A Swiss approach to the EPO’s gold standard

Reading time: 4 minutes

Case No. O2016_016 | Decision of 6 June 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.

Develco’s logo

Develco sought annulment of EP(CH)’825 for various reasons, i.e. undue extension of subject-matter, non-enablement and invalidity of the priority claim. Please see this Blog here for a brief summary of the main hearing in this matter, and some relevant prior art Develco has asserted against patentability of the claimed subject-matter.

MundiPharma’s logo

Defendant / patentee MundiPharma countersued for infringement. MundiPharma not only countersued the plaintiff, but rather also attempted to involve the German branch of Develco as well as Konapharma. This attempt failed.

It was evident from the pleadings at the main hearing that the expert opinion of the judge-rapporteur had held that the patent was invalid for undue extension of subject-matter. Thus, it does not come as a big surprise in the decision that EP(CH)’825 is held invalid for undue extension of subject-matter. Consequently, the decision does not address the other grounds of invalidity asserted by Develco; and the counterclaim for infringement is moot, too.

In my perception, the detailed assessment of undue extension of subject-matter is nothing out of the ordinary. It’s all about the EPO’s ‘gold standard’ (G 2/10 in ¶4.3, with reference to G 3/89 and G 11/91), i.e.

[…] any amendment […] can […] only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of [the application as filed].

What is interesting, though, is how the decision addresses the so-called essentiallity-test (‘Wesentlichkeits-Test’), in particular how this test fits with the ‘gold standard’. In brief, in T 331/87 the Board held that the replacement or removal of a feature from a claim may (referred to in the Case Law of the Boards of Appeal as a ‘might’) not be in breach of Art. 123(2) EPC 1973 if the skilled person would directly and unambiguously recognise that

  1. the feature was not explained as essential in the disclosure;
  2. it was not, as such, indispensable for the function of the invention in the light of the technical problem it served to solve; and
  3. the replacement or removal required no real modification of other features to compensate for the change.

It is important to note that even this Board apparently (in view of the conditional language used; see mark-up above) did not consider compliance with the above three criteria as a sufficient condition for compliance with Art.123(2) EPC in any given case. Accordingly, the present decision holds that the only thing that really matters is the ‘gold standard’ discussed above, which cannot be deviated from. With reference to the Swiss Supreme Court decision 4A_109/2011, 4A_111/2011 (¶4.3.1), however, the decision further holds that in a case where not even the criteria of the essentiallity test are fulfilled, it must be assumed that an undue extension of subject-matter occured.

What suprises me, though, is that the decision holds (¶31):

Otherwise this would again amount to a materiality test, which was expressly rejected in G 2/98.

Frankly, I don’t see that in G 2/98, at least not explicitly (‘ausdrücklich’). One may well conclude from the gist of G 2/98, in particular ¶8.3, that it does not endorse a distinction of technical features which are related to the function and effect of the invention and technical features which are not. But there is no discussion of the essentiallity test at all in G 2/98. Else, if there was, the essentiallity test would surely not be referred to anymore in the most recent edition of the Case Law of the Boards of Appeal and the Guidelines.

But still, my personal take-away message from this decision is that the essentiallity test is of no avail (until someone comes along and proves me wrong).

The decision is not yet final / may still be appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_016 | Decision of 6 June 2019

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Develco:

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

Representative(s) of Mundipharma:

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

DECISION

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

Case No. O2018_003 ¦ Hearing of 17 June 2019

Reading time: 3 minutes

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

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

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

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

Pemetrexed disodium
Pemetrexed disodium

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

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

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

Sandoz’s logo

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

Lilly’s logo

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

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

Reported by Andreas WELCH and Martin WILMING

BIBLIOGRAPHY

Case No. O2018_003 ¦ Hearing of 17 June 2019

Sandoz Pharmaceuticals AG
./.
Eli Lilly and Company

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

ANNOUNCEMENT

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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

ANNOUNCEMENT

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Fumarate and phosphate: Same same, but different?

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Case No. O2017_023 | Decision of 3 May 2019

DISCLOSURE NOTICE

Hepp Wenger Ryffel is involved in this case on behalf of the defendant.

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 products are Truvada® and Atripla® which are pharmaceuticals 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 was not an issue anymore, this had already been affirmed by the Supreme Court; see this Blog here.

