Low dosage form of tadalafil held obvious, preliminary injunction denied

Reading time: 13 minutes

Case No. S2019_007 | Decision of 1 October 2019


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.


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:


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Writing instrument: The Supreme Court’s final stroke

Case Nos. 4A_435/2018, 4A_441/2018 (Supreme Court) | Decision of 29 January 2019 on appeal against O2015_018 (FPC) | Decision of 15 June 2018 | ‘Instrument d’écriture’

Please see this Blog here for a detailed review of the underlying decision of the FPC in this matter.

Both parties had lodged an appeal — but the Supreme Court dismissed both appeals. While the FPC’s judgement was quite a booklet of 50+ pages, it took the Supreme Court only 7 pages to deal with both appeals. Most of the judgment indeed is pretty straight forward. Still, the judgment has quite some interesting aspects, in my perception:

  1. Assignment of a patent does not imply assignment of the universal right to the invention per se 
Montres Valgine logo

Guenat had requested that Swiss Finest‘s Swiss patent be annulled based on Art. 26(1) lit. d PatA, i.e. for lack of entitlement. However, such request can only be brought by the entitled person; Art. 28 PatA. Guenat alleged that Frédéric Garinaud transferred ‘full and complete ownership’ of the European patent application to Guenat. But that did not help. Frédéric Garinaud specifically assigned the European patent application to Guenat, but not the universal rights in the ‘invention’ itself. Guenat’s request for declaration of nullity based on Art. 26(1) lit. d PatA was thus held inadmissible for lack of standing.

On appeal, Guenat criticises the FPC’s ‘artificial dichotomy’ between the invention and the related patent application, and claims complete control over the invention in dispute. The Supreme Court didn’t buy into that. The decision holds in ¶3.2 that Guenat’s argument is based on an assumption about the parties’ intention in respect of the transfer agreement of April 2013. This is not a question of law, but of fact. But the FPC had not found that the real and common intention the parties had been to assign all intellectual property rights to the invention and the right to be granted all related patents. On the contrary, according to the FPC, the agreement in question ‘clearly refers only to the European patent application and the resulting European patent, and not to the invention as such’ — which finding is binding on the Supreme Court since it is not ‘arbitrary.’

Thus, the Supreme Court apparently had no doubt that the assignment of a specific patent does not necessarily imply the assignment of the universal rights in the invention itself.

  1. Assessment of inventive step is a question of law, but …

Guenat argued on appeal that the FPC had violated the principle of party disposition because it took facts into account that had not been alleged by the defendant.

Now, what had happened?

The FPC had held that a specific feature (C3-1) was not disclosed in the closest prior art document. Guenat had a different understanding of the specific feature, and had argued that based on a ‘correct’ understanding of the feature it had well been disclosed in the closest prior art.

Swiss Finest logo

On appeal, Guenat argued that Swiss Finest had not even alleged that feature C3-1 was not disclosed in that document. Unfortunately, it is not readily clear from the decision to which version of feature C3-1 that allegation pertained: The feature as construed by the Guenat, or the feature as construed by the FPC?

The Supreme Court held that it had not been disputed that all the factual elements necessary for the analysis of obviousness had been brought on file by the parties. Further, the Supreme Court held that Guenat had not asserted that the FPC had to supplement the facts on its own, and that such conduct was also not apparent from the file. In the Supreme Court’s view, the FPC was thus in a position to assess obviousness, which is a question of law. It is irrelevant in this respect that the presence or absence of specific features in the prior art and/or the patent have been alleged by the defendant or the plaintiff. On the basis of the facts gathered by the parties in order to consider a question of law, the court did not violate the principle of party disposition.

Without any in-depth knowledge of what had or had not been argued by the parties, I just cannot say whether I would agree with the assessment on the merits of the case. But the Supreme Court’s general considerations on questions of law vs. questions of fact trigger some further thoughts.

Clearly, assessment of obviousness is a question of law — but the underlying factual elements still need to be asserted by the parties. But what are the ‘factual elements’? They must be something more specific than just ‘the patent in suit’, ‘D1’ or the like. Else, a court could just combine whatever is on file in its assessment of obviousness, fully detached from the pleadings. This cannot be it. Now, let’s assume that both parties come up with a somewhat strange claim construction, and base all their obviousness attacks / defenses on a wrongly construed claim. In my understanding, claim construction clearly is a question of law, too (see e.g. X ZR 255/01 – ‘Bodenseitige Vereinzelungseinrichtung’ of the German Federal Supreme Court in ¶5, with further reference). But what if no party ever pointed to the relevant underlying ‘factual elements’ (i.e. specific sections of the patent in suit) that support the ‘correct’ claim construction? May the court then even come up with a different / the ‘correct’ claim construction at all?

UPDATE 21 March 2019:

Note that the FPC had held in the recent decision S2018_006 that claim construction is a question of law. In that case, both parties had not construed the feature in question at all, and the FPC came up with a construction on its own:

Wie der Begriff korrekt auszulegen ist, tragen die Beklagten hingegen ebenso wenig wie die Klägerin vor. Da die Auslegung des Patentanspruchs eine Rechtsfrage ist,15 geht die Annahme der Beklagten fehl, das Gericht dürfe den Anspruch mangels entsprechenden Vortrags der Klägerin nicht so auslegen, dass er auch etwas anderes als einen Schneidprozess erfasst.
15 Federal Supreme Court: 4A_142/2011, ¶1.3
But, again, what if both parties came up with a claim construction mutually agreed upon — but which, in the courts view, is just wrong? Or, what if both parties come up with different constructions which are both wrong in the court’s view? Can the court then correct such (a) construction(s) if it would have to rely on ‘factual elements’ that have never been pointed at by the parties, just because it is a question of law? And if that was the case, then where is the limit in the assessment of obviousness — which is a question of law, too?

The theory of separating questions of law from questions of fact is simple. But life is complicated …

On a sidenote: Wouldn’t it be good to establish common ground on what the claim actually is all about before diving any deeper? This is what a Markman hearing in the U.S. is all about. Even though I am not overly enthusiastic about quite some aspects of patent litigation in the U.S., this one certainly is useful.

Reported by Martin WILMING


Case No. 4A_435/2018 (Supreme Court) | Decision of 29 January 2019 on appeal against O2015_018 (FPC) | Decision of 15 June 2018 | ‘Instrument d’écriture’

Guenat SA Montres Valgine (appellant)
Swiss Finest SA (respondent)


Case No. 4A_441/2018 (Supreme Court) | Decision of 29 January 2019 on appeal against O2015_018 (FPC) | Decision of 15 June 2018 | ‘Instrument d’écriture’

Swiss Finest SA (appellant)
Guenat SA Montres Valgine (respondent)
Both proceedings were jointly dealt with by the Supreme Court.

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL

Court Clerk:

  •  Nicolas CURCHOD

Representative(s) of Guenat SA Montres Valgine:

Representative(s) of Swiss Finest SA:

  • Christoph KÜNZI (CBK)

on appeal against O2015_018 (FPC) | Decision of 15 June 2018
Case nos.: 4A_435/2018
Decision of: 29 January 2019
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Case no.: O2015_018
Decision of: 15 June 2018

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CH 704 790 B1

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CH 704 790 C1

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EP 2 497 648 B1

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Expectation of success: Please, be reasonable! (Part 1/2)

Reading time: 16 minutes
Famous dreamer

I have a dream today …

No, not about the civil rights movement. I am far less ambitious. I am just wondering: Wouldn’t it be great if one day we would all do the same when assessing obviousness?

