The first dissenting opinion: A limping decision on a joint prosthesis

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Case No. O2016_012 | Decision of 28 October 2019 | ‘Einschlagbarer Hüftgelenkprothesengrundkörper’

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

Implantec’s logo

The patent in suit is EP 1 411 869 B1; see Swissreg and EPO Register for further information. Stemcup asserted that Implantec‘s ANA.NOVA® hybrid socket infringes the patent; see Implantec's ANA.NOVA® product flyer for further information about the allegedly infringing product.

Defendant (1) is the Austrian manufacturing company of the allegedly infringing ANA.NOVA® hybrid socket, which defendant (2) is then placing on the Swiss market.

Partial waiver of the patent
Stemcup’s logo

The plaintiff partially waived EP 869 at the IPI, to overcome the judge-rapporteur’s finding in his expert opinion with respect to a presumably undue extension of subject-matter. The partial waiver has thus been filed at a very late stage of the proceedings, i.e. only after formal closure of the file and only about nine months after the defendant’s rejoinder wherein the undue extension of subject-matter had been asserted.

The partial waiver has been published on 15 August 2018. Independent claims 1 and 2 now read as follows (inofficially translated; changes marked-up):

  • Claim 1
  • Claim 2
A joint prosthesis (1) with a base body (10) for knocking into a bone, characterised in that there are arranged at least two locking elements (20) on the outer side of the base body (10) which in each case comprise at least one knock-in web (21) which from the distal web beginning up to the proximal web end defines at least a continuous, linear gradient of 85° to 60° with respect to the base surface (GP), which corresponds to an angle of twist of 5° to 30°.
A socket (1) for an artificial hip joint with a base body or a shell (10) which comprises an in particular spherical, ellipsoidal or conical superficies (11) essentially rotationally symmetrical to the socket axis (AP), characterised in that on the outer side of the base body (10) there are arranged at least two locking elements (20) which in each case comprise a knock-in web (21) which from the distal web beginning up to the proximal web end defines at least a continuous, linear gradient of 85° to 60° with respect to the base surface (GP), which corresponds to an angle of twist of 5° to 30°.

Noteworthy, the plaintiff’s statement of claim had not been changed, and no new factual allegations had been brought forward. The parties heavily disagree on whether or not the partial waiver of the patent at this stage of the proceedings was admissible as a novum according to Art. 229 CPC, and whether the plaintiff’s conduct was in good faith; Art. 2 CC.

The decision holds that the plaintiff made use of a possibility that is explicitly provided for in Art. 24 PatA, and that this partial waiver is effective ex tunc, i.e. the patent is treated as if it had been granted only to that extent from the outset. This is a new fact within the meaning of Art. 229(1) lit. a CPC (proper novum), because the patent in that limited form was only created after the formal closure of the file. The fact that the plaintiff could have requested the partial waiver with the IPI well before the closure of the file, or that the partial waiver represents a new fact created by the plaintiff himself, does not change anything in this respect. Art. 229(1) lit. a CPC does not regulate how or by whom a new fact must have arisen or been created for it to qualify as a new fact. The emergence of a fact after the conclusion of the exchange of letters is the only necessary and thus sufficient condition for a proper novum.

Further, the decision holds that a new fact has actually arisen which did not exist before: The plaintiff’s patent in the original version no longer exists, but the plaintiff’s patent in the partially waived version has been newly created. This is why the proceedings have not become devoid of purpose, as the defendants argued; this would only be the case if no patent existed at all anymore. In the FPC’s view, it must be possible to take into account new developments concerning the facts on which the action is based; otherwise the proceedings will just miss the point. In addition, the decision holds that consideration of the partial waiver is proper for reasons of procedural economy: If the partial waiver was not permitted as a proper novum, the FPC would have to hand down a meaningless judgment because it assesses the legal situation on the basis of a patent which no longer exists in that form. 

