Fulvestrant, the never-ending story(?)

Reading time: 9 minutes

Case No. O2017_014 | Hearing of 20 January 2020

Fulvestrant, a breast cancer medication of the class of antiestrogens, is probably the most frequently appearing bone of contention at the FPC to date.

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

Fulvestrant per se is generic since about 2004 (EP 138 504 B1). However, patents relating to certain second-medical uses of fulvestrant are still in force today.

The St Gall’ish part of the story
AZ logo

AstraZeneca asserts that EP(CH) 1 272 195 (see EPO Register and Swissreg for further information) is infringed by Sandoz’s generic version of AZ’s Faslodex®, i.e. Fulvestrant Sandoz 250 mg/5ml (Swissmedic approval no. 56778).

KSSG logo

The FPC’s seat is in St. Gall — you knew this. But this time, even the inventor is based in St. Gall: Prof. Dr. Beat THÜRLIMANN, chief physician at the breast center of the St. Gall cantonal hospital. A very St. Gall’ish part of the complex portfolio of fulvestrant patents and litigation in Switzerland and beyond, isn’t it?

Sandoz logo

Note that Sandoz’s generic has been on the market in Switzerland ever since 26 July 2016, despite various attempts of AZ to stop this; see this Blog here (PI proceedings, based on EP 2 266 573 B1) and here (PI proceedings, based on EP 1 250 138 B2). Yet further proceedings between AZ and Sandoz are currently co-pending at the FPC (O2018_010), with AZ asserting infringement of EP 2 266 573 B1 in main proceedings. I understood from the pleadings that AZ’s reply (incl. the first counter to Sandoz’s nullity plea in defense) was due only after this hearing, i.e. on 23 January 2020.

A quick recap of the procedural history

It all started off with a pretty standard exchange of briefs in infringement proceedings (AZ’s submissions in red; Sandoz’s submissions in blue; court interventions in yellow):

10 Jul 2017 Stmt of claim
11 Oct 2017 Stmt of defense w plea for nullity
8 Dec 2017 Partial reply re validity
4 Sep 2018 Preparatory hearing
22 Oct 2018 Full reply
6 Dec 2018 Rejoinder
11 Dec 2018 Closure of the file
18 Jan 2019 Comments on rejoinder
12 Mar 2019 Expert opinion of judge-rapporteur
5 Apr 2019 Summons for main hearing (28 Aug 2019)
10 May 2019 Cmt on expert opinion Cmt on expert opinion

The judge-rapporteur’s expert opinion had been unfavorable for AZ: In the judge-rapporteur’s view, EP 195 as granted was neither valid nor infringed.

I understood from the pleadings that AZ had apparently asserted EP 195 as granted only, without any ‘verbal limitation’ inter partes, neither as a main request nor as an auxiliary request. Later, proceedings ran off the rails (as defendant put it):

29 Jul 2019 Advance notice, patent will be partially waived
8 Aug 2019 Notice that partial waiver has been filed
12 Aug 2019 Main hearing cancelled; defendant to comment on partially waived patent
11 Sep 2019 Request that deadline be lifted
13 Sep 2019 Setting deadline for defendant
11 Oct 2019 Comments on partially waived patent
15 Oct 2019 Publication of the partially waived patent

I understood from the pleadings that the actual subject-matter of the partially waived patent had never been pleaded by AZ, neither with respect to validity nor infringement. Apparently, it was only at the main hearing that AZ did so — partially due to the fact that the FPC had ordered AZ to respond to defendant’s submission of 11 October 2019 at the main hearing.

the leftovers of the patent in suit after the partial waiver

Claim 1 of EP 195 as granted and maintained in EPO opposition/appeal proceedings was quite concise, a straight-forward second medical use claim:

Use of fulvestrant in the preparation of a medicament for the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment.

The partial waiver in accordance with Art. 24 PatA added quite a lot to this (marked-up):

Additional features in claim 1, by way of a partial waiver
The pleadings in a nutshell

AZ argued that validity of the partially waived patent had essentially already been decided by the FPC, in proceedings O2018_009 with decision of 27 May 2019 (in line with T 1680/17 of an EPO Board of Appeal), with only the target patient group being now even more more precisely defined. AZ emphasized that this was the trigger for the partial waiver that had been filed only shortly therafter, on 30 July 2019; not defendant’s nullity plea in defense and/or the judge-rapporteur’s expert opinion.

It was also referred to decision X ZR 59/17 of the German Supreme Court, revoking EP 1 250 138 B2 within the same patent family. In AZ’s view, this was due to an incorrect formulation of the technical problem, disregarding the problem-solution approach; and with the threshold for a reasonable expectation of success being set much too low.

Both parties disagreed on what ‘failure with a treatment’ means; see ¶ [0018] of EP 195 for a definition. In AZ’s view, this covers both adjuvant and palliative therapy. Defendant pointed out that switching therapy does not necessarily mean that the first therapy had failed. Rather, therapy is frequently switched before resistance occurs; thus, therapy has not yet failed.

Defendant pointed out that no substantiated assertions had been on file until the day before the hearing concerning the actual scope of the partially waived patent, as well as validity and infringement thereof.

Further, admissibility of the partial waiver after formal closure of the file was a big issue. Note that this has also been at stake in the recent decision O2016_012, where the panel of judges had been split 3:2 in favor of admissibility. However, defendant noted that the factual setup was very different. Contrary to the present matter, the partial waiver in O2016_012 did not require any new pleadings or assertions:

In O2016_012, the partially waived patent integrated smoothly into the proceedings as pleaded beforhand. This was of great importance ('von ganz wesentlicher Bedeutung') for admissiblity in that case.