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; we had reported about the main hearing in this matter on this Blog here. The SPC concerns tenofovir disoproxil fumarat + emtricitabin (emphasis added) . Mepha’s attacked generics (Swissmedic MAs No. 66181 and 66217)  instead comprise tenofovir disoproxil phosphate.

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

The decision holds in ¶26-27 that in order to not frustrate the objective of an SPC the understanding of the term ‘product’ in the context of an SPC must be aligned with the understanding of the same term in the context of the Therapeutic Products Act (TPA). Thus, the scope of protection is not strictly limited to what is named in the MA or in the SPC, but rather extends to derivatives, salt forms, etc. which do not differ significantly in their properties with regard to safety and/or efficacy. In other words, the decision holds that the scope of protection extends to everything for which a simplified approval according to the TPA can be obtained (see Swissmedic Guidelines, ¶1.1.1).

Thus, the decision holds that the ‘product’ in the sense of Art. 140d PatA is (¶28):

Emtricitabine plus tenofovirdisoproxil fumarate and all derivatives (i.e. in particular all salt forms) thereof, provided that they have the same pharmacological effects.

Since the attacked embodiments had been approved by Swissmedic by way of a simplified approval, the decision holds that they are presumed to have the same pharmacological effects and are thus the same ‘product’ in the sense of Art. 140d PatA.

For the sake of completeness, the decision also analyses the alleged infringement under the DoE (¶33 et seqq.). As proposed by some scholars, the scope of protection of an SPC is determined by the content of the claims of the basic patent, whereby the description and the drawings are to be used for interpretation, and the Protocol on the Interpretation of Art. 69 EPC is also to be observed. Since the SPC is only product-related and purpose-related, the patent claim of the basic patent is to be defined artificially as if only the active substance designated in the certificate were mentioned, for the approved use of the active substance as a pharmaceutical. The description and drawings of the basic patent shall be used for the interpretation of the claim so formulated.

In brief, the decision holds that the three questions of the Swiss test for infringement under the DoE are to be answered in the affirmative, i.e. that the ‘same effect’ (Gleichwirkung), ‘obviousness’ (Auffindbarkeit) and ‘same value’ (Gleichwertigkeit) are given. Noteworthy, the decision holds that one cannot assume that the SPC holder made a purposive selection in favor of one salt over other salts mentioned in the specification. If one were to see this differently, equivalence for SPCs in different salt forms would in fact be excluded if only one specific salt had been used for the MA and the wording of the SPC. On the contrary, on the basis of an objective reading of the patent specification and in the knowledge that such an artificial claim is to be interpreted for the scope of protection of an SPC, the skilled person will readily assume that other salts,  because they are mentioned in the description, are not excluded from the scope of protection (¶43):

Im Gegenteil wird der fachkundige Dritte bei objektiver Lektüre der Patentschrift und im Wissen darum, dass ein solcher fiktiver Anspruch für den Schutzbereich eines ESZ auszulegen ist, in einer solchen Situation gerade davon ausgehen, dass natürlich diese anderen Salzformen, weil sie in der Beschreibung genannt werden, nicht vom Schutzumfang ausgeschlossen sind.

In any event, the decision holds that there was no specific, individualized disclosure of tenofovir disoproxil phosphate in the specification of the basic patent.

LDCs

Injunctive relief was thus granted. However, Mepha shall be permitted to export products that it had on stock when interim injunctive relief had been granted to any of the least developed countries, LDCs, according to the list of the the United Nations.

The decision is still open to appeal.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_023 | Decision of 3 May 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. Kilian SCHÄRLI (MLL)
  • Dr. Michael RITSCHER (MLL)
  • Dr. Andreas SCHÖLLHORN (LSP), assisting in patent matters

Representative(s) of Defendant:

DECISION IN FULL

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

Reading time: 5 minutes

Case No. O2016_012 | Hearing of 29 May 2019

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

Implantec’s ANA.NOVA® hybrid socket website

See Implantec's ANA.NOVA® product flyer for further information about the allegedly infringing product.

Defendant (1) is the Austrian manufacturing company of the allegedly infringing ANA.NOVA® hybrid socket, which defendant (2) is then placing on the Swiss market.

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

A socket (1) for an artificial hip joint with a base body or a shell (10) which comprises an in particular spherical, ellipsoidal or conical superficies (11) essentially rotationally symmetrical to the socket axis (AP), characterised in that on the outer side of the base body (10) there are arranged at least two locking elements (20) which in each case comprise a knock-in web (21) which from the distal web beginning up to the proximal web end defines at least a gradient of 85° to 60° with respect to the base surface (GP), which corresponds to an angle of twist of 5° to 30°.

