Generic Kivexa®: Interim injunctive relief granted, appeal pending

Reading time: 6 minutes

Case No. S2018_004 | Decision of 22 October 2018

As to the background of this case, please see the report about the hearing of 10 September 2018 on this Blog here.

Appeal pending

Making a long(er) story short: The FPC granted interim injunctive relief to prohibit Sandoz from placing its generic version of Kivexa®, i.e. ‘Abacavir Lamivudine Sandoz®’, on the Swiss market. Noteworthy, Sandoz has apparently already lodged an appeal with the Supreme Court — long before the due date.

The decision is pretty straight-forward, at least at first glance. But still, it comes along with some quite pointed conclusions.

The standard of novelty

D1 (WO 96/06844) is not pre-published prior art, but might be relevant for the assessment of novelty under Art. 54(3) EPC 1973. The timeline is a bit tricky. The FPC holds that the priority claims of the patent in suit are valid, with particular reference to GB 9506490.3, claim 16. Still, D1 might be prior art under Art. 54(3) EPC if i) it had been further prosecuted before the EPO, and ii) the designation fees had been validly paid (R. 23a EPC 1973) — what is actually the case (see EPO Register), but had not been argued by the parties. The FPC thus left this issue undecided and did correctly not investigate this of its own motion. Rather, it moved on to the assessment of novelty vis-à-vis D1 as a matter of precaution, and held that novelty is given.

Interestingly, the German Federal Patent Court had apparently held in an interim assessment (which is not publicly available, to the best of my knowledge) that novelty was not given over D1. Now, how does the FPC explain the different outcome? That’s an interesting read, indeed. In a nutshell, the FPC bluntly notes that the standard of novelty is interpreted differently in Germany and at the European Patent Office — and that the FPC follows the approach taken by the EPO. Noteworthy, the FPC holds that the different standard is taken in particular with selection inventions. I am wondering: With all selection inventions, or only some kind of selection inventions? And what does in particular mean here? Is the different standard not even limited to selection inventions?

Dass das deutsche Bundespatentgericht in seiner vorläufigen Stellungnahme zu einem anderen Schluss gekommen ist, hängt damit zusammen, dass der Neuheitsbegriff in Deutschland anders interpretiert wird als vom Europäischen Patentamt, insbesondere [Anm.: Hervorhebung hinzugefügt] bei Auswahlerfindungen. Während beim europäischen Patentamt ein strenger Massstab angelegt wird hinsichtlich dessen, was im geltend gemachten Dokument des Standes der Technik für Neuheitsschädlichkeit offenbart sein muss (gewissermassen streng fotografischer Ansatz), wird gemäss deutscher Rechtsprechung ein grosszügigerer Massstab angelegt.4 D.h. ein Dokument ist gemäss deutscher Rechtsprechung bei Auswahlerfindungen eher neuheitsschädlich als gemäss Auffassung der Rechtsprechung der Beschwerdekammern des europäischen Patentamts.

Das Schweizer Bundespatentgericht folgt dem Ansatz der Beschwerdekammern des europäischen Patentamts, weswegen wie oben dargelegt Neuheit glaubhaft vorliegt.

4 Vgl. z.B. Moufang in Schulte, PatG, 10. Auflage, §3 Anm. 128 und 129.

Loosely translated:

The fact that the German Federal Patent Court came to a different conclusion in its provisional statement is due to the fact that the concept of novelty is interpreted differently in Germany than by the European Patent Office, in particular [Note: emphasis added] with regard to selection inventions. While the European Patent Office applies a strict standard with regard to what must be disclosed in the asserted prior art document in order to destroy novelty (to a certain extent a strictly photographic approach), according to German case law a more generous standard is applied.4 I.e. according to German case law a document is more harmful to novelty in selection inventions than according to the case law of the Boards of Appeal of the European Patent Office.

The Swiss Federal Patent Court follows the approach of the Boards of Appeal of the European Patent Office, which is why, as explained above, novelty is plausible.

