A very serious soap opera

Reading time: 6 minutes

Case No. O2019_001 | Hearing of 16 September 2020

Frosch® product

As mentioned earlier on this Blog here, Werner & Mertz (well known e.g. for its brands Erdal® and Frosch®) has sued Compad Consulting GmbH for lack of entitlement to a patent application, i.e. unlawful usurpation thereof.

The patent application at stake is EP 2 592 134; the patent application is licensed to the Swiss start-up company Good Soaps. See the European Patent Register for further bibliographic information.

The file wrapper at the EPO is telling: The complaint of 9 January 2019, the reply of 20 September 2019 (including all appendices) as well as the comments on the rejoinder of 5 December 2019 are available online. The instruction hearing took place on 8 July 2019 — without a settlement being reached.

There had already been some attention in the media a while ago (see e.g. here and here), when the defendant had lodged a press release. Apparently, the plaintiff now also approached the media shortly before the hearing. SRF reported again about this case yesterday in Regionaljournal Zentralschweiz:

Frankly, I am not going to participate in reading the tea leafs here, trying to conclude something from the fact that the inventor has waived her right to be publicly mentioned; or that the applicant is not Good Soaps itself, but rather a consulting firm that has given a license to Good Soaps. These things per se may well happen for good and serious reasons. And I cannot readily spot any troll-like behaviour, either.

UPDATE 18 September 2020:

For some strange reason, the designation of inventor is available in the online file wrapper at the EPO, contrary to R. 144 (c) EPC.

In the end, for an assignment action to be successful, a plaintiff has to prove the following:

    1. that he actually made the invention on his own (when, where and how);
    2. how the defendant was made aware of this invention; and
    3. how this invention is reflected in the application(s) in suit.

See e.g. O2012_001 (r 27) and O2015_009.

The main hearing took place earlier today, and it was definitely one worth attending.

Good Soaps product

Ms Regine SCHNEIDER had met with some people of Werner & Mertz on 27 August 2009 in Mainz, in particular with Mr Karl-Heinz QUADE. That is one of the few things on which the parties can agree. At that time, Ms SCHNEIDER had been employed by Kolb, as head of the business unit New Business. I understood from the pleadings that Ms SCHNEIDER had been decruited on the very next day, i.e. 28 August 2009, and that she was immediately released from work because Kolb closed down the whole business unit. Accordingly, it will be decisive whether the invention — as claimed in the application at stake, or at least the basic concept thereof — had been communicated by Mr QUADE to Ms SCHNEIDER in that meeting.

Evidently, the content of this single meeting is of critical importance. Since there is only very limited written evidence in this respect (only an agenda or invitation, in my understanding), witness testimony will likely be decisive. Accordingly, Ms SCHNEIDER was deposed as a witness today. To the best of my knowledge, this was actually the first time that a witness has been publicly deposed in a main hearing at the FPC. Ms SCHNEIDER was first deposed by the President and the judge-rapporteur, and both parties were given the opportunity to ask follow-up questions. This was actually a pretty smooth exercise.

Frog’s home turf?

But, maybe, Mr QUADE remembers things differently(?). Unfortunately, we did not learn more about this meeting from his perspective today. I understood from the pleadings that the defendant had pressed criminal charges against Mr QUADE, for some wrongdoing in connection with the present matter, and that he was therefore prevented from being deposed as a witness in the hearing today.  The FPC has apparently initiated proceedings for judicial assistance of the German authorities, to have Mr QUADE deposed in Germany. Defendant’s counsel requested the FPC to reconsider this procedural move: Even if Mr QUADE would confirm all that has been asserted by the plaintiff by now, it would still not be sufficient for the plaintiff to fulfill all three criteria as outlined above. Note that judicial assistance might easily take a further 4-30(!) months.

The further course of the proceedings is not yet cast in stone. If the FPC abstains from having Mr QUADE deposed, the judgment would be issued as a next step. If Mr QUADE is being deposed, the parties will again have an opportunity to comment on his testimony, be it in writing or yet another hearing.