In any event, defendant apparently considers the partial waiver after formal closure of the file as an improper novum (‘gewillkürtes Novum’; ‘Potestativ-Novum’), contrary to what had been held in O2016_012. Defendant referred to a decision of the Cantonal Court Zug in this respect, i.e. ES 2018 449. This decision is totally unrelated to patents. But it has been held that a document that has only been created after closure of the file cannot be admitted anymore into the proceedings when the respective assertion of the counterparty had already been made in the statement of defense, i.e. when the document could well have been created and submitted before closure of the file; see ¶2.7:

A document that had only been created after closure of the file, even though the respective assertion that the document was meant to counter had already been made in the statement of defense, is belated.
UPDATE 30 January 2020:

I have obtained a copy of this decision only yesterday. Accordingly, this post has been updated today with some more information about the actual content of the decision.

Finally, defendant placed the procedural request that a deadline be set for a written response to AZ’s validity arguments presented at the hearing, should the court admit them into the proceedings.

Please find some quick notes from the hearing below this post.

A hot potato?

The presiding judge made an opening remark that ‘contrary to what defendant  apparently assumed the court has not yet decided on the admissiblity of the partial waiver after closure of the file.’ That was not much of a surprise. However, the presiding judge further noted that the court is not inclined to decide on that issue while the appeal in case O2016_012 is still pending.

I was flabbergasted. I understood from the later pleadings that admissibility of the partial waiver after formal closure of the file might not necessarily be the decisive issue in this case. But let’s assume it was: Is an informal stay of proceedings appropriate? I have my doubts. It might easily take the Supreme Court six months or more to decide on that issue, which is (much) longer than what it normally takes from the main hearing to the decision being handed down.

Meanwhile in Germany

A PI request of AZ based on EP 195 has been rejected by the Regional Court Dusseldorf (4C O 10/18, 5 July 2018). Likewise, AZ’s appeal failed at the Higher Regional Court (2 U 28/18, 9 January 2018). In a nutshell, AZ could not establish that the treatment regime as claimed had actually been used to an extent that could not remain unnoticed by the defendant (if it had been used at all in more recent times).

Nullity proceedings re EP 195 are pending at the FPC since 14 August 2017, with case no. 3Ni32/17(EP).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_014 | Hearing of 20 January 2020

AstraZeneca AB
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

    • Prof. Dr. Daniel KRAUS
    • Prisca VON BALLMOOS
    • Marco ZARDI

Judge-rapporteur:

    • Prisca VON BALLMOOS

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Michael RITSCHER (MLL)
    • Dr. Kilian SCHÄRLI (MLL)
    • Andreas BRAUN (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant / Patentee:

    • Dr. Andri HESS (Homburger)
    • Julian SCHWALLER (Homburger)
    • Dr. Elisabeth GREINER (df-mp), assisting in patent matters

ANNOUNCEMENT

PATENT IN SUIT

EP 195 as granted by the EPO:

 

EP 195 after partial waiver in Switzerland:

T 0108/09 – 3.3.02

Maintenance of EP 195 as granted by a BoA of the EPO:

SOME LIVE NOTES FROM THE HEARING

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Mixed feelings about the assessment of mixed inventions

Case No. O2017_007 | Decision of 1 November 2019 | ‘Beatmungsgerät’

Reading time: 16 minutes

The decision is a booklet of about 100 pages; even the recitals of the procedural history and the requests cover 37 pages. Cutting a long story short, the FPC held that some of imtmedical‘s Bellavista ventilation machines with the ‘Animated Lung‘ feature infringe Hamilton Medical‘s EP 1 984 805 B1; see EPO Register and Swissreg for further bibliographic information.

Defendant argued for nullity of EP 805 in defense, as follows:

    • Claim 1 was not novel over both WO 02/071933 A2 (see ¶ 56) and Wachter et al. (2003), The employment of an iterative design process to develop a pulmonary graphical display (see ¶ 57);

and, with respect to (lack of) inventive step (see ¶ 67):

However, the plea for nullity in defense was unsuccessful. The decision holds that features 1F [b] and 1F [c] were not disclosed in WO 02/071933 A2 and Wachter et al. (2003); thus, novelty was acknowledged. Further, the decision holds that features 1F [b] and 1F [c] were also not rendered obvious by any combination of prior art asserted by defendant.

  • Claim 1, broken down into features
The decisive features re novelty and inventive step are highlighted.

1A A device with a screen
1B in order on this to represent acquired, changing values with a mechanical ventilation of a patient,
1C with means for acquiring at least three changing values of different origin,
1D [a] and means for representing the values,
[b] which permit the acquired values to be qualitatively represented together on the screen
[c] in a single element
1E [a] said graphical element including
[b] a pictorial representation of a lung shape,
[c] a current design of the lung shape containing qualitative information on the compliance of the lung,
characterized in that
1F [a] the means for representing [the] values are designed such
[b] that a volume change of the ventilated lung which is acquired with each breath, is represented in an animated manner
[c] by way of a size change of the lung shape corresponding to this volume change,
[d] involving an animation of a contour line of the lung shape,
[e] the design of which containing qualitative information on the compliance of the lung.

The defendant was thus ordered to abstain from further use of ventilation machines with the ‘Animated Lung‘ feature, and to provide information and accounting concerning previous use thereof.

All that appears pretty straight-forward to me, even though the prior art comes pretty close. But still, there are some quite pointed remarks in the decision on various aspects, both procedurally and on the merits.

