Schöck and Basys twisting things

Reading time: 5 minutes

Case No. O2020_017 | Hearing of 11 May 2022

DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of the Plaintiff.
Schöck’s logo

Schöck asserts infringement of EP 2 455 556 B1 (cf. EPO Register and Swissreg) and EP 2 455 557 B1 (cf. EPO Register and Swissreg). The attacked embodiments of Basys are the so-called ‘Normalkraftanschlüsse’ of types Basycon N, UZ and Seismolock.

Basycon ‘Normalkraftanschluss’ of type N (illustration taken from the FPC‘s tweet)

According to the announcement of the hearing, Basys argues that the patents were insufficiently disclosed and not novel or obvious in view of no less than 14 documents in total (of which the following are mentioned in the announcement: EP 1 072 729 A1, EP 1 881 119 A2, DE 87 00 301 U1, DE 197 05 698 A1, CH 678 076 A5, DE 200 08 570 U1, CH 690 966 A5, DE 30 05 571 C2, a Basycon Flyer of Jan 2005 and a Basycon catalogue of 2008). Further, the patents were not infringed when construed correctly.

At the beginning of the hearing, Basys presented a sample of an attacked embodiment; Art. 168 para. 1 lit. c CPC. The various features of the sample were briefly discussed, and even some manual tests were made on the sample, by both parties. The President closed this part of the hearing with a smirk:

Oder möchten Sie sonst noch etwas verbiegen?

In the first round of pleadings, Schöck asserted various violations of the principle of party disposition in the judge-rapporteur‘s expert opinion. Further, Basys’ comments on the expert opinion contained inadmissible novae that must not be relied on. On the merits, Schöck focused on admissibility of amendments in general, and intermediate generalisations in particular. The judge-rapporteur had apparently held that the omission of the rectangular shape of a plate in an auxiliary request amounts to an intermediate generalisation. But what does «rechteckig hochkant orientiert» in [0045] and [0047] of EP 556 actually mean: a rectangular shape or a rectangular orientation of the plate? With reference to T 1471/10 (r. 3.3.2 et seq.), Schöck held that the feature could well be omitted because there was no indication whatsoever in EP 556 of the relevance of the form of the plate; and the orientation of the plate is already contained in the claim language to the extent necessary.

With respect to novelty and non-obviousness, Schöck addressed a photography on page 1 (similar to this one) and a schematic illustration on page 3 of the Basycon Flyer 2005; and EP 792 (not mentioned in the announcement).

Basys‘ logo

After a 15 min break, Basys’ pleadings began at 11:20 hrs. Basys rebutted selected arguments of Schöck’s latest submissions. Some arguments referred to the skilled person; on the funny side, Basys held that the skilled person cannot be willing and able to understand unclear features of EP 556 on the one hand, and be dull-witted in the assessment of the prior art on the other hand.

An interesting discussion circled around whether (or not) a specific attack (with a certain combination of prior art) of a sub-eventualiter inter partes limitation of a patent can be considered by the court ex officio for higher-ranking requests.

After a lunch break from 12:30 hrs to 13:30 hrs, Schöck and Basys made their respective second submissions, until 14:20 hrs. It appears that the actual expenses for patent attorneys were almost identical on both sides; but the parties disagreed on the responsibility for the costs.

No settlement discussions took place.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2020_017 | Hearing of 11 May 2022

Schöck Bauteile GmbH
./.
Basys AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Markus MÜLLER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

ANNOUNCEMENT

PATENTS IN SUIT

EP 2 455 556 B1:

EP 2 455 557 B1:

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Bayer’s uphill fight re sorafenib tosylate

Reading time: 6 minutes

Case No. S2021_006 | Hearing of 4 April 2022

Zentiva logo

Bayer HealthCare is seeking preliminary injunctive relief against Sorafenib Zentiva of Helvepharm, the Swiss branch of Zentiva. Bayer’s product is Nexavar® (see Compendium and Bayer’s Nexavar website for more information); the active ingredient (AI) is sorafenib, a kinase inhibitor inter alia for the treatment of primary kidney and liver cancer.

Sorafenib
Bayer logo

The basic patent on sorafenib is EP 1 140 840 B1 which lapsed on 11 January 2020. An SPC had been in force until 28 March 2021; C01140840/01. The present litigation is about alleged infringement (and validity) of EP 2 305 255 B1 (see EPO Register), specifically claiming the tosylate salt of sorafenib. EP 255 will only lapse on 3 December 2022.

As patent protection is fading out, Bayer’s turnover generated with Nexavar® fell sharply in 2021:

Nexavar® package

Patent practitioners might recall Nexavar® and/or sorafenib tosylate for the first compulsory license that had been issued in India already back in 2012, which has been confirmed through all instances.

Lately, EP 255 was held to be invalid both in Germany (Federal Patent Court, judgment of 29 September 2021 in cases 3 Ni 12/20 and 3 Ni 13/21) and the U.K. (judgment of 8 October 2021 in case [2021] EWHC 2690 (Pat); the Court of Appeal decided on 1 April 2022 to hear the appeal).

Helvepharm logo

From the announcement of the hearing, it had been known that Helvepharm asserts invalidity of EP 255 in view of unallowable amendments, lack of novelty over WO 00/42012 A1 and obviousness in view of Lyons et al. (the acronym BAY 43-9006 refers to sorafenib as such, i.e. the free base; not sorafenib tosylate).