The decision also emphasizes that the patent after the partial waiver fits smoothly into the subject-matter as it was already discussed in the proceedings, and the parties’ right to be heard had well been observed.

Further, the FPC assessed whether introduction of a new fact created by the plaintiff himself after closure of the file was an abuse of the possibilities foreseen in Art. 229 CPC. The decision holds that this is not the case since the partial waiver pursuant to Art. 24 PatA was expressly provided by the legislator, without limits. However, the fact that the plaintiff requested the partial waiver only after the judge-rapporteur had already established his expert opinion was taken into account in the apportionment of costs: 1/3 is to be covered by the plaintiff, despite his success on the merits.

Finally, the FPC did not share defendant’s concerns that patentees would henceforth trigger new expert opinions on a rolling basis, as long as the result is not (yet) favorable:

Schliesslich ist noch auf die Bemerkung der Beklagten einzugehen, wonach es im Interesse des Patentgerichts sei, zu sagen, wann fertig sei. Sonst könne der Patentinhaber ja beliebig oft zuerst sich vom Fachrichter eine Beurteilung holen und dann wieder einschränken, und dann nochmals eine Beurteilung und dann nochmals einschränken. Irgendwann müsse mal Schluss sein, das sei Sinn und Zweck von Fristen und der Novenregelung.

In short, as Giovanni Trappatoni would likely put it: Defendants argued that, after the formal closure of the file, it is time for the court to say …

Giovanni Trappatoni (1998); see full video here

However, the FPC notes (again) that the expert opinion of the judge-rapporteur in no way anticipates the final judgment. The patentee thus runs the risk that the partial waiver at the IPI, which is final and binding, could be in vain or even counter-productive. Further, it is not carved in stone that a second, revised expert opinion will be established.

All this is definitely lawyers’ playground. But in my opinion as a patent attorney, the FPC took a non-formalistic, pragmatic approach — which I like. However, not all judges were comfortable with it; see below.

Undue extension of subject-matter

Defendants objected that the partially waived patent was unduly amended both in terms of Art. 123(2) and Art. 123(3) EPC. Those issues are always very case-specific, and I do not believe that it is worthwile to dive deeper here, at least for the time being. In short: The FPC did not buy defendants’ arguments.

Novelty

The decision acknowledges novelty over FR 1 781 363 (D1; see e.g. Fig. 1) and an apparently corresponding product, ‘Equateur’ (D2):

Equateur®; see amplitude-ortho.com for further information

Likewise, novelty over DE 196 06 057 (D5; see e.g. Fig. 2) is also acknowledged.

Inventive step

In a nutshell, the decision holds that the claimed subject-matter is based on an inventive step in view of

I have no strong opinion on the actual outcome, i.e. whether the claimed subject-matter was obvious or not. However, some minor flaws in terminology will likely add to the ‘land of confusion’ re obviousness. For instance, I just don’t get what is meant with

naheliegende Veranlassung

(obvious motivation / pointer) in ¶84. Is this intentionally demanding for more than mere existence of a motivation or pointer? Does the motivation or pointer itself have to be obvious, too; and not only the claimed subject-matter as such? I hope not so.

Further, I do have some methodological concerns.

i)   Motivation and reasonable expectation of success?

The FPC has repeatedly committed to apply the EPO’s problem-solution approach, at least as a rule. Even though the present decision does not reiterate this, I have no reason to assume that it is an exception to the rule.

The decision provides a very concise summary of how obviousness is to be assessed (¶60, emphasis in original), presumably according to the problem-solution approach:

Damit mangelnde erfinderische Tätigkeit begründet werden kann, muss gezeigt werden, dass ausgehend von einem als Ausgangspunkt gewählten Dokument des Standes der Technik eine Motivation bestand, die erfindungsgemässe Änderung vorzunehmen, und dass angemessene Aussichten auf Erfolg bestanden, dass eine solche Modifikation auch die erfindungsgemäss vorteilhafte Wirkung nach sich zieht.

