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

Case No. O2018_003 ¦ Hearing of 17 June 2019

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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?

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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

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

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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):

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

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NOTES FROM THE HEARING

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The first thematically structured main hearing at the FPC: Role model or nonstarter?

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Case No. O2016_016 | Hearing of 8 May 2019

The patent at stake is MundiPharma‘s EP 2 425 825 B9; see EPO Register and Swissreg.

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.

Develco’s logo

Develco 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, Develco argues that EP’825 is not novel over WO 01/58451 A1, and that it is obvious in view of EP 0 352 361 A1 or WO 01/58447 A1 or WO 02/092060 A1 or in view of the entry in the ‘Rote Liste’ 2001 for the product Valoron® N capsules from Gödecke.

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) and the Barcelona Commercial Court No. 4 (19 December 2018) came to the same conclusion. While an appeal is still pending at the EPO, the decision in Spain is already final.

The most interesting part of the hearing was actually how the FPC had structured it. Normally, the parties are just given the floor, one after the other, to plead on all relevant aspects of the case. Not so this time. The FPC wanted to hear the parties on a single aspect only, before moving on to the next aspect. Very much like hearings at the EPO are conducted. Apparently, the FPC had also indicated beforehand that a preliminary opinion would be given on each aspect right after the pleadings relating thereto. However, the patentee / defendant objected, and the court thus abstained from doing so.

Maybe, or maybe not …

On a personal note, I don’t see much value in a ‘preliminary’ opinion of the court being issued in the main hearing. Since one cannot take this opinion for granted, one has to effectively ignore it in all the following pleadings, and be prepared for an outcome to the contrary.

But it still is an interesting approach that could well be taken to the next level, in my perception: What about making a break after the pleadings on each aspect for the judges to deliberate and actually decide on that issue, and pronounce the decision right thereafter? That works perfectly fine at the EPO, and a nullity case at the FPC doesn’t differ much.

Lawyers may prove me wrong, but I do not readily see why this shouldn’t be possible in civil proceedings governed by the CPC.

Reported by Tina VOCI and Martin WILMING

BIBLIOGRAPHY

Case No. O2016_016 | Hearing of 8 May 2019

Develco Pharma Schweiz 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 Develco:

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

Representative(s) of Mundipharma:

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

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Truvada®: PrEPared for a decision on the scope of an SPC

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Case No. O2017_023 | Hearing of 4 April 2019

Note that Hepp Wenger Ryffel is involved in this case on behalf of the defendant.
Gilead’s Truvada®

This case is about an alleged infringement of Gilead’s SPC C00915894; the basic patent is EP 0 915 894 B1 (see EPO Register and Swissreg). Gilead’s product is Truvada®, a pharmaceutical for the treatment of HIV-1 infection. The present main proceedings are following-up on summary proceedings S2017_006 when the FPC granted interim injunctive relief; see this Blog here.

Validity of the SPC is not an issue anymore, it has already been affirmed by the Supreme Court; see this Blog here.

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.

The dispute is all about whether or not the scope of an SPC that specifically refers to a unique salt form does extend to other salts. The SPC concerns tenofovir disoproxil fumarat + emtricitabin (emphasis added) .

Mepha’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

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

The parties agreed to disagree on this issue in the hearing. Gilead insisted that the ‘typical product definition’ has to be applied, in a sense that the fumarate is only to be understood as a ‘reference’ for the assessment of whether or not yet another salt form has the same pharmacological effect. If it had, then it should be considered ‘the same product’.

On the other hand, Mepha argued that the term ‘product’ is defined in Art. 140a(2) PatA, and it is to be construed within the context of the PatA; the Therapeutic Products Act (TPA) was not relevant in this respect. Thus, infringement has to be assessed as it is routinely done, i.e. deciding on whether there is literal infringment or infringement under the DoE. Mepha argued that the SPC is neither literally infringed, nor under the DoE.

The expert opinion of the judge-rapporteur held that the SPC was infringed, apparently essentially along the line of Gilead’s arguments. Still, in case the court followed the expert opinion, Mepha requested the court to provide a full assessment of infringement in the judgment, also including an assessment of literal infringement and infringement under the DoE. The Supreme Court would then be in a position to review the whole matter at once and in a timely manner, without the need to remit the case back to the FPC to carry out yet another assessment.