Reported by Martin WILMING

Credit: Header image by Karsten Lamprecht from Pixabay

BIBLIOGRAPHY

Case No. O2019_001 | Hearing of 16 September 2020

Werner & Mertz
./.
Compad Consulting GmbH

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Frank SCHAGER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

ANNOUNCEMENT

PATENT APPLICATION IN SUIT

Clean version of the DREX, i.e. the version for which the EPO indicated its intention to grant a patent:

 

Application as filed, published as EP 2 592 134 A2:


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Cluster Failure During a Hearing about Cluster Failure

Reading time: 4 minutes

Case No. O2019_004 | Hearing of 30 June 2020

We first reported here that a blockchain infringement case might be pending at the FPC with some involvement of MLL. Shortly thereafter, on June 4, 2020, the official announcement followed and revealed that Sunshine Software Development GmbH had taken action against FRIENDZ SA for alleged infringement of the Swiss part of EP 1 151 591; see EPO Register and Swissreg for further information. Note that the patent has lapsed on 13 January 2020, after 20 years.

FRIENDZ SA describes itself as a start-up that aims to

[…] decentralize the digital advertising industry.

According to their website,

[…] brands can use Friendz Coins to access digital advertising.

These coins seem to be at the center of the present case.

As noted previously, little information is publically available about Sunshine Software Development.

EP 591 is directed to data access and management. From what could be gathered from the arguments made at the hearing, the subject matter of EP 591 seems to be relevant at least to Ethereum, and possibly other blockchain platforms. Much of the discussion related to infringement seemed to evolve around whether defendants shifted («verschieben») or replicated data, or what the difference between the two would be. Specifically, the two independent claims 1 and 30 of EP 591 comprise the following features:

the data storage means shift data redundantly stored in the system independent of an access of the computer unit as a function of the determined parameters of data transmissions between the data storage means.

redundantly stored data is shifted independently of an access of the computer unit (CL) to the data as a function of the determined parameters of data transmissions between the data storage means.

Apparently, the judge-rapporteur had concluded in his expert opinion that defendants did not shift data, and consequently did not infringe on claims 1 and 30.

We gathered from the pleadings that plaintiffs alleged a replication and subsequent deletion of data, which might realize a shift of data. Defendants appeared to argue that accidental deletion of redundantly saved data would not constitute a shift of data, and that replication was done for data safety reasons.

Speaking of accidental things related to IT,  the hearing was up to a rocky start when the monitors of the judges would not work. But a FPC hearing on blockchain was not going to be stopped by some measly IT issue – or was it? The IT gods stepped up their game and also let the microphones fail, and at a later point the projector. But even when every piece of IT had apparently failed at least once during the hearing, the President shrugged off the cluster failure — «[…] ein Clusterausfall!» —, determined to continue the hearing. Cluster failure is apparently not only a potential blockchain issue …

As usual, the parties were asked whether they would be interested in settlement talks under the court’s guidance. Both parties affirmed, though plaintiffs indicated that while the amount of compensation may be negotiable, the validity and infringement would not be.

As always, the public was not allowed to stay for the settlement talks, and it remains to be seen if a judgement will ever see the light of the day.

Reported by Philippe KNÜSEL and Martin WILMING

BIBLIOGRAPHY

Case No. O2019_004 | Hearing of 30 June 2020

Sunshine Software Development GmbH
./.
FRIENDZ SA

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dany VOGEL
    • Christoph MÜLLER

Judge-rapporteur:

    • Dany VOGEL

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Kilian SCHÄRLI (MLL)
    • Dr. Simon HOLZER (MLL)
    • Andreas ASCHERL (K. A. L & E), assisting in patent matters

Representative(s) of Defendant:

ANNOUNCEMENT

PATENT IN SUIT

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The dark side of the novum

Reading time: 6 minutes

Case No. O2018_004 | Hearing of 3 September 2020

Some background of the subject-matter at stake can be found on this Blog here. In brief, Synova asserts EP 1 833 636 B1 » against Avonisys, while Avonisys counter-claims for nullity and seeks a declaration of non-infringement. Further bibliographic information about EP 636 B1 » can be found in the European Register and Swissreg.

Sometimes, the Supreme Court clarifies things once and for all. Sometimes, it doesn’t. The very recent decision 4A_583/2019 of 19 August 2020 (published on 28 August 2020) very likely is an example of the latter.