In the hearing, it became clear that the judge-rapporteur‘s expert opinion held that the claimed subject-matter was obvious, in line with the judgments in Germany and the U.K.

Plaintiff urged the court to independently assess the matter, in particular in view of the many expert declarations on file in the present proceedings which the foreign courts had not at hand. Plaintiff emphasized that the skilled person had not been in a position at the priority date to reliably determine the dissolution rate of sorafenib tosylate; the experimental setup previously known in the art had not been suitable. Further, a tosylate had not been a promising candidate for a weak base such sorafenib in any event.

However, the inventors had a moment of genius:

Die Erfinder hatten einen genialen Moment.

With its concluding remarks of the first pleadings, Bayer essentially held that if ever a salt form of a pharmaceutical compound was patentable, then sorafenib tosylate is it.

Expenses for the assistance of a patent attorney were orally indicated (and detailled to some extent) as kCHF 52, but no evidence was handed over.

After a break, the President gave the floor to Zentiva‘s counsel, indicating that the judges had a lively discussion during the break, and that they are now eagerly awaiting Zentiva‘s pleadings:

Die Diskussionen im Spruchkörper in der Pause waren heftig! Wir sind gespannt auf Ihre Ausführungen.

Defendant focused its pleadings on non-obviousness only.

In defendant‘s view, Lyons does not teach that the free base has been used in the clinical trials. Lyons is just silent about this (in my understanding, contrary to what had been held in the judge-rapporteur‘s expert opinion). In any event, the first step would be a salt screening in order to assess the bioavailability of sorafenib — and tosylate would have been included in such a salt screening, essentially as outlined in Bastin. A salt screening involves not only the assessment of solubility, but also the dissolution rate. The skilled person would not have disregarded the tosylate in view of its low solubility. Further, defendant argued that it had well been possible for the skilled person to determine the dissolution rate, actually with reference to an experimental setup that had been known in the art and which is similar to the one used by plaintiff.

Defendant handed over a cost note for assistance of the patent attorney. Further, defendant objected to plaintiff‘s asserted costs of kCHF 52 as somewhat high for summary proceedings („etwas hoch“), and not evidenced anyway.

An entertaining aspect of the second round of pleadings circled around the (lack of) plaintiff‘s cost note for patent attorney expenses. Plaintiff was seemingly taken by surprise that the expenses were not accepted by defendant, and asked for a break to come up with written evidence of the expenses in the amount as indicated earlier. The judges were noticeably perplexed (instructions for the hearing typically remind the parties that cost notes shall be provided in the first round of pleadings). Still, the President interrupted the proceedings for ten minutes, for the plaintiff to gather the written evidence of expenses, and defendant to prepare the rebuttal to plaintiff‘s pleadings. Worse comes to worst: Plaintiff apparently had a letter in its electronic dockets that set forth the costs incurred, but could not provide any printout. Defendant did not consent to an on-the-spot visual inspection of the electronic file.

The parties did not engage in settlement discussions.

/MW

BIBLIOGRAPHY

Case No. S2021_006 | Hearing of 4 April 2022

Bayer HealthCare LLC
./.
Helvepharm AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Andreas SCHÖLLHORN

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

    • Dr. Simon HOLZER (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant:

ANNOUNCEMENT

PATENT IN SUIT

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The (serious) soap opera, cont’d

Reading time: 5 minutes

Case No. O2019_001 | Hearing of 24 January 2022

The background of this case has already been extensively discussed on this Blog here and here. The hearing earlier today was a continuation of the main hearing of 16 September 2020, with the parties’ closing submissions according to Art.  232 CPC focussing on the witness testimony of Mr. QUADE that had been obtained via judicial assistance of the local court of Alzey, Germany (worth a visit, apparently).

Werner & Mertz

Mr. QUADE was personally present at the FAC today, but did not attend the first round of pleadings because plaintiff offered that the court might address him directly for follow-up questions or clarifications. The President asked defendant‘s representative whether he would agree — which he did not. The President indicated that a formal comment on this will be given by the court only after deliberation (before the lunch break, the President announced that there is no room for interviewing Mr QUADE anymore).

In a nutshell, plaintiff stressed that Mr QUADE‘s testimony was backed-up by contemporary written documents, and that Ms Regine SCHNEIDER‘s testimony was clearly less credible.

Good Soaps

After a short break of about 20 minutes, defendant reminded that the burden of proof is on the plaintiff to establish that i) the invention had been made by its employee(s), i.e. when, where and how; ii) it had been communicated to the allegedly unlawful applicant; and iii) how that corresponds with the claims of the patent application in suit; see e.g. O2015_009. Defendant highlighted that Dr ENDLEIN of Werner & Mertz only recently received the Meyer-Galow award for the development of cleaning products on the basis of European plant-based surfactants. However, Dr Edgar ENDLEIN only joined the plaintiff in 2010 and the respective R&D project ‘Einsatz europäischer Tenside’ had only been started at Werner & Mertz in 2012, i.e. years too late. No mentioning of Mr QUADE in this project whatsoever.