4 See e.g. Moufang in Schulte, PatG, 10th edition, §3 Notes 128 and 129.

Practitioner may or may not share the FPC’s view in this respect. In any event, I feel that I have never seen this in writing, without any sugarcoat. Even Moufang in Schulte (referred to in fn 4 of the decision) only gives examples of decisions of the EPO and in Germany for closed numerical ranges, but does not draw any conclusions beyond that.

About motivation and expectation (of success)

The decision holds that in the assessment of inventive step the question arises whether there was a motivation for the combination of the two active ingredients and a reasonable expectation that this combination would also show the same or at least comparable effectiveness, i.e. that it is effectively a valid alternative; see ¶4.8. But there is no reference in the decision why it should be done this way.

I have mentioned earlier on this Blog here that I do not readily agree with the cumulative application of both the motivation and reasonable expectation of success criteria. And I still don’t. But this issue is not relevant for the outcome of the present matter; the decision denies a motivation and does not deal at all with the issue of a reasonable expectation.

The risk of a not easily repairable harm

Is the plaintiff actually at risk of a ‘not easily repairable harm’ as required by Art. 261(1) lit. b CPC?

ViiV corporate tree (section), as illustrated by respondent

Defendant firmly insisted in the hearing of 10 September 2018 that this is not the case, with reference to an illustration similar to the one shown on the right. In brief, plaintiff ViiV Healthcare UK Ltd is the holder of the Swiss SPC, and is fully owned by ViiV Healthcare Ltd; cf the right branch of the illustration.

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

The decision literally recites what has been argued by the defendant in the written reply to plaintiff’s request for injunctive relief (loosely translated below):

Plaintiff has failed to provide prima facie evidence, let alone to state reasons, and to prove that he would suffer any damage which could not easily be remedied if the request for interim injunctive relief was refused. In particular, the defendant contests the allegations in para. 138-141 of the application, namely the allegations (i) that the applicant would suffer damage consisting of a decrease in the number of units sold in Switzerland; (ii) that the applicant would be affected by a price review by the Federal Office of Public Health; (iii) that the applicant would suffer financial losses in the event of a price review; and (iv) that the Federal Office of Public Health would require the applicant either to reduce the ex-works price of Kivexa® or to accept a higher deductible. In any event, the defendant cannot be held liable for any losses resulting from the market entry of a second generic manufacturer (see the allegations in paragraph 1. 139 of the application regarding Art. 38 of the Swiss Care Allowance Ordinance).

Further, defendant had apparently submitted in writing (again, loosely translated):

Paragraph 14 of the request for interim injunctive relief states that ViiV Healthcare GmbH (hereinafter ViiV Switzerland) is a group company and not a subsidiary of the plaintiff. According to the extract from the commercial register (act. 1_5), ViiV Switzerland is 100% owned by ViiV Healthcare Overseas Limited (UK), which is a 100% subsidiary of the parent company of the ViiV Group, ViiV Healthcare Limited. ViiV Healthcare Limited is the sole shareholder of the applicant.

The above had been submitted under the heading ‘Parties’, but apparently not in relation to the (lack of a) not easily repairable harm. The decision holds that the fact that the plaintiff itself does not suffer any damage due to the aforementioned corporate structure, but rather ViiV Switzerland, had not been asserted by the defendant in his written reply to the request for injunctive relief, but only for the first time at the hearing on 10 September 2018 — i.e., after the closure of the file after a single exchange of briefs (see decision 144 III 117 of the Supreme Court, ¶2.2).

But even if these allegations were admitted into the proceedings, the decision holds that a not easily repairable harm would be sufficiently credible. In the FPC’s view, it is ‘obvious and notorious’ that in such group constellations of pharmaceutical companies a disadvantage that cannot be easily repaired arises for the group and thus at least indirectly also for the formal holder of the SPC. The FPC failed to see why / to what extent this should not be the case in the present setup.

Es ist offensichtlich und notorisch, dass in derartigen Gruppenkonstellationen von pharmazeutischen Konzernen ein nicht leicht wiedergutzumachender Nachteil bei der Gruppe anfällt und damit wenigstens indirekt auch bei der formellen Inhaberin des Schutzrechts. Inwiefern dies in der vorliegenden Konstellation nicht der Fall sein sollte, ist nicht ersichtlich.