I have a dream that one day we all agree on

Aiming high now: Maybe not only in prosecution, but even in litigation therafter!

We are surely not yet there.

For instance, the German Federal Court of Justice (FCJ) has some reservations, as discussed by judge Klaus GRABINSKI here:

The [EPO] Guidelines stipulate that deviation from this strictly schematic approach should be exceptional. The approach serves the interests of objective and predictable assessment in the examination procedure, in which, under Article 18(2) EPC, only the applicant and one member of the examining division are normally involved. Its appropriateness in this context is not to be questioned here; however, for a court procedure conducted on an adversarial basis between two or more plaintiffs and defendants, its suitability is limited.

But what are these reservations?

Firstly, the choice of a (single) closest prior art as the starting point in the assessment of obviousness, in GRABINSKI’s view:

Experience shows that, in nullity proceedings, the plaintiff generally presents several starting points (documents, public prior uses, etc.) in respect of inventive step. The court then has to assess whether the skilled person would actually have selected these starting points. According to the case law of the German FCJ, the choice of a specific starting point for the consideration of inventive step requires particular justification. This can be derived from the skilled person’s endeavour to find, for a specific purpose, a solution better than or different from the solution provided in the prior art. The test can be applied with one or more starting points (documents, public prior uses, etc.). There is no reason to limit the assessment of inventive step from the outset to the “closest prior art”. Otherwise, there is the risk of an inadmissible ex post evaluation of the prior art with regard to what is “closest”.

However, GRABINSKI holds that the EPO’s approach essentially does not differ much (what I believe is true, and I will come back to this in the below):

Ultimately, the same view would appear to prevail in the [then] current Guidelines for Examination. The authors concede, with reference to several decisions of the boards of appeal, that in some cases there are several equally valid starting points for the assessment of inventive step and that, in the event of refusal, it is sufficient to show, on the basis of relevant prior art in respect of at least one solution, that the claimed subject-matter lacks an inventive step. In such a situation, there is no need to discuss which document is “closest” to the invention; the only relevant question is whether the document used is a feasible starting point for assessing inventive step.

The formulation of the objective technical problem is key in the EPO’s problem-solution approach. Admittedly, this involves a somewhat artificial, retrospective approach. But it does so by design and in the interest of legal certainty, for that it be a reliable tool with predictable results. In my perception, the German FCJ takes a somewhat different approach; the problem(s) it typically refers to is/are not the objective technical problem of the problem-solution approach  at least not necessarily; see e.g. the discussion of the FCJ’s decision X ZR 29/15 - Pemetrexed by Rainer ENGELS here.

But be that as it may, I have no reason to blame the German FCJ for its approach. It may or may not be better suitable to avoid hindsight, or to provide legal certainty for users. There is more than one way to skin a cat, and the German FCJ never said to have adopted the EPO’s problem-solution approach.

However, the Swiss FPC did — repeatedly and in no uncertain terms (see e.g. O2015_018, ¶30):

Le Tribunal fédéral des brevets applique l’approche problème-solution développée par l’Office européen des brevets dans le cadre de l’évaluation de l’activité inventive.

Loosely translated:

The Federal Patent Court applies the problem-solution approach developed by the European Patent Office in the context of the evaluation of inventive step.

Hooray! They play the game as I know it!!

Thus, European patent attorneys in civil proceedings at the FPC can just do what they do all day long in proceedings at the EPO, at least in the assessment of obviousness? Actually, this would not come as a complete surprise since the second permanent judge (Tobias Bremi) and 27 of the non-permanent judges have a technological background and are European patent attorneys by training.

But hold on, it’s maybe not that easy.

Clearly, the FPC has the same reservations with respect to the choice of a (single) closest prior art; see O2013_011 in the hn and ¶5.6, with further reference to T 967/97, as well as S2017_001, ¶4.6.

But I feel that GRABINSKI is right in that this is nothing out of the ordinary in EPO practice (as it should be, taking into account the case-law of the Boards of Appeal); it is just that the term closest prior art used in the problem-solution approach might be misleading in that it suggests that this is always just a single document.

But what concerns me in recent times is the concept of a reasonable expectation of success; see this Blog here. The argument that there had been no reasonable expectation of success is easily made and thus frequently seen. And it is always easy to cast doubts in the assessment of obviousness:

Just imagine what could have gone wrong!

What is worse, such arguments cannot be proven wrong: Indeed, life is risky.

Not fully according to expectation …

Now, what the heck is actually a reasonable expectation in the skilled person‘s eyes?

The EPO Guidelines

The Guidelines are firm instructions to the first instance bodies of the EPO; see the foreword:

As a general rule, parties may expect the EPO to act in accordance with the Guidelines until such time as they – or the relevant legal provisions – are amended. […] In case of diverging decisions of the Legal or Technical Boards of Appeal, EPO examiners and formalities officers will, as a rule, follow the common practice as described in the Guidelines.

Patent applications filed with the EPO (Source: EPO)

More than 160’000 patent applications are filed with the EPO per year. And obviousness is to be assessed for all these applications; Art. 56 EPC.

If the concept of a reasonable expectation of success was of general importance for the daily practice of the first instance bodies at the EPO, one would readily expect it to be addressed in the Guidelines.

But, interestingly, it is not discussed at all — at least not in the chapter on assessment of obviousness.

The term reasonable expectation of success is only mentioned once in the Guidelines, but only a contrario, in the context of novelty of selection inventions in G-VI, 8:

The concept of seriously contemplating, or ‘ernsthaft in Betracht ziehen’ in German, is fundamentally different from the concept used for assessing inventive step, namely whether the skilled person would have tried, with reasonable expectation of success, to bridge the gap between a particular piece of prior art and a claim whose inventiveness is in question (see G-VII, 5.3), because in order to establish anticipation, there cannot be such a gap (T 666/89).

If you follow the link to G-VII, 5.3 in the hope to learn more about the concept of a reasonable expectation of success, you will be disappointed: There is nothing about reasonable expectation of success. G-VII, 5.3 is all about the could-would approach as we all know it. It reads as follows:

[T]he question to be answered is whether there is any teaching in the prior art as a whole that would (not simply could, but would) have prompted the skilled person, faced with the objective technical problem, to modify or adapt the closest prior art while taking account of that teaching, thereby arriving at something falling within the terms of the claims, and thus achieving what the invention achieves (see G‑VII, 4).

In other words, the point is not whether the skilled person could have arrived at the invention by adapting or modifying the closest prior art, but whether he would have done so because the prior art incited him to do so in the hope of solving the objective technical problem or in expectation of some improvement or advantage (see T 2/83).


Hold on a second.

It is worth reading the second paragraph again. The expectation of some improvement or advantage language is taken literally from T 2/83. But did you notice the other alternative?

I don’t know where the wording in the hope of solving the objective technical problem comes from; this inconsistency has already been discussed by discussed by Wooden, Blaseby and Visser recently. It somehow found its way into the Guidelines already back in 2003. But T 2/83 is silent about hope. The could-would approach clearly is not about hope; it is about an expectation.

Anyway, there is nothing about a reasonable expectation of success. It is only about an expectation of some improvement or advantage.

Now, do these terms maybe both mean essentially the same? I.e., is

  • success only the short for some improvement or advantage; and
  • the expectation (implicitly) meant to be reasonable in any event?
Too many people
making too many problems?

If so, fine. But wouldn’t it be good to use the same terms when referring to the same things? It’s a land of confusion anyway.

Or are they not the same? If that was the case, then the concept of a reasonable expectation of success just cannot be of any broader relevance for the first instance bodies at the EPO at all. Else, it would surely be referred to in the Guidelines.

