Fulvestrant, again

Reading time: 4 minutes

Case No. O2017_014 | Decision of 10 March 2020 | ‘Fulvestrant use’

When you have read the report about the main hearing of 20 January 2020 on this Blog here, you probably won’t be overly surprised by the outcome: AZ’s complaint has been dismissed.

In brief, AstraZeneca asserted 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). The patent has been partially waived after closure of the file, in accordance with Art. 24 PatA (newly added features marked-up):

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

Here are my take-away messages from the decision:

Expert opinion

The decision clarifies in no uncertain terms the nature of the judge-rapporteur’s expert opinion (EO):

... is a legal assessment of the facts as pleaded before closure of the file.

Loose translation to English:

The [EO] is established after closure of the file, and it is the judge-rapporteur’s legal assessment of the facts put forward by the parties. It provides a contribution to the discussion for the purpose of rendering a judgment. The [EO] can therefore only deal with questions of law, but not with questions of fact. Accordingly, [an EO] cannot entitle the submission of new facts from the outset. Certainly, a party cannot use [the EO] as a trigger to remedy incomplete factual allegations.

Admissibility of partial waiver

Nosy? Me too. But it’s not yet time. Admissibility of the partial waiver after closure of the file is left undecided, in view of the appeal in case O2016_012 that is currently still pending at the Supreme Court. Irrespective of the answer to this highly interesting question, the complaint had to be dismissed for other reasons; see below.

Belated and insufficient factual allegations re infringement of the partially waived patent

A partial waiver after closure of the file per se cannot carry the day.

The decision holds that AZ’s pleadings re infringement of the partially waived patent — for the first time at the hearing — were belated and insufficiently substantiated:

... and insufficiently substantiated pleadings re infringement of the partially waived patent.

Accordingly, the complaint was dismissed.

How to (formally correctly) introduce a partially waived patent into the proceedings

AZ had submitted the partially waived patent to the court with letter of 8 August 2019, and Sandoz had been given the opportunity to comment thereon. The decision holds:

... and how it had been introduced into the proceedings.

Loose translation to English:

In this respect, it is not clear to the Court what the defendant means when asserting that the partially waived patent has not yet been asserted or formally correctly introduced into the proceedings.

Frankly, I am confused. My understanding from what had been pleaded at the hearing was that AZ had indeed submitted the partially waived patent — but merely as an annex, i.e. without asserting the substance of the partially waived patent in the submission itself. That could have been an interesting issue, somewhat similar to the situation that gave rise to the order of 3 May 2012 in O2012_022; see ¶¶ 10.4 et seqq. But, maybe, I just got it wrong. Anyway, that’s not the decisive issue here.

UPDATE 27 May 2020:

According to an update on the FPC’s website earlier today, the decision has not been appealed / is final.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_014 | Decision of 10 March 2020 | ‘Fulvestrant use’

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. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters

Representative(s) of Defendant / Patentee:

DECISION IN FULL

PATENT IN SUIT

EP 195 as granted by the EPO:

 

EP 195 after partial waiver in Switzerland:

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A flow sensor in limbo: Up, and down. Up, and … – down or done?

Reading time: 5 minutes

Case No. O2019_008 | Decision of 17 December 2019, on remittal of 4A_70/2019 | Decision of 6 August 2019 | ‘Flow sensor II’

The flow sensor litigation between Hamilton Medical and imtmedical is popping up once in a while. We had reported already on this Blog about the main hearing of 29 October 2018, the first decision of the FPC (case O2016_009 of 18 December 2018) and the Supreme Court decision (case 4A_70/2019 of 6 August 2019). The Supreme Court had remitted the case to the FPC, to assess one specific issue; see 4A_70/2019, ¶2.5.4:

... for which the Supreme Court had remitted the case back to the FPC.

Inofficially translated:

[The FPC] did not examine whether there was a causal connection between the improper novum [document E10] in the rejoinder and the verbal limitation of the patent claim, i.e. whether the limitation was specifically occasioned by [E10]. The case must thus be remitted to [the FPC] for assessment of this issue.