As noted above, defendant has apparently already appealed the decision.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2018_004 | Decision of 22 October 2018

ViiV Healthcare UK Ltd.
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

DECISION IN FULL

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PATENT IN SUIT

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Laurastar ./. Innosteam: Register ban upheld, but what is next?

Case No. S2018_003 | Decision of 24 August 2018 | ‘chaudière-miniature’

Reading time: 4 minutes

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

We have reported on this Blog here about the provisional register ban that had been issued without hearing the defendant beforehand, and the subsequent hearing.

Laurastar logo

The main disagreement between the parties relates to the relevant time period in which the inventions had been made: While Laurastar alleges that the inventions had been made by Mr. Mantegazzi and Mr. Pasche when they had been employed by Laurastar, defendant submits that the inventions had only been made thereafter, i.e. when Mr. Mantegazzi and Mr. Pasche have been employed by the defendant.

Plaintiff inter alia relied on the following document that was undisputedly created by Mr. Pasche during his employment with the plaintiff:

act. 1_8, created by M. Pasche while employed by the plaintiff

In a nutshell, the present decision maintains the register ban while main proceedings are pending, to sort out the ownership dispute. And this might turn out to be a tricky exercise: The decision provisionally holds that the subject-matter of

  • claims 1, 5, 7, 11, 20 and 21 of WO’653; and
  • claims 1, 5, 7, 8, 9, 11 (first and second option), 22 and 23 of WO’994

had likely already been invented by the two inventors when they had been employed by the plaintiff, in fulfilment of their contractual duties. Rights in these aspects would reside with the plaintiff; Art. 332(1) CO. The two PCT applications may thus have to be partially assigned to the plaintiff (Art. 29(1) PatA) — but only in main proceedings. This co-ownership would be kind of a forced marriage. If it doesn’t work out in practice and the parties get divorced, it will be hard to cut out and reshuffle the respective shares in the inventions.

Now, how to proceed with the two PCT applications in the meantime? They need to be nationalized in early 2019, and a decision in main proceedings is unlikely to be final by then. The decision unmistakably holds that it will be up to the plaintiff to decide how to best protect his interests in this respect:

On ne saurait manifestement condamner la défenderesse à entrer dans les phases nationales dans tous les Etats contractants du PCT, car cela pourrait se révéler prohibitif. Il appartiendra à la demanderesse de décider comment sauvegarder ses intérêts une fois que le délai d’entrée dans les phases nationales approchera de sa fin, ce qui semble être le 5 janvier 2019 (pour WO’994) respectivement le 24 février 2019 (pour WO’653).

Loosely translated:

It is clearly not possible to order the defendant to enter the national phases in all the contracting states of the PCT, as this could be prohibitive. It will be up to the plaintiff to decide how to safeguard its interests once the deadline for entry into the national phases approaches its end, which appears to be 5 January 2019 (for WO’994) and 24 February 2019 (for WO’653), respectively.

Not to be missed

I am very much looking forward to see how this finally unfolds. The immanent time pressure requires some creativity to ensure that no rights in at least the most relevant designated states are lost.

On the procedural side, it is worthwile to note how the FPC dealt with a document that had been submitted by the defendant that contained additional technical data. The defendant requested that this information shall be considered by the court, but not being handed over to the plaintiff. The court held that either a redacted copy shall be submitted that can be provided to the plaintiff, or the defendant shall agree to have the unredacted version provided to the plaintiff’s attorney and patent attorney, for attorney’s-eyes-only and under threat of sanctions according to Art. 292 CC. The defendant chose to not agree to any of these options. Thus, the court did not take this additional document into account at all.

UPDATE 10 October 2018:

No appeal has been filed; the decision in summary proceedings has become final; main proceedings pending.

Reported by Leila MÜLLER and Martin WILMING

BIBLIOGRAPHY

Case No. S2018_003 | Decision of 24 August 2018 | ‘chaudière-miniature’

Laurastar SA
./.
Innosteam Swiss SA

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Giovanni GERVASIO

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

  • Dr. Ivan CHERPILLOD (Bourgeouis)
  • André ROLAND (Roland), assisting in patent matters

Representative(s) of Defendant:

  • Jacy PILLONEL (BCP)

DECISION IN FULL

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WO 2018/006994 A1

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WO 2018/036653 A1

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Claim dismissed, counterclaim dismissed: Huge expense, no recompense

Case No. O2015_018 | Decision of 15 June 2018 | ‘Instrument d’écriture’

The FPC handed down the decision in this remarkable litigation about a highly complex mechanical writing system. Please see this Blog here for a report about the main hearing and some background information.