As mentioned above, Truvada® is a pharmaceutical for the treatment of HIV-1 infection. But Mepha recently obtained the market authorization of its Emtricitabin-Tenofovir-Mepha® in Switzerland also for PrEP – which is short for Pre-Exposure Prophylaxis; see Swissmedic Journal 02/19. More information on PrEP can be found on Gilead’s website here. However, Gilead currrently has no MA for PrEP in Switzerland; Mepha’s MA is the only one in Switzerland for this indication.

PrEP likely is the reason why this case attracted quite some public attention. There has even been an organised Facebook event in St. Gallen; and flyer have been distributed, see here and here.

Groupe sida‘ activists

On a sidenote, when a member of the audience wore a shirt with one of these slogans on it, the presiding judge held that this was an attempt to influence the judges, and thus ordered him to either hide the slogan / change clothes; or to leave the court room.

The NZZ reported on the matter, as well as the ‘Tagesschau‘:

 
Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_023 | Hearing of 4 April 2019

Gilead Sciences Inc.
./.
Mepha Pharma 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)
  • Dr. Andreas SCHÖLLHORN (LSP), assisting in patent matters

Representative(s) of Defendant:

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Roses are red; violets are blue — It’s all obvious! Well, is that true?

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Case Nos. O2016_010, O2016_011 | Hearing of 20 March 2019

Twice upon a time …

I have attended the main hearings in both these nullity cases, i.e. O2016_010 relating to EP 2 347 250 B1 (see EPO Register and Swissreg ) and O2016_011 relating to EP 2 352 018 B1 (see EPO Register and Swissreg). Note that EP’018 is based on a divisional application of EP’250.

The inventions are all about the capacitive testing of yarns or fabric, wherein the dielectric property of a capacitor arrangement is determined.

Patentability

It became clear from the pleadings that the defendant’s main request in both cases was that the patent be maintained in amended form only. In my understanding, the expert-opinion of the judge-rapporteur had held that the main request in O2016_010 / EP’250 was allowable, but not in O2016_011EP’018.

Novelty has not been an issue anymore, in both cases. Only obviousness, undue extension of subject-matter (interim generalisation) and clarity (of the additional feature) have been discussed. D2 (US 4,843,879; referred to in EP’250, ¶[0007]) was apparently agreed to be the closest prior art, and was combined in the assessment of obviousness with either D4 or D11 — both of which have unfortunately not been identified.

For me as a chemist, the highlight of the day was the plaintiff’s emotional release:

That’s not chemistry here; it’s physics!

The formulation of the ‘objective technical problem’ was quite a big deal in the hearing. This is what EP’250 says in ¶[0009] (emphasis added):

It is therefore the aim of the present invention to provide a method for the symmetry adjustment of a device for the capacitive examination of a moving elongated textile test sample which does not have the above disadvantages. The device should be simple, fast, cost-effective and, in particular, automatically adjustable.

Flower power, with roses in particular

Now, can automation be considered as the ‘objective technical problem’? In the plaintiff’s view, the ‘in particular’ is an emphasis of the aim of automation. The defendant disagreed: Automation was an add-on, and the other advantages could well be realised without automation. On the funny side, the following example has been used:

She likes flowers, in particular roses.

Now, imagine that the rose-loving woman visits a florist. Which flowers will she recognise first, amidst all the other flowers? The roses, of course!

Costs

Compensation of the ‘necessary expenses’ for the assisting patent attorney pursuant to Art. 3 lit. a and Art. 9(2) CostR-PatC was yet another point of discussion. The plaintiff requested reimbursement of about kCHF 45 for each case and argued, that the defendant triggered the additional costs because the amended claims had only been filed with the rejoinder which then had effectively restarted the whole discussion. I did not get the value in dispute, but the presiding judge indicated that kCHF 45 is about twice as much as the amount that would be awarded for legal respresentation, i.e. ‘according to the tariff’ that is based on the value in dispute.

Now, why is that important?

Since O2012_043, the FPC’s practice is that, as a rule, the ‘necessary expenses’ for the patent attorney may well be within the same order of magnitude of the costs for legal representation. But what about nullity cases? A patent attorney could do that on his/her own, without any legal representative; Art. 29(1) PatCA. Compensation would then be awarded according to the tariff for legal representatives; Art. 9(2) CostR-PatC.

The defendant questioned whether costs incurred for the assisting patent attorney are ‘necessary expenses’ at all, on top of the costs for legal representation according to the tariff, if he/she could have done the whole case on his own.