Next, defendant exemplified how Mr QUADE gave testimony on critical issues only in an evasive manner, apparently in knowledge of the file and likely with the desired result in mind. Further, I understood from the pleadings that Mr QUADE had testified that it had been perhaps a little too early in 2009 for an internal invention disclosure notice («wohl auch noch ein bisschen früh»).

At one point, the President intervened and enquired how defendant would explain the content of a letter of Mr QUADE to Kolb, indicating that he sent an Ecover sample to Kolb. Notably, defendant’s representative hesitently expressed in plain language that defendant has serious doubts as to the authenticity of this letter. Defendant had no positive knowledge of this letter since Ms SCHNEIDER had already left Kolb at that time.

As to the question of whether or not Ms SCHNEIDER had already been aware of rapeseed MEE before the meeting with Mr QUADE, Kolb (as a third party) on defendant’s request provided an internal memorandum that predates the meeting of 27 August 2009, indicating that Ms SCHNEIDER had been well aware of the fact that Ecover contained MEE with a chain length of seven:

Ecover, which is based in Belgium, incorporates rapeseed MEE (7-mole) in its laundry wash.

Had the chain length been a topic at the meeting of 27 August 2009? Parties heavily dissent on this aspect. Defendant notes that it is simply implausible that a chain length of seven had been discussed in that meeting, let alone that such a sample had been requested by Mr QUADE, given that subsequently only a sample with a chain length of ten had been provided by Kolb, without any further ado.

Defendant finally emphasized that it has not even been pleaded that on 27 August 2009 Mr QUADE had already made the invention. I understood from the pleadings that the judge-rapporteur’s expert opinion held that the missing pieces actually did still require a certain creative effort, i.e. the invention had not been made at the time, let alone communicated to the defendant.

Finally, defendant requested that the tariff for legal representation be exceeded by 50%, in view of the additional witness testimony via judicial assistance in Germany that had to be attended (2d), and two main hearings — which is not just a standard case anymore.

The second round of pleadings after the lunch break was pretty uneventful. Plaintiff‘s representative rebutted the request to exceed the tariff. On the contrary, judicial assistance had only been necessary because defendant had initated criminal investigations against Mr QUADE which prevented him from coming to Switzerland. In reply, defendant insisted that at least an initial suspicion was well founded.

The President indicated that a judgment can be expected within the next 6-8 weeks (more than three years after the complaint has been filed).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2019_001 | Hearing of 24 January 2022

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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Hearing in G1/19 re computer-implemented simulation

The hearing in case G1/19 took place today.

The decision of the EPO’s Enlarged Board of Appeal will undoubtedly be of outstanding relevance for a whole (service) industry with respect to access to adequate patent protection at the EPO.

Here are my notes from the hearing (please be patient, it may take a few seconds to load):

Anything but a quick fix: Coram beavering away at knocking out a patent

Reading time: 7 minutes

Case No. S2018_007 | Hearing of 15 April 2019

C&E Fein’s logo

The patent at stake is EP 3 027 362 B1 which is jointly owned by C&E Fein GmbH and Robert Bosch GmbH; see the EPO Register and Swissreg for further information. The invention is about a tool which is intended to be used with a machine tool, in particular a hand guided machine tool. The machine tool has a rotational drive, e.g. an oscillating drive. Examples include a drill, a grinding disc, a cutting disc or a circular saw. If you are interested in such detailed information, you will easily get the gist of the invention from e.g. Fig. 11 of EP’362 (see header picture) when reading the main claim of the patent.


Claim 1 of EP'362

A tool device (1, 1b) which is suitable for use with a machine tool (22), and in particular suitable for use with a hand guided machine tool, which has a driving device moving around a driving axis, and in particular oscillating around the driving axis,

and which has an attachment device (12) by means of which it can be fastened to a machine tool (22) in such a manner that the driving axis and a tool axis of rotation (5) are substantially coincident,

wherein, for receiving a driving force, the attachment device (12) comprises at least two driving area regions (2, 2a, 2b) each having a plurality of surface points (3) and which are spaced from this tool axis of rotation (5),

characterized in that tangent planes (4) at these surface points (3) are inclined relative to an axial plane (7), which includes the tool axis of rotation (5),

wherein the tangent planes (4) are inclined relative to a radial plane (6), which extends perpendicular to the tool axis of rotation (5),

wherein the attachment device (12) comprises a side wall,

wherein the side wall extends spaced radially from the tool axis of rotation (5),

wherein the side wall extends between a first, upper boundary plane (8a) and a second, lower boundary plane (8b), and

wherein the side wall comprises the driving area regions (2, 2a, 2b),

wherein a substantially hollow conical section is formed in the region of the attachment device by means of the side wall, which section has a cross section with a variable spacing of the side wall to the tool axis of rotation in a plane orthogonal to the tool axis of rotation.



The invention aims at providing a tool device in such a manner that the torque which is effectuated by the driving device of the machine is reliably transferred to the tool device. This is achieved by an attachment device (12) which comprises side walls that comprise driving area regions (2). Those driving areas (2) are spaced apart from the tool axis and inclined with respect to the axial plane. It is the function of the driving areas to receive a driving force.