Now, was the verbal limitation of the patent been occasioned by E10 (JP S61-205023) that had been submitted only with the rejoinder? The decision discusses three criteria in order to assess this question; ¶ 16:

    1. Is the limitation admissible; Art. 24 PatA?
    2. Is the claimed subject-matter after the limitation new and non-obvious?
    3. Does the limited claim still cover the attacked embodiment?

All three criteria are met here. And the decision holds that it would not be realistic to assume that this just happened by accident:

It is hardly conceivable that the patentee would come up with a permissible limitation leading to a claim which is infringed by the attacked embodiments without reacting to [E10 and other prior art] in a technical sense.

But what is more, the plaintiff specifically argued why the limited claim was new and non-obvious over E10. Accordingly, the decision holds that the limitation had effectively been occasioned by E10. 

A further aspect of the decision relates to timing. The law requires submission of improper nova (such as a limitation of the claims) ‘immediately’; Art. 229(1) CPC. The decision holds that a submission within 10 days is fine, but not mandatory: As long as a time limit is currently pending for the respective party for a submission on the merits of the case, submission of the novum within that time limit is also fine.

... means within the pending period for a party to make a submission, as long as this submission is in relation to the novum. Else, without delay means within ten (10) days.

The Supreme Court had already made clear that the mere fact that the plaintiff had presented the very same limitation with the second part of the reply (according to the old practice) is irrelevant; see 4A_70/2019, ¶ 2.5.3.

Still, I am bursting with curiosity: How comes that the plaintiff had limited the claim in exactly the same way with the completed reply, i.e. at a time when E10 had not yet been at stake? Is that just a coincidence? I can hardly believe that.

From the Supreme Court decision in ¶ 2.5.3, one might read between the lines that E10 had been at stake at the instruction hearing:

On the other hand, the present decision clarifies that E10 had not been at stake in the informal part of the instruction hearing:

Anyway, it is left explicitly undecided whether a mentioning of E10 in the informal part of the instruction hearing would have allowed the plaintiff to react thereon in any event, in view of Art. 8(4) lit. b of the Guidelines on Proceedings before the FPC.

Maybe, E10 had been discussed between the parties, outside of the court proceedings? There is an obiter dictum in the decision that suggests that this would not oblige the plaintiff to react on this in the proceedings in advance:

In sum, the FPC confirmed the substance of the earlier decision.

Up & Down (Vengaboys)

So, that’s it?

No, not yet. The advantage of being late with this report is that I now already know that this decision has (again) been appealed to the Supreme Court. Up, and down. Up, and … – down? Or done? We shall see.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2019_008 | Decision of 17 December 2019, on remittal of 4A_70/2019 | Decision of 6 August 2019 | ‘Flow sensor II’

Hamilton Medical AG (Plaintiff)
./.
imtmedical AG (Defendant)

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Lorenzo PARRINI

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

SECOND FPC DECISION

on remittal of 4A_70/2019 | Decision of 6 August 2019:
O2019_008 17 December 2019

SUPREME COURT DECISION

on appeal against O2016_009 | Decision of 18 December 2018:
4A_70/2019 6 August 2019

FIRST FPC DECISION 

O2016_009 18 December 2018

CH 701 755 B1


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How many deaths can one die?

Reading time: 11 minutes

Case No. O2017_015 | Decision of 7 November 2019 | ‘Rame ferroviaire modulaire’

HEADNOTE

Art. 56 EPC, Art. 1(2) PatA: Inventive step and technical disadvantages in the event of a change in the teaching of the state of the art.

If an obvious technical disadvantage for the skilled person results from a change of the teaching of a prior art leading to the claimed invention, it cannot be asserted, that the skilled person would not seriously consider such a change of the teaching of the prior art, if at the same time the claimed invention does not remedy that disadvantage in an unexpected manner, but merely accepts it.

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

Alstom alleged 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 Bombardier’s swissdosto.ch website and fact sheet. The video below is embedded from swissdosto.ch, for amusement of the railway enthusiasts out there before we are going to have a closer look at the more legal issues of the case …

Promo video, embedded from swissdosto.ch (Bombardier)

The relevant claims are the independent claim 1 and its dependent claim 7 (emphasis added), as asserted by Alstom:


Claim 1:

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.

Claim 7:

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.
Bombardier Logo

Bombardier took the position that the IR100 did not make use of the features as marked-up in bold above; in particular, that the IR100 was not modular and did not have two superposed levels in the sense of EP’070.