Use of the technical infrastructure in the court room

It is quite hard for the public to follow the arguments when the representatives just argue with acronyms and references. It’s sometimes frustrating, but I got used to it. But still, one of the basic ideas of a public hearing is to give the public the opportunity to follow the proceedings, isn’t it? But how would you even get a glimpse of what is really at stake when the parties only refer to ‘EP’111’ or ‘D1’ or ‘feature 1da’. That’s not information — it’s just noise.

I was very happy that the recent hearing in case S2018_006 was different (see this Blog here): Whenever someone referred to a specific document, the President put the same on the screen for it to be easily recognisable by the whole audience and the judges; projector and screen are fixedly installed in the ceiling anyway (see yellow arrow in the image below). Much appreciated!

Let there be information …

But that’s not only great for the audience; I strongly feel that it is also beneficial for representatives when arguing their case. When referring to a certain paragraph in a specific document in your pleadings, or a technical drawing, you always want to make sure that all the judges are on the same page, right? But how would you know that, with the judges sitting on a podium that even has an elevated front side that makes sure that nobody reveals a hand up there, behind the monitors. Yes, there are fixedly installed monitors (green arrows in the above image).

Now, did they all pick up the document that you are upon to discuss? You never know. So, why not actually use the monitors that each judge has in front of him/her, and the projector/screen for the audience, to make sure that everybody sees what you want to be seen? I could not think of any more powerful way to focus the discussion and thoughts on a specific argument.

Unfortunately, it didn’t work out that way in this hearing even though the defendant suggested it. I hope this was for technical reasons only, and does not indicate a general change of practice again.

Reported by Martin WILMING

BIBLIOGRAPHY

Case Nos. O2016_010, O2016_011 | Hearing of 20 March 2019

Gebr. Loepfe AG
./.
Uster Technologies AG

Panel of Judges:

  • Frank SCHNYDER
  • Dr. Tobias BREMI
  • Christoph MÜLLER

Judge-rapporteur:

  • n/a

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

  • Dr. Andri HESS (Homburger)
  • Dr. Pavel PLISKA (inhouse)

O2016_010

Official announcement:

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Patent in suit:

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O2016_011

Official announcement:

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Patent in suit:

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Return of the non-return valves

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Case No. O2018_013 | Hearing of 18 March 2019

There you go …

These proceedings are following-up on the case O2014_002 (discussed on this Blog here in more detail) where the FPC held that certain non-return valves for urinals produced by von Allmen AG were infringing EP 1 579 133 B1.

From what has been argued at the hearing, it appears that the defendant had obtained valves from a Swiss supplier (presumably Enswico AG; meanwhile liquidated) which in turn had obtained the valves from von Allmen AG. Thus, infringement was not an issue anymore.

Based on the information obtained in proceedings O2014_002, the plaintiff alleged that Aquis Systems had obtained 17’500 infringing valves. On the contrary, Acquis Systems argued that it had only obtained 4’700 valves in total, that those valves had been produced while a license agreement had still been in place and that it had believed in good faith that a license fee of CHF 1,85 per piece had been paid to Mr Dahm. Note that the patent had initially been granted to Mr Dahm, but has been assigned to the plaintiff Daspaco AG in 2013; see Swissreg.

Further, Aquis Systems argued that Daspaco had no standig to bring this suit, since it had not been the proprietor of the patent at the relevant time.

Meeting the goal …

The presiding judge pushed the parties to have settlement discussions, given the small amounts of money involved. And, indeed, both parties agreed.

Hopefully, the parties got this resolved.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_013 | Hearing of 18 March 2019

Daspaco AG
./.
Aquis Systems AG

Panel of Judges:

  • Dr. Christoph GASSER
  • Dr. Tobias BREMI
  • Dr. Ralph SCHLOSSER

Judge-rapporteur:

  • n/a

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Cyrill RIEDER (FMP)
  • Kurt STOCKER (KHP), assisting in patent matters

Representative(s) of Defendant:

  • Philip SCHNEIDER (SMS)

O2014_002
Partial decision of 21 November 2016

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Silicon hairspring technology being litigated

Reading time: 5 minutes

Case No. S2018_006 | Hearing of 17 January 2019

CSEM logo

The plaintiff CSEM is the patentee of EP 1 422 436 B1; see Swissreg and the EPO register for further bibliographic details.