It is not the first time that I am troubled by this standard; see e.g. this Blog here and here. In S2017_001 (¶4.7), reference had been made to Kroher (Singer/Stauder, EPÜ, 7th ed., Art. 56, ¶73-74) in this respect, but this reference is not convincing for at least the reasons given on this Blog here.

Now, the present decision does not give any reference anymore.

The EPO’s problem-solution approach does not require the assessment of a reasonable expectation of success. The Guidelines are clear in this respect. It was only in the most recent 2019 edition of the Guidelines that the ‘reasonable expectation of success’ has first been mentioned in the context of obviousness at all (G-VII, 13), as follows:

EPO Guidelines (2019; G-VII, 13)

According to the title, this mentioning of a ‘reasonable expectation of success’ is being made exclusively for the ‘field of biotechnology’. And, what is more, the Guidelines correctly discuss three level of confidence with respect to the results, i.e.:

    • clear predictability;
    • reasonable expectation of success; and
    • mere ‘try and see’ attitude.

Even for the lowest level of confidence, i.e. the mere ‘try and see’ attitude, it is held that this does not necessarily render a technical solution inventive. Rightly so; this is in full conformance with the established case law of the Boards of Appeal; see here.

Now, think about it:

    • On the one hand, in view of ¶60 of the decision, it is an absolute show-stopper  (“[…] muss gezeigt werden, dass […]”) for a plaintiff in nullity proceedings if he cannot establish a ‘reasonable expectation of success’; while
    • on the other hand, in accordance with the established case law of the Boards of Appeal, even a ‘try and see’ attitude may well have carried the day for an applicant / patentee before the EPO.

This cannot be it.

In my perception, the criteria as defined in ¶60 are not in accordance with the problem-solution approach as it is applied by the first instance bodies of the EPO (which mandatorily apply the Guidelines) and as it is interpreted by the Boards of Appeal. The ‘reasonable expectation of success’ clearly is not a cornerstone of the problem-solution approach per se (not to mention beyond biotech) — contrary to what the general emphasis in ¶60 of the decision suggests, as well as the frequent repetition in the individual assessment of attacks (¶64, ¶73, ¶84).

Don’t get me wrong, I am not saying that the requirements defined in ¶60 are unsuitable for the assessment of obviousness in accordance with Art. 56 EPC and Art. 1(2) CH-PatA. It would just not be the EPO’s problem-solution approach as I know it. Rather, this interpretation of the problem-solution approach would effectively lower the bar for patentees: A mere ‘try and see’ attitude would inevitably lead to a finding of non-obviousness — contrary to EPO practice.

Notably, the same issue had been a sideshow in S2019_007; see this Blog here. In that case, it had essentially been held that ‘reasonable expectation of success’ is not necessary if the skilled person has an incentive for any other reason. 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. I do concur with this.

ii)   What is not mentioned or suggested in the closest prior art must not be considered in the context of the objective technical problem?

The decision holds that a certain aspect must not be considered in the context of the objective technical problem because this aspect is not mentioned in the closest prior art; see ¶74, second paragraph:

Der Aspekt der Verdrehung ist entsprechend etwas, was der D5 nicht zu entnehmen ist, darf also auch nicht im Rahmen der Aufgabe berücksichtigt werden.

In my perception, it is indeed correct to not recite this specific aspect in the wording of the objective technical problem. But this is not because this aspect is not disclosed in the closest prior art. This is just irrelevant. Rather, it must not be recited in the wording of the objective technical problem because it would be a pointer towards the solution, and this is what the EPO Guidelines on the problem-solution approach prohibit (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).

The latter is the reason for non-consideration of the specific aspect in the formulation of the objective technical problem. It has nothing to do with the closest prior art.

See also the discussion about a similar issue on this Blog here.