ANA.NOVA® hybrid socket

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

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

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

The hearing

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

Closed docket

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

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

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

A socket (1) for an artificial hip joint with a base body or a shell (10) which comprises an in particular spherical, ellipsoidal or conical superficies (11) essentially rotationally symmetrical to the socket axis (AP), characterised in that on the outer side of the base body (10) there are arranged at least two locking elements (20) which in each case comprise a knock-in web (21) which from the distal web beginning up to the proximal web end defines at least a continuous, linear gradient of 85° to 60° with respect to the base surface (GP), which corresponds to an angle of twist of 5° to 30°.

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

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

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

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

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

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

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

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

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_012 | Hearing of 29 May 2019

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

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Stemcup :

Representative(s) of Implantec:

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

ANNOUNCEMENTS

Main hearing of 29 May 2019:

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Main hearing of 3 October 2018 (cancelled):

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The FPC’s cancellation note:



PATENT IN SUIT

EP 1 411 869 B1 (as initially granted):

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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?

Reading time: 3 minutes

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

ANNOUNCEMENT

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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?

Reading time: 5 minutes

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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Writing instrument: The Supreme Court’s final stroke

Case Nos. 4A_435/2018, 4A_441/2018 (Supreme Court) | Decision of 29 January 2019 on appeal against O2015_018 (FPC) | Decision of 15 June 2018 | ‘Instrument d’écriture’

Please see this Blog here for a detailed review of the underlying decision of the FPC in this matter.

Both parties had lodged an appeal — but the Supreme Court dismissed both appeals. While the FPC’s judgement was quite a booklet of 50+ pages, it took the Supreme Court only 7 pages to deal with both appeals. Most of the judgment indeed is pretty straight forward. Still, the judgment has quite some interesting aspects, in my perception:

  1. Assignment of a patent does not imply assignment of the universal right to the invention per se 
Montres Valgine logo

Guenat had requested that Swiss Finest‘s Swiss patent be annulled based on Art. 26(1) lit. d PatA, i.e. for lack of entitlement. However, such request can only be brought by the entitled person; Art. 28 PatA. Guenat alleged that Frédéric Garinaud transferred ‘full and complete ownership’ of the European patent application to Guenat. But that did not help. Frédéric Garinaud specifically assigned the European patent application to Guenat, but not the universal rights in the ‘invention’ itself. Guenat’s request for declaration of nullity based on Art. 26(1) lit. d PatA was thus held inadmissible for lack of standing.

On appeal, Guenat criticises the FPC’s ‘artificial dichotomy’ between the invention and the related patent application, and claims complete control over the invention in dispute. The Supreme Court didn’t buy into that. The decision holds in ¶3.2 that Guenat’s argument is based on an assumption about the parties’ intention in respect of the transfer agreement of April 2013. This is not a question of law, but of fact. But the FPC had not found that the real and common intention the parties had been to assign all intellectual property rights to the invention and the right to be granted all related patents. On the contrary, according to the FPC, the agreement in question ‘clearly refers only to the European patent application and the resulting European patent, and not to the invention as such’ — which finding is binding on the Supreme Court since it is not ‘arbitrary.’

Thus, the Supreme Court apparently had no doubt that the assignment of a specific patent does not necessarily imply the assignment of the universal rights in the invention itself.

  1. Assessment of inventive step is a question of law, but …

Guenat argued on appeal that the FPC had violated the principle of party disposition because it took facts into account that had not been alleged by the defendant.

Now, what had happened?

The FPC had held that a specific feature (C3-1) was not disclosed in the closest prior art document. Guenat had a different understanding of the specific feature, and had argued that based on a ‘correct’ understanding of the feature it had well been disclosed in the closest prior art.

Swiss Finest logo

On appeal, Guenat argued that Swiss Finest had not even alleged that feature C3-1 was not disclosed in that document. Unfortunately, it is not readily clear from the decision to which version of feature C3-1 that allegation pertained: The feature as construed by the Guenat, or the feature as construed by the FPC?