The problem at heart of the invention is the variability of resonance frequency with temperature: The frequency at which a spring oscillates depends on the elastic modulus of the material of which it is made, which in turn is temperature-dependent. The changes in frequency with temperature may not be huge, but if one is in the business of counting seconds (and watchmakers arguably are), this effect can become a problem. Just imagine that time flies faster while skiing than in a warm office!

Figures of EP'436
Figures of EP’436

EP’436 proposes a solution to this problem by coating the hairspring with a material that changes its elastic properties with temperature in the opposite direction of the base material. This can be best understood with the figures at hand. The hairspring is schematically illustrated in Fig. 1 (somehow reminding me of my favorite sweets when I was younger). Figures 2a and 2b illustrate the outer layer on the silicon core.

The relevant claim 1 in its version for Switzerland reads as follows:

A hairspring intended to equip the balance wheel of a mechanical timepiece and in the form of a spiraled rod (10) cut from an {001} single-crystal silicon plate having a first thermal coefficient (C1) and a second thermal coefficient (C2) of its spring constant C, the turns of said hairspring having a width w and a thickness t, characterized in that said rod comprises a silicon core (12) and an external layer (14) of thickness ξ formed around the silicon core and made of a material having a first thermal coefficient of the Young’s modulus of opposite sign to that of the silicon.

CSEM sued Cendres+Métaux Microtech AG and Cendres+Métaux SA for infringement of EP’436.

Note that the claim requires

a spiraled rod cut from a {001} single-crystal silicon plate […].

In our understanding, the allegedly infringing CMK1 movement features a hairspring that is cut from a differently oriented silicon plate.

CMMT‘s CMK1 movement
C+M logo

Still, CSEM alleges an infringement under the DoE and apparently argues that i) all crystal facet terminations would have the same effect (‘Gleichwirkung’); ii) a person skilled in the art would have identified other crystal facet terminations as having the same effect (‘Auffindbarkeit’); and iii) the person skilled in the art would have recognized different terminations as being solutions of equal value (‘Gleichwertigkeit’; see the discussion of the DoE questionnaire on this Blog here).

The defendant’s argument against infringement evolved around plaintiff’s citation of JPH06117476 in the description. Defendant argued that by way of the citation of JP’476 all three orientations had been disclosed to the skilled person. Thus, in the defendant’s view, limitation of the claim to just one specific crystal orientation excludes other orientations from the scope of the claim under the DoE.

As to the requested interim injunctive relief, it had been discussed when the plaintiff actually gained knowledge of the alleged infringement. Defendants apparently started marketing the CMK1 movement as early as 2015 and argued that plaintiffs had ample opportunity to recognize the alleged infringement, for example when the defendants presented the movement at a large exhibition. The plaintiff, on the other hand, argued that while it would have been theoretically possible to discover the alleged infringement earlier, he only actually gained knowledge of it in late 2018 and immediately sought legal remedy. According to the plaintiff, investigative measures to discover possible infringements (such as purchasing and analyzing competitors’ products) are not necessary in order to safeguard the right to interim injunctive relief.

Moreover, the plaintiff argued that only in 2018 the contested product went from a prototype stage to a commercially relevant product. In our understanding, the movement is used in Horage‘s Multiply series of watches:

Horage Multiply configurator (www.horage.eu, visited Jan 20, 2019)
Horage logo

It had been reported in Horological Times of August 2015 that the hairspring in this caliber is made from silicon.

Further, the defendants argued that CSEM as the licensor was not at risk of a not easily reparable harm, and that interim injunctive relief should not be granted for this reason, too. On the other hand, the plaintiff argued that CSEM is not only a licensor, but rather also a manufacturing entity.

Here it is!

Typically, it is quite hard for the public to follow the arguments when the representatives just argue with acronyms and references. Not so this time: Whenever anybody referred to a specific document, the President put the same on the screen so that it could be easily seen by the whole audience, incl. the interpreters. Much appreciated!

The oral proceedings closed with the President’s question whether the parties were interested in settlement talks. Both parties affirmed. The President, however, cooled down the enthusiasm and closed the hearing for lunch:

Wenn wir hier ernsthafte Vergleichsgespräche führen wollen, dann schaffen wir das nicht mehr vor dem Mittagessen!

(If we’re going to have serious settlement talks, we’re not going to be done before lunch!) It remains to be seen whether they could agree on an amicable solution or not.