It became clear at the main hearing that the publication of 4A_583/2019 derailed the proceedings to some extent. From the official announcement of the hearing, we already knew that the plaintiff / patentee had partially waived the patent in suit after receipt of the judge-rapporteur’s expert opinion, i.e. well after the closure of the file (request of 19 June 2020, published 14 August 2020); see the corresponding CH/EP 1 833 636 H1.

The independent claims as amended read as follows (available in German only):

Claim 1

Verfahren zur Erzeugung eines Flüssigkeitsstrahls (5), der zur Führung einer in ihn eingekoppelte[n] Laserstrahlung (10) in der Art eines Wellenleiters geeignet ist der als Strahlleiter für eine Laserstrahlung (10) dient, wobei eine in ihn eingekoppelte Laserstrahlung (10) in der Art eines Wellenleiters geführt ist zwecks Bearbeitung eines Werkstücks (3), wobei der Flüssigkeitsstrahl (5) mit einer Flüssigkeitsdüse (1) erzeugt wird und wobei derFlüssigkeitsstrahl (5) mantelseitig mit einem Gasstrom (35) umgeben wird, dadurch gekennzeichnet, dass zur Verlängerung des stabilen Bereichs der Strahllänge der Flüssigkeitsstrahl (5) durch eine, entfernt von der Flüssigkeitsdüse (1) angeordnete, den Gasstrom (35) formende Gasauslassdüse (23, 79) hindurchgeführt wird, wobei zwischen der Flüssigkeitsdüse und der Gasauslassdüse (23, 79) ein Zwischenraum mit einer trichterförmigen, nach unten zusammenlaufenden Wandung ausgebildet ist, wobei ein Gehäuse (7) mit einer umlaufenden Wandung (20, 24) als vertikal stehender Doppelkegel mit einander gegenüberliegenden Kegelspitzen ausgebildet ist, wobei in der einen oberen Kegelspitze die Flüssigkeitsdüse und in der gegenüberliegenden unteren Kegelspitze die Gasauslassdüse angeordnet ist, wobei das Beaufschlagungsgas in einen Hohlraum des Gehäuses derart eingebracht wird, dass der eingebrachte Gasstrom den Flüssigkeitsstrahl nicht direkt trifft, sondern dass der gesamte Hohlraum mit dem Beaufschlagungsgas füllbar ist und dass das Beaufschlagungsgas als den Flüssigkeitsstrahl umhüllender Gasstrom das Gehäuse verlässt.

Claim 6

Vorrichtung zur Erzeugung eines Flüssigkeitsstrahls (5), der zur Führung einer in ihn eingekopelten[n] Laserstrahlung (10= in der Art eines Wellenleiters geeignet istder als Strahlleiter für eine Laserstrahlung (10) dient, wobei eine in ihn eingekoppelte Laserstrahlung (10) in der Art eines Wellenleiters geführt ist zwecks Bearbeitung eines Werkstücks (3), mit einer Flüssigkeitsdüse (1) zum Erzeugen des Flüssigkeitsstrahls (5) und mit Mitteln zum mantelseitigen Umgeben des Flüssigkeitsstrahls (5) mit einem Gasstrom (35), dadurch gekennzeichnet, dass zur Verlängerung des stabilen Bereichs der Strahllänge die Mittel zum mantelseitigen Umgeben des Flüssigkeitsstrahls (5) mit einem Gasstrom (35) eine entfernt von der Flüssigkeitsdüse (1) angeordnete, den Gasstrom (35) formende Gasauslassdüse (23, 79) umfassen, durch welche der Flüssigkeitsstrahl (5) hindurchgeführt werden kann, wobei zwischen der Flüssigkeitsdüse und der Gasauslassdüse (23, 79) ein Zwischenraum mit einer trichterförmigen, nach unten zusammenlaufenden Wandung ausgebildet ist, wobei ein Gehäuse (7) mit einer umlaufenden, die Flüssigkeitsdüse aufnehmenden Wandung (20, 24) und mit wenigstens einem Gaseinlass (25a-d) für ein Beaufschlagungsgas vorgesehen ist, wobei der wenigstens eine Gaseinlass (25a-d) der Flüssigkeitsdüse (1) strömungsmässig nachgeordnet ist, und wobei das Gehäuse (7) als Doppelkegel ausgebildet ist, wobei in der einen Kegelspitze die Flüssigkeitsdüse (1) angeordnet ist, und die andere Kegelspitze die Gasauslassdüse (23) hat, wobei das Beaufschlagungsgas in eine m Hohlraum eines Gehäuses derart eingebracht wird, dass der eingebrachte Gasstrom den Flüssigkeitsstrahl nicht direkt trifft, sondern dass der gesamte Hohlraum mit dem Beaufschlagungsgas füllbar ist und dass das Beaufschlagungsgas als den Flüssigkeitsstrahl umhüllender Gasstrom das Gehäuse verlässt.