Getting confused? Hold on tight, it’s not getting easier …

Learnings from the FPC

Decision S2017_001 in r 4.7 embraces the EPO’s could-would approach recited above. With reference to Kroher (Singer/Stauder, EPÜ, 7th ed., Art. 56, ¶73-74) the decision further holds that the ‘would’ is satisfied if there is a motivation to arrive at the claimed solution and an expectation of success that this solution actually works:

Dass der Fachmann die erfindungsgemässe Lösung effektiv finden würde gilt als gezeigt, wenn aus den Unterlagen ersichtlich ist, dass der Fachmann einen Anlass hatte (‘motivation’), zur erfindungsgemässen Lösung zu kommen, und er eine Erfolgserwartung hatte, dass die erfindungsgemässe Lösung auch funktioniert (‘expectation of success’).

Noteworthy, this does not even require the ‘expectation of success’ to be reasonable, and that the ‘success’ is realistically achievable — at least not explicitly. Kroher did not put it like this. This is what Kroher exactly says (emphasis added):

Zum Could-would Ansatz gehört auch die Wertung, ob für den Fachmann eine angemessene Erfolgserwartung bestand, ob er auf der Grundlage seines Wissens und Könnens realistisch mit einem Erfolg rechnen konnte oder nicht (vgl Rdn 136).161

161 T 60/89, Abl 1992, 268, Nr 3.2.5 ff; T 149/93 vom 23.03.1995, Nr 5; DE-BGH vom 15.05.2012 – Calcipotriol-Monohydrat, GRUR 2012, 803.

I have several issues with that.

First, none of the references cited in the fn actually says that the assessment of a reasonable expectation of success is part of the could-would approach. So, where does this come from?

Second, assuming that it really was part of the could-would approach, then how can it be that examiners and opposition divisions of the EPO deal with more than 160’000 cases per year in the absence of any instructions in the Guidelines? An integral part of the could-would approach did not make it into the Guidelines for decades? I can hardly believe that.

Third, the cross-reference to ¶136 in the Kroher chapter exclusively relates to biotech cases. And this is where it belongs — pretty exclusively, in my perception. Actually, the Boards of Appeal of the EPO have come up with the concept of a reasonable expectation of success in biotech cases. Frankly, I am not aware of any non-pharma or non-biotech case where the reasonable expectation of success argument had ever been successfully invoked to establish non-obviousness.

In sum, Kroher’s conclusion is not readily convincing to me, and it is not supported by the references given. I could only agree, again, if the reasonable expectation of success does not mean anything different than the expectation of some improvement or advantage according to the problem-solution approach.

What troubles me is that the FPC’s concise summary in S2017_001 is not just a summary of Kroher, or any other reference cited by Kroher. Rather, it adds further terms and interpretation, and appears to be more harsh in that the terms ‘reasonable’ and ‘realistic’ are just omitted.

Why adding to the confusion when mere application of the could-would approach — which is an integral part of the problem-solution approach — could just be it? The could-would approach (only) asks whether

[…] the skilled person would have arrived at the invention by adapting or modifying the closest prior art because the prior art incited him to do so […] in expectation of some improvement or advantage (see T 2/83).

In my understanding, the test is fairly easy. The skilled person could have done a lot. What the could-would approach is all about is to sort out what he actually would have done. Nothing more, nothing less. It does so by requiring prompters (sometimes referred to as pointers) or incentives in the prior art for the skilled person to arrive at the invention.

Ask Google for a definition of ‘motivation’, and you will get this.

Now, where does the ‘motivation’ referred to in S2017_001 come into play? There is no need for the additional term ‘motivation’ in the could-would approach. It might even cause confusion with the former teaching-suggestion-motivation (TSM) test in the U.S., or the Veranlassung approach of the German FCJ (which GRABINSKI says is very similar but not the same as the EPO’s could-would approach).

But be that as it may, a motivation in its broadest sense (according to Google) is

a reason or reasons for acting or behaving in a particular way.

Thus, I feel it is fair to say that the motivation referred to in S2017_001 is nothing more than the prompter or incentive. No need to fiddle around with yet another term in discussing the could-would approach. Talking about incentives, prompters (and pointers) is already complicated enough.

But that’s not the end of the story. The could-would approach cannot and does not just demand for an incentive in the prior art. An incentive to do … what? Adapting or modifying the closest prior art is no value in itself. It’s all about an incentive to achieve something; it must have a goal. The could-would approach consequently asks for an incentive to adapt or modify the closest prior art in expectation of some improvement or advantage — well, actually to solve the objective technical problem.

In a nutshell

The problem-solution approach which the FPC has comitted to apply includes the could-would approach which is a pretty decent tool that has been applied by the first instance bodies of the EPO for decades.

However, there is no mentioning of a reasonable expectation of success in the could-would approach. I am currently not sure whether the FPC tends to apply a somewhat modified could-would approach, or whether it understands and applies the expectation of some improvement or advantage in the sense of a reasonable expectation of success — a concept that the Boards of Appeal have developed and applied by now only in biotech cases, to the best of my knowledge.

On a sidenote, I do not readily agree with the threshold the FPC seemingly sets as reasonable; see S2017_001 (¶4.7; emphasis added):

Ob eine angemessene Erfolgserwartung gegeben ist, hängt immer stark von den konkreten Umständen und dem betrachteten technischen Gebiet ab und dabei unter anderem erheblich davon, ob es rational möglich ist, eine Vorhersage über den Erfolg zu machen. (Fn: Vgl. z.B. Medimmune Ltd v Novartis Pharmaceuticals UK Ltd & Ors [2012] EWCA Civ 1234 (10 October 2012), Reasons 91-95)

Note, that Medimmune v Novartis in no way puts such emphasis on the predictability of success, which is rather referred to as just one of many circumstances to consider. It reads as follows (¶91):

Whether a route has a reasonable or fair prospect of success will depend upon all the circumstances including an ability rationally to predict a successful outcome, how long the project may take, the extent to which the field is unexplored, the complexity or otherwise of any necessary experiments, whether such experiments can be performed by routine means and whether the skilled person will have to make a series of correct decisions along the way.

The FPC apparently focusses on the predictablity of a success. I do not feel that this is supported by Medimmune v Novartis, nor by the case-law of the Boards of Appeal of the EPO and/or the problem-solution approach. Rather, it reminds me of the focus on predictability in the aftermath of KSR Int’l Co. v. Teleflex Inc.; see MPEP, ¶2141.

I will dig a bit further into this with a review of the case-law of the Boards of Appeal of the EPO in a second post on this issue soon.


The objective technical problem should not be that much of a problem

Reading time: 14 minutes

We have seen some interesting decisions lately that deal with basic principles in the assessment of inventive step / obviousness. For instance, the Supreme Court provided guidance how to deal with a non-enabling disclosure as a closest prior art document; see this Blog here. But there is yet another decision of potentially wider relevance, i.e. in that it apparently re-defines how to formulate the ‘objective technical problem’.

It’s silly season now, and I could not help but reflect a bit about the typical learning curve of a patent attorney trainee when getting acquainted with such basics. If you are in a rush, feel free to jump over here.

Patent law is somewhat mysterious. The basics of patentability are very simple: The claimed subject-matter shall

  • be new (‘just don’t claim exactly what has been out there already’); and
  • involve an inventive step (‘a bit creative, please – not just obvious’);

On the merits, that’s pretty much it. Admittedly, there are some side aspects to observe, e.g.