Bosch’s logo

The plaintiffs asserted that EP’362 is infringed by defendant’s saw blades ‘B-Cut’ with ‘Quick Fixture’, and requested interim injunctive relief. Indeed, at least at first sight there are quite some similarities between Coram’s saw blades with ‘Quick Fixture’ (header image, right hand side) and the figures of the allegedly infringed patent (header image, left hand side). But the question of whether or not the allegedly infringing devices actually read on the claim was not an issue in the hearing. Likewise, it was only a sideshow in the hearing whether the matter was urgent, and whether the alleged violation threatened to cause not easily reparable harm to the plaintiffs (Art. 261(1) lit. b CPC).

An allegedly infringing saw blade with ‘Quick Fixture’
Coram’s logo

However, the defendant argued for nullity as a plea in defense, i.e. asserted a lack of novelty over EP 0 596 831 A1 and DE 2 120 669. The defendant construed EP’362 broadly and, thus, found the claimed subject-matter more readily anticipated in the prior art than the plaintiffs — and apparently also more readily than the judge-rapporteur. Specifically, the defendant argued that a ‘side-wall’ not necessarily implies a 3D-structure but is anticipated already by a 2D-surface (as disclosed in Fig. 4 of EP'831). With regard to DE'669, the defendant argued that a feature having a certain function (‘driving area […] for receiving a driving force’) is anticipated by a feature which might not exclusively have that function but nevertheless supports it (‘carrier with an projecting attachment’ as shown in Figs. 5 and 6 of DE'669).

In order to support views on correct claims construction from a Swiss perspective, O2013_008 (‘Sprühpistole’) was cited repeatedly by the parties. Unless the case was settled by agreement after the public part of the hearing, we might gain more insight on this issue soon.

The defendant further argued that the request for interim injunctive relief was overly broad and covered embodiments of the prior art.

Both representatives requested reimbursement of the necessary expenses for the assisting patent attorney in the same amount as are costs for legal representation according to the tariff (~kCHF 25 each).

On the procedural side, it was good to see that the projector / screen infrastructure was used again by at least one party and the court (connection of Windows® devices apparently is unproblematic). Further 8562532553 who call , plaintiffs’ counsel inquired whether the court wishes to be provided with pleading notes or not (see this Blog here for my very personal view, and the results of a little survey). Obviously, some judges appreciate written pleading notes; and some judges don’t. From a personal note of the president, however, it could be inferred that he liked pleadings in free speech. So, now we know!

Reported by Jolanda MINDER and Martin WILMING

BIBLIOGRAPHY

Case No. S2018_007 | Hearing of 15 April 2019

C&E Fein GmbH
Robert Bosch GmbH
./.
Coram Tools GmbH

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Markus MÜLLER-KÄGI
  • Dr. Stefan KOHLER

Judge-rapporteur:

  • Dr. Markus MÜLLER-KÄGI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

ANNOUNCEMENT

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ViiV seeking injunctive relief against Sandoz’s generic Kivexa®

Reading time: 9 minutes

Case No. S2018_004 | Hearing of 10 September 2018

ViiV logo

Infringement of ViiV‘s SPC based on EP 0 817 637 B1 is at stake. See EPO Register and Swissreg for bibliographic details of the patent; and Swissreg for further bibliographic details of the SPC C00817637/01.

Claim 1 of EP’637 is straight forward — at least when the IUPAC names of the compouds are replaced with the respective INNs:

A combination comprising [abacavir; ABC] or a physiologically functional derivative thereof and [lamivudine; 3TC] or a physiologically functional derivative thereof.

For the chemists out there, these are the molecules:

Both these compounds are nucleoside reverse-transcriptase inhibitors (NRTIs). Both compounds alone and the fixed-dose combination thereof are included in the WHO Model List of Essential Medicines.

ViiV’s Kivexa®

ViiV‘s own product is Kivexa® (aka Epzicom® in the U.S.); see compendium.ch.

The European public assessment report (EPAR) of the European Medicines Agency (EMA) provides a wealth of further information about this antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

Sandoz‘s generic version ‘Abacavir Lamivudine Sandoz®’ had obtained market approval on December 15, 2017, and it has been listed since April 1, 2018; see compendium.ch.

Sandoz logo

Sandoz contests infringement of the SPC solely on the ground that EP’637 and the SPC are null and void. A lack of novelty and inventive step is alleged, and that the priority claim was not valid. Sandoz had refused to undertake not to put the product on the market before the expiry of the SPC (October 30, 2020); Sandoz rather informed ViiV that it would start marketing in calendar week 21 — and has consequently been sued by ViiV.

I have attended the hearing yesterday; see the official announcement and some live notes below.

The following issues have been discussed:

  1. Is EP’637 entitled to the priorities claimed?

The parties dissent about whether or not EP’637 is actually entitled to the priorities claimed; see a compilation of the two priority documents here. Respondent argued that the whole disclosure of the priority documents is about a combination of three active substances, compared to a combination of only ABC and 3TC finally claimed in the patent in suit; plaintiff disagreed.

If priority was not validly claimed, D1 (WO 96/06844) would be pre-published prior art, i.e. relevant for both novelty and inventive step assessment.