What follows is a rather lengthy post, but this is due to the complexity of the case, both procedurally and technically.

  1. Party positions in a nutshell

It started off with Guenat‘s request that Swiss Finest‘s CH 704 790 B1 be declared invalid; note that the patent has been limited in March 2017 and re-published as CH 704 790 C1, see Swissreg for further bibliographic details. Guenat argued that the invention had been made by Frédéric Garinaud, an independent inventor who is quite renown for being the mastermind behind the Harry Winston Opus 8. Frédéric Garinaud had filed a patent application for a writing instrument; this patent application has then been assigned to Guenat and a patent was granted; EP 2 479 648 B1, see Swissreg and European Patent Register for further bibliographic details.

In Guenat’s view, the subject-matter of the Swiss Patent was invented by Frédéric Garinaud before it was used by Swiss Finest, and Frédéric Garinaud never transferred his patent rights to Swiss Finest. Guenat further argued that the invention of the Swiss Patent is obvious in view of a PowerPoint Presentation which had been sent to a third party without confidentiality obligation. Frédéric Garinaud being the only creator of the technical teachings contained in Garinaud’s European Patent and having transferred his patent rights to the plaintiff, Guenat argues that the defendant has no right to the Swiss Patent.

Swiss Finest countersued and requested that Guenat’s EP’648 be declared invalid, or assigned to Swiss Finest. Swiss Finest argued that in autumn 2010, Frédéric Garinaud had only a vague idea but had not yet completed an invention at that time. The invention was only made later with the substantial contribution of Swiss Finest’s employees after Frédéric Garinaud’s appointment as Creative Director, and any rights in the invention had been assigned to the defendant by employment contract.

Later, Swiss Finest argued that if Frédéric Garinaud was nevertheless considered to have already conceived the invention in the fall of 2010, the patent rights in this invention had been transferred to a simple partnership founded by Fabrice Thueler (owner of Swiss Finest) and Frédéric Garinaud in the preparation of a company ‘Garinaud SA’ which was foreseen to exploit the invention in dispute. Swiss Finest held thus to be the legitimate owner of the rights in the invention which is the subject of the Swiss Patent and, since the invention of the European Patent is the same, it is also entitled to the European Patent. Further, the subject-matter of the Swiss Patent was new and inventive in Swiss Finest’s view, since the PowerPoint presentation had not become publicly available because it had been sent only under an implicit confidentiality obligation. Even if one were to consider that the presentation was to be considered as prior art, the subject-matter of the Swiss patent is nonetheless inventive.

As if all this was not confusing enough, the case was spiced up further with Swiss Finest’s counterclaim for infringement by the Mechanical Fountain Pen RMS05:

Fountain Pen RMS05 by Richard Mille

This product has some amazing mechanics; see yourself:

In brief:

It’s complicated. Very complicated.

  1. The parties’ requests — and why they failed

The stage is set with a rather complicated factual situation. But at least some of the request could be dealt with quite straight forward by the court:

  1. Nullity for lack of entitlement

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. Even though the inventions in both (Guenat’s) European and (Swiss Finest’s) Swiss patent may well be the same, this did not help. Frédéric Garinaud specifically assigned only the European patent application to Guenat, but not to 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.

  1. Nullity for lack of inventive step

Novelty of Swiss Finest’s Swiss patent after partial surrender was not contested anymore. But Guenat alleged obviousness over the PowerPoint presentation that had been sent to Hamdi Chatti of Louis Vuitton in 2010, in further view of i) F. Lecoultre, Les Montres Compliquées, 3ème éd. Neuchâtel 1985; ii) Huguenin / Guye / Gauchat, Les Echappements, 2ème éd. Neuchâtel 1974; and/or EP 1 221 383 A1.