Lack of legal interest in certain requests for injunctive relief

In parallel to the requests for injunctive relief that had finally been allowed, the plaintiff also requested essentially the same again in more limited form, i.e. with i) the additional recitation of the machine types ‘bellavista 1000’, ‘bellavista 1000e’ and ‘bellavista 1000 neo’; and ii) the combination with certain flow-through sensors. 

The decision holds that the plaintiff has no legal interest in these requests since the broadest request already cover these more limited requests. Noteworthy, 20% or the costs were clapped on the plaintiff despite his success on the merits with respect to the broadest requests.

Despite his success on the merits of the broadest request, the plaintiff has to bear 20% of the costs since a large number or the more limited requests were rejected (for lack of legal interest).
The requirement of definiteness of a request for injunctive relief

The decision gives a finely chiseled differentiation of the requirement of definiteness of a request for injunctive relief on the one hand (which is a bar to proceeding, to be examined ex officio), and the plea in defense that the request for injunctive relief is overhooting on the other hand, i.e. that it extends beyond the scope of the patent as asserted (not to be examined ex officio; potentially leading to (partial) dismissal of the action):

Interestingly, the decision holds in very general terms that the FPC will only very reluctantly assume indefiniteness of a claim for injunctive relief, in the absence of a respective complaint of the defendant; see ¶15, above.

Further, it is held that an overshooting request for injunctive relief will lead to ‘(partial) dismissal’ of the action; see ¶15, above. Maybe I am overinterpreting the ‘partial’ in brackets here, but I wonder what that means in practice: In first place, the request for injunctive relief stands as requested — and cannot be allowed as-is because it is overshooting. In principle, I believe that the court could re-phrase the request to make it commensurate with the scope of the patent as asserted (even though that might be a tricky exercise). Similarly, see e.g. the hn in O2015_009 with respect to sole vs. joint ownership of a patent application. As much as I recall, the FPC never actually narrowed down an overshooting request for injunctive relief, to make it commensurate with the patent as asserted.

A broad feature is not necessarily unclear

Broadness of features is frequently confused with (un)clarity, in particular when it comes to functional features. The decision holds in no uncertain terms that this is a misconception; see ¶16:

Der Begriff ‘Gerätesteuerung’ ist ein funktionaler Begriff, der alles umfasst, was das (Beatmungs-)Gerät steuert. Nicht jeder breite Begriff ist automatisch unklar. Der Begriff ‘Gerätesteuerung’ ist zwar breit, aber klar.

By the way, the same holds true in prosecution: I am prepared to deal with any prior art that is thrown at me as long as it reasonably reads on a broad, functional feature. But it goes against the grain for me when an objection re clarity is raised presumably only for convenience.

Admissibility of reply to new assertions in the rejoinder

The defendant apparently came up with a whole lot of new assertions only in the rejoinder, i.e. that i) EP 805 extended beyond the application as originally filed; ii) the invention was not disclosed in a manner sufficiently clear and complete for it to be carried out by a skilled person; iii) the attacked embodiment did not provide qualitative information with the contour line of the lung; and iv) that the claim to priority was not valid, alongside with new evidence and reliance on a witness.

The decision holds that plaintiff’s filing of new pieces of evidence had effectively been triggered by the rejoinder, and the evidence was thus admitted into the proceedings; see ¶19:

Filing of the new pieces of evidence had been triggered by defendant's new allegations in the rejoinder. Thus, they were admitted into the proceedings.
What witnesses are (not) for

The defendant had requested that Mr Frank DREWS be heard as a witness. To no avail. The decision umistakably holds that witnesses are not to be heard with respect to questions of law, such as e.g. the definition of the skilled person, the issue of technicality (see below), or the skilled person’s understanding of certain features; see ¶21:

Vorab ist festzuhalten, dass Zeugen zu Tatsachen befragt werden, nicht zu Rechtsfragen.

Further, the decision holds that the procedure of taking evidence (Art. 150 et seqq. CPC) cannot replace lacking allegations or supplement incomplete allegations. Rather, appropriate allegations are the prerequisite for the taking of evidence (see ¶20, with reference to 4A_338/2017, ¶2.1):

Das Beweisverfahren dient […] nicht dazu, fehlende Behauptungen zu ersetzen oder zu ergänzen, sondern setzt solche vielmehr voraus.

The decision holds that defendant’s reliance on Mr Frank DREWS as a witness did not meet this standard. Accordingly, the witness had not been heard.

The FPC follows the EPO’s ‘Comvik’-approach

In EPO practice, a so-called mixed invention that comprises both technical and non-technical features is assessed according to the ‘COMVIK’ approach, in accordance with T 641/00 (Two identities / COMVIK). In a nutshell, an invention is not excluded from patentability under Art. 52(1), (2) EPC when it comprises at least one technical feature. This threshold is easily met; mere presence of e.g. a computer, a display, etc. is sufficient to pass the test. However, those features that do not have (or contribute to) a non-obvious technical effect cannot render the claimed subject-matter inventive.

Note that the IPI applies a different test, according to the IPI Guidelines for Examination (January 2019, p. 16):

This may well give different results than the EPO's COMVIK-approach.

The IPI applies a ‘holistic’ approach (‘Ganzheitsbetrachtung’) in the assessment of technicality of the claimed subject-matter. In contrast to the EPO’s ‘COMVIK’ approach (T 641/00), this means that e.g. a claim directed to e.g. an method for analysis of certain items that is carried out with the help of a computer may well be refused by the IPI for lack of technicality (if it can e.g. be used for both technical and non-technical purposes), while the mandatory use of a computer would establish technicality at the EPO in any event. Whether or not the method would ultimately be considered inventive or not by the EPO, that’s of course a different story.