The Supreme Court held that it had not been disputed that all the factual elements necessary for the analysis of obviousness had been brought on file by the parties. Further, the Supreme Court held that Guenat had not asserted that the FPC had to supplement the facts on its own, and that such conduct was also not apparent from the file. In the Supreme Court’s view, the FPC was thus in a position to assess obviousness, which is a question of law. It is irrelevant in this respect that the presence or absence of specific features in the prior art and/or the patent have been alleged by the defendant or the plaintiff. On the basis of the facts gathered by the parties in order to consider a question of law, the court did not violate the principle of party disposition.

Without any in-depth knowledge of what had or had not been argued by the parties, I just cannot say whether I would agree with the assessment on the merits of the case. But the Supreme Court’s general considerations on questions of law vs. questions of fact trigger some further thoughts.

Clearly, assessment of obviousness is a question of law — but the underlying factual elements still need to be asserted by the parties. But what are the ‘factual elements’? They must be something more specific than just ‘the patent in suit’, ‘D1’ or the like. Else, a court could just combine whatever is on file in its assessment of obviousness, fully detached from the pleadings. This cannot be it. Now, let’s assume that both parties come up with a somewhat strange claim construction, and base all their obviousness attacks / defenses on a wrongly construed claim. In my understanding, claim construction clearly is a question of law, too (see e.g. X ZR 255/01 – ‘Bodenseitige Vereinzelungseinrichtung’ of the German Federal Supreme Court in ¶5, with further reference). But what if no party ever pointed to the relevant underlying ‘factual elements’ (i.e. specific sections of the patent in suit) that support the ‘correct’ claim construction? May the court then even come up with a different / the ‘correct’ claim construction at all?

UPDATE 21 March 2019:

Note that the FPC had held in the recent decision S2018_006 that claim construction is a question of law. In that case, both parties had not construed the feature in question at all, and the FPC came up with a construction on its own:

Wie der Begriff korrekt auszulegen ist, tragen die Beklagten hingegen ebenso wenig wie die Klägerin vor. Da die Auslegung des Patentanspruchs eine Rechtsfrage ist,15 geht die Annahme der Beklagten fehl, das Gericht dürfe den Anspruch mangels entsprechenden Vortrags der Klägerin nicht so auslegen, dass er auch etwas anderes als einen Schneidprozess erfasst.
15 Federal Supreme Court: 4A_142/2011, ¶1.3
But, again, what if both parties came up with a claim construction mutually agreed upon — but which, in the courts view, is just wrong? Or, what if both parties come up with different constructions which are both wrong in the court’s view? Can the court then correct such (a) construction(s) if it would have to rely on ‘factual elements’ that have never been pointed at by the parties, just because it is a question of law? And if that was the case, then where is the limit in the assessment of obviousness — which is a question of law, too?

The theory of separating questions of law from questions of fact is simple. But life is complicated …

On a sidenote: Wouldn’t it be good to establish common ground on what the claim actually is all about before diving any deeper? This is what a Markman hearing in the U.S. is all about. Even though I am not overly enthusiastic about quite some aspects of patent litigation in the U.S., this one certainly is useful.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_435/2018 (Supreme Court) | Decision of 29 January 2019 on appeal against O2015_018 (FPC) | Decision of 15 June 2018 | ‘Instrument d’écriture’

Guenat SA Montres Valgine (appellant)
./.
Swiss Finest SA (respondent)

and

Case No. 4A_441/2018 (Supreme Court) | Decision of 29 January 2019 on appeal against O2015_018 (FPC) | Decision of 15 June 2018 | ‘Instrument d’écriture’

Swiss Finest SA (appellant)
./.
Guenat SA Montres Valgine (respondent)
Both proceedings were jointly dealt with by the Supreme Court.

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL

Court Clerk:

  •  Nicolas CURCHOD

Representative(s) of Guenat SA Montres Valgine:

Representative(s) of Swiss Finest SA:

  • Christoph KÜNZI (CBK)

SUPREME COURT
on appeal against O2015_018 (FPC) | Decision of 15 June 2018
Case nos.: 4A_435/2018
4A_441/2018
Decision of: 29 January 2019
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PATENT COURT
Case no.: O2015_018
Decision of: 15 June 2018

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CH 704 790 B1

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CH 704 790 C1

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EP 2 497 648 B1

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Return of the non-return valves

Reading time: 2 minutes

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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Obviousness is a question of law – but the court will only pick up lines of attack that have been asserted

Case No. O2016_009 ¦ Decision of 18 December 2018 ¦ ‘Durchflussmessfühler’

Reading time: 11 minutes

HEADNOTE

Art. 226, 229 CPC New facts, amendment of patent claims.