Thus, the complaint has to be dismissed as devoid of purpose, in view of 4A_583/2019, right?

Oh man, if it only was that easy …

The presiding judge had immediately informed the parties by e-mail of the Supreme Court’s judgment 4A_583/2019, and that the FPC tends towards a decision that the complaint is to be dismissed as devoid of purpose — provided that the defendant did not rely on the partial waiver as a novum.

It was bound to happen: This is exactly what the defendant did the very next day.

The dark side …

The main hearing dealt with only this procedural issue in first place. After deliberation, the presiding judge held that the plaintiff‘s submission of the partial waiver was impermissible, in view of 4A_583/2019. But this did not result in the case being devoid of purpose: The defendant‘s submission of the partial waiver was held to be admissible as a proper novum.

Now that the partial waiver is being considered in the proceedings, it will be highly interesting to see how this finally unfolds, i.e. what this means for the complaint (infringement) and the counterclaim (nullity; declaration of non-infringement).

We understood from the pleadings that the judge-rapporteur’s expert opinion was quite favorable for the defendant in that EP 636 B1 » was not infringed.

The parties did not settle; we are eagerly awaiting the judgment!

Reported by Tina VOCI and Martin WILMING

BIBLIOGRAPHY

Case No. O2018_004 | Hearing of 3 September 2020

Synova AG
./.
(1)
(2)
(3)
(4)
Avonisys AG
Stephan Mohren
Jens Gäbelein
Jeroen Hribar

Panel of Judges:

    • Dr. Andri HESS
    • Dr. Tobias BREMI
    • Lara DORIGO

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Michael RITSCHER (MLL)
    • Louisa GALBRAITH (MLL)
    • Werner ROSHARDT (K&P), assisting in patent matters
    • Stephan KESSLER (K&P), assisting in patent matters

Representative(s) of Defendants:

    • Dr. Ralph SCHLOSSER (KasserSchlosser)
    • Dr. Christoph ENGELBRECHT (Blum), assisting in patent matters
    • Dr. Regula RÜEDI (Blum), assisting in patent matters
    • Dr. Zacharias STELZER (Blum), assisting in patent matters

ANNOUNCEMENT

PATENT IN SUIT

As initially granted:

 

After the partial waiver:


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Compad Consulting and Werner & Mertz litigating over entitlement to a patent

Reading time: 2 minutes

As reported by Christopher GILB in the Luzerner Zeitung today, there is some litigation going on at the FPC about entitlement to a European patent pertaining to a washing agent that is free from palm oil.

Where’s the patent?

It appears that Werner & Mertz (well known e.g. for its brands Erdal® and Frosch®) has sued the Swiss start-up company Good Soaps for lack of entitlement to the patent, i.e. unlawful usurpation thereof.

The patent has not been identified in the news. I could not leave it at that and did my homework. The patent application at stake is EP 2 592 134 »; the currently registered applicant is Compad Consulting GmbH. See the European Patent Register for further information. The file wrapper is telling: The complaint of 9 January 2019, the reply of 20 September 2019 (including all appendices) as well as the comments on the rejoinder of 5 December 2019 are available online. The instruction hearing took place on 8 July 2019 — without a settlement being reached.

The main hearing is said to be scheduled for 16 September 2020. I trust this will get interesting …

UPDATE 19 August 2020:

The official announcement of the main hearing has just been published by the FPC. No surprises anymore, it’s indeed all about EP 2 592 134 ».