The decision holds that the FPC will apply the ‘COMVIK’-approach, and it is noted in passing that it will also do so for Swiss national patents; see ¶ 46:

Not only for European patents, but also for Swiss national patents.

But what does the IPI’s ‘holistic’ approach actually imply? Here is what the Guidelines say:

In brief, the IPI takes the following into consideration in the assessment of whether or not an invention is 'technical':
(i) The _problem_ to be solved;
(ii) the _means_ for solving the problem;
(iii) the _effects achieved with the solution of the problem; and
(iv) the necessity of _technical considerations_ in order to arrive at the invention.

Being trained as a European patent attorney, I had always felt that the ‘holistic’ approach was examination on the merits in disguise. In order to properly assess these criteria, one necessarily has to consider the invention as claimed in light of the prior art — what in my opinion is not sth the IPI should currently be doing (but maybe in the future; see this Blog here). I feel that time is ripe to abolish with the ‘holistic’ approach / ‘Ganzheitsbetrachtung’. It appears odd to me to systematically apply two different approaches in prosecution and nullity proceedings, in the mere hope that in the end the overall result re patentability might be the same, i.e. that non-patentable inventions are sorted out in any event, just by a different token.

On a sidenote, the decision discusses the different approaches being taken by Boards of Appeal in the assessment of novelty of mixed inventions; see ¶54. Nowadays, the majority considers all features in the assessment of novelty, irrespective of whether they are technical or not. Some other decisions apply the concept of ‘technical novelty’, i.e. only technical features are considered in the assessment of novelty; see also the discussion in Case Law of the Boards of Appeal, I.D.9.1.3 c), second paragraph. In practice, that only matters when intervening prior art under Art. 54(3) EPC is at stake — which is not the case here. Anyway, the decision rightly holds that consideration of all features in the assessment of novelty would be pragmatic since only the new features would have to be assessed re technicality in the next step; if a feature is not new, it just doesn’t matter whether it is technical or not.

burden of proof for the actual fulfillment of an ambitious technical problem in the assessment of inventive step

The decision raises an interesting question in relation to the assessment of inventive step; see ¶65. Just assume that the patent in suit asserts that an ambitious technical problem is solved by the invention. Later, in civil proceedings and in view of the same prior art as discussed in the patent in suit, the counterparty asserts that this ambitious technical problem is not solved. Now, is the burden of proof on that issue with the patentee or the counterparty?

Who has the burden of proof that an ambitious technical problem is actually solved: The patentee or the opposing party asserting nullity?

That’s a tough question, indeed. The decision avoids to give an answer; the FPC could do so in the case at hand because the invention was held non-obvious even in view of the least ambitious technical problem to be solved.

That’s definitely lawyers’ playground. But in my perception, neither party should benefit from a mere ‘sit back and relax’ mentality in such instances. Assuming there is at least some reasonable indication (in the patent itself or through secondary evidence) that the ambitious technical problem is actually solved, I would see a burden on the counterparty to overturn this circumstantial evidence, with at least the same degree of certainty. It would appear somewhat artificial to me if the full burden of proof would be on the patentee right from the outset. Similarly, according to Art. 178 CPC, the authenticity of a document needs only to be proven when disputed, and when adequate grounds for disputing are given.

No plea OF free state of the art in case of literal infringement

The decision holds that the defendant cannot argue as a plea in defense that the attacked embodiment is free state of the art (or rendered obvious by the free state of the art). This plea effectively is a nullity plea in defense (asserting lack of novelty or inventive step, respectively), and to be examined as such.

Is the argument that an attacked embodiment is free state of the art (or rendered obvious by the free state of the art) admissible as a plea in defense?

With reference to O2013_008 (¶4.6), the decision holds that the plea of free state of the art can only be legitimately raised in order to rebut the assertion of infringement under the DoE, but not in cases of literal infringement.

But … why?

I am not so sure. Does it really have to be so dogmatic?

Assuming a defendant can show that the attacked embodiment is an exact blueprint of what has been described 50 years ago. Undoubtedly, no valid patent that is currently in force can cover the attacked embodiment anymore. Not the patent in suit, and not any other one. Why bother with a detailed feature analysis and all the tedious questions of claim construction in the assessment of nullity? There is just no need for that. One may construe the patent in suit in any way whatsoever: It cannot be valid and at the same time read on the attacked embodiment. In view of procedural economy, it would make perfectly sense to shut the docket based on the plea of free state of the art, in my perception. See e.g. BGE 115 II 491 (¶2b) and F. Blumer in sic! 1/1998, p. 3 et seqq. in this respect, and Eugène Brunner’s critical comments in sic! 4/1998, p. 428-429 (with which I do not concur, for e.g. the reasons outlined above).

Information on downstream commercial customers

The decision holds in ¶86 that the identity of downstream commercial users and the extent to which the infringing products had been passed on to them is not a secret worthy of protection once infringement is established; the interests of the patentee take precedence (Art. 66 lit. b PatA):

Die Identität der gewerblichen Abnehmer und das Ausmass der Weitergabe von patentverletzenden Produkten an sie ist bei nachgewiesener Patentverletzung kein schützenswertes Geheimnis; die Interessen des Patentinhabers gehen vor (Art. 66 lit. b PatG)

This principle had been established in O2013_008 (hn), but the recent decision O2016_012 appears to be at odds with this, at least at the face of it; see O2016_012, ¶102.

The value in dispute of an action by stages

The decision discusses the issue of the value in dispute in an action by stages (see ¶92): Should the value in dispute in patent infringement proceedings be fixed based on the first stage only (i.e. information / accounting and injunctive relief), or should the aggregate (monetary) claim that is subsequently dealt with in the second stage of the proceedings also be taken into account?