If in a patent infringement proceeding the plaintiff files before the instructional hearing a reply limited to the defense of the validity and no pleadings take place at the instructional hearing, the plaintiff may submit new allegations of fact, and therefore also amended patent claims, in the completed reply filed after the instructional hearing without having to meet the requirements of art. 229 para. 1 CPC.

Please find some background information about the subject-matter at stake on this Blog here, and a report about the main hearing of 29 October 2018 on this Blog here.

Vyaire logo

In brief, Hamilton Medical AG alleged infringement of its Swiss patent CH 701 755 B1 (see Swissreg for further bibliographic details) by some of imtmedical AG‘s iFlow sensors. Note that Vyaire has recently taken over imtmedical’s ventilator and related consumables business; see imtmedical’s press release here.

The only independent claim 1 of CH’755 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.

Inofficially translated to English language:

Flow sensor (10) with a passage defining a cylindrical housing (10) with a first passage opening (13) and a second passage opening (29); a flow resistor (23) arranged in the passage of the housing which divides the housing into a first and a second housing part (11 and 27); a first terminal (17) having a connection to the interior of the first housing part (11); and a second terminal (19) having a connection to the interior of the second housing part; characterised in that the first and second terminals (17, 19) are spaced apart on the same housing part.

Fig. 1 of CH’755 surely helps to understand what the invention is about:

Fig. 1 of CH 701 755 B1

The defendant denied an infringement, and argued for nullity as a plea in defense.

The verbal limitation of the patent

This is what the hn is all about. Imagine a plaintiff / patentee in infringement proceedings who is confronted with a plea for nullity in defense: When is his last chance to formally assert his patent only to a more limited and presumably valid extent?

First, it is important to understand how the FPC conducts the proceedings. If the defendant raises a plea for nullity in his answer to plaintiff’s statement of claim in infringement proceedings, the FPC invites the plaintiff to file a reply which is strictly limited to only the nullity aspects of the case. What follows next is an instructional hearing. In preparation of that hearing, the limitation of plaintiff’s reply to only the nullity aspects is to assure that the court has a single exchange of opinions at hand for both infringement and nullity. If the case moves on after the instructional hearing, it is again up to the plaintiff to complete his reply. Thereafter, the defendant provides the rejoinder re both infringement and nullity. This is the end of the regular exchange of briefs in which the parties can present facts and arguments without the need to comply with Art. 229(1) CPC (novae). However, the plaintiff may of course comment on new allegations and facts presented by the defendant in his rejoinder — within a deadline set by the FPC (typically two weeks, extendable by one further week; see this Blog here), or under the unconditional right to be heard (within 10 days).

The below is an illustrative summary of this chain of events:

Plaintiff Defendant
Statement of Claim
re infringement
Answer
w nullity plea in defense
First reply
re alleged nullity only
Instructional hearing w/o pleadings
Second reply
re infringement and nullity
Rejoinder
re infringement and nullity
Comments
on new factual allegations in the rejoinder, if any
Judge rapporteur’s expert opinion

Note the subtitle to the second reply in the above: The decision holds that the plaintiff may present arguments and facts in his second reply after the instructional hearing not only relating to infringement aspects, but rather also to the nullity aspects of the case.

In the defendant’s view, the plaintiff thus had three chances to deal with validity / nullity of the patent, i.e. in his initial statement of claim and both his replies. The FPC disagreed: There is no reason for a plaintiff to deal with nullity in the beginning. How would he even do so in the absence of any knowledge of the defendant’s potential arguments? Thus, the FPC held that both parties had exchanged their views on both aspects of the case for the first time only after plaintiff’s first reply (limited to nullity). With the second reply and the rejoinder, both without limitations re novae, the double exchange of briefs is concluded.

Undoubtedly, an amended claim is to be considered a new fact (decision 4A_543/2017 of the Supreme Court, ¶2.3); as such, it would be an inadmissible novum after the normal exchange of briefs.

The plaintiff ‘verbally limited’ the claim only in his second reply. The defendant argued that this second reply was limited to only infringement aspects; it should only complement the first reply that had already dealt with nullity. Defendant argued that this was established practice at the FPC. Again, the FPC disagreed: There was not an established practice of the FPC in that sense.

now, what?!