Reported by Martin WILMING

Header image courtesy of T. K. Naliaka, under CC BY-SA 4.0

BIBLIOGRAPHY

Case No. O2019_001

Werner & Mertz
./.
Compad Consulting GmbH

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Frank SCHAGER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant / Counterclaimant:

PATENT APPLICATION IN SUIT

Clean version of the DREX, i.e. the version for which the EPO indicated its intention to grant a patent:

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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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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

ANNOUNCEMENT

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Alstom and Bombardier litigating over the Twindexx train; hearing canceled

Reading time: 4 minutes

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

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

Cancellation notice on the website of the FPC

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

Alstom’s logo

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

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

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

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

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


Claim 1 of EP'070 reads as follows:

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

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

UPDATE 21 August 2019:

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

Reported by Martin WILMING

BIBLIOGRAPHY

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

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

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The heat is on between Laurastar and Innosteam

Case No. O2018_016 | Hearing of 25 June 2019

Reading time: 7 minutes
Laurastar logo

Laurastar and Innosteam are litigating about ownership of two PCT applications, WO 2018/006994 A1 and WO 2018/036653 A1; see the EPO Register here and here. The patent applications are about devices and methods for producing instant steam (WO’994) and instant hot water (WO’653), for use e.g. in devices for ironing.

Innosteam logo

Briefly, plaintiff alleges that the subject matter of both PCT applications had been invented by the inventors in fulfillment of their contractual duties while they were employees of Laurastar.

We have reported on this Blog here about the provisional register ban that had been issued without hearing the defendant beforehand, and the subsequent hearing. The register ban had finally been maintained in summary proceedings S2018_003; see this Blog here.

Note that both PCT applications have meanwhile been nationalized inter alia at the EPO, but the EPO has stayed its proceedings on request of Laurastar SA pursuant to R. 14(1) EPC while main proceedings at the FPC are pending; see here (re WO’693) and here (re WO’994). It is still (too) early to obtain full and complete information about the status of nationalization elsewhere in the world, but WIPO’s PatentScope indicates further nationalizations in the Ukraine and the Russian Federation; see here (re WO’653) and here (re WO’994). Anyway, we could now catch a glimpse of what is going on in main proceedings O2018_016 at the hearing on June 25, 2019 in Neuchâtel. The hearing was held in French language — well, at least the most of it.

Plaintiff’s pleadings emphasized that the invention was conceived before the inventors left Laurastar SA to work for Innosteam Swiss SA. A significant part of the argument evolved around a document created by Mr. Pasche that allegedly shows all the features of the patent applications in question (hereinafter refered to as ‘Pasche’):

The document created by M. Pasche while employed by the plaintiff

But even if there were any potential differences between Pasche and the two patent applications, they were only of minor importance and could not render the claimed subject-matter inventive. And, in the plaintiff’s view, this has to be taken into account; else, one could just steal an invention, add an insignificant feature to it and be unassailable.

Plaintiff further questioned to what extent a detailed claim analysis, as apparently done by the judge rapporteur, was appropriate. In the plaintiff’s view, the claims are still subject to change and do not necessarily represent the invention as a whole. For this reason, according to the plaintiff, the judge rapporteur should have analyzed the description as well. In addition, plaintiff argued that the inventiveness of the subject matter over Pasche should have been analyzed as well.

Defendant, by contrast, argued that the subject-matter outlined in Pasche was free state of the art, in any event. Thus, even if it showed all the features of the patent applications in question, just for the sake of argument, it could not be proprietary to Laurastar SA or anybody else. This led to some discussion about the term ‘invention’: Does it imply non-obviousness over the prior art, i.e. an inventive step? It has been argued that under the Swiss Code of Obligations (Art. 332), an invention does not require an inventive step (emphasis added):

Inventions and designs produced by the employee alone or in collaboration with others in the course of his work for the employer and in performance of his contractual obligations belong to the employer, whether or not they may be protected.

A decision on these issues might be an interesting read — if the parties haven’t settled.

On the procedural side, the hearing was quite illustrative of Switzerland:

Defendant’s representative started his pleadings with reference to the federalism in Switzerland and explained that he was going to structure his pleadings according to what is customary in Geneva. This may have contributed to some confusion that arose after a (brief) first part of defendant’s pleadings. Defendant’s representative sat back down, and the President asked if he was done, which the representative affirmed. The president then firmly told the parties that the time to make arguments was now:

Le temps de répondre, c’est maintenant!

This prompted defendant’s councel to get back up again and finish his pleadings. The assisting patent attorney then added his share to the pleadings — in German language. This was apparently not appreciated by everybody in the room, and the opposing patent attorney could not help himself but leave a snarky remark about this in his own pleadings later.