The decision opts for the latter. If a complaint is dismissed, this also implies dismissal with respect to monetary claims; it would thus be inconsistent if the value in dispute would be systematically addressed differently only because the outcome of the proceedings is different on the merits. However, the court fee is fixed to only CHF 70’000,– which is even less than what the tariff at the lower end would allow for in Art. 1(1) CostR-PatC in view of a value in dispute of CHF 4m, in consideration of the fact that it is only a partial decision that not yet deals with the monetary claims.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_007 | Decision of 1 November 2019 | ‘Beatmungsgerät’

Hamilton Medical AG
./.
imtmedical AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Philipp RÜFENACHT
    • Dr. Andri HESS
    • Dr. Simon HOLZER
    • Christoph MÜLLER

Judge-rapporteur:

    • Dr. Philipp RÜFENACHT

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Christoph GASSER (BianchiSchwald)
    • Renato BOLLHALDER (Bohest), assisting in patent matters
    • Dr. Torben MÜLLER (Bohest), assisting in patent matters

Representative(s) of Defendant:

    • Dr. Rudolf RENTSCH (IPrime)
    • Ernst BREM (IPrime)
    • Paul ROSENICH (PPR)
    • Joachim KÜNSCH (PPR)

DECISION IN FULL

EP 1 984 805 B1

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

Reading time: 21 minutes

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. O2013_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 O2013_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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Oxycodone / Naloxone II, III, … and counting(?)

Reading time: 7 minutes

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

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

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

Patents in suit: EP’821 and EP’824

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

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

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

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

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

AR 1, mark-up over the claims as granted

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

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

AR 2, mark-up over the claims as granted

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

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

AR 1, mark-up over the claims as granted

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

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

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

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

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

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

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

Reported by Martin WILMING

BIBLIOGRAPHY

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

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

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

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Develco:

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

Representative(s) of Mundipharma:

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

DECISION IN FULL

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PATENTS IN SUIT

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The Supreme Court will not have its say on O2018_009 re Fulvestrant

Case No. 4A_332/2019 (Supreme Court) | Order of 13 November 2019, on appeal against O2018_009  (FPC) | Decision of 27 May 2019 | ‘Patentnichtigkeit Fulvestrant’

Reading time: 3 minutes

A quick recap: Actavis had challenged validity of AZ’s Swiss part of EP 2 266 573 back in 2015, and the FPC had indeed held in 2017 that EP 573 was invalid for lack of inventive step; see this Blog here. However, the Supreme Court overruled that decision and remitted the case back to the FPC for re-assessment of obviousness; see this Blog here. In the second round, the FPC held that the subject-matter of EP 573 did involve an iventive step; see the decision O2018_009 of 27 May 2019. In brief, the FPC held that neither

rendered the claimed subject-matter obvious. That decision was again appealed to the Supreme Court, and I have been eagerly awaiting a good read. But nothing like that. The Supreme Court only published a dismissal order. The parties have apparently reached an amicable settlement; court fees are shared.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_332/2019 (Supreme Court) | Order of 13 November 2019, on appeal against O2018_009  (FPC) | Decision of 27 May 2019 | ‘Patentnichtigkeit Fulvestrant’

Mepha Schweiz AG
(formerly Actavis Switzerland AG)
(Appellant / Plaintiff)
./.
AstraZeneca AB (Respondent / Defendant)

Single Judge:

    • Dr. Kathrin KLETT

Court Clerk:

    •  Dr. Thomas WIDMER

Representative(s) of Appellant / Plaintiff:

Representative(s) of Respondent / Defendant:

    • Dr. Michael RITSCHER (MLL)
    • Dr. Kilian SCHÄRLI (MLL)

SUPREME COURT DECISION

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FPC DECISION

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EP 2 266 573 B1

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

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

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

Now, nullity is at stake.

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

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

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

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

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

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

The decision can still be appealed to the Supreme Court.

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

Reported by Martin WILMING

BIBLIOGRAPHY

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

Sandoz Pharmaceuticals AG

./.

Eli Lilly & Company

Panel of Judges:

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

Court Clerk:

    •  Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

DECISION IN FULL

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

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PATENT IN SUIT

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Is Bombardier’s Twindexx train modular? We shall see …

Reading time: 7 minutes

Case No. O2017_015 | Hearing of 20 September 2019

Alstom logo

The patent at stake in this infringement case is Alstom‘s EP 1 024 070 B1; see EPO Register and Swissreg for further bibliographic information.

Alstom alleges that Bombardier‘s Twindexx train in the IR100 (SBB RABe 502) configuration infringes EP’070:

The IR100 configuration of Bombardier’s Twindexx train
SBB logo

Please find some further information about the Twindexx train on SBB’s website and on Wikipedia.

The relevant claims are the independent claim 1 and its dependent claim 7 (emphasis added):

  • Claim 1:
  • Claim 7:
A modular railway rake formed of at least two vehicles (1, 2) with two superposed levels, including at least one bogie (10) including at least one driving axle, at least one bogie (11) including at least one carrying axle, and on-board equipment including at least one power supply electronic unit (19) for supplying motive power to one or more traction motors, at least one motive power supply unit (22, 25) for supplying power to the electronic unit (19), at least one auxiliary power supply unit (30) for supplying power to auxiliary equipment, and at least one device (21) for connection to an overhead power supply network, in which rake the motive power factor of a vehicle or a group of vehicles is defined as the ratio of the number of driving axles to the total number of axles of the vehicle or group, the rake being characterized in that at least one vehicle (1) includes at least one bogie (10) including at least one driving axle and at least one bogie (11) including at least one carrying axle, at least one bogie (11) of the rake including at least one carrying axle is associated with at least one of said on-board equipment items (19; 22, 25; 30; 21) disposed approximately over that bogie, and the ratio between the respective motive power factors of any two groups of two vehicles of the rake is not less than 1/3 and not more than 3.
A railway rake according to claim 1, characterized in that at least one power supply unit (22, 25; 30) is disposed approximately over a bogie (11) including at least one carrying axle.