Interestingly, the former President Dieter Brändle had apparently indicated in the instructional hearing that the patent could not be asserted in a more limited form any more after the instructional hearing. Defendant argued that it is against good faith if the limitation was now accepted nevertheless. However, the decision holds that it is up to the whole panel of judges to finally rule on admissibility of new facts; Mr. Brändle only gave his personal, preliminary opinion on this issue at that time. When the defendant had been invited to provide his rejoinder, this came along with an explicit note to deal with plaintiff’s reply as a whole, and that the whole panel of judges would finally decide on admissibility of the limitation of the patent. Thus, the defendant had no procedural disadvantage.

On a sidenote, I am wondering what the last point of time would be for a patentee / plaintiff to limit the claim when faced with a full-fledged counterclaim for nullity, i.e. when there are two parallel tracks of claim and counterclaim:

Plaintiff
Defendant
Statement of Claim
(re infringement)
Answer
re claim
Counterclaim
(re nullity)
Answer
re c’claim
Instructional hearing w/o pleadings
Reply
re claim
 
Rejoinder
re claim
Reply
re c’claim
Rejoinder
re c’claim
  Comments
on new factual allegations in the rejoinder re c’claim, if any
Judge rapporteur’s expert opinion

Would the plaintiff’s reply after the instructional hearing then be limited to the infringement part, and the final chance to limit the claim be the rejoinder re c’claim? This remains to be seen in a case to come.

General remarks on claim construction

The decision summarises certain key aspects of claim construction in ¶25 (and, later on, in ¶47). I do readily agree with most of it, but stumbled upon the following:

When case-law refers to ‘broadest interpretation’ of claim features,15 the feature must still be capable of fulfilling its purpose in the context of the invention. This means that the claim must not be interpreted under its wording, but also not in such a way that embodiments are covered which do not achieve the inventive effect.

15 FPC, decision O2013_008 of 25 August 2015, ¶4.2 — ‘elektrostatische Pulversprühpistole’ [see this Blog here]

The decision cites ample case-law, but there is no fn in the last sentence. Now, where does that come from? The sentence somehow reminds me of hn 3 of the ‘Spannschraube’ decision of the German Federal Supreme Court, X ZR 85/96 of 2 March 1999. The German Supreme Court had held:

The scope of protection of a European patent cannot be extended to embodiments which wholly (or to an extent which is practically insignificant) waive the success sought by the patent.

However, the Swiss Supreme Court had to assess the same subject-matter shortly thereafter, and explicitly disagreed; 4C.348/1999 of 12 April 2001: What had been considered to be no infringement in Germany, was well an infringement in Switzerland!

The Swiss Supreme Court did not see any reason to deviate from the literal and technically plausible meaning of the feature — even though an explicit object of the patent that had been recited in the specification was not achieved by such embodiments, i.e.  the use of very short clamping screws (see EP 0 319 521 B1, col. 1, l. 54-57):

Der Erfindung liegt die Aufgabe zugrunde, eine Rohrschelle der eingangs genannten Art zu schaffen, die sich auch mit einer sehr kurzen Spannschraube gut handhaben und leicht schliessen lässt.

It remains to be seen whether the present decision might indicate a gradual departure from the old Spannschrauben approach of the Swiss Supreme Court.

Alleged nullity 

The claims at stake can be summarized as follows, structured into features:

a) Flow sensor (10) with
b) a passage defining a cylindrical housing (10) having a first through opening (13) and a second through opening (29);
c) a flow resistor (23) arranged in the passage of the housing, which divides the housing into a first and a second housing part (11 and 27);
d) a first connection point (17) having a connection to the interior of the first housing part (11);
e) a second connection point (19) having a connection to the interior of the second housing part;
f) the first and second connection points (17, 19) being arranged at a distance from one another on the same housing part;
i) claim 4 as granted:
wherein flanges are provided on the first housing part (11) and on the second housing part (27) for connecting the housing parts with flange pressure surfaces (15, 16, 31, 32) are formed;
j) first variant of claim 10 as granted:
wherein the connections run partly in the flange pressure surfaces,
and/or
k) second variant of claim 10 as granted:
[wherein the connections] exit through the flange pressure surface as openings on the sealing surface side (17, 19, 21, 33, 35, 37) .

Features a) – f) correspond to claim 1 as granted (marked in bold in the above); the whole set of features, i.e. a) – f) and j) – k), corresponds to the claim as limited with plaintiff’s second reply. Don’t get confused by the missing features g) and h): The parties referred to these features in their feature analysis; but they are irrelevant for the present decision since they only relate to dependent claims 2 and 3 which are not at stake.