I wonder whether I should better immediately refresh my French and learn some Italian, just to be prepared for some spontaneous pleadings in a language that hasn’t been announced beforehand(?).  (Just kidding) /MW
Where do we go now?

At the end of the hearing, the President asked whether the parties were interested in settlement talks. Both parties gave answers along the same lines, saying that in principle they would of course be interested in a settlement. However, neither party found it realistic to find a mutually agreeable compromise since a joint assignment of the patent applications was not desirable to either party. Thus, according to both parties, settlement negotiations were pointless.

OMG

The President buried the face in his hands and, after a sigh, explained to the parties in German (‘Erlauben Sie mir, das auf Deutsch zu sagen’) that it was conceivable that a judgment could give exactly that result: Joint ownership. Such a forced marriage may not facilitate things for either party and the President gently reminded both parties that a settlement may well be the better course of action.

A three-legged race is a tricky exercise. It may work, but one may also stumble miserably.

The parties asked for a short break to discuss the President’s comment, after which it was discussed non-publicly whether the parties may be willing to settle after all.

Reported by Philippe KNÜSEL and Martin WILMING

BIBLIOGRAPHY

Case No. O2018_016 | Hearing of 25 June 2019

Laurastar SA
./.
Innosteam Swiss SA

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Ralph SCHLOSSER
  • Dr. Giovanni GERVASIO

Judge-rapporteur:

  • Dr. Giovanni GERVASIO

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

  • Dominique GUEX (Bourgeois)
  • André ROLAND (Roland), assisting in patent matters

Representative(s) of Defendant:

ANNOUNCEMENT

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WO 2018/006994 A1

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WO 2018/036653 A1

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Lilly’s patent on combination of pemetrexed and vitamin B12 challenged

Case No. O2018_003 ¦ Hearing of 17 June 2019

Reading time: 6 minutes

The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further information. The independent claims of EP’508 read as follows (emphasis added):

1.   Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.

12.   A product containing pemetrexed disodium, vitamin B12 or a pharmaceutical derivative thereof said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.

It’s all about a combination of the antifolate pemetrexed disodium, vitamin B12 and, optionally, folic acid. Briefly, pemetrexed is an antifolate that inter alia inhibits synthesis of thymidine and thus de novo DNA synthesis. Evidently, antifolates are quite toxic. But according to EP’508, toxicity can be successfully controlled by co-administration of pemetrexed with vitamin B12 and, optionally, folic acid.

Pemetrexed disodium
Pemetrexed disodium

EP’508 had already been litigated in infringement proceedings in Switzerland, resulting in a landmark decision of the Supreme Court on the Doctrine of Equivalents and how amendments of the patent during prosecution are to be dealt with in this respect; see this Blog here.

This time, validity of EP’508 is being challenged, based on a lack of novelty or, at least, lack of an inventive step; and added matter. Only inventive step has been pleaded in the hearing. With respect to the other grounds of nullity, the Sandoz merely referred to the written submissions.

It was evident from the pleadings that the opinion of the judge-rapporteur had been in favour of the defendant. This interim opinion is in line with the decision of an EPO opposition division, the Rechtbank Den Haag (Case No. C/09/533354 / HA ZA 17-581; judgment available as Dutch original and inofficial English translation), the IP High Court of Japan and the U.S. CAFC. On the other hand, the German Federal Patent Court had revoked the German part of EP’508; an appeal before the Supreme Court is still pending.

Sandoz’s logo

Sandoz started from Jackman as closest prior art in the assessment of inventive step. With reference to Worzalla et al., Jackman describes experiments in which pemetrexed was administered alongside with folic acid. Further, phase I clinical trials had been reported in which pemetrexed was administered together with folic acid (Hammond et al.). In consideration of the biochemical pathways, Sandoz argued that it had been obvious to add vitamin B12 to said known combination.

Lilly’s logo

Eli Lilly of course disagreed. In Lilly’s view, the skilled person would not have pursued a combination of pemetrexed and folic acid, let alone to add vitamin B12. In real life, phase II clinical trials began with pemetrexed alone, irrespective of the experiments of Hammond et al. Toxicity of pemetrexed had intially been deemed controllable. It was only in the course of phase II clinical trials that the therapy scheme was switched because toxicity was found to be too severe.