  1. Has D1 (WO 96/06844) to be considered in the assessment of novelty?

From the pleadings, I conclude that in the exchange of briefs the plaintiff himself had submitted that D1 (WO 96/06844) forms prior art that is (only) relevant for the assessment of novelty. Respondent had agreed. Only later, in my understanding in the judge-rapporteur’s expert opinion, it has been held that D1 does not form part of the prior art under Art. 54(3) and (4) EPC 1973 or Art. 7(3) lit. a old PatA, respectively. Respondent disagrees on the merits, and further argued that the principle of party disposition was violated.

  1. Is D1 (WO 96/06844) novelty destroying?

From the pleadings it could be concluded that the expert opinion established by the judge-rapporteur was advantageous for the plaintiff, i.e. that novelty of EP’637 over D1 was given. The EPO’s approach of how to deal with selections from two or more lists of a certain length will be decisive.

Respondent argued that the German Federal Patent Court and a Stockholm court had denied novelty. I could not yet spot any such decision; maybe these were only interim assessments of the courts before the respective parties settled(?).

If you know more, I would be grateful if you would let me know.

UPDATE 12 September 2018:

I have meanwhile been informed of the decision issued in Sweden (Case PMÖ 3565-17 of the Svea Hovrätt), briefly reviewed on EPLAW Blog.

  1. An ‘optional’ disclaimer in summary infringement proceedings?

In a secondary line of defense, plaintiff offered to limit the patent with a disclaimer, to exclude the disclosure of D1 and to restore novelty if necessary.

Defendant argued that this was not possible and referred to an order of the Zurich Commercial Court (HE070010 of 22 August 2007, issued by Dieter BRÄNDLE, the later President of the FPC) that was upheld by the Zurich Court of Appeal (AA070145/U/Ia of 25 January 2008). At that time, it had been held (emphasis in original; cf ¶3.2):

Im Massnahmeverfahren [kann] sich der Kläger somit nur auf ein Zertifikat bzw. das diesem zugrundeliegende Patent in der aktuellen (d.h. uneingeschränkten) Fassung berufen.

Loosely translated:

In summary proceedings the plaintiff may thus only rely on the SPC or the basic patent, respectively, in its current (i.e. unamended) version.

  1. Risk of a not easily reparable harm for the plaintiff?

Further, the requirement of a ‘not easily reparable harm’ for interim injunctive relief to be granted has been addressed at length by the parties. Is the plaintiff actually at risk of a ‘not easily reparable harm’ as required by Art. 261(1) lit. b CPC?

ViiV corporate tree (section), as illustrated by respondent

Respondent firmly insisted that this is not the case, with reference to an illustration similar to the one shown on the right. In brief, plaintiff ViiV Healthcare UK Ltd is the holder of the Swiss SPC, and is fully owned by ViiV Healthcare Ltd; cf the right branch of the illustration.

Likewise, ViiV Healthcare GmbH (holder of the Swiss MA for Kivexa® according to the ‘Spezialitätenliste‘) is fully owned by  ViiV Healthcare Overseas Ltd, which in turn is fully owned by ViiV Healthcare Ltd; cf the left branch of the illustration.

Respondent argued that none of the boilerplate arguments like confusion of the market, price erosion, etc can apply here, since this does not affect the plaintiff / SPC holder. Plaintiff inter alia argued in the hearing that the Swiss MA holder has a license under SPC. This was firmly rebutted by the respondent as ‘not true’, or at least not to be a royalty-bearing license — and procedurally belated in any event. In my understanding, it had not been argued in the written exchange of briefs that a license is in place.

Finally, the parties were asked whether they were interested in settlement discussions. I would have loved to hear the answer, but the public has been excluded on request of the plaintiff even before the general (un)willingness to talk settlement has been indicated.

Reported by Martin WILMING

P.S.: After plaintiff’s initial pleadings, the presiding judge asked whether the pleading notes that had obviously at least partially been read out would be handed over to the court (“not necessarily to the other party”), to ease compilation of the minutes. The parties agreed. A pragmatic approach. Still, I strongly feel that whenever pleading notes are handed over to the court, the other party should get a copy, too. Frankly, I would not feel comfortable when the counter-party submits something in writing that I haven’t seen. How would I know that there was no change or omission in the speech vis-à-vis the pleading notes, and how easily might a different message silently sneak into the minds of the judges …

BIBLIOGRAPHY

Case No. S2018_004 | Hearing of 10 September 2018

ViiV Healthcare UK Ltd.
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

  • Dr. Christoph GASSER
  • Dr. Tobias BREMI
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Benjamin THOMAS (Simmons), assisting in patent matters

Representative(s) of Defendant:

PATENT IN SUIT

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Does the wording of an SPC matter?

Case No. S2107_006 ¦ Hearing of 9 October 2017

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

The supplementary protection certificate C00915894 is at stake; see the official court information about the hearing. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

It’s not the first time that the parties litigate about this SPC. Nullity proceedings are co-pending; see this Blog here and here. A major issue at stake now is the alleged infringement of the SPC. The FPC had granted ex parte interim injunctive relief; see this Blog here. Note, however, that the SPC concerns (emphasis added):

tenofovir disoproxilfumarat + emtricitabin

Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

Now, is that still ‘the product’ in the sense of Art. 140d PatA?