The decision holds that claim 1 as granted lacks novelty over document E10, i.e. (JP S61-205023); see Fig. 1:

JP S61-205023, Fig. 1

Next, the decision assesses and acknowledges novelty of the more limited claim over E1 (US 6,585,662 B1) which lacks features j) and k). Defendant had also argued that a prior use of the device of E1 had occured (prior use ‘Jones’). However, the decision holds that this prior use does not need to be assessed any further: Defendant had argued that the prior use disclosed a device according to the teaching of E1. Thus, the decision holds that any such prior use would necessarily also have lacked features j) and k).

Novelty over E10 (JP S61-205023; see above), E11 (JP H02-55123) and E12 (JP H03-44627) is also acknowledged in the decision.

Moving on to the assessment of obviousness, the decision emphasizes that it is up to the party that alleges nullity of a patent to make the relevant allegations. The court only examines whether the grounds put forward lead to the invalidity of the patent. Even though obviousness is a question of law, the relevant factual assertions must be made by the party that asserts nullity. In the following, therefore, the decision only deals with the assessment of obviousness starting from document E2 that has been referred to as ‘closest prior art’ by the defendant, i.e. US 4,083,245.

Features f), j) and k) are missing in E2.

With E2 as closest prior art, the decision holds that documents E7 (DE 32 25 114 C1, erroneously referred to as DE 32 25 115 C1 in the decision), E8 (US 1,768,563 A) and E9 (JP H03-21735 U) fail to render the limited claim obvious — mainly because these devices are made from metal / intended for use in high pressure applications, contrary to flow sensors in the medical field which are typically made of plastic, using die casting methods.

In sum, the more limited claim that the plaintiff had submitted with his second reply was thus held to be valid.

Infringement

Defendant most fiercely contested that the adult version of the flow sensors has flange pressure surfaces and, even if there were flange pressure surfaces, that the connections from the connection points to the inside of the first/second half of the housing run partially into or through the flange pressure surfaces. Defendant referred to the computer tomographic images that had been submitted by the plaintiff:

CT image of the flange of an attacked embodiment

The above figure shows a cross-section through the flanges of the two halves of the housing. The flow resistor which is clamped between the flanges is marked with 23. Identifiers 45 and 47 mark a groove and comb structure. Defendant argued that the gas-tight connection is made exclusively via the groove/comb structure. However, the flange surfaces would not touch each other (red arrows in the above figure); only the planes of the comb and groove that protrude perpendicularly from the flange surface would be in contact (white arrows in the above figure). Defendant argued that this is intentional because it allows flow resistors of different thicknesses to be used without the housing halves having to be designed differently, contrary to the teaching of the patent in suit. Since, by definition, flange pressure surfaces would have to lie against each other under pressure, flange pressure surfaces are missing in the adult version, in the defendant’s view. And even if the area in which the flow resistor is trapped by the flanges (marked with a yellow arrow in the figure above) were still called the ‘flange pressure surface’, no connections would occur there in any case. Defendant referred to the below figure in this respect (with the white squares / annotations added by the court):

Flange, annotated by the court

The above figure again shows a cross-section of an adult version of the flow sensor. The thin vertical line is the flow resistor; identifier 33 refers to one of the connections to a connection point which seems to end on the right because it runs diagonally in the Z plane. The decision holds that ‘flange pressure surface’ and ‘flange surface’ are used as synonyms in the patent. A flange pressure surface in the sense of the claim is the surface of a flange facing away from the body part to which the flange is attached and serving to connect the body part to another body part, whereby the connection need not necessarily be made over the entire surface.

Thus, the flange pressure surface of the attacked embodiment runs over the entire width of the flange, i.e. in the above figure from point a) to point b). Consequently, the decision holds that the connections from the connection points to the inside of the first/second housing parts also run through the flange pressure surfaces, as can be seen in the figure above.

The decision holds that the defendant may have improved the teaching of the patent in suit, and the improvement might even be patentable. This does not, however, lead out of the scope of protection of the earlier patent (cf. Art. 36 PatA). In sum, the decision holds that the version for adults is literally covered by the limited claim of the patent. Likewise, the version for children is also held to be literally covered by said claim.