Louis Vuitton logo

With respect to the PowerPoint presentation, the parties dissented whether or not it had been sent to Hamdi Chatti with an implied confidentiality obligation. The last page of the PowerPoint presentation mentioned ‘breveté’ (‘patented’), even though the Swiss patent application had not yet been filed. Frédéric Garinaud was apparently aware of this faux-pas; he wrote to his patent attorney:

I confess I anticipated the patent application.

The decision holds that under the specific circumstances there was no implicit confidentiality obligation associated with the PowerPoint presentation.

It then remained undisputed that the PowerPoint presentation was the closest prior art. However, quite a lot of differentiating features were missing. The missing features could be grouped into three aspects, and three partial problems are dealt with in the decision:

amovibilité the removable endpiece allows wide access to the pen holder, and indirectly to the other components housed in the front part of the writing instrument, avoiding manipulation by the writing tip;
échappement the choice of an escapement as a control mechanism offering a simple and proven solution to control energy release, while producing an audible indication;
verrouillage cooperation between the actuator and the locking system to unlock the power source to release the writing tip when the actuator is actuated, without additional action.

This is the only picture from the PowerPoint presentation in the decision:

PowerPoint presentation

As to the locking system (‘verrouillage‘), the decision holds that this was readily obvious (if not implicitly disclosed already in the PowerPoint presentation). Likewise, the escapement (‘échappement‘) is held obvious in further view of Lecoultre:

Lecoultre, p. 113

However, the removable endpiece (‘amovibilité‘) was more tricky, and the decision holds that this was not obvious from the cited prior art. When seeking a solution to the problem of replacing the ink cartridge, the skilled person would not have thought of a removable endpiece. Instead, he would have e.g. made a pen in which the writing tip as such is detachably mounted on the body or tip, like e.g. in EP'383:

EP 1 221 383 A1, Fig. 1

Thus, the subject-matter claimed in Swiss Finest’s Swiss patent was held to be non-obvious over the cited prior art.

  1. Nullity for yet further reasons

Guenat argued for nullity of Swiss Finest’s Swiss patent for yet further reasons.

First, an alleged undue extension of subject-matter (Art. 26(1) lit. c PatA) in the course of the partial surrender according to Art. 24 PatA; see the B1 and the C1 version of the Swiss patent below.

Second, Guenat alleged a lack of enabling disclosure; Art. 26(1) lit. b PatA.

Without setting out all the details here, both these alleged grounds of nullity failed for apparently straight forward reasons.

  1. Entitlement to Guenat’s European patent

The invention disclosed in the European Patent was already disclosed or was obvious to a large extent from the PowerPoint Presentation prepared and sent by Mr. Garinaud on November 17, 2010; see above — with the only exception of the removable endpiece. This removable endpiece was first mentioned by Frédéric Garinaud’s patent attorney François-Régis Richard (e-patent). In an email dated December 9, 2010, he wrote to Frédéric Garinaud:

I am also realizing that for the change of the cartridge, it would probably be simpler to disassemble the pen by its front part to avoid exposing the watch mechanism in the back.

This undisputedly was the first note of the removable endpiece. Whether the rights to this creative contribution were transferred to Frédéric Garinaud, as alleged by Guenat, could remain open. In any event, it had not been alleged that François-Régis Richard transferred the rights to Swiss Finest. Rather, Swiss Finest only held that the invention was made by Frédéric Garinaud when he was employed at Swiss Finest — which could not be true given the PowerPoint presentation and the email of December 9, 2010.

The decision thus holds that the subject-matter of claim 1 of the Swiss patent was created by Frédéric Garinaud before its use by Swiss Finest — with the exception of the removable endpiece which was proposed by François-Régis Richard without having assigned his rights in this contribution to the defendant.

In anticipation of this outcome, Swiss Finest apparently modified its position later and alleged that it had obtained rights in the European Patent by virtue of a simple partnership agreed between Frédéric Garinaud and Fabrice Thueler in preparation of a company ‘Garinaud SA’ to be established.