Plaintiff essentially argues that an SPC would always extend to all salts of (a component of) a product, irrespective of its wording. On the contrary, defendant argues that this is a misunderstanding of the ‘Farmitalia’ decision of the ECJ (C-392/97): In that case, the market authorisation related to a specific salt, but the ECJ had allowed the registration of an SPC also for salts and esters. It had been held in ¶27 that

[…] where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent.

The ECJ’s judgment only concerned the requirements for grant of an SPC, but not the scope of protection. The FPC will now have to decide on the scope of an SPC directed to a combination product wherein a first component is identified as a specifically named salt (fumarate) which is not used in the attacked product (using a phosphate instead); and wherein the second component (emtricitabin) is not mentioned at all in the basic patent.

The President noted that no expert opinion of the judge-rapporteur will be established. The parties did not enter into settlement discussions.

Reported by Martin WILMING

Header image reproduced with kind permission and copyright of the Swiss Federal Administrative Court (St. Gallen) where the hearings of the FPC take place.

BIBLIOGRAPHY

Case No. O2107_001 ¦ Hearing of 9 October 2017

Gilead Sciences Inc. ./. Mepha Pharma AG

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

Representative(s) of Defendant:

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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To be, or not to be … (protected by an SPC)

Case No. O2107_001 ¦ Main hearing of 21 August 2017

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

This case is all about the SPC granting practice in Switzerland, ie whether or not – and if so, how – the granting practice shall be brought in line with the recent case law of the CJEU post-Medeva.

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

Towards this end, the so-called ‘infringement test’ has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998. On the contrary, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva in 2011.

Gilead's Truvada
Gilead’s Truvada®

For more background information see this Blog here and the official court information about the hearing.

The pleadings initially focussed on two issues, ie the relevance of the reasons for harmonization given by the CJEU for Switzerland; and the differently phrased criteria used by the CJEU in its decisions post-Medeva. The court had explicitly invited the parties to extend their pleading to these two issues.

Plaintiff essentially argued that the ratio legis of the Swiss SPC regulation requires that the ‘infringement test’ be set aside, and that this change of practice shall be applicable with immediate effect for SPCs granted under the Fosinopril regime. It has been referred to various other European jurisdictions where this has been the outcome in parallel proceedings.

On the contrary, defendant argued with multiple lines of defense. First, when the legal situation of 2006 was applied, the case should be dismissed. Only if it was now decided in favour of a change of practice, it would still need to be decided whether or not this should have retroactive effect. If one were to accept a retroactive effect, the criteria established by the CJEU would need to assessed. The parties disagreed whether the CJEU has established a sufficiently consistent approach.

All in all, the hearing took very long. The plaintiff’s reply was finished after 2h at about 12am; defendant asked for a break of 2h to adapt his rejoinder which then took about 3h. It remains to be seen whether reply/rejoinder in a hearing in main proceedings is a model for success.

The parties did not enter into settlement discussions.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Prof. Dr. Daniel KRAUS
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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NOTES BEFORE AND FROM THE HEARING

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Applied Nanostructures, Inc. ./. Nanoworld AG

Case No. O2013_013 ¦ Main hearing of 23 June 2016

This case is a nullity suit of Applied NanoStructures against the Swiss part of Nanoworld‘s European patent EP 1 860 424 B1, pertaining to self-aligning scanning probes for scanning probe microscopes; see Swissreg for further bibliographic details. More precisely, EP’424 pertains to scanning probes for alternative use, claimed as follows:

1.   Scanning probes (1) for alternative use in a scanning probe microscope where the scanning probes (1) have a micro cantilever beam (4) whose one end (5) has a scanning tip (6) for scanning a sample and whose other end (13) has a holding element (2) for the non-permanent attachment of the scanning probe (1) a probe holder, and where the scanning probes (1) have a support element (3) secured in position on the probe holder for coupling and aligning the scanning probe (1), wherein corresponding alignment elements (8, 8′, 8″), (16, 16′, 16″) are incorporated in the holding element (2) and in the support element (3) that align the holding element (2) in automatically reproducible fashion relative to the probe holder when coupled with the support element (3) and wherein the micro cantilever beams (4) of the scanning probes (1) have different lengths (14) and in each case the distance (12) between the scanning tip (6) and a defined reference point (9) of the holding element (2) is constant, characterized by the feature that the reference point (9) is arranged in all cases of the scanning probe (1) at he same distance and in the same position to the alignment elements (8, 8′, 8″) of the holding element (2).

2.   Scanning probes according to claim 1, characterized by the feature(s) that with the scanning probe (1), the distance (24) in each case between the defined reference point (9) of the holding element (2) and a front edge of the holding element (2) that is associated with the micro cantilever beam (4) is variable, depending on the length (14) of the micro cantilever beam (4).

This can be best understood with Figure 3 of EP’424 at hand:

EP 1 860 424 B1, Fig. 3
EP 1 860 424 B1, Fig. 3

A first court order in this matter has already been published more than two years ago, in April 2014; see this Blog here. The suit had already been filed in September 2013. Nothing has surfaced since then. But the parties have been quite busy in the meantime, with 26(!) submissions in total.