InFRINGEMENT

The tricky issue is the gradient of the knock-in web of 85° to 60°. In a nutshell, the decision holds that, in accordance with the patent in suit, the gradient is to be measured with the so-called ‘optical method’. Further, based on the evidence submitted by the plaintiff, the decision holds in ¶94 that the gradient in the attacked embodiment is within a range of 84.31 – 85.04°, and that at least two knock-in webs feature a gradient below 85°. Apparently, this was also supported by defendants’ own submissions. However, defendants argued that their knock-in webs were curved, not linear; and that it was thus not possible to rely on the ‘optical method’. However, the decision holds that the curvature, if it existed at all, was de minimis (¶95).

The decision holds that there is literal infringement. As a consequence, the second request for injunctive relief was allowed. The primary request for injunctive relief, that extended beyond the range of the claim in an attempt to cover infringement under the DoE, was denied for lack of legal interest in the assessment of a request that reached beyond the wording of the claim (83° to 86.5°).

Request for information on Downstream commercial users

While the request for production of accounting information about defendants’ own net sales and gross profit was allowed, plaintiff’s request for information about downstream commercial users was denied. The decision holds that no reasoning / legal interest in this information had been established, and the defendants’ interest in secrecy prevailed:

[Es] wird bezüglich der Erforderlichkeit von Angaben zur Identität der gewerblichen Abnehmer und das Ausmass der Weitergabe von patentverletzenden Produkten seitens der Klägerin keinerlei Begründung oder rechtliche schützenswertes Interesse angeführt, sodass das von den Beklagten geltend gemachte Geheimhaltungsinteresse in diesem Punkt zu berücksichtigen ist.

Frankly, this is somewhat surprising to me. I had assumed that, once infringement was established, a plaintiff was entitled to such information simply by virtue of Art. 66 lit. b PatA; cf. O2018_008, hn and ¶5.4 (emphasis added):

[H]insichtlich des zivilrechtlichen Schutzes [kann] der Beklagte verpflichtet werden […], Herkunft und Menge der in seinem Besitz befindlichen Gegenstände, die in Verletzung des Klagepatentes widerrechtlich hergestellt oder in Verkehr gebracht wurden, anzugeben und Adressaten sowie Ausmass einer Weitergabe an gewerbliche Abnehmer zu nennen. Dieser materiell-rechtliche Anspruch auf Auskunftserteilung und Rechnungslegung besteht bei Vorliegen einer Patentverletzung zunächst unabhängig davon, ob die Patentinhaberin die Grundlagen eines Anspruchs auf finanzielle Kompensation aufgezeigt hat.

The present decision does not make any reference to O2013_008. What a pity! It would have been very interesting to learn more about why the request for information about downstream commercial users was denied in the present case, despite the ratio decidendi of O2018_008.

Dissenting opinion

It is for the first time that a decision of the FPC comes along with a dissenting opinion attached to it, in accordance with Art. 13(3) of the Regulations on the FPC. Interestingly, the dissenting opinion had not yet been attached when the decision was first published on 13 November 2019; see here.

Neither the actual split of the panel (4:1 or 3:2) is disclosed, nor the name(s) of the dissenter(s). Admittedly, I am bursting with curiosity. However, I do appreciate that this is a way to preserve the judges’ independence; see e.g. the 2012 Study on behalf of the European Parliament on Dissenting opinions in the Supreme Courts of the Member States; p 37, ¶ 3.3.5, last paragraph.

UPDATE 4 December 2019:

It had been mentioned at the occasion of the INGRES conference on 3 December that the actual split of the panel was 3:2.