However, this was not convincing, either. The decision holds that it is unclear how the right to the patent, even if it had been transferred to the simple partnership, should finally reside with Swiss Finest. Members of a simple partnership are joint owners of the assets, with the consequence that they can only dispose of them jointly. In any event, according to the defendant’s allegations, Frédéric Garinaud and Fabrice Thueler were the partners of the simple partnership. A patent right could therefore only belong to them jointly. However, the defendant did not allege that Frédéric Garinaud agreed to transfer the right to the patent to it.

  1. Injunctive relief

Swiss Finest’s request for injunctive relief in respect of the ‘Mechanical Fountain Pen RMS05’ failed for a lack of concreteness of the attacked embodiment. See e.g. this Blog here (O2012_004, ‘Leichtbeton’) for further information on the necessary concreteness of a request for injunctive relief.

Swiss Finest did not argue for literal infringement, but rather only for infringement under the Doctrine of Equivalents (DoE); see below. Still, the request for injunctive relief merely recited the wording of the claims, and was thus held inadmissible.

  1. Infringement by the Mechanical Fountain Pen RMS05
RMS05 (annotated)

Even though the request for injunctive relief was held inadmissible, the court still dealt with had to assess whether or not the RMS05 was infringing. Confused? I will clarify this later; see below.

It was undisputed that the RMS05 did not comprise a removable endpiece (’embout amovible’). However, Swiss Finest alleged that the function of the removable endpiece is to allow the writing tip to be removed from the pen body to allow an ink cartridge to be inserted or replaced. Swiss Finest further alleged that the fountain pen holder (indicated by the white arrow in the annotated figure) can be unscrewed and removed from the body using a wrench formed in the cap of the pen to place and replace an ink cartridge. In Swiss Finest’s view, the removable fountain pen holder inserted into the endpiece of the RMS05 amounts to an infringement under the DoE.

First, the court carefully defined the function of the removable endpiece in the context of the invention and reverted to ¶ [0015] of the Swiss patent:

It can still be noted that, to have access to the pen holder, the endpiece is screwed on the body and can therefore be unscrewed. The ink supply can then be changed by disassembling the pen holder and the intermediate holder.

The decision holds that this function does not exist in the RMS05. The endpiece is not removable and the disadvantage of the access to the fountain pen holder still remains in the RMS05. The fact that the fountain pen holder of the attacked embodiment can be removed does not change anything in this respect, because according to the Swiss Patent, after unscrewing the endpiece and facilitating access, the fountain pen holder is also removed to replace the cartridge.

As can be seen in the below screenshot of this video on YouTube, the fountain pen holder can be gripped with the cap and removed to replace the ink cartridge. However, the endpiece is fixed (indicated by the white arrow in the screenshot below).

RMS05, replacement of ink cartridge

Therefore, there is no removable endpiece in the RMS05, neither literally nor under the DoE, because the function of the removable endpiece is not realized in this pen. Thus, already the first question of the questionnaire established with O2014_002 was denied.

In sum, neither party succeeded with any attack. This somehow reminds me of the ‘Hornberg salute’:

‘Hornberger Schiessen’
  1. What the decision might be cited for
  1. Competency for assignment of all national validations of a European patent

Swiss Finest had requested that Guenat’s European patent be assigned to them. This was interpreted by the court as to concern all national validations of the meanwhile granted patent. To the best of my knowledge, it had been mentioned for the first time in O2015_009, ¶ 2.1, that the FPC is competent to decide also on ownership of foreign rights — without any in-depth discussion because it had not been decisive anymore in that case.

Not so here. The court now took the chance to set out its reasoning in any detail in ¶ 10 of the decision. The question of ownership of IP rights does not fall within the exclusive jurisdiction under Art. 22(4) of the Lugano Convention; see decision C-288/82 of the ECJ, Ferdinand M.J.J. Duijnstee ./. Ludowijk Goderbauer and further literature in fn 1 of the decision. Under Swiss national law, international jurisdiction for disputes relating to intellectual property rights is governed by Art. 109 CPIL. However, only validity and infringement actions are mentioned, but not assignment actions. Jurisdiction for actions for the assignment of an IP right, in particular a patent, is therefore determined in accordance with the general rule of Art. 2 CPIL, according to which the Swiss judicial or administrative authorities of the defendant’s domicile are competent. As the plaintiff (defendant of the counterclaim) is domiciled in Switzerland, the FPC is also competent for counterclaims relating to the transfer of foreign patents.