The plaintiff apparently argued in the writ that the subject matter of independent claim 1 is not novel over EP 0 444 697 A2 (referred to as D1), or — relatively global — at least not inventive. With the rejoinder, the defendant/patentee had submitted various auxilliary requests to maintain the patent at least in more limited form. I understood from what has been discussed in the hearing that the plaintiff did not expand on the lack of novelty and/or inventive step of these requests in his comment on the rejoinder. Rather, elaborated arguments with respect the alleged lack of an inventive step were only submitted later, i.e. with the comment on the interim assessment of the reporting judge. Apparently, these belated arguments had been held inadmissible by the court and were not considered any further. The plaintiff requested reconsideration in the hearing, though without success.

Apparently, the reporting judge had concluded that claim 1 as granted was not novel over EP’697 (D1), but that the combination of claims 1 and 2 was valid (see quotation above for the wording of claim 2). While the defendant/patentee did not agree with the novelty assessement of the reporting judge, it was pretty clear in my perception that maintenance of the patent in amended form (combination of claims 1 and 2) was kind of acceptable.

It has been noted in the hearing that co-pending proceedings at the Federal Patent Court in Germany (5Ni12/14(EP)) have also moved forward. In an interim assessment of 16 March 2016, the German court apparently held that claim 1 as granted is novel, but not inventive. This interim assessement of the German court has been accepted into the proceedings as proper novum; Art. 229 CPC.

As to the costs, it comes at no surprise that 26 submissions aren’t a bargain buy. The plaintiff incurred costs of CHF 217’000,–. On the other hand, the defendant/patentee submitted a cost note of EUR 85’000,– for the assisting patent attorney. Note that compensation for professional legal representation will be awarded within the ranges of Art. 5 CostR-PatC, in accordance with a value in dispute of CHF 250’000,–.

I had to leave before the parties were asked whether they wish to enter into settlement negotiations; but I have the dim feeling that, maybe … — well, let’s wait and see.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. O2013_013 ¦ Main hearing of 23 June 2016

Applied NanoStructures, Inc ./. Nanoworld AG

Subject(s):

  • Nullity

Board of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Peter RIGLING

Reporting Judge:

  • (not identified)

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Peter KLOCKE (Abacus), assisting in patent matters

— PATENT IN SUIT —

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Lässer ./. Saurer, reloaded

Case No. O2014_009 ¦ Hearing of 27 January 2016

Dejà-vu! Lässer and Oerlikon Saurer Arbon were already litigating in the matters S2012_004 and S2014_004. We note a change in Lässer’s litigation team: Lässer is now represented by Andri Hess (Homburger). Again, but now for the first time in main proceedings, EP 1 983 083 B1 is at stake. The patent is about heat cut technology used in embroidery machines.

Independent claim 1 of EP’083 reads as follows:

1.   Method for applying flat pieces of material of any desired form onto an embroidery base (Fig. 6: 42) by means of an embroidery machine, wherein at least one material layer is arranged above the embroidery base (42) and, controlled by the program of the embroidery machine, a relative movement is produced between a cutting device (47) and the material layer (Fig. 6: 44), and, as a result, a flat piece of material of the desired form is cut out of the material layer (44), characterised in that the cutting is carried out by a heatable tip (47) and the penetration depth of the heatable tip (47) into the material layer (44) is determined by a spacer (55) provided at the tip (47), such that the tip only penetrates into the material layer (44) which is to be cut.

EP 1 983 083 B1, Fig. 3 and 3a
EP 1 983 083 B1, Fig. 3 and 3a

Heatable tip (47) and spacer (55) can be seen e.g. in Fig. 3 and Fig. 3a of the patent; see also paragraph [0017] of EP’083 for further details on the spacer.

Apparently, the interim assessment of the reporting judge had not been in favour of the defendant, neither concerning infringement nor with respect to the plea of nullity.

From what has been discussed in the hearing, it seems that the interim assessment ignored the underlined feature of the claim, at least in the feature analysis. It remains to be seen whether this has the potential to turn the interim assessment or not.

HeatCut illustration (Source: Saurer)
HeatCut illustration (Source: Saurer)

Saurer’s HeatCut technology evidently makes use of a heating tip; see the black tip in the middle of the picture taken from Saurer’s HeatCut website. This technology also relies on so-called fabric pressers; see the silvery bars that are intermittently arranged on top of the fabric. Apparently, a key issue in this case is whether these fabric pressers are spacers (55) in the sense of the patent in suit.

The defendant showed a PowerPoint presentation during his submission; printouts were handed over. Various figures and aspects of this presentation were objected as inadmissible  / in violation of Art. 229 CPC; presentation of new facts and evidence at the main hearing is only admissible if they are so-called proper novae or, at least, improper novae. Hearings are always good for surprises, but the President was not amused:

Erzählen Sie zu dem Bild, was Sie wollen — wir müssen uns das Bild halt wegdenken.

Tell us what you want concerning this picture — we have to imagine it wasn’t there.

Finally, the value in dispute was adjusted. The parties had initially agreed on CHF 300’000,–, but reality is way ahead of this; expenses so far for legal representation: kCHF 127 (plaintiff) and kCHF 221 (defendant); patent attorney costs: kCHF 41 (plaintiff) and kCHF 73 (defendant; in-house patent attorney in the group of companies of the defendant). In view of these relatively high costs the value in dispute was set to CHF 5m; both parties agreed. These party costs are a great deal of money, indeed — but their former case HG.1998.27 before the Commercial Court of St. Gallen had been even more costly.