Alstom had amended the request for injunctive relief after the instructional hearing in that the term ‘modular’ was replaced by the following:

What ‘modular’ means, in Alstom’s view

With regard to modularity, the court came to the conclusion that only a modularity could be meant which allows the train operator to react on momentary needs, by way of adding vehicles to preexisting train compositions. The decision refers to ¶¶[0002]-[0003] of the general specification of EP’070, as well as the explanations with respect to specific embodiments:

Alstom had argued that also modifications in medium and long term would be covered by the term ‘modular’ when properly construed. This, however, did not convince the judges because such broad reading would cover virtually any system composed of a plurality of parts. The term must necessarily have a (more narrow) meaning. Otherwise, so the decision, it would not have been used (¶19):

Par conséquent, étant donné que la rame ferroviaire est définie dans la revendication comme etant «modulaire», ce terme doit nécessairement avoir une signification particulière, sinon il n’aurauit pas été spécifié dans la revendication.

That’s pretty catchy, isn’t it? I would not be surprised if (mis?)use of this reasoning will become somewhat popular in response to an invalidity challenge:

Uuhu, hold on, the feature is in the claim, it must have a very specific meaning, else it wouldn’t be there.

Well, not necessarily. Sometimes there are features in a claim that are just trivial — and can be (easily) challenged as such.

Anyway, the decision holds that omission of the term ‘modular’ in the plaintiff’s request for injuctive relief as amended resulted in the court’s finding that the request went beyond the scope of protection of EP’070 and that it had to be rejected already for this reason alone; ¶21. Death #1.

This could have been it. However, the decision gives even more reasons as to why the complaint had to be rejected: EP’070 was neither valid nor infringed.

After a detailed claim construction, the decision holds that EP’070 to the invoked extent was novel over the closest prior art, D1, at least for the modularity of the rake and for the positioning of heavy elements approximatively above the carrying axle bogie.

Now … what is D1?!

But … what the heck is D1?

The decision is silent on what D1 is — which is regrettable. No chance to really review the stringency of the court’s line of arguments. It can only be assumed from what had been pleaded at the main hearing and some annotations in figures reproduced in the decision that D1 is a publication about the first generation DD-IRM (1994) train of the Dutch Railways (see Wikipedia: NS_VIRM).

Anyway, the decision holds that the subject-matter of EP’070 to the invoked extent did not involve an inventive step over the teachings of D1. The differentiating features (first, the modularity; and, second, the positioning of heavy elements approximatively above the carrying axle bogie) are associated with the technical effects that the weight is distributed evenly over the length of the train rake and that train operation becomes more profitable.

As to modularity, the decision holds that the skilled person would arrive at a modular train without further ado if he/she were to develop a more flexible and hence more profitable train rake.

With regard to the positioning of heavy equipment (such as the down chopper module in D1) the judges agreed with the patentee in that such heavy equipment would intuitively be placed in the lowest possible location of the rake, e.g. at the bottom of a low voltage machine room. However, and this is where the headnote stems from, if the claimed invention merely accepts an obvious disadvantage without suggesting any remedy thereto, the unfavorable feature cannot support the finding of an inventive step.

... when an apparent technical disadvantage of a technical solution is not overcome in a non-obvious manner but merely accepted.

In consequence, EP’070 was found obvious over D1 in combination with the skilled person’s general technical knowledge. Death #2.

At the face of it, the hn makes much sense against the background of the case at hand. But is the absolute character of the statement justified? One might well think of situations, where a particular disadvantage of a feature would be merely accepted (rather than remedied), but where the choice of the feature would still be non-obvious. For example, when the commonly known and persisting drawbacks are set off by other, unrelated or indirect advantages associated with the feature. In our perception, the hn should be understood with the provision marked-up below:

[…] if at the same time the claimed invention does not remedy that disadvantage in an unexpected manner, but merely accepts it and does not compensate for it by any unexpected technical advantage.

This would actually be perfectly in line with established case law of the Boards of Appeal of the EPO; see Case Law of the Boards of Appeal (2019), I.D.9.19.1, in particular T 119/82 (hn 2).