Note that apparently this is not the first time that this patent is being litigated at the FPC. L’ AGEFI had reported already back in 2013 that an earlier dispute between CSEM (or the licensees Rolex, Swatch and Patek Philippe, hereinafter the consortium) and Sigatec (a joint-venture of Mimotec and Ulysse Nardin) had been settled, which settlement remained widely unnoticed, and the terms of the settlement agreement remained unavailable. Likewise, no details were disclosed in a technical review in 2017:

Screenshot from www.monochrome-watches.com (visited Jan 20, 2019)
Screenshot from www.monochrome-watches.com (visited Jan 20, 2019)

Reported by Philippe KNÜSEL and Martin WILMING

BIBLIOGRAPHY

Case No. S2018_006 | Hearing of 17 January 2019

CSEM Centre Suisse d’Electronique et de Microtechnique SA

./.

  1. Cendres+Métaux Microtech AG
  2. Cendres+Métaux SA

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Philipp RÜFENACHT
  • Dr. Lorenzo PARRINI

Judge-rapporteur:

  • Dr. Philipp RÜFENACHT

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Andri HESS (Homburger)
  • Noëmi SCHÄR (Homburger)
  • Thierry RAVENEL (ICB), assisting in patent matters
  • Bernard MAYJONADE (Micheli), assisting in patent matters

Representative(s) of Defendant:

  • Dr. Demian STAUBER (Rentsch Partner)
  • Fabio VERSOLATTO (Rentsch Partner)
  • Dr. Alfred KÖPF (Rentsch Partner), assisting in patent matters
  • Dr. Theodore CHOI (Rentsch Partner), assisting in patent matters

EP 1 422 436 B1

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Go with the flow

Reading time: 3 minutes

Case No. O2016_009 | Hearing of 29 October 2018

iFlow sensor

Please find some background information about the subject-matter at stake on this Blog here.

In brief, Hamilton Medical AG alleges infringement of its Swiss patent CH 701 755 B1 (see Swissreg for further bibliographic details) by some of imtmedical AG‘s iFlow sensors. The only independent claim 1 of the patent as granted reads as follows:

Durchflussmessfühler (10) mit einem ein zylindrisches Gehäuse (10) definierenden Durchgang mit einer ersten Durchgangsöffnung (13) und einer zweiten Durchgangsöffnung (29); einem im Durchgang des Gehäuses angeordneten Strömungswiderstand (23), welcher das Gehäuse in einen ersten und einen zweiten Gehäuseteil (11 und 27) unterteilt; einer ersten Anschlussstelle (17) mit einer Verbindung zum Innern des ersten Gehäuseteils (11); und einer zweiten Anschlussstelle (19) mit einer Verbindung zum Innern des zweiten Gehäuseteils; dadurch gekennzeichnet, dass die ersten und zweiten Anschlussstellen (17, 19) in einem Abstand voneinander auf dem gleichen Gehäuseteil angeordnet sind.

Fig. 1 of CH 701 755 B1

The defendant denies an infringment, and argues for nullity as a plea in defense.

This case is already pending for two years. Likewise, the main hearing yesterday has been quite lengthy: Plaintiff’s initial pleadings took about 2.5 hours, and defendant’s reply took yet another two hours. The hearing was not even finished thereafter, but we just could not attend any longer. Anyway, some key aspects of the case became pretty clear from both parties’ first pleadings.

In our understanding, the expert opinion of the judge-rapporteur had held that the patent as granted was not valid. However, the judge-rapporteur apparently also held that the patent would be valid in a more limited extent, and that it would still be infringed to that extent. The plaintiff had invoked the patent to that limited extent in the second part of his reply, after the instructional hearing. Defendant firmly denied that this ‘verbal limitation’ (verbale Einschränkung) was admissible and argued that the case had to be dismissed if claim 1 of the patent as granted was invalid.

UPDATE 10 February 2019:

A previous version of this post noted that the patentee invoked the patent to a more limited extent only after receipt of the expert opinion of the judge-rapporteur. This was wrong. He did so already in the second part of his reply, after the instructional hearing. This has been corrected in the above.

Further, the defendant relied on i) a prior use; and ii) US 6,585,662 when arguing for lack of an inventive step.

Fig. 8 of US 6,585,662
Uphill fight

It remains to be seen how all this turns out, but from what has been argued at the hearing we conclude that it is currently an uphill fight for the defendant. And it did not seem as if this was a case to be concluded with a settlement. Stay tuned.