Wording of the injunctive relief

The defendant objected to the wording of the request for injunctive relief, for that it is too indefinite and merely recites the wording of claim features that are under dispute between the parties (such as e.g. the term ‘flange pressure surface’). The decision holds that the features are defined in the reasons of the decision beyond any doubt, so that a mere factual check by the competent authorities is well sufficient. Thus, it is neither necessary nor helpful for each and every feature to be defined in the prayer for relief itself.

Again, this reminds me a bit of the German approach where the mere claim wording is typically used in prayers for injunctive relief, and the exact scope is then to be deduced from the reasons of the decision. I do have some symphathy for the FPC’s approach that keeps the verdict clean and simple, with all the potential ambiguities being resolved by way of definitions given in the reasons.

In sum, the defendant was ordered to abstain from further use of the infringing embodiments, and to provide information and accounting concerning the same.

The parties commented on the decision with the following press releases:

The decision is not yet final; an appeal is pending at the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_009 ¦ Decision of 18 December 2018 ¦ ‘Durchflussmessfühler’

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:

Representative(s) of Defendant:

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

DECISION IN FULL

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CH 701 755 B1

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Paying annuities may have unexpected consequences …

Case No. O2018_018 ¦ Order (excerpt) of 4 January 2019 ¦ ‘Klageüberfall’

Reading time: 3 minutes
HEADNOTE

Art. 106(1), 107(1) lit. e CPC:

Allocation of costs.

The patentee who deletes their patent from the patent register after the filing of a nullity action is liable to pay the procedural costs even if they have not been forewarned before the filing of the action.

The hn highlights in no uncertain terms the risk associated with maintaining patents of doubtful validity in Switzerland: Even in case of a nullity action out of the blue, and even if the patent is then withdrawn immediately, the patentee / defendant still has to bear the procedural costs.

Frankly, this does not come as a complete surprise. The tendency has already been clear since O2015_010, decision of 5 January 2016. The present order again confirms that Swiss law (unlike Germany, cf. § 93 DE-ZPO) does not provide for an obligation to issue a prior warning letter. With reference to the practice of the cantonal court of Zug (A3 2010 58, ‘Geburtsgel’), the order holds that clapping all costs on the defendant is justified if the defendant had

[…] given the impression by his pre-litigation conduct that he had not had the patent cancelled on mere warning.

Noteworthy, the present order holds that this conclusion can already be drawn from the mere existence of a formally valid patent. This is because the patent is cancelled if the renewal fees due are not paid on time (Art. 15(1) lit. b PatA). It would be unreasonable to assume that the patentee would pay the annuities on time but cancel the patent on first demand.

And, in fact, the patentee in the present matter did not respond immediately to the (informal) notification of the action by cancelling the patent, but rather offered the plaintiff a licence. This suggests that even in the case of a pre-litigation request, the patent would not have been cancelled immediately.

Feller logo

The order has been published in highly truncated form only. But still, I am reasonably sure about the patent at stake. Searches in Swissreg give only a single perfect fit, i.e. EP(CH) 1 204 164 B1 of Feller AG; see Swissreg. Annuities had been validly paid until 30 November 2018, but the patent had been withdrawn shortly before that date, with letter of 6 November 2018 (published in Swissreg on 8 November 2018).

The invention of EP’164 apparently is all about a screwless connecting terminal for electrical conductors, with more secure releasability of the conductors. Claim 1 reads as follows:

Device (1) with screwless terminals for connecting electrical conductors, with at least one spring comprising an elastic terminal arm (7) and a brace (2) which encloses it, where a contact tongue (8) of the terminal arm (7) cooperates with a retaining part (5) of the brace (2) so as to maintain a conductor introduced between the contact tongue (8) and the retaining part (5), where the brace (2) leaves the contact tongue (8) at least partially accessible on both sides of the retaining part (5), so that it can be acted upon from outside the brace (2) on both sides of the retaining part (5), characterized in that the brace (2) comprises a base (3) and a lateral wall (4) the upper part of which is bent so as to form the retaining part (5) in such a way that this retaining part (5) is only connected through its longer side with the lateral wall (4), and that the latter comprises at least one recess (11) in the vicinity of the extremity of the contact tongue (8).

All this is more readily understandable with Fig. 1 of EP’164 at hand:

EP 1 204 164 B1, Fig. 1

Unfortunately, I failed miserably to track the plaintiff of this case. If someone out there does know more, please let me know.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_018 ¦ Order (excerpt) of 4 January 2019 ¦ ‘Klageüberfall’

n/a
./.
Feller AG

ORDER (EXCERPT)

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EP 1 204 164 B1

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