Both parties agreed to enter into the non-public part of the hearing / settlement negotiations.

Reported by Susanna RUDER and Martin WILMING

— BIBLIOGRAPHY —

Case No. O2014_009 ¦ Hearing of 27 January 2016

Lässer AG Stickmaschinen ./. Oerlikon Saurer Arbon AG

Subject(s):

  • Infringement
  • Plea of nullity

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE (President, Judge)
  • Dr. Tobias BREMI (Judge)
  • Frank SCHNYDER (Judge)
  • André ROLAND (Judge)
  • Dr. Christian HILTI (Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of claimant:

  • Dr. Andri HESS (Homburger)
  • Hans Rudolf GACHNANG (Gachnang), assisting in patent matters

Representative(s) of defendant:

  • Dr. Stefan KOHLER (Vischer AG)
  • n/a, assisting in patent matters

— PATENT IN SUIT —

EP 1 983 083 B1:

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Nordson EFD ./. Gema Switzerland

Case No. O2013_008 ¦ Main Hearing of 15 June 2015

The patent in suit is EP 899 016 B1 of Nordson Corp.; the defendant is GEMA Switzerland GmbH. See Swissreg for further bibliographic details of the patent in suit. It pertains to a spray gun like the one shown in Fig. 2:

Fig. 2 of EP 899 016 B1
Fig. 2 of EP 899 016 B1

The only independent claim 1 reads as follows:

An apparatus (20) for use in applying coating material to an object comprising a spray gun (24) having a handle portion (26) Illinois area code , an extension portion (28) which is connected with the handle portion (26), a nozzle (42) connected with the extension portion (28), an electrode (46) disposed adjacent to the nozzle (42) and away from which electrostatically charged coating material flows toward the object, a coating material flow control member (74) connected with the handle portion (26) and manually operable to an actuated condition to initiate a flow of coating material from a coating material passage (62) in said extension portion (28) through the nozzle (42) toward the object, characterised in that the spray gun (24) also has a purge air flow control member (110) connected with the handle portion (26) and which is manually operable to initiate a flow of air from the coating material passage (62) in the extension portion (28) through the nozzle (42) to remove coating material from the spray gun (24).

Note that the Federal Patent Court of Germany in a recent decision of April 29, 2015 had maintained the patent only in a limited extent (see DPMAregister and 4 Ni 26/13 for details). It is unclear whether this decision has been appealed.

Neither party was interested in settlement negotiations. We may thus await a decision on the merits of this case.

Reported by Ingo LUMMER and Martin WILMING

— BIBLIOGRAPHY —

Case No. O2013_008 ¦ Main Hearing of 15 June 2015

Nordson EFD ./. GEMA Switzerland GmbH

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Herbert LÄDERACH
  • Christoph MÜLLER
  • Dr. Simon HOLZER

Court Clerk

  • Susanne ANDERHALDEN

Reporting Judge:

  • [unknown]

Representative(s) of Plaintiff:

  • Dr. Christian HILTI (Rentsch)
  • Dr. Jens OTTOW (Rentsch), assisting in patent matters

Representative(s) of Defendant:

— PATENT IN SUIT —

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Brief report on the main hearing in O2013_009 — “Drospirenone”

Case No. O2013_009 ¦ Main Hearing of 09 December 2014

ContraceptiveThe FPC has already issued a landmark decision Drospirenone in summary proceedings last year. Drospirenone is a compound used in contraceptives (birth control pills). This first decision S2013_001 mainly dealt with the doctrine of equivalents; please refer to the earlier post for all the technical matters that are at stake.

Later on, a procedural decision on the non-consideration of a late filed subsidiary request has been issued.

In a nutshell, infringement of EP 1 149 840 B2 is at stake. It is to be decided whether dehydration in the presence of pyridine/water as the replacing feature is an equivalent to p-toluenesulfonic acid (which is the claimed feature).

I have attended the main hearing yesterday. The parties had already been provided with the preliminary written assessment of a technically qualified judge. This assessment held that the use of pyridine/water infringes the claim under the doctrine of equivalents, in confirmation of the outcome of the summary proceeding S2013_001. The parties referred to sections of this written assessment at page numbers > 30; it is thus reasonable to assume that it already contains an exhaustive discussion of the technical matter at stake.

Thus, it was an uphill struggle for the defendant in the hearing, but it was fought well. The defendant pointed to alleged inconsistencies in the chain of arguments of the written assessment, and I have heard prima facie convincing arguments of both parties. I am keen to read the final decision, to cross-check whether and how yesterday’s hearing changes any of the conclusions of the preliminary assessment. But the parties finally entered into non-public settlement negotiations and it remains to be seen if a final decision will be issued.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2013_009 ¦ Main Hearing of 09 December 2014

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE (President; Judge)
  • Dr. Tobias BREMI (Reporting Judge)
  • Dr. Erich WÄCKERLIN (Judge)
  • Dr. Roland DUX (Judge)
  • Dr. Thomas LEGLER (Judge)

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Gregor S. KÖNIG (KSVR), assisting in patent matters

Representative(s) of Defendant:

  • Dr. Christoph WILLI (Streichenberg)
  • Dr. Rainer FRIEDRICH (df-mp), assisting in patent matters