  • it should have industrial applicability (‘it should be useful’);
  • it should not be excluded from patentability by law (‘don’t do what is explicitly forbidden’);
  • it should be sufficiently disclosed (‘tell the world how to make use of it’).

But that doesn’t seem to be a big deal. A quite common first thought of a patent attorney trainee goes like:

Well, that’s it? Why do I have to wait three years to sit (and pass!) the exam?

Learning by doing

Later, one realizes that things are much more complicated than it seemed at first glance — and that it’s probably not a bad idea to test these basic concepts in real cases for a while, and one is grateful for some supervision before actually sitting the exam (while still at least hoping to pass).

Thereafter, it’s like driving a car. Passing the exam does not yet mean that you are a good driver. Still, at some point sooner or later and with some experience in the field, almost everybody will fairly get along on the streets.

This is no invention. No way!

It’s the same with patent attorneys: We are said to have quite firm opinions (when we finally have made up our mind), and it’s our bloody job to transfer this opinion to whoever needs to be convinced, every single day.

But patent attorneys constantly fail. Just look at all the negative office actions in the mailbox every day. Still, we know how to play the guitar. No doubt that a case only failed because the specific piece of music was not well perceived by the audience.

But once in a while, even the basic concepts are challenged. Things are heavily on the move in recent times, e.g. in terms of the assessment of infringement under the DoE or the abolition of the infringement test for SPCs. Still, all this is not too much out of the ordinary.

But when the common general understanding of how to assess inventive step / obviousness is whobbling, I am getting concerned. That’s my day-to-day business! Do I still play the game correctly?

Assessment of ‘inventive step’

In knowledge of what the invention is, it’s hard (if not impossible) to objectively evaluate whether or not it had been obvious before the invention has seen the light of day. As soon as you are aware of the invention, the unavoidable hindsight bias undermines any objective assessment.

Case law should be predictable, and individual judgments must be ‘right’. That’s a tricky balance — and whenever things are tricky, it’s comfy to have standardized tools at hand. This is where the EPO’s problem-and-solution approach comes into play (Guidelines, G-VII, 5), and which the FPC has repeatedly indicated to apply. It aims to avoid hindsight bias, and it does so with a rigid framework to be worked through. In brief, the problem-and-solution approach involves three main steps:

  1. determining the ‘closest prior art‘;
  2. establishing the ‘objective technical problem‘ to be solved; and
  3. considering whether the claimed invention would have been obvious to the skilled person.
Close, but hard to reach

Step i), i.e. the question of whether or not something should be considered as the ‘closest prior art’, is mostly a major issue in any discussion of inventive step. I won’t dive into this now, but I strongly recommend Oliver Randl’s Post on an his Blog ‘K’s Law‘. (The Blog is dormant now because he became a member of the Boards of Appeal.) His comparison of assessment of inventive step with mountaineering is just great.

Further, one may well discuss for quite a while in step iii) what a skilled person would actually have done or not. The EPO’s could-would approach requires that

[…] the prior art as a whole […] would (not simply could, but would) have prompted the skilled person, faced with the objective technical problem, to modify or adapt the closest prior art while taking into account of that teaching, thereby arriving at something falling within the terms of the claims, and thus achieving what the invention achieves.

The gist is that hindsight should not be an issue if there is a pointer or an objective incentive to combine two pieces of prior art. Fine. But …

The definition of the ‘objective technical problem’

Everything hinges on the definition of the objective technical problem in step ii), and this is what this Post is all about. According to the EPO Guidelines (G-VII, 5.1),

[…] one establishes in an objective way the technical problem to be solved. To do this one studies the application (or the patent), the ‘closest prior art’ and the difference (also called ‘the distinguishing feature(s)‘ of the claimed invention) in terms of features (either structural or functional) between the claimed invention and the ‘closest prior art’, identifies the technical effect resulting from the distinguishing features, and then formulates the technical problem. […]

It is noted that the objective technical problem must be so formulated as not to contain pointers to the technical solution, since including part of a technical solution offered by an invention in the statement of the problem must, when the state of the art is assessed in terms of that problem, necessarily result in an ex post facto view being taken of inventive activity (see T 229/85).

That’s how I’ve learned to play the game. A plain and simple mechanism:

  • identify the distinguishing feature (e.g. bolt and nut instead of a nail);
  • identify the technical effect of the distinguishing feature in the context of the invention (e.g. ease of detachability)
  • define the objective technical problem based on the technical effect of the distinguishing feature (e.g. facilitate detachability)

Does O2015_008 lower the bar?

When re-reading the judgment O2015_008 of 14 March 2018 (commented on this Blog here), I stumbled upon a general remark in ¶66 that I had overlooked before. It reads as follows (translated from French):

Nevertheless, the question must be asked whether the objective problem that is used for the problem-and-solution approach […] finds a basis or motivation in the closest prior art document or is part of the standard problems for the skilled person, and does not incorporate elements of the proposed solution into the patent (cf. T 59/90, r. 8). This is important to avoid hindsight bias.

(A reasoning along these lines, but in less explicit terms, can also be found in ¶33 of the decision O2015_018 of 15 June 2018, with the very same reference to T 59/90; see this Blog here.)

First, I just don’t know for sure what is meant with ‘standard problems’; but maybe this refers to e.g. ‘less expensive’, ‘faster’, ‘more efficient’ or similar things.

But be that as it may, I feel that the whole approach is flawed.

Why should it be required to have a basis or motivation for the ‘objective technical problem’ in the ‘closest prior art’?

Let’s take a simple example:

The invention is a car with an allegedly clever engine — but there is a lot of other stuff recited in the claim, e.g. wheels, mirrors, bumper, a radio, etc.

Obviously great

The ‘closest prior art’ shows almost everything, in particular the allegedly clever engine. So this really is a reasonably chosen ‘closest prior art’. In fact, it is almost novelty destroying. It is only silent about the radio.

Car radios are perfectly known, but in no way mandatory. Thus, there clearly is no implicit disclosure of a radio in the ‘closest prior art’, and one has to deal with it as a matter of obviousness.

In my perception, a proper definition of the objective technical problem will somehow need to address entertainment and/or information in a car, while carefully avoiding to mention a radio.

The alleged invention correctly just cannot survive the problem-and-solution approach because there are a lot of car radios in the prior art as a whole, and the skilled person would surely have integrated them as a straight-forward solution to the objective technical problem to be solved.

But I am not so sure about this if the reasoning in ¶66 of O2015_008 was correct. To be frank, I don’t even have a clue how the objective technical problem should then be defined. There just is no ‘basis or motivation’ towards entertainment or information in that document.

Alternatively, let’s start from a car with wheels, mirrors, bumpers and a radio as the ‘closest prior art’, and then try to combine it with the (not anymore) ‘closest prior art’ showing the engine. Assume the clever engine is just shown somewhere in the smallprint, without any indication of advantages or further explanations. It’s just there, and it’s not immediately apparent why it actually is clever. You will then have a hard time to hunt this April Fool’s joke of an ‘invention’ down with the problem-and-solution approach, in the absence of any pointer towards the invention, i.e. to use  the engine from the prior art in a car with wheels, mirrors, bumper and — believe it or not — a radio.

Frankly, this cannot be it. I feel there must be a bug in a test that does not reliably sort out such non-inventions.

Struggling with this, I sought for guidance in T 59/90 (¶8) referred to in ¶66 of O2015_008. But there is none. It might be the last paragraph of ¶8 that appears to support the view taken in ¶66 of O2015_008, at least at first glance. It reads as follows:

Daraus muss geschlossen werden, dass aus [dem nächstliegenden SdT] das der patentgemässen Aufgabe zugrundeliegende Problem nicht bekannt war, und demzufolge auch die Lösung der Aufgabe aus [dem nächstliegenden SdT] in Verbindung mit dem allgemeinen Fachwissen nicht nahegelegt gewesen sein kann.