First, the parties addressed the so-called ‘verbal limitation’ in their pleadings. Apparently, the plaintiff’s prayer for injunctive relief had been directed from the very beginning to an embodiment that was covered by a combination of claims 1 and 7, as well as (of course) also by claim 1 alone. Further, the arguments on infringement also dealt with the feature(s) of claim 7. The jugde-rapporteur’s expert opinion, however, did not deal with validity of the combination of claims 1 and 7. Now, how formally does a plaintiff have to ‘verbally limit’ his patent in consideration of a nullity plea in defense? This case might provide some further clarification on this issue, in addition to  S2018_007, ¶20.

Bombardier logo

As to non-infringement, Bombardier argues that the feature of a ‘modular railway rake formed of at least two vehicles’ was not fulfilled by the IR100. In Bombardier’s view, it must mean something different than just a railway rake formed of at least two vehicles since the term ‘modular’ must have been intentionally put there to have a meaning. Otherwise, it could just have been omitted. Bombardier held that ‘modular’ means that modules can be added or removed on short notice. This is not the case in the IR100 since the software needs to be adapted and the enlargement or reduction of the capacity by adding or removing modules is only possible in a service facility.

And, indeed, the judge rapporteur had apparently held that the feature ‘modular’ when properly construed in view of the description and the figures at least comprises an adaptability of the passenger capacity in a way that he did not see fulfilled in the IR100.

Some further discussion apparently circles around the feature ‘approximately over’ in claim 7; and the term ‘said on- board equipment’ in claim 1.

Further, Bombardier argues for nullity of EP’070 as a plea in defense. We conclude from the pleadings that obviousness is alleged in view of a publication about the first generation DD-IRM (1994) train of the Dutch Railways (referred to as D1; see Wikipedia and, by way of illustration, this picture of an IRM 1 EMU (embedded from www.railfaneurope.net, i.e. tinyurl.com/y5fmc9y5)) and EP 0 631 917 A1 (referred to as D4).

Some notable side issues:

First, even though judge DUCOR is presiding the panel of judges in this case, judge BREMI was acting as chair at the hearing.

Second, it is always interesting to see how the parties deal with pleading notes. Defendant’s counsel handed over pleading notes to the counterparty and the clerk, but not to the other judges because he

[…] thought that they would prefer to just listen.

Indeed, judge BREMI confirmed that he prefers to just listen to the pleadings.

A lawyer in a hurry …

Third, it turned out around noon that defendant’s counsel had to leave early because he had to catch an international flight that had initially been booked for later, but was cancelled and re-scheduled to an earlier time. Judge BREMI emphasized that summons are not issued with a specific end time and one should not generally expect hearings at the FPC to be finished around noon. Anyway, plaintiff’s counsel co-operated to conclude the hearing fairly soon thereafter.

No settlement discussions took place.

Reported by Susanna RUDER and Martin WILMING

BIBLIOGRAPHY

Case No. O2017_015 | Hearing of 20 September 2019

Alstom Transport Technologies SASU
./.
Bombardier Transportation (Switzerland) AG

Panel of Judges:

  • Dr. Philippe DUCOR
  • Dr. Tobias BREMI
  • Christophe SAAM

Judge-rapporteur:

  • n/a

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Christian HILTI (Rentsch Partner)
  • Moritz MEISSNER (Bombardier (inhouse)), assisting in patent matters

ANNOUNCEMENT

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PATENT IN SUIT

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Hold on tight: Sanipat and Hafner litigating about sealing strips with cut protection

Case No. O2019_005

Reading time: 2 minutes
Hafner’s logo

I came across the complaint in an infringement case that is pending at the FPC, between Sanipat GmbH and Hafner AG.

Sanipat asserts EP 2 405 067 B1 and CH 703 691 against certain sealing strips for shower trays, i.e. Hafner’s ISO-SET®.

Hafner’s website

Sanipat’s CH’691 has already been partially surrendered twice, see below.

EP’067 is currently being challenged in EPO opposition proceedings, see EPO Register. Hafner joined the pending opposition proceedings by intervention; Art. 105(1) lit. a EPC. Oral proceedings are scheduled for 28 November 2019.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2019_005

Sanipat GmbH
./.
Hafner AG

Panel of Judges:

  • [tbc]

Judge-rapporteur:

  • [tbc]

Court Clerk:

  • [tbc]

Representative(s) of Sanipat:

Representative(s) of Hafner:

  • [tbc]

COMPLAINT AS FILED

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EP 2 405 067 B1

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CH 703 691

Second partial surrender, published on 30 April 2019:

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First partial surrender, published 30 November 2016:

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Patent as initially granted:

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Clarification on clarity

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

Reading time: 15 minutes

HEADNOTE in O2016_010

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

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

Loepfe logo

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

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

O2016_010 re EP’250

Uster logo

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

Added Matter

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

AR1 and AR2 failed for the very same reason.

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

  • Claim 1 of AR3

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

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

Inventive Step of AR3

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

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

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

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

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

Clarity

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

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

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

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


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

Costs

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

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

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

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

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

O2016_011 re EP’018

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

Main Request: Added matter?