Again, the decision could have ended at this point. But the decision also expands on the question of infringement, i.e. that Bombardier’s Twindexx IR100 was not modular in the sense as described above. In particular, it could not, due to software issues, be supplemented with additional coaches nor could coaches be removed by the train operator in the short run. Also, no equivalent feature providing such flexibility could be found in the IR100 train. Death #3.

It is remarkable that the decision gives no less than three reasons for rejecting the request for injunctive relief. This is rarely seen. Still, it may well serve procedural economy: Both the parties and the appellate body are provided with a more complete picture of the first instance’s views. This way, the unsuccessful party can make a more informed decision on whether or not to lodge an appeal; and if an appeal is lodged, the appellate body might not have to remit the case back to the first instance — hence saving time and money.

Patent Reaper

But as if three reasons were not enough, death #4 was just around the corner: EP’070 lapsed after 20y in January 2020.

The decision has not been appealed / is final.

Reported by Jolanda MINDER and Martin WILMING

BIBLIOGRAPHY

Case No. O2017_015 | Decision of 7 November 2019 | ‘Rame ferroviaire modulaire’

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

Panel of Judges:

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

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

PATENT IN SUIT

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How to interpret expressions stating a purpose in a patent claim

Reading time: 10 minutes

Case No. O2018_017 | Decision of 31 January 2020

Aschwanden’s logo

F.J. Aschwanden on the one hand, and acG Holding (Anita and Clément Gutzwiller) and Andreas (André) Robert on the other hand are litigating over validity of EP 2 475 827 in Switzerland. We had reported about the main hearing in this matter on this Blog here.

Basys’ logo

From the earlier case S2018_005 it is known that Basys is the exclusive licensee of EP 827; Aschwanden’s ‘Dura Box‘ line of products had been asserted to infringe EP 827.

EP 827 pertains to reinforcing elements that can be integrated in concrete structures in order to support recesses for conduits (water, electricity, etc.).

No suspension of proceedings / the judgment

Opposition proceedings are currently pending at the EPO, and the parties have been summoned for oral proceedings on 31 March 2020. One of the two opponents is F.J. Aschwanden, i.e. the plaintiff in the present case. The second opponent is Jordahl H-Bau AG. The latter has submitted the judgment to the EPO with letter of 18 February 2020.

The FPC may suspend proceedings, and in particular defer the judgment, where a final decision has not yet been taken in EPO opposition proceedings; Art. 128 lit. b PatA. The decision holds that the timeline is decisive. If a legally binding decision is to be expected soon by the EPO, it is justified in order to avoid contradictory decisions to suspend the national proceedings, or the judgment only. However, if it is likely to take longer for the EPO to reach a final decision, the constitutional right to an assessment within a reasonable period of time will prevail.

Defendant’s request to suspend proceedings had already been dismissed with order of 30 October 2019. The request at the main hearing to only suspend the judgment was unsuccessful, either. First, a delay of at least one year could hardly be considered acceptable for the plaintiff, in view of the constitutional acceleration requirement; Art. 29(1) FC, Art. 6(1) CPHR. Second, the decision holds that there is not even a risk of conflicting decisions since the claims for which the Opposition Division provisionally indicated allowability are not to be considered in the present proceedings; see below.

Belated claim amendment

The patentee / defendant had requested twice to maintain the patent in amended form: For the first time with the rejoinder, and for the second time in an even more limited form with the comment on the expert opinion of the judge-rapporteur. Clearly, the former was still timely filed, i.e. well before closure of the file. On the other hand, the latter was filed only after closure of the file. What is more, the patentee had submitted the very same claims in EPO opposition proceedings already well before the rejoinder was filed. The decision holds that the mere fact that the Opposition Division of the EPO indicated allowability of these claims (Auxiliary Request 2) with the summons to oral proceedings in no way justifies the belated submission of the claims in proceedings at the FPC.

On the merits

The decision extensively deals with claim construction on about five pages. Clearly, this facilitates the analysis of novelty and inventive step later on.

Neither claim 1 as granted nor claim 1 as amended with the rejoinder is held to be novel over Suzuki et al. (Nippon Steel Technical Report No. 96 July 2007: High Strength Deformed Bar-in-Coil «HDC800» for Shear Reinforcement of RC Beam with Web-opening) and JP 6-32280; an automated translation of the latter (which is actually not too bad) is available via the Global Dossier.