A significant point of discussion was whether a skilled person would have been motivated to add vitamin B12 in light of some marker experiments. Niyikiza, the main inventor of the patent in suit, had published a report that described a correlation of pemetrexed toxicity with an unspecific marker (homocysteine), but not with the vitamin B12-specific marker MMA (methlymalonic acid). Accordingly, in Lilly’s view, a skilled person would not have been prompted towards the invention.

Reported by Andreas WELCH and Martin WILMING

BIBLIOGRAPHY

Case No. O2018_003 ¦ Hearing of 17 June 2019

Sandoz Pharmaceuticals AG
./.
Eli Lilly and Company

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

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What’s the point about pointer?

Reading time: 4 minutes

Case No. O2016_017 | Hearing of 3 June 2019

The patent at stake is MundiPharma‘s EP 2 425 825 B9; see EPO Register and Swissreg. Besides Acino Pharma AG, the plaintiff in the present proceedings, Develco is also fighting this patent in parallel proceedings; see this Blog here.

EP’825 pertains to a combination of oxycodone hydrochloride (in an amount of 10 to 150g) and naloxone hydrochloride (in an amount of 1 to 50g), in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma. Oxycodone is an opioid that has pain-relieving effects. Naloxone opposes the effects of opioids but is poorly absorbed when given orally; it stays within the gastrointestinal tract and reduces the local side effects of oxycodone.

Acino’s logo

Acino seeks annulment of EP(CH)’825 for various reasons, i.e. undue extension of subject-matter, non-enablement and invalidity of the priority claim. On the merits, Acino argues that EP’825 is not novel over WO 01/58451 A1, and that it is obvious in view of WO 01/58447 A1 (if the claim to priority is invalid) or in view of WO 02/092060 A1. Further documents referred to by the plaintiff in the assessment of obviousness are US 3,966,940, US 3,773,955 (erroneously referred to as US 3,773,995 in the announcement) and a paper of Skarin (most likely this one).

MundiPharma’s logo

Defendant / patentee MundiPharma countersued for infringement.

It was evident from the pleadings that the expert opinion of the judge-rapporteur had held that the patent was invalid for undue extension of subject-matter. Note that the first instance decision at the EPO (11 December 2018) came to the same conclusion, but an appeal is still pending at the EPO.

The hearing has again been thematically structured, similar to O2016_016. I could only attend until noon, and not even the most controversial issue of undue extension of subject-matter had been finished. Still, I believe that the major issues had already been raised at that time. Patentee had submitted that if the ‘pointer concept‘ in the assessment of whether or not sth is clearly and unambiguously disclosed in the application as filed would be properly used, no undue extension of subject-matter had occured. The ‘two lists concept‘ must not be used as an end in itself, but it is rather only the so-called gold standard that applies (clear and unambiguous disclosure in the application as filed, in the skilled persons understanding).

It will be very interesting to see how this will play out. Stay tuned.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_017 | Hearing of 3 June 2019

Acino Pharma AG
./.
MundiPharma Medical Company

Panel of Judges:

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

Judge-rapporteur:

  • n/a

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Acino:

Representative(s) of Mundipharma:

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

ANNOUNCEMENT

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Hip Hip Hooray: Stemcup and Implantec litigating about the ANA.NOVA hybrid socket

Reading time: 8 minutes

Case No. O2016_012 | Hearing of 29 May 2019

The patent in suit is EP 1 411 869 B1; see Swissreg and EPO Register for further information. Stemcup alleges that Implantec‘s ANA.NOVA® hybrid socket infringes the patent (either literally or under the DoE):

Implantec’s ANA.NOVA® hybrid socket website

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.

The relevant claim 2 of EP’869 as initially granted reads as follows:

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 gradient of 85° to 60° with respect to the base surface (GP), which corresponds to an angle of twist of 5° to 30°.

ANA.NOVA® hybrid socket

To get a better idea of what is meant by ‘knock-in web (21)’ (or ‘Einschlagsteg’ in German), please see the winglets on the outer shell of the allegedly infringing product on the right.

According to the patent, the locking elements can twist the cup by a few degrees when the implant is driven in. In the plaintiff’s view, this is decisive for the patent in suit. Defendants contest the infringement and argue for invalidity as a plea in defense.