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

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

… but is it inventive?

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

Plan B

The FPC then moved on to AR1:

  • Claim 1 of AR1

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

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

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

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

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

Clarity and costs

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

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

Reported by Philippe KNÜSEL and Martin WILMING

BIBLIOGRAPHY

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

Gebr. Loepfe AG
./.
Uster Technologies AG

Panel of Judges:

  • Frank SCHNYDER
  • Dr. Tobias BREMI
  • Christoph MÜLLER

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

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

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

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

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Be specific!

Reading time: 9 minutes

Case No. O2016_001 | Decision of 27 June 2019

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

Comadur logo

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

Parallel proceedings elsewhere

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

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

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

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

limitation of the patent

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

Claim 1 as amended reads as follows:

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

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

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

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

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

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

novelty and inventive step

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

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

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

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

Accordingly, novelty was acknowledged.

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

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

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

Costs

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

No compensation for legal represenatation was awarded.

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

UPDATE 9 September 2019:

The decision has been appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_001 | Decision of 27 June 2019

Harcane Sàrl
./.
Comadur SA

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

  • Jean-Claude SCHWEIZER (SLB)

Representative(s) of Defendant:

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

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

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Alstom and Bombardier litigating over the Twindexx train; hearing canceled

Reading time: 4 minutes

Case No. O2017_015 | Hearing of 1 July 2019 (canceled)

First things first: The hearing scheduled for today did not take place. It had been cancelled on short notice because a judge got sick.

Cancellation notice on the website of the FPC

Thus, the following is just a quick teaser of the things to come.

Alstom’s logo

The patent at stake in this infringement case is Alstom‘s EP 1 024 070 B1; see EPO Register and Swissreg for further bibliographic information.

Alstom alleges that Bombardier‘s Twindexx train in the IR100 (SBB RABe 502) configuration infringes EP’070:

The IR100 configuration of Bombardier’s Twindexx train
SBB’s logo

Please find some further information about the Twindexx train on SBB’s website and on Wikipedia.

Bombardier, on the other hand, argues for nullity of EP’070 as a plea in defense. Further, Bombardier argues for non-infringement because the IR100 train does not literally reproduce the feature of a ‘modular’ train, and the feature of ‘two superposed levels’ (marked-up in the claim recited below).

  • Claim 1 of EP'070 reads as follows:
A modular railway rake formed of at least two vehicles (1, 2) with two superposed levels, including at least one bogie (10) including at least one driving axle, at least one bogie (11) including at least one carrying axle, and on-board equipment including at least one power supply electronic unit (19) for supplying motive power to one or more traction motors, at least one motive power supply unit (22, 25) for supplying power to the electronic unit (19), at least one auxiliary power supply unit (30) for supplying power to auxiliary equipment, and at least one device (21) for connection to an overhead power supply network, in which rake the motive power factor of a vehicle or a group of vehicles is defined as the ratio of the number of driving axles to the total number of axles of the vehicle or group, the rake being characterized in that at least one vehicle (1) includes at least one bogie (10) including at least one driving axle and at least one bogie (11) including at least one carrying axle, at least one bogie (11) of the rake including at least one carrying axle is associated with at least one of said on-board equipment items (19; 22, 25; 30; 21) disposed approximately over that bogie, and the ratio between the respective motive power factors of any two groups of two vehicles of the rake is not less than 1/3 and not more than 3.

A new date for the hearing will now be fixed with the parties. Stay tuned.

UPDATE 21 August 2019:

New summons have been issued for 20 September 2019; see here.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_015 | Hearing of 1 July 2019 (canceled)

Alstom Transport Technologies SASU
./.
Bombardier Transportation (Switzerland) AG

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No recusal of the judge-rapporteur — but there still is an elephant in the room …

Reading time: 8 minutes

Case No. 4A_56/2019 (Supreme Court) | Decision of 27 May 2019 on appeal against O2017_024 (FPC) | Order of 11 December 2018

The Supreme Court had to deal with an appeal against an (unpublished) order issued by the Administrative Commission (AC) of the FPC in case no. O2017_024, by which order the requested recusal of the judge-rapporteur had been denied. Defendant / appellant felt that some statements of the judge-rapporteur at the occasion of the instruction hearing (Art. 226 CPC) gave rise to the appearance of bias. It is important to understand that the instruction hearing at the FPC consists of two parts (Art. 8(4) of the Guidelines on Proceedings before the Federal Patent Court), i.e.:

a)   The court delegation discusses with the parties the matter at issue, asks questions where the party submissions are unclear, and provides substantiation advice. Evidence may also be accepted. This first part is transcribed.

b)   The court delegation explains its preliminary assessment of the matter in dispute off the record and attempts to bring about a settlement between the parties. The parties and the Court are prohibited from subsequently invoking any submissions made during this second part of the hearing; it serves exclusively to bring about a settlement.

Notably, the appellant did not object to the formal part a) of the instruction hearing (where the judicial duty to ask and inform applies), but rather to the informal part b) which serves exclusively to bring about a settlement.

After having read the first lines of the decision, I so much hoped that this decision would finally help me understand the metes and bounds of the informal part of the instruction hearing, and maybe even the formal part. Unfortunately, it doesn’t. The Supreme Court did not even assess the issue on the merits, but rather dismissed the appeal for formal reasons. What a pitty.