Claim 1 as granted (EN translation)

A Device for the reinforcement of concrete structures
B which, by means of inserted structural elements, bridges weakened zones
C which are produced by recessed parts
D and which transmits the forces
E wherein in addition to the conventional design of the reinforcement (11) originally calculated by the structural engineer
F and before the concrete is cast
G  the recessed parts are surrounded by at least one structural element
H the structural element (1) comprises at least one tension element (2) in the form of a straight tension rod, a bent rod or a frame
I which is connected at both ends to an anchoring
J at least one holder (4) is provided, which is connected to the tension element (2) or to the anchoring (3) or is formed by the tension element itself
K wherein a force model is formed by the structural element
L which reinforces the local shear behavior of the statics in the region of the recessed parts
M and thus improves the concrete structure weakened by the recessed parts by transferring the forces
N and reduces or eliminates the static weaknesses of the concrete structure caused by the recessed parts
O the tension element taking over shear, compression, transverse, tensile forces and / or bending moments
P wherein force-neutral zones are formed for the recessed parts by the force model
Q the structural element surrounds these force-neutral zones at least partly on two opposite sides
R and completely on a third side connecting the two sides
S the holder is arranged to hold the recessed parts in the force-neutral zone and the recessed parts are accommodated in the force-neutral zones

Claim 1 of the Auxiliary Request (EN translation), marked-up

A Device for the reinforcement of reinforced-concrete floorsstructures
B which, by means of inserted structural elements inserted into the reinforced-concrete floor, bridges weakened zones
C which are produced by recessed parts
D and which transmits the forces
E wherein in addition to the conventional design of the reinforcement (11) originally calculated by the structural engineer
F and before the concrete is cast
G  the recessed parts are surrounded by at least one structural element
H the structural element (1) comprises at least one tension element (2) in the form of a straight tension rod, a bent rod or a frame
I which is connected at both ends to an anchoring
J at least one holder (4) is provided, which is connected to the tension element (2) or to the anchoring (3) or is formed by the tension element itself
K wherein a force model is formed by the structural element
L which reinforces the local shear behavior of the statics in the region of the recessed parts
M and thus improves the concrete structure weakened by the recessed parts by transferring the forces
N and reduces or eliminates the static weaknesses of the concrete structure caused by the recessed parts
O the tension element taking over shear, compression, transverse, tensile forces and / or bending moments
P wherein force-neutral zones are formed for the recessed parts by the force model
Q the structural element surrounds these force-neutral zones at least partly on two opposite sides
R and completely on a third side connecting the two sides
S the holder is arranged to hold the recessed parts in the force-neutral zone and the recessed parts are accommodated in the force-neutral zones

The statements in the claim that indicate a purpose are the most crucial ones for the outcome of the case; see below.

Interpretation of expressions stating a purpose

The decision holds that according to the Supreme Court (122 III 81, r. 4b), in the case of a device claim (product claim), indications of purpose, effect or function do not normally have a restrictive effect on the scope of protection. Such statements generally are only to ease understanding. The situation is different if the disclosed use is not merely a statement of purpose, but already indicates the functional suitability of the device and its physical properties by way of explanation.

According to the practice at the EPO, on the other hand, the indication of a purpose in a device claim must in principle be interpreted such that the device is suitable for the specified purpose; see Guidelines F-IV, 4.13.1 and Case Law of the Boards of Appeal, 9th ed. (2019), I.C.8.1.5.

UPDATE 09 March 2020:

I only realized now that indications of a purpose had already been at stake in S2012_004 of 24 March 2012; see this Blog here. At that time, the FPC had applied the EPO’s approach without hesitation; see ¶8.

Anyway, the decision holds that the principles of interpretation of the Supreme Court and the EPO lead to same result: A known device prejudices the subject matter of a later claim if that known device was suitable for the purpose stated in the claim.

Even though it is a non-issue for the case at hand, I am still struggling with the reasons in 122 III 81, r. 4b.

Do you get it? I don’t.