Loosely translated:

It must be concluded that the actual technical issue underlying the objective technical problem was not known from [the closest prior art], and therefore the solution of the problem could not have been obvious from [the closest prior art] in connection with the general technical knowledge.

However, the Board did not deal with the formulation of the objective technical problem here. It took the objective technical problem as it had been properly defined beforehand, and then summarized its assessement according to step iii), i.e. the could-would approach.

At closer scrutiny, it turns out that all this was only intended to sum up the reasons in respect of a single attack based on the ‘closest prior art’ per se, only in further view of the common general knowledge of the skilled person. Thus, it had essentially been argued by the opponent that the ‘closest prior art’ in itself would render the claimed subject-matter obvious for the skilled person. In that case, I might agree that the ‘objective technical problem’ needs to have a basis or motivation in the ‘closest prior art’ because it is not combined with yet another document but rather is considered self-contained, only seen with the eyes of the skilled person (common general knowledge). Where else should the pointer come from, if not from the ‘closest prior art’ in such a case?

But as soon as the ‘closest prior art’ is considered in further view of yet another document, the basis or motivation may well be derived from that further document.

And this is exactly what has been done in T 59/90. The Board moved on to assess in ¶9 whether there is any incentive towards the solution of the objective technical problem in any other prior art document:

It remains to be checked whether a suggestion for the solution of the objective technical problem can be derived from any of the other documents on file.

Note that the Board did not touch the wording of the ‘objective technical problem’ when moving on to check the combinations with the other documents on file. This is the problem-and-solution approach; nothing more, nothing less.

Further, I strongly doubt that this decision is of much relevance at all. It had been only distributed to Chairmen of other Boards (classified as ‘C’), and it has been cited by other Boards only once in 25 years (T 1009/96), for an unrelated aspect. And it is not that this Board had cited it by its own volition. Rather, it had to bother with T 59/90 because a party brought it up. It had been argued that a piece of prior art cannot be considered as ‘closest prior art’ at all because it did not deal with the specific problem of the invention. But this is not my point here, and the argument failed anyway. What is more, T 59/90 is not even mentioned in the reference book ‘Case Law of the Boards of Appeal‘. Thus, the decision has effectively been ignored by other Boards for a quarter of a century. Rightly so, because there is nothing special in it.

Concluding, I don’t see that T 59/90 supports the view taken in ¶66 of O2015_008 (except for the special situation where lack of inventive step is argued based on a single reference, i.e. the ‘closest prior art’ per se), and the above example shows how it would almost inevitably lead to obviously wrong results. In my perception, there is no need to spice up the well established framework of the problem-and-solution approach with yet further requirements. Rather, it can and should be applied as set forth in the Guidelines, for that case law remains predictable. And I have no reason to doubt that it leads to ‘right’ decisions — if applied correctly.

UPDATE 26 Sep 2018:

Decision T 910/90 states the following in ¶5.1 (and I fully concur with this):

Dabei kommt es nicht darauf an ob diese Aufgabe bereits im nächstkommenden Stand der Technik angesprochen ist, sondern darauf was der Fachmann beim Vergleich des nächstkommenden Standes der Technik mit der Erfindung als Aufgabe objektiv erkennt.

Loosely translated:

It does not matter whether this problem is already addressed in the closest prior art; rather, it is decisive what the skilled person objectively recognizes as the problem when comparing the closest prior art with the invention.

Reported by Martin WILMING


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T 59/90

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¶33, translated from French:

However, [the definition of the objective technical problem according to the problem-and-solution approach] is only valid insofar as the technical problem thus determined can reasonably be presumed to be a problem that arises without inventive effort within the general framework of the closest prior art document. Otherwise, this approach would focus the disclosure of the closest prior art and its interpretation in the direction of the invention, and introduce hindsight. (cf. T 59/90, ¶8)


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Claim dismissed, counterclaim dismissed: Huge expense, no recompense

Case No. O2015_018 | Decision of 15 June 2018 | ‘Instrument d’écriture’

The FPC handed down the decision in this remarkable litigation about a highly complex mechanical writing system. Please see this Blog here for a report about the main hearing and some background information.

What follows is a rather lengthy post, but this is due to the complexity of the case, both procedurally and technically.

  1. Party positions in a nutshell

It started off with Guenat‘s request that Swiss Finest‘s CH 704 790 B1 be declared invalid; note that the patent has been limited in March 2017 and re-published as CH 704 790 C1, see Swissreg for further bibliographic details. Guenat argued that the invention had been made by Frédéric Garinaud, an independent inventor who is quite renown for being the mastermind behind the Harry Winston Opus 8. Frédéric Garinaud had filed a patent application for a writing instrument; this patent application has then been assigned to Guenat and a patent was granted; EP 2 479 648 B1, see Swissreg and European Patent Register for further bibliographic details.

In Guenat’s view, the subject-matter of the Swiss Patent was invented by Frédéric Garinaud before it was used by Swiss Finest, and Frédéric Garinaud never transferred his patent rights to Swiss Finest. Guenat further argued that the invention of the Swiss Patent is obvious in view of a PowerPoint Presentation which had been sent to a third party without confidentiality obligation. Frédéric Garinaud being the only creator of the technical teachings contained in Garinaud’s European Patent and having transferred his patent rights to the plaintiff, Guenat argues that the defendant has no right to the Swiss Patent.

Swiss Finest countersued and requested that Guenat’s EP’648 be declared invalid, or assigned to Swiss Finest. Swiss Finest argued that in autumn 2010, Frédéric Garinaud had only a vague idea but had not yet completed an invention at that time. The invention was only made later with the substantial contribution of Swiss Finest’s employees after Frédéric Garinaud’s appointment as Creative Director, and any rights in the invention had been assigned to the defendant by employment contract.

Later, Swiss Finest argued that if Frédéric Garinaud was nevertheless considered to have already conceived the invention in the fall of 2010, the patent rights in this invention had been transferred to a simple partnership founded by Fabrice Thueler (owner of Swiss Finest) and Frédéric Garinaud in the preparation of a company ‘Garinaud SA’ which was foreseen to exploit the invention in dispute. Swiss Finest held thus to be the legitimate owner of the rights in the invention which is the subject of the Swiss Patent and, since the invention of the European Patent is the same, it is also entitled to the European Patent. Further, the subject-matter of the Swiss Patent was new and inventive in Swiss Finest’s view, since the PowerPoint presentation had not become publicly available because it had been sent only under an implicit confidentiality obligation. Even if one were to consider that the presentation was to be considered as prior art, the subject-matter of the Swiss patent is nonetheless inventive.

As if all this was not confusing enough, the case was spiced up further with Swiss Finest’s counterclaim for infringement by the Mechanical Fountain Pen RMS05:

Fountain Pen RMS05 by Richard Mille

This product has some amazing mechanics; see yourself:

In brief:

It’s complicated. Very complicated.

  1. The parties’ requests — and why they failed

The stage is set with a rather complicated factual situation. But at least some of the request could be dealt with quite straight forward by the court:

  1. Nullity for lack of entitlement

Guenat had requested that Swiss Finest’s Swiss patent be annulled based on Art. 26(1) lit. d PatA, i.e. for lack of entitlement. However, such request can only be brought by the entitled person; Art. 28 PatA. Guenat alleged that Frédéric Garinaud transferred ‘full and complete ownership’ of the European patent application to Guenat. Even though the inventions in both (Guenat’s) European and (Swiss Finest’s) Swiss patent may well be the same, this did not help. Frédéric Garinaud specifically assigned only the European patent application to Guenat, but not to the invention itself.