Reported by Tina VOCI and Martin WILMING

BIBLIOGRAPHY

Case No. O2016_009 | Hearing of 29 October 2018

Hamilton Medical AG
./.
imtmedical AG

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

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

CH 701 755 B1

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Laurastar and Innosteam Swiss working flat out

Case No. S2018_003 | Hearing of 28 June 2018

UPDATE 14 July 2018:

This post initially mentioned that the prohibition to dispose of the applications at stake has been lifted. We have learned meanwhile that this was unfortunately not correct. Rather, the register ban was maintained. The post has accordingly been corrected.

Laurastar logo

Laurastar and Innosteam are litigating about ownership of two PCT applications filed in the name of Innosteam; see the announcement of the hearing here. It is pretty clear that WO 2018/006994 A1 and WO 2018/036653 A1 are at stake; see the EPO Register here and here.

Innosteam logo

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.

Plaintiff alleges that the two patent applications pertain to subject-matter that has been invented by two of its former employees that are now employed by the defendant. On the contrary, defendant argues that the claimed subject-matter had been invented when the inventors had no longer been employed by the plaintiff. In the hearing, the role of yet another former employee of Laurastar was briefly touched who apparently changed sides, too. He is not named as an inventor in the applications at stake, but from what the defendant has argued we understand that he apparently has referred his new employer to publicly available documents (inter alia patents / patent applications) of his former employer. Further clarification in this respect may well be subject of main proceedings which are pending.

On plaintiffs request, the President of the Court had ordered the defendant in a summary judgement of 20 April 2018 (unpublished) and without hearing the defendant beforehand not to dispose of the two patent applications while the main proceedings are pending.

The hearing was remarkable for some procedural reasons.

First, an exhaustive expert opinion of the judge-rapporteur in accordance with Art. 183(3) CPC has been given orally — for the first time ever, to the best of our knowledge. This expert opinion was not favorable for the plaintiff. The parties were then given the opportunity to comment on the expert opinion immediately thereafter.

Not yet done …

The parties were then asked for their interest in settlement discussions, but both parties denied.

Typically, this would have been it, and a decision on whether or not the interim measures are upheld would be issued in writing. Not so here. The President asked the second judge for his brief opinion, which was unfavorable for the plaintiff, too.

The prohibition for the defendant to dispose of the two patent applications while the main proceedings are pending has been upheld, for the time being.

Reported by Leila MÜLLER and Martin WILMING

BIBLIOGRAPHY

Case No. S2018_003 | Hearing of 28 June 2018

Laurastar SA
./.
Innosteam Swiss SA

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Giovanni GERVASIO

Court Clerk:

  • Agniezka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Jacy PILLONEL (BCP)

ANNOUNCEMENT

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WO 2018/006994 A1

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WO 2018/036653 A1

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Hard materials, hard times …

Case No. O2016_001 ¦ Main Hearing of 3 May 2018

comadur.com

This case started off already on 27 February 2016, between Harcane and Comadur. There is not much known about the plaintiff, but the defendant is a company of the Swatch Group, specialising in hard materials. Noteworthy, the owner of Harcane, Rui Carolla, apparently had spent part of his career with Comadur; see SHAB.

Quite some background information was already included in the official announcement of the hearing. The plaintiff in first place requests that CH 707 572 B1, concerning a binder for an injection molding composition, be declared null and void. As an auxiliary measure, it is requested that the patent be assigned to the plaintiff. Allegedly, the patent lacks novelty over US 5,266,264, several PhD theses and the sale of a certain “feedstock” including the patented binder. The defendant had allegedly been provided with it back in November 2012. Further, the plaintiff alleges that the mixture according to CH 707 572 B1 had in fact been invented by Mr. Lestarquit, who was at the time an employee of the Plaintiff.

The defendant holds the view that the claimed subject-matter is new and inventive. All the compositions had been developed by Mr. Cartier, an employee of the defendant since 1999. The “mix sheets” developed by Mr. Cartier allegedly have only been put into practice by employees of the plaintiff, including Mr. Lestarquit. The defendant thus requests that the case should be dismissed in its entirety.

In the hearing, the alleged obviousness of CH 707 572 B1 was intensely discussed. Both parties had identified the characterizing part of claim 1 as the distinguishing feature, but proposed (opposing) problem-and-solution approaches (EPO Guidelines, G-VII, 5). The expert opinion of the judge-rapporteur had apparently been in favor of the plaintiff. Further, it was discussed whether the feedstock that had been exchanged between the parties during the collaboration had become public / is part of the prior art.