Clearly, the procedural question of whether or not the partial waiver is to be considered in the proceedings at such a late stage is a highly interesting one. The decision itself expands on this issue pretty exhaustively on about six pages, and finally admits the partial waiver into the proceedings; see above. On the other hand, the dissenter(s) — in an opinion which is twice as long! — would have thrown the case out entirely (¶13 of the dissenting opinion, loosely translated):

[T]he minority of the judges takes the view that the [partial waiver] cannot be accepted as a novum in these proceedings. The partial waiver cannot be considered as a proper or improper novum within the meaning of Art. 229 para. 1 CPC. Moreover, the plaintiff’s conduct is also contrary to good faith. Accordingly, the complaint is not to be considered. The plaintiff has no legal interest in having the infringement of a [patent claim] examined by the court which is no longer in place and which has never had effect from the outset (cf Art 28a PatA).

On a separate issue, I do not readily get the point of ¶14 of the dissenting opinion. On the one hand, the minority argues that proceedings for taking evidence would be necessary in order to properly assess the question of infringement, because the court lacks the appropriate measuring instruments for a reliable determination. On the other hand, the minority also acknowledges that the burden of proof is with the plaintiff in this respect(?).

Now, let’s see what the Supreme Court does with all this; I have no reason to assume that this decision will not be appealed.

On the funny side

Last but not least, I stumbled upon the following in ¶77 (with my personal annotations on a working copy of the decision):

What the heck … ?!
offset screwdriver

I cannot help but think about what is probably the most versatile item in my toolbox: The offset screwdriver (‘Winkelschrauber’ in German).

Oh, if only the skilled person had had an offset screwdriver at hand, to fiddle with the angle of approach! But, maybe, the skilled person might still have screwed things up …

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_012 | Decision of 28 October 2019 | ‘Einschlagbarer Hüftgelenkprothesengrundkörper’

Stemcup Medical Products AG
./.
(1) Implantec GmbH
(2) Endoprothetik Schweiz GmbH
(formerly ImplanTec Schweiz GmbH)

Panel of Judges:

    • Dr. Christoph WILLI
    • Dr. Tobias BREMI
    • Dr. Daniel M. ALDER
    • Frank SCHNYDER
    • Dr. Kurt SUTTER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Stemcup :

Representative(s) of Implantec:

    • Dr. Michael RITSCHER (MLL)
    • Dr. Kilian SCHÄRLI (MLL)
    • Herwig MARGOTTI (Schwarz & Partner)
    • Dr. Martin MÜLLNER (Müllner Katschinka), assisting in patent matters
    • Werner ROSHARDT (Keller), assisting in patent matters

DECISION IN FULL

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PATENT IN SUIT

EP 1 411 869 B1 (as initially granted):

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EP(CH) 1 411 869 H1 (after partial waiver):

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2 Replies to “The first dissenting opinion: A limping decision on a joint prosthesis”

  1. The criterion of “reasonable expectation of success” might not be current when assessing inventive step, but is a notion used by the Boards of Appeal of the EPO.

    There are a few dozen of decisions using this notion when dealing with IS.
    – In T 65/10, IS was denied as when starting from the CPA there was a reasonable expectation of success.
    – In T 318/02 IS was denied for the same reasons as in T 65/10.
    – In T 1737/10, IS was acknowledged as it not obvious to choose the quinone methides of claim 1 with an expectation of success.
    – In T 1683/06, the same conclusion as in T 1737/10 was reached.

    The most recent decision using the notion of “reasonable expectation of success” is T 1680/17 dealing with “Fulvestrant”.

    It is a notion which is used in certain chemistry boards, but has not been adopted in other fields of technique, like it has been the case for the classical problem-solution-approach, which stems originally from chemistry boards..

    1. I fully agree, Daniel. Thanks for your time to comment on this. I once worked me through the whole chapter I.D.7.1 in the Case Law of the Boards of Appeal book (https://www.epo.org/law-practice/legal-texts/html/caselaw/2016/e/clr_i_d_7_1.htm), and in my recollection not a single decision concerned sth else than biotech or chemistry. And when it is used, than typically as a corrective to a lower standard, i.e. to counter the argument that one could not be sure that the invention would work like a charm.

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