Guenat’s request for declaration of nullity based on Art. 26(1) lit. d PatA was thus held inadmissible for lack of standing.

  1. Nullity for lack of inventive step

Novelty of Swiss Finest’s Swiss patent after partial surrender was not contested anymore. But Guenat alleged obviousness over the PowerPoint presentation that had been sent to Hamdi Chatti of Louis Vuitton in 2010, in further view of i) F. Lecoultre, Les Montres Compliquées, 3ème éd. Neuchâtel 1985; ii) Huguenin / Guye / Gauchat, Les Echappements, 2ème éd. Neuchâtel 1974; and/or EP 1 221 383 A1.

Louis Vuitton logo

With respect to the PowerPoint presentation, the parties dissented whether or not it had been sent to Hamdi Chatti with an implied confidentiality obligation. The last page of the PowerPoint presentation mentioned ‘breveté’ (‘patented’), even though the Swiss patent application had not yet been filed. Frédéric Garinaud was apparently aware of this faux-pas; he wrote to his patent attorney:

I confess I anticipated the patent application.

The decision holds that under the specific circumstances there was no implicit confidentiality obligation associated with the PowerPoint presentation.

It then remained undisputed that the PowerPoint presentation was the closest prior art. However, quite a lot of differentiating features were missing. The missing features could be grouped into three aspects, and three partial problems are dealt with in the decision:

amovibilité the removable endpiece allows wide access to the pen holder, and indirectly to the other components housed in the front part of the writing instrument, avoiding manipulation by the writing tip;
échappement the choice of an escapement as a control mechanism offering a simple and proven solution to control energy release, while producing an audible indication;
verrouillage cooperation between the actuator and the locking system to unlock the power source to release the writing tip when the actuator is actuated, without additional action.

This is the only picture from the PowerPoint presentation in the decision:

PowerPoint presentation

As to the locking system (‘verrouillage‘), the decision holds that this was readily obvious (if not implicitly disclosed already in the PowerPoint presentation). Likewise, the escapement (‘échappement‘) is held obvious in further view of Lecoultre:

Lecoultre, p. 113

However, the removable endpiece (‘amovibilité‘) was more tricky, and the decision holds that this was not obvious from the cited prior art. When seeking a solution to the problem of replacing the ink cartridge, the skilled person would not have thought of a removable endpiece. Instead, he would have e.g. made a pen in which the writing tip as such is detachably mounted on the body or tip, like e.g. in EP'383:

EP 1 221 383 A1, Fig. 1

Thus, the subject-matter claimed in Swiss Finest’s Swiss patent was held to be non-obvious over the cited prior art.

  1. Nullity for yet further reasons

Guenat argued for nullity of Swiss Finest’s Swiss patent for yet further reasons.

First, an alleged undue extension of subject-matter (Art. 26(1) lit. c PatA) in the course of the partial surrender according to Art. 24 PatA; see the B1 and the C1 version of the Swiss patent below.

Second, Guenat alleged a lack of enabling disclosure; Art. 26(1) lit. b PatA.

Without setting out all the details here, both these alleged grounds of nullity failed for apparently straight forward reasons.

  1. Entitlement to Guenat’s European patent

The invention disclosed in the European Patent was already disclosed or was obvious to a large extent from the PowerPoint Presentation prepared and sent by Mr. Garinaud on November 17, 2010; see above — with the only exception of the removable endpiece. This removable endpiece was first mentioned by Frédéric Garinaud’s patent attorney François-Régis Richard (e-patent). In an email dated December 9, 2010, he wrote to Frédéric Garinaud:

I am also realizing that for the change of the cartridge, it would probably be simpler to disassemble the pen by its front part to avoid exposing the watch mechanism in the back.

This undisputedly was the first note of the removable endpiece. Whether the rights to this creative contribution were transferred to Frédéric Garinaud, as alleged by Guenat, could remain open. In any event, it had not been alleged that François-Régis Richard transferred the rights to Swiss Finest. Rather, Swiss Finest only held that the invention was made by Frédéric Garinaud when he was employed at Swiss Finest — which could not be true given the PowerPoint presentation and the email of December 9, 2010.

The decision thus holds that the subject-matter of claim 1 of the Swiss patent was created by Frédéric Garinaud before its use by Swiss Finest — with the exception of the removable endpiece which was proposed by François-Régis Richard without having assigned his rights in this contribution to the defendant.

In anticipation of this outcome, Swiss Finest apparently modified its position later and alleged that it had obtained rights in the European Patent by virtue of a simple partnership agreed between Frédéric Garinaud and Fabrice Thueler in preparation of a company ‘Garinaud SA’ to be established.

However, this was not convincing, either. The decision holds that it is unclear how the right to the patent, even if it had been transferred to the simple partnership, should finally reside with Swiss Finest. Members of a simple partnership are joint owners of the assets, with the consequence that they can only dispose of them jointly. In any event, according to the defendant’s allegations, Frédéric Garinaud and Fabrice Thueler were the partners of the simple partnership. A patent right could therefore only belong to them jointly. However, the defendant did not allege that Frédéric Garinaud agreed to transfer the right to the patent to it.

  1. Injunctive relief

Swiss Finest’s request for injunctive relief in respect of the ‘Mechanical Fountain Pen RMS05’ failed for a lack of concreteness of the attacked embodiment. See e.g. this Blog here (O2012_004, ‘Leichtbeton’) for further information on the necessary concreteness of a request for injunctive relief.

Swiss Finest did not argue for literal infringement, but rather only for infringement under the Doctrine of Equivalents (DoE); see below. Still, the request for injunctive relief merely recited the wording of the claims, and was thus held inadmissible.

  1. Infringement by the Mechanical Fountain Pen RMS05
RMS05 (annotated)

Even though the request for injunctive relief was held inadmissible, the court still dealt with had to assess whether or not the RMS05 was infringing. Confused? I will clarify this later; see below.

It was undisputed that the RMS05 did not comprise a removable endpiece (’embout amovible’). However, Swiss Finest alleged that the function of the removable endpiece is to allow the writing tip to be removed from the pen body to allow an ink cartridge to be inserted or replaced. Swiss Finest further alleged that the fountain pen holder (indicated by the white arrow in the annotated figure) can be unscrewed and removed from the body using a wrench formed in the cap of the pen to place and replace an ink cartridge. In Swiss Finest’s view, the removable fountain pen holder inserted into the endpiece of the RMS05 amounts to an infringement under the DoE.

First, the court carefully defined the function of the removable endpiece in the context of the invention and reverted to ¶ [0015] of the Swiss patent:

It can still be noted that, to have access to the pen holder, the endpiece is screwed on the body and can therefore be unscrewed. The ink supply can then be changed by disassembling the pen holder and the intermediate holder.

The decision holds that this function does not exist in the RMS05. The endpiece is not removable and the disadvantage of the access to the fountain pen holder still remains in the RMS05. The fact that the fountain pen holder of the attacked embodiment can be removed does not change anything in this respect, because according to the Swiss Patent, after unscrewing the endpiece and facilitating access, the fountain pen holder is also removed to replace the cartridge.

As can be seen in the below screenshot of this video on YouTube, the fountain pen holder can be gripped with the cap and removed to replace the ink cartridge. However, the endpiece is fixed (indicated by the white arrow in the screenshot below).