This case surfaced for the first time back in March 2017; see this Blog here. But one got no idea of the subject-matter at stake since that order only related to a procedural issue. The main hearing had been announced for 3 October 2018 for the first time, but it was cancelled. The silence was deafening since then. Finally, the main hearing took place on 29 May 2019, as announced.

The hearing

It is rare that a presiding judge at the FPC opens the main hearing with a remark that the case is somewhat special. But this case is indeed a bit out of the ordinary. In my understanding of the pleadings, the expert opinion of the judge-rapporteur had been quite positive for the plaintiff re infringement and validity — except for an undue extension of subject-matter in claim 2 as asserted.

Closed docket

Now, what to do after the formal closure of the file?

The plaintiff partially renounced EP’869 at the IPI, to overcome the objection. The partial renouncement has been published on 15 August 2018.

Claim 2 after the partial renouncement reads as follows (inofficially translated; changes marked-up):

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°.

A first version of this post erroneously mentioned that only ‘at least’ had been deleted. This has been corrected in the above.

What had been uncomplicated on the merits at the IPI caused a lot of trouble in the pending proceedings at the FPC: The panel of judges had been enlarged to five judges, with the clear intention to render a decision on all aspects of the case. Consequently, the judge-rapporteur gave a second, updated expert opinion which, in my understanding, was again very positive for the plaintiff’s position re infringement and validity, but did not expand any further on the tricky issue of admissibility of the partial renouncement.

Noteworthy, the plaintiff’s statement of claim had not been changed. It was not in dispute between the parties that it was not a question of an amendment to the statement of claim; Art. 227 CPC. It’s all about whether or not the partial renouncement of the patent at this stage of the proceedings was admissible as a proper novum or improper novum, according to Art. 229 CPC.

The plaintiff holds that the partial renouncement is a proper novum that has been timely introduced into the proceedings, i.e. immediately upon registration with the IPI.

On the other hand, defendants essentially argue that a new fact created by the plaintiff’s own volition and at a time / to an extent of his own choice cannot be considered a proper novum, and that the plaintiff acted much too late in any event: The request for partial renouncement had been filed only about nine months after the defendants had raised the issue of an undue extension of subject-matter with their rejoinder. Defendants requested that the case be dismissed as groundless since the patent in suit does not exist anymore in the form as it once had been asserted.

Some further procedural issues arose with respect to admissibility of certain elements of defendants’ comments on the second expert opinion of the judge-rapporteur. Plaintiff requested in the hearing that it should be decided on this issue beforehand, for him to be in a position to comment the remainder, if any. This request was denied.

Further, defendants had prepared a slide deck to illustrate certain aspects of their pleading concerning the alleged infringement (presumably some tricky geometric concepts of how to properly measure a gradient, according to the patent in suit), and printouts of this slide deck had been handed over to the plaintiff and the judges before a break. Finally, however, the slide deck had not been used at all: The presiding judge returned the handouts to defendants’ counsel after the break and noted that the court will not expose itself to the accusation that it accepted novae into the file. Still, I well understood from the pleadings that defendants argue for non-infringement because the gradient in the attacked embodiment is outside of the claimed range. It’s a borderline case, apparently: Plaintiffs allege that the gradient is 84.7° (i.e. within the claimed range), while defendants allege that the gradient is 85.6° (i.e. outside the claimed range).

Unfortunately, I had to leave at about 2:15 pm and thus don’t know whether the parties finally had settlement talks. But, frankly, I would be surprised if the parties have settled.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_012 | Hearing of 29 May 2019

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

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Stemcup :

Representative(s) of Implantec:

  • Dr. Michael RITSCHER (MLL)
  • Noelle STALDER (MLL)
  • Dr. Martin MÜLLNER (Müllner Katschinka), assisting in patent matters
  • Werner Roshardt (Keller), assisting in patent matters
  • Dr. Susanne FINKLENBURG (Keller), assisting in patent matters

ANNOUNCEMENTS

Main hearing of 29 May 2019:

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Main hearing of 3 October 2018 (cancelled):

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The FPC’s cancellation note:



PATENT IN SUIT

EP 1 411 869 B1 (as initially granted):

Fullscreen view (new tab)

CH/EP 1 411 869 H1 (after partial renouncement):

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NOTES FROM THE HEARING

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