In a claim directed to a «[d]evice for [doing x], wherein the device comprises [y and z]», how would I ever know whether the indicated purpose is only meant ‘to ease understanding’ («Verständnishilfe») or whether it defines ‘the functional suitability of the device and its physical properties by way of explanation’ («die funktionelle Eignung der Vorrichtung und deren körperliche Ausgestaltung erläuternd klarstellt»). Frankly, that doesn’t make much sense to me; it is the exact opposite of legal certainty. Anyway, the decision is almost a quarter of a century old. I would assume that the Swiss Supreme Court would nowadays assess the issue similar as the German Supreme Court did in the hn of Xa Zr 140 05 of 28 May 2009:

[Purpose features] regularly have the task of defining the subject-matter protected by the patent in such a way that it does not only have to fulfil the spatial-physical features recited in the claim, but that it must also be designed in such a way that it can be used for the purpose stated in the claim.

approaches 'purpose' features in pretty much the same way as the EPO.

Well, this is it. Period.

UPDATE 12 March 2020:

The decision has not been appealed / is final now.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_017 | Hearing of 18 November 2019

F.J. Aschwanden AG

./.

  1. acG Holding AG
  2. Andreas (gen. André) ROBERT

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Natalia CLERC
    • Dr. Kurt SUTTER

Judge-rapporteur:

    • Natalia CLERC

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant / Patentee:

    • Felix GRETHER (EBD)
    • Daniel MAIER (euromaier), assisting in patent matters

DECISION IN FULL

PATENT IN SUIT

EPO SUMMONS

EPO AUXILIARY REQUEST 2

RELATED CASE S2018_005


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A dossier that has risen like yeast dough

Reading time: 7 minutes

Case No. O2017_002 | Hearing of 5 February 2020

On 5 February 2020 the main hearing in this matter took place at the FPC. We have reported on this matter already on 3 February 2017 when ex parte interim measures had been denied (see this Blog here) and on 26 May 2017 when EPO prosecution and opposition proceedings had been stayed (see this Blog here).

Tomologic logo

In first place, Tomologic‘s EP 2 485 864 B1 (see EPO Register) is at stake. Bystronic requested that EP(CH) 864 be declared null and void, or that it be assigned to co-ownership as an auxiliary measure. Some further patents or patent applications are concerned in addition, in particular national parts of WO 2012/136262 A1 such as e.g. EP 2 694 241; see EPO Register).

Tomologic has countersued for infringement of EP 864 by Bystronic’s software product Bysoft 7 with the implemented function to create cutting plans:

As an introductory remark, the presiding judge invited Tomologic to provide a translation of a Swedish decision that had been submitted earlier; unfortunately, it was not indicated in the hearing what that decision was all about. Even though Bystronic had not commented on that Swedish document, the court felt «not at ease» with having a document on file which is not comprehensible for the judges.

Both parties gave PPT presentations. The presiding judge reminded the parties that this case was already extraordinarily voluminous, even before oral pleadings, and that there was no need to repeat the assertions already made in writing.

Clunky mike

Tomologic used flipchart sketches and short films in further support of the PPT presentation. In our perception, flipcharts are generally welcomed by the court. But how tho deal with the table-top microphone in such situations? Any drawer / presenter should be prepared to be reprimanded by the court clerk to use the microphone. Furthermore, flip chart collages, once they are completed, shall form part of the minutes and should not be re-arranged too heavily in later pleadings.

On the merits of the case, we understand that the judge-rapporteur’s expert opinion had been in favor of Bystronic, at least to the extent nullity of EP 864 is concerned. Claim 1 of EP 864 as granted reads as follows (underlined feature amended over claim 1 as originally filed; potentially distinguishing feature over the prior art highlighted in yellow):


Claim 1 of EP 864, marked-up

Method for machine cutting several parts out of a piece of material using a beam cutting technology, said method providing a set of controlling rules and variables for cutting two dimensional shapes or patterns, where one rule or a combination of several rules are used for the cutting operation depending on the shape or pattern to be cut, said shape or pattern forming said parts out of said piece of material, characterised in that said set of controlling rules comprises rules for the forming of a cluster of parts with free form shapes, said parts being positioned so close to each other so that only the thickness of one cut made by the cutting beam is found between adjacent parts whenever the shape of said parts allows it.

