expert opinion of the judge-rapporteur had held that the patent was invalid for undue extension of subject-matter. Thus, it does not come as a big surprise in the decision that EP(CH)’825 is held invalid for undue extension of subject-matter. Consequently, the decision does not address the other grounds of invalidity asserted by Develco; and the counterclaim for infringement is moot, too.

In my perception, the detailed assessment of undue extension of subject-matter is nothing out of the ordinary. It’s all about the EPO’s ‘gold standard’ (G 2/10 in ¶4.3, with reference to G 3/89 and G 11/91), i.e.

[…] any amendment […] can […] only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of [the application as filed].

What is interesting, though, is how the decision addresses the so-called essentiallity-test (‘Wesentlichkeits-Test’), in particular how this test fits with the ‘gold standard’. In brief, in T 331/87 the Board held that the replacement or removal of a feature from a claim may (referred to in the Case Law of the Boards of Appeal as a ‘might’) not be in breach of Art. 123(2) EPC if the skilled person would directly and unambiguously recognise that

  1. the feature was not explained as essential in the disclosure;
  2. it was not, as such, indispensable for the function of the invention in the light of the technical problem it served to solve; and
  3. the replacement or removal required no real modification of other features to compensate for the change.

It is important to note that even this Board apparently (in view of the conditional language used; see mark-up above) did not consider compliance with the above three criteria as a sufficient condition for compliance with Art.123(2) EPC in any given case. Accordingly, the present decision holds that the only thing that really matters is the ‘gold standard’ discussed above, which cannot be deviated from. With reference to the Swiss Supreme Court decision 4A_109/2011, 4A_111/2011 (¶4.3.1), however, the decision further holds that in a case where not even the criteria of the essentiallity test are fulfilled, it must be assumed that an undue extension of subject-matter occured.

What suprises me, though, is that the decision holds (¶31):

Otherwise this would again amount to a materiality test, which was expressly rejected in G 2/98.

Frankly, I don’t see that in G 2/98, at least not expressly (‘ausdrücklich’). One may well conclude from the gist of G 2/98, in particular ¶8.3, that it does not endorse a distinction of technical features which are related to the function and effect of the invention and technical features which are not. But there is no discussion of the essentiallity test at all in G 2/98. Else, if there was, the essentiallity test would surely not be referred to anymore in the most recent edition of the Case Law of the Boards of Appeal and the Guidelines.

But still, my personal take-away message from this decision is that the essentiallity test is of no avail in proceedings at the FPC (until someone comes along and proves me wrong).

The decision is not yet final / may still be appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_016 | Decision of 6 June 2019

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

  • Dr. Daniel M. ALDER
  • Dr. Tobias BREMI
  • Dr. Hannes SPILLMANN

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Develco:

  • Andrea MONDINI (TIMES)
  • Dr. Cornelia HOFFMANN (SBMP), assisting in patent matters

Representative(s) of Mundipharma:

  • Dr. Simon HOLZER (MLL)
  • Dr. Dirk BÜHLER (Maiwald), assisting in patent matters
  • Dr. Andreas LEDL (Maiwald), assisting in patent matters

DECISION

Don’t be misled by the patent no. on the bottom of the title page. EP 2 245 825 is a typo; this should read EP 2 425 825.
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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.

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.

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

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:

DECISION IN FULL

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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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