  1. Right to accounting

The court re-visited the right to accounting based on Art. 66 lit. b PatA in view of critical voices in the aftermath of O2013_008; see ¶ 58 of the decision (note that fn 33 erroneously refers to O2012_008). However, the decision explicitly confirms the FPC’s practice that in case the court finds infringement there is a substantive entitlement to information and accounting based on Art. 66 lit. b PatA.

  1. Request for accounting with reference to a trademark / product name

As mentioned above, the request for injunctive relief was held inadmissible for lack of concreteness. Still, the court did the whole exercise of infringement analysis. It had to because of the request for accounting. The request for accounting referred to the ‘Mechanical Fountain Pen RMS05’. Such a description would be perfectly inadmissible in a request for injunctive relief, because the product name could be changed at any time. But not so in a request for accounting. The name of a product that has been sold in the past cannot be changed anymore:

However, in the case of conduct that has taken place in the past, it is permissible to specify the allegedly infringing object by means of a type designation or trademark. Such a designation cannot be changed for the past and one therefore knows exactly which product — namely in this case the product previously offered under the designation ‘Mechanical Fountain Pen RMS05’ — is the subject of the information request.

I guess we will see more such simplified requests for accounting in the future.

  1. No mixing-up of functions of features in the test for infringement under the DoE

There is an interesting general remark in ¶ 63 of the decision, i.e.:

One cannot reasonably expand the function of a claim feature and argue that this expanded function is fulfilled by another feature of the attacked embodiment, when the same element (penholder) with the same functionality (can be dismantled to replace the cartridge) is found in the invoked patent in parallel to claimed features, and independently of it (removable endpiece).

Reported by Martin WILMING

IMAGE CREDIT

Header image (Hôtel de Ville de Neuchâtel, Salle du Conseil Général) courtesy of Lucas Vuitel – ArcInfo.

BIBLIOGRAPHY

Case No. O2015_018 | Decision of 15 June 2018 | ‘Instrument d’écriture’

Guenat SA Montres Valgine
./.
Swiss Finest SA

Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Tobias BREMI
  • Dr. Philippe DUCOR
  • Christoph MÜLLER
  • Dr. Ralph SCHLOSSER

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Nathalie TISSOT (Etude Tissot)
  • Christophe SAAM (P&TS), assisting in patent matters

Representative(s) of Defendant:

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

DECISION IN FULL

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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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FRÉDÉRIC GARINAUD

Harry Winston Opus 8

Frédéric Garinaud apparently is a master of complicated mechanics. He developed the Harry Winston Opus 8, a manually-wound watch with a ‘digital’ display of the hours and minutes.

The numbers appear only on demand, when a slide on the right side of the watch is activated. I could not help but do some further research on the Opus 8. It was a limited edition of 50 pieces only, on 9 July 2018 seen at luxurybazaar.com with a price tag of US$ 350’125,–. A somewhat fair deal in view of a purported retail price of US$ 449’700,–.

www.luxurybazaar.com; July 9, 2018

Get to know Mr Garinaud in this video, talking about the Opus 8:

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No further grounds for nullity of an SPC beyond Art. 140k of the Patent Act

Case No. O2017_016 ¦ Decision of 12 June 2018 ¦ “Verletzung Ergänzendes Schutzzertifikat; Sevelamer”

Following-up on a decision granting interim injunctive relief (reported here), the present decision in main proceedings now confirms this outcome. I have reported about the hearing in main proceedings on this Blog here.

As indicated earlier, the defendant neither disputed validity of the basic patent EP 0 716 606 B1 of Genzyme Corporation, nor that the subject-matter of the SPC C00716606/01 is covered by the basic patent or that the attacked embodiment (sevelamer carbonate) is covered by the SPC. Rather, the defendant (only) alleged 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 FPC now confirms that the list of grounds for nullity of an SPC as set forth in Art. 140k PatA is exhaustive. The alleged wrongful reinstatement is thus no valid ground of nullity. In particular, the decision refers to the dispatch