It appears that the introduction of «one cut made by» may have caused an issue under Art. 123(2) EPC. Further, the correct understanding of (rules for the forming of a cluster of parts with) «free form shapes» in the characterizing part of the claim was a big issue in the hearing.  In Tomologic’s view, this was a reference to «free form nesting». Free form nesting is a technique which — in contrast to «rectangular nesting» or «rectangular bounding box nesting» — arranges free form parts in a space-saving manner, based on perimeter segments rather than outer perimeter boxes.

In a nutshell, Tomologic held that the claim requires forming of a cluster by means of free from nesting. On the contrary, Bystronic held that it could only be the parts themselves which have a free from shape, without any indication whatsoever of the envisaged nesting technique. It is our understanding that only according to Tomologic’s interpretation, the respective claim feature might potentially constitute a differentiating feature over so-called rectangular nesting. At this point of the hearing, the linguistic discussion about English grammar was quite intense. Bystronic explained the difference by way of a «baking dilemma», i.e. that «baking products with yeast» is not necessarily the same as «products baked with yeast»; the term «with» could not be construed as «by means of» at will.

We understood that the expert opinion had apparently held that the feature as claimed is not much of a limitation, and that it does in particular not exclude rectangular clustering; see e.g. ¶ [0052] of EP 864 in this respect:

Faszination Blech

It has been referred in the pleadings re (lack of) novelty to JP H09-285886 (D1, also available as EN translation) and a further document called «Rao» (likely Rao et al., Int J Adv Manuf Tenchnol (2007) 33: 436-448; available here). Further, it was referred to the publication «Faszination Blech» (you cannot make this up).

We conclude from the pleadings that the above issues had likely not been resolved by Tomologic’s auxiliary request(s) to maintain and assert EP 864 in amended / limited form. Rather, the auxiliary request(s) occasioned further issues re clarity and, maybe, enablement.

Interestingly, Bystronic had initially requested a declaratory judgement of non-infringement; see p 1-9 of the complaint as filed and the FPC’s letter of 16 January 2017:

by the FPC, indicating the case number (O2017_002) and the subject-matter of the complaint, i.e. request for declaratory judgement of non-infringement.

We conclude from the pleadings that the court might have (partially?) not considered this request for declaratory judgement, but this remains to be confirmed in the final judgement.

The pleadings further circled around Bystronic’s alleged contribution to the subject-matter of EP 864, as the basis for the requested assignment to co-ownership. Note that Bystronic had initially requested assignment to co-ownership for the whole patent family of EP 864, as well as the patent family of WO 2012/136262 A1.

The value in dispute was indicated as 2m CHF for the main claim and 1m CHF for the counterclaim. Actual costs incurred by the parties apparently by far exceed the refundable amounts according to the tariff.

The parties finally agreed to have settlement discussions.

Reported by Jolanda MINDER and Martin WILMING

BIBLIOGRAPHY

Case No. O2017_002 | Hearing of 5 February 2020

Bystronic Laser AG
./.
Tomologic AB

Panel of Judges:

    • Dr. Thomas LEGLER
    • Dr. Tobias BREMI
    • Christoph MÜLLER
    • Christophe SAAM
    • Dr. Rudolf RENTSCH

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Markus FRICK (Walder Wyss)
    • Manuel BIGLER (Walder Wyss)
    • Dr. Peter WALSER (Frei), assisting in patent matters
    • Dr. Markus MÜLLER (Frei), assisting in patent matters
    • Dr. Michael BERGER (Bystronic), assisting in patent matters

Former representative(s) of Plaintiff:

    • Catherine WEISSER
    • Paul ROSENICH (PPR), assisting in patent matters

Representative(s) of Defendant / Counterclaimant:

    • Dr. Simon HOLZER (MLL)
    • Martin TOLETI (Blum), assisting in patent matters
    • Dr. Christoph ENGELBRECHT (Blum), assisting in patent matters
    • Henrik HÄGGLÖF (Zacco), assisting in patent matters

ANNOUNCEMENT

 

PATENT IN SUIT

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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

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°.

Claim 2

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 has been appealed to the Supreme Court.

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

UPDATE 18 June 2020:

The Supreme Court has dismissed Sandoz’s appeal with decision of 1 May 2020 (published 17 June 2020); the full judgment is available here.

The operative part of the judgment has been published earlier by Lilly’s counsel on EPLaw Blog; available here.

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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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:

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.

Claim 7:

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

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