Initially, the defendant had no interest in settlement discussions, in view of some parallel proceedings elsewhere. Rather, the defendant requested that the present proceedings be stayed until after such parallel proceedings are concluded. Still, the defendant finally agreed to enter into settlement discussions as a first step.

Note that CH 707 572 B1 (filed 15 July 2013) has no further family members. However, we came across patent family WO 2014/191304 A1, claiming priority of CH 01021/13, filed 28 May 2013 and published as CH 708 097 A2, which is pretty similar to the patent in suit. It remains to be seen how all this will be sorted out.

Reported by Ingo LUMMER and Martin WILMING

BIBLIOGRAPHY

Case No. O2016_001 ¦ Main Hearing of 3 May 2018

Harcane Sàrl

./.

Comadur SA

Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

  • Jean-Claude SCHWEIZER (SLB)

Representative(s) of Defendant:

  • Dr. Nathalie TISSOT (Tissot)

ANNOUNCEMENT

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Are rights re-established once and for all?

Case No. O2017_016 ¦ Main Hearing of 25 April 2018

Signpost

I have attended the hearing in this matter earlier today. Infringement of the Swiss SPC C00716606/01 concerning sevelamer is at stake; the basic patent is EP 0 716 606 B1 of Genzyme Corporation. Interim injunctive relief had been granted in earlier proceedings S2016_009; see this Blog here.

Notably, infringement per se is undisputed, as well as validity of the basic patent. However, the defendant (only) alleges that the SPC is invalid because the Office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.

The parties had been summoned to the main hearing after a single exchange of briefs; plaintiff’s reply and defendant’s rejoinder were pleaded in the hearing. Since the only question at stake is a legal one, this worked out smoothly. It was also noted that no expert opinion of the judge-rapporteur will be established.

Now, can the SPC still be challenged for wrongful reinstatement in the present civil proceedings?

Undisputedly, wrongful reinstatement is not explicitly listed as a ground for nullity in Art. 140k PatA. However, the parties dissent on whether or not the list is exhaustive.

Defendant essentially argued that the Swiss legislator voluntarily aligned the Swiss law with the respective EU regulation, and that also further developments of the EU law need to be taken into account; BGE 129 III 135, ¶6. In the view of the defendant, the ECJ in all its decisions on SPCs essentially declared SPCs invalid whenever its grant had not been objectively justified — irrespective of whether or not the ground was explicitly listed in Art. 15 of Regulation (EC) 469/2009.

Plaintiff disagreed; the ECJ never introduced additional grounds of nullity but rather only interpreted the grounds that are explicitly mentioned. Further, the nullity grounds referred to in Art. 140k(1) lit a PatA explicitly only refer to Art. 146(1). However, the time limit for filing the SPC request is defined in Art. 146(2). The plaintiff noted that this focus only on paragraph 1 underlines the legislator’s intent to not include paragraph 2 into the list of grounds for nullity. Plaintiff further argued that any interested third party could well have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but the defendant failed to do so. See also the summary judgment in ¶3.5 in this respect. The decision on reinstatement is thus formally final, and the defendant has to live with it. Plaintiff further referred to BGE 90 I 186 (¶3) which held that re-establishment of rights according to Art. 47 PatA only concerns the relationship of the patentee to the Office; the effects on third parties are regulated exhaustively (sic!) by Article 48 PatA with the prior user right for bona fide third parties.

The later the day, the more pronounced the arguments: The parties reproached each other for having not been able to refer to a prior decision on precisely this issue to their favour. On the funny side, plaintiff noted that this is only because so far just no one has come up with this absurd idea.

So sad

The parties were then asked by the presiding judge whether they were interested in settlement discussions. Unfortunately, I cannot tell what the answer was because it was requested that the public be excluded before the question is answered, and this request was granted.

UPDATE 05 May 2018:

I meanwhile obtained the request and the grant of reinstatement.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_016 ¦ Main Hearing of 25 April 2018

  1. Genzyme Corporation
  2. Sanofi-Aventis (Suisse) SA

./.

Salmon Pharma GmbH

Composition of the Board of the FPC:

  • Dr. Ralph SCHLOSSER
  • Dr. Tobias BREMI
  • Prof. Dr. Daniel KRAUS
  • Dr. Andreas SCHÖLLHORN SAVARY
  • Dr. Stefan KOHLER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

ANNOUNCEMENT

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BASIC PATENT

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