RMS05, replacement of ink cartridge

Therefore, there is no removable endpiece in the RMS05, neither literally nor under the DoE, because the function of the removable endpiece is not realized in this pen. Thus, already the first question of the questionnaire established with O2014_002 was denied.

In sum, neither party succeeded with any attack. This somehow reminds me of the ‘Hornberg salute’:

‘Hornberger Schiessen’
  1. What the decision might be cited for
  1. Competency for assignment of all national validations of a European patent

Swiss Finest had requested that Guenat’s European patent be assigned to them. This was interpreted by the court as to concern all national validations of the meanwhile granted patent. To the best of my knowledge, it had been mentioned for the first time in O2015_009, ¶ 2.1, that the FPC is competent to decide also on ownership of foreign rights — without any in-depth discussion because it had not been decisive anymore in that case.

Not so here. The court now took the chance to set out its reasoning in any detail in ¶ 10 of the decision. The question of ownership of IP rights does not fall within the exclusive jurisdiction under Art. 22(4) of the Lugano Convention; see decision C-288/82 of the ECJ, Ferdinand M.J.J. Duijnstee ./. Ludowijk Goderbauer and further literature in fn 1 of the decision. Under Swiss national law, international jurisdiction for disputes relating to intellectual property rights is governed by Art. 109 CPIL. However, only validity and infringement actions are mentioned, but not assignment actions. Jurisdiction for actions for the assignment of an IP right, in particular a patent, is therefore determined in accordance with the general rule of Art. 2 CPIL, according to which the Swiss judicial or administrative authorities of the defendant’s domicile are competent. As the plaintiff (defendant of the counterclaim) is domiciled in Switzerland, the FPC is also competent for counterclaims relating to the transfer of foreign patents.

  1. Right to accounting

The court re-visited the right to accounting based on Art. 66 lit. b PatA in view of critical voices in the aftermath of O2013_008; see ¶ 58 of the decision (note that fn 33 erroneously refers to O2012_008). However, the decision explicitly confirms the FPC’s practice that in case the court finds infringement there is a substantive entitlement to information and accounting based on Art. 66 lit. b PatA.

  1. Request for accounting with reference to a trademark / product name

As mentioned above, the request for injunctive relief was held inadmissible for lack of concreteness. Still, the court did the whole exercise of infringement analysis. It had to because of the request for accounting. The request for accounting referred to the ‘Mechanical Fountain Pen RMS05’. Such a description would be perfectly inadmissible in a request for injunctive relief, because the product name could be changed at any time. But not so in a request for accounting. The name of a product that has been sold in the past cannot be changed anymore:

However, in the case of conduct that has taken place in the past, it is permissible to specify the allegedly infringing object by means of a type designation or trademark. Such a designation cannot be changed for the past and one therefore knows exactly which product — namely in this case the product previously offered under the designation ‘Mechanical Fountain Pen RMS05’ — is the subject of the information request.

I guess we will see more such simplified requests for accounting in the future.

  1. No mixing-up of functions of features in the test for infringement under the DoE

There is an interesting general remark in ¶ 63 of the decision, i.e.:

One cannot reasonably expand the function of a claim feature and argue that this expanded function is fulfilled by another feature of the attacked embodiment, when the same element (penholder) with the same functionality (can be dismantled to replace the cartridge) is found in the invoked patent in parallel to claimed features, and independently of it (removable endpiece).

Reported by Martin WILMING


Header image (Hôtel de Ville de Neuchâtel, Salle du Conseil Général) courtesy of Lucas Vuitel – ArcInfo.


Case No. O2015_018 | Decision of 15 June 2018 | ‘Instrument d’écriture’

Guenat SA Montres Valgine
Swiss Finest SA


  • Dr. Mark SCHWEIZER
  • Dr. Tobias BREMI
  • Dr. Philippe DUCOR
  • Christoph MÜLLER
  • Dr. Ralph SCHLOSSER


  • Dr. Tobias BREMI

Court Clerk:


Representative(s) of Plaintiff:

  • Dr. Nathalie TISSOT (Etude Tissot)
  • Christophe SAAM (P&TS), assisting in patent matters

Representative(s) of Defendant:

  • Christoph KÜNZI (CBK)
  • Tarik KAPIC (Bovard), assisting in patent matters


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CH 704 790 B1

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CH 704 790 C1

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EP 2 497 648 B1

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Harry Winston Opus 8

Frédéric Garinaud apparently is a master of complicated mechanics. He developed the Harry Winston Opus 8, a manually-wound watch with a ‘digital’ display of the hours and minutes.

The numbers appear only on demand, when a slide on the right side of the watch is activated. I could not help but do some further research on the Opus 8. It was a limited edition of 50 pieces only, on 9 July 2018 seen at luxurybazaar.com with a price tag of US$ 350’125,–. A somewhat fair deal in view of a purported retail price of US$ 449’700,–.

www.luxurybazaar.com; July 9, 2018

Get to know Mr Garinaud in this video, talking about the Opus 8:


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Fulvestrant, reloaded (and still to be continued)

Case Nos. O2015_011 and O2015_012 ¦ Main hearing of 13 June 2017

A first glimpse of these disputes could be catched in parallel proceedings O2015_010 concerning nullity of AstraZeneca’s CH 696 260 A5 (commented on this Blog here). From r 4 of this decision, it has been evident that nullity proceedings are pending at the FPC for the two corresponding European patents in the same patent family:

The only independent claim 1 of EP’573 reads as follows (emphasis added):

A pharmaceutical formulation for use in the treatment of breast cancer by intra-muscular injection, wherein the pharmaceutical formulation comprises fulvestrant, a pharmaceutically-acceptable alcohol being a mixture of 10 % weight of ethanol per volume of formulation and 10 % weight of benzyl alcohol per volume of formulation, and the formulation contains 15 % weight of benzyl benzoate per volume of formulation and a sufficient amount of a ricinoleate vehicle so as to prepare a formulation of at least 45 mgml-1 of fulvestrant, wherein the ricinoleate vehicle is castor oil, and wherein the total volume of the formulation is 6 ml or less.

EP’138 B2 comprises various independent claims; only claim 1 is given below for illustrative purposes:

Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of a benign or malignant disease of the breast or reproductive tract by intra-muscular administration, wherein the formulation comprises fulvestrant in a ricinoleate vehicle, a pharmaceutically acceptable non-aqueous ester solvent, and a pharmaceutically acceptable alcohol, and wherein the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration for at least 2 weeks.


The main hearing covered both cases. We concluded from what has been discussed that  the assessment of inventive step in view of McLeskey and Howell will be key. It would be inappropriate for us to judge on the prospects based on the limited information at hand. But from the pleadings, it became clear that the expert opinion of the judge-rapporteur must have been disadvantageous for the patentee / defendant.

EP’573 has been fully revoked by an OD of the EPO in a hearing of May 8, 2017. The reasoned decision is not yet available, but the President of the FPC pushes for it, repeatedly.

UPDATE Sep 4, 2017:

The OD’s decision is published meanwhile. Appeal proceedings are pending.

Likewise, EP’138 has been fully revoked in Germany, in line with the interim assessment of the German FPC. But the reasoned decision had not been available until Friday before the hearing (Tuesday). The FPC was informed therof by the defendant / patentee in the hearing, and it turned out that the plaintiff’s representatives had not been aware of this at all. The parties will be given the opportunity to comment on this decision in writing.

The patentee / defendant also requested during the hearing that one of his auxiliary requests be amended by addition of yet another feature. The parties disagreed on whether this was admissible at this stage of the proceedings. The President noted that an order or a decision will be issued on this aspect.