First, the Supreme Court holds that the appellant raised the objection belatedly, i.e. only 24 days after the instruction hearing. The Supreme Court did not buy into the argument that the procedural violations had only been noticed well after the instruction hearing (¶4.3):

It is not convincing that the appellant has only gained knowledge of the (alleged) ground for recusal until two weeks after the hearing, since the appellant does not object to a single error in the conduct of the proceedings, which may not be discernible at first sight, but «a large number of inadmissible statements by the judge-rapporteur», which «substantiated a serious violation of the duties of the judge by the disregard of fundamental principles of civil procedure.»


Further, the appellant criticised a statement made by the judge-rapporteur in his opinion of 26 September 2018, which the appellant considered would in itself give rise to the appearance of bias, and which should have been taken into account by the FPC’s AC ex officio. This statement is literally recited in the decision in ¶5.2, as follows (jump here for an English translation):

Die Instruktionsverhandlung dient gemäss Art. 226 ZPO unter anderem der freien Erörterung des Streitgegenstandes und dem Versuch einer Einigung. Um eine Einigung zu ermöglichen, nimmt der Instruktionsrichter eine vorläufige und unpräjudizielle Einschätzung der Sach- und Rechtslage vor. Dass es sich dabei um eine vorläufige Einschätzung handelt, die sich im Laufe des weiteren Verfahrens ändern kann und von den weiteren Mitgliedern des Spruchkörpers nicht geteilt werden muss, wird den Parteien klar kommuniziert. Die genannten Zwecke der Instruktionsverhandlung können nur erreicht werden, wenn sich der Instruktionsrichter – im Rahmen des von den Parteivorträgen umrissenen Streitgegenstandes – frei äussern kann. Eine strikte Bindung an einzelne Tatsachenbehauptungen ist in diesem frühen Verfahrensstadium, in dem das Behauptungsverfahren noch nicht abgeschlossen ist, nicht möglich und nicht zielführend.

Inofficially translated:

According to Art. 226 CPC, the instruction hearing serves, among other things, the free discussion of the subject matter in dispute and the attempt to reach an agreement. In order to enable an agreement to be reached, the judge-rapporteur makes a preliminary and unprejudiced assessment of the factual and legal situation. The parties are clearly informed that this is a preliminary assessment, which may change in the course of further proceedings and need not be shared by the other members of the panel. The stated purposes of the instruction hearing can only be achieved if the judge-rapporteur can freely express himself within the framework of the subject matter of the dispute outlined by the party submissions. A strict link to individual factual assertions is not possible and not expedient at this early stage of the proceedings, at which the assertion proceedings have not yet been concluded.

The FPC’s AC did not see any reason for recusal in the above statements. But still, and ‘for the sake of completeness’, the FPC’s AC addressed the opinion of the judge-rapporteur and concluded — in general terms, detached from the case at hand — that ‘there was no basis for supplementing the relevant alleged facts by the judge, neither outside nor within settlement discussions.’

[…] keine Grundlage für eine Ergänzung des relevanten behaupteten Sachverhalts durch den Richter, weder ausserhalb noch innerhalb von Vergleichsgesprächen.

A judge-rapporteur, navigating on difficult territory

I am not fully sure what is meant with ‘no basis’. If this is to be understood in a sense that supplementing the alleged facts (within or beyond ‘the framework of the subject matter of the dispute outlined by the party submissions’) is a clear no-go, then I could not agree more. It may be a tough exercise for a judge-rapporteur to stick to the facts as they have been asserted after only a single exchange of briefs, in particular when the forthcoming further assertions are all too obvious. But still, parties sometimes just do not make even the most obvious next assertion (intentionally or unintentionally), and any helping hand for a potentially negligent or ignorant party would be to the disadvantage of the respective other party.

But in the matter at hand, the Supreme Court did not need to deal with this issue on the merits. The decision holds that the appellant’s criticism misses the point: Procedural errors (as well as a decision that is potentially wrong on the merits) cannot in themselves justify the appearance of bias. The situation is different only if there are particularly blatant or repeated errors which must be assessed as a serious violation of the duties of the judge. Consequently, the request for recusal of a judge cannot normally serve to assess alleged procedural or other errors of the judge. Such complaints must be raised on appeal; see 4A_149/2018 in ¶5.2. Accordingly, the Supreme Court did expressly not assess to what extent the statements made by the judge-rapporteur — in particular the last two sentences — are in conformity with the law. The only decisive point is, in the Supreme Court’s view, that this statement was not a particularly blatant error of such a kind that would make the rejected judge appear almost biased. Thus, also appellant’s second criticism failed.

Now, what can be learned from this decision?

Unfortunately, not too much for the time being, because the Supreme Court took a formal shortcut. But, in my perception, there is some handwriting on the wall, isnt’t it? And, maybe, we will see the appellant’s second criticism being raised again on appeal if this case moves on and the appellant / defendant is unsuccessful in first instance proceedings on the merits.

UPDATE 27 January 2020:

From this presentation I just learned that the litigants were Rotho Kunststoff and Keter Plastic. See slides 10/11.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_56/2019 (Supreme Court) | Decision of 27 May 2019 on appeal against O2017_024 (FPC) | Order of 11 December 2018

n/a (appellant / defendant)
./.
n/a (respondent / plaintiff)

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Fabienne HOHL
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  • Dr. Christian KÖLZ

Representative(s) of Appellant:

  • Dr. Rudolf A. RENTSCH (IPrime)

Representative(s) of Respondent:

  • Dr. Simon HOLZER (MLL)

SUPREME COURT
on appeal against O2017_024 (FPC) | Order of 11 December 2018
Case no.: 4A_56/2019
Decision of: 27 May 2019
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PATENT COURT
Case no.: O2017_024
Order of: 11 December 2018

Upublished; not available yet.

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