If you are interested in what has happened elsewhere, these are corresponding decisions we got get a hand on from public files:

This list surely is incomplete. If you have further references to be included here, please send them in and we will accordingly update the list.

Reported by Ingo LUMMER and Martin WILMING


Case Nos. O2015_011 and O2015_012 ¦ Main hearing of 13 June 2017

Actavis Switzerland AG ./. AstraZeneca AB

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Prisca VON BALLMOOS
  • Dr. Hannes SPILLMANN
  • Dr. Daniel ALDER


  • n/a
    (most likely Dr. Hannes SPILLMANN since the judge-rapporteur has always been referred to by the parties in the male form)

Court Clerk:


Representative(s) of Plaintiff:

Representative(s) of Defendant:

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


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Amlodipine & Valsartan: Lessons on assessment of inventive step

Case No. S2017_001 ¦ Decision of 01 June 2017 ¦ “Interim injunctive relief refused; valsartan / amlodipine combined dosage form not inventive”

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

The patent in suit is EP 2 322 174 B1; see EPO Register and Swissreg for further details. Oral proceedings before an EPO opposition division are scheduled for December 6, 2017.

In general terms, the patent is about a fixed dose combined unit dose form of two active ingredients for effective control of blood pressure, ie amlodipine and valsartan. The former is a dihydropyridine calcium-channel blocker, the latter is an angiotensin II antagonist.

Respondent had lodged a nullity suit against this patent earlier; O2016_006. While nullity proceedings were still pending, the patentee requested interim injunctive relief to be ordered without hearing the defendant beforehand. This request had not been granted; see this Blog here. Now, after the respondent had been heard, the request for interim injunctive relief has been rejected: The decision holds that the patent is invalid for lack of inventive step over Corea in further view of the skilled person’s knowledge. In brief, Corea  already disclosed a combination therapy with amlodipine and valsartan, and that a combined therapy results in less side effects. The fixed dose combination of amlodipine and valsartan was held to be obvious in further view of the skilled person’s knowledge as illustrated by WaeberEpstein and Makrilakis.

This outcome is not extraordinary. Rather, it is in line with recent decisions of the Regional Court Düsseldorf of 10 April 2017 and the Commercial Court Barcelona of 22 March 2017.

Still, this decision will be cited for its general considerations on how inventive step is to be assessed. The law itself is pretty clear: An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art; Art. 56 EPC. The state of the art shall be held to comprise everything made available to the public […]; Art. 54(2) EPC. Consequently, the decision holds that it is not permissible to just exclude a document from consideration as a potential springboard towards the invention; see also O2013_011, r 5.6, commented on this Blog here. The term ‘closest prior art’ is held misleading in that it suggests that (i) there is always a single piece of prior art that comes closest to the invention; and (ii) this single piece of prior art also is the best springboard towards the invention. Both assumptions will only rarely be valid. The FPC thus explicitly disagrees with the approach taken in r 11 by an opposition division of the EPO concerning EP 1 096 932, the grandparent patent of the patent in suit, ie to just rule out Corea (referred to as ‘C2’ in these proceedings) as a proper springboard.

The decision also embraces the EPO’s could-would approach; r 4.7.  In the could-would approach one has to ask

[…] whether there is any teaching in the prior art as a whole that would (not simply could, but would) have prompted the skilled person, faced with the objective technical problem, to modify or adapt the closest prior art while taking account of that teaching, thereby arriving at something falling within the terms of the claims, and thus achieving what the invention achieves.

The EPO Guidelines go on to clarify this as follows:

In other words, the point is not whether the skilled person could have arrived at the invention by adapting or modifying the closest prior art, but whether he would have done so because the prior art incited him to do so in the hope of solving the objective technical problem or in expectation of some improvement or advantage (see T 2/83).

With reference to Kroher (Singer/Stauder, EPÜ, 7th ed., Art. 56, #73-74) the decision holds that the ‘would’ is satisfied if there is a motivation to arrive at the claimed solution and an expectation of success that this solution actually works:

Dass der Fachmann die erfindungsgemässe Lösung effektiv finden würde gilt als gezeigt, wenn aus den Unterlagen ersichtlich ist, dass der Fachmann einen Anlass hatte (‘motivation’), zur erfindungsgemässen Lösung zu kommen, und er eine Erfolgserwartung hatte, dass die erfindungsgemässe Lösung auch funktioniert (‘expectation of success’).

On a personal note, I do agree that there is definitely no inventive step involved when both ‘motivation’ and ‘expectation of success’ can be shown. But I do not readily understand why both criteria are linked with an — even emphasized — ‘and’ in the above citation. To me, the assessment of ‘expectation of success’ is part of the assessment of ‘motivation’: If the skilled person does not have a reasonable expectation of success, ‘motivation’ can hardly be acknowledged. Having no reasonable expectation of success rather is a de-motivation to further pursue this way. In my perception, ‘expectation of success’ is subordinated to the overall assessment of ‘motivation’, not coordinated. This may also explain why ‘expectation of success’ is not routinely addressed in the EPO’s could-would approach. If there is a specific pointer from one piece of prior art to another one, and if this combination leads straightforward to the claimed invention, then the could-would approach is satisfied. The check for a reasonable expectation of success is typically used as a corrective in cases where an applicant / patentee can show that the pointer at that time would have been ignored for other reasons, and/or the pointer still leaves the skilled person with an undue burden to actually arrive at the invention. Unsurprisingly, by far the most of the EPO’s case-law on ‘reasonable expectation of success’ stems from the fields of genetic engineering and biotechnology where such kind of problems frequently occur. Anyway, all this does not make any difference for the outcome of the case at hand.

The decision also expands on the issue of an alleged undue extension of subject-matter. The only independent claim 1 as granted reads as follows (changes over the claim as initially filed are marked-up):

A pharmaceutical combination composition for use in treating or preventing hypertension comprising:

(i) the AT1-antagonist valsartan or a pharmaceutically acceptable salt thereof;

(ii) amlodipine a calcium channel blocker or a pharmaceutically acceptable salt thereof, and

a pharmaceutically acceptable carrier,

wherein the combination composition is in one fixed combination combined unit dose form.

The decision holds that no multiple selections are necessary in order to arrive at the claimed subject-matter. Explicitly following EPO case law, the decision holds that a selection from a single list does not constitute an undue extension of subject-matter.

Update 12 July 2017:

The decision has not been appealed.

Reported by Martin WILMING


Case No. S2017_001 ¦ Decision of 01 June 2017 ¦ “Interim injunctive relief refused; valsartan / amlodipine combined dosage form not inventive”

n/a  ./.  n/a


  • Inventive step
  • Expert opinion of the judge-rapporteur
  • Ex-parte interim injunctive relief refused
  • Nullity plea in defense
  • Undue extension of subject-matter (Art. 123(2) EPC)
  • Interim injunctive relief

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Prisca VON BALLMOOS

Court Clerk:

  • Esther SCHEITLIN

Representative(s) of Requester:

Representative(s) of Respondent:


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I won’t start selling you my stuff with some cute cat pictures. But since cats are somewhat famous when it comes to IP Blogs, I just cannot help. I started writing this post while we stayed at a friend’s house. Out of a sudden, a cat jumped on the table and glared at me! An IP cat watching me? Whatever I was typing, he would not look happy. Sweet-talking didn’t help, either. What was so wrong?! It took me a while to understand: He wasn’t concerned about what I was doing. He just wanted me to realize that it was well past his dinner time. (No cat pictures any time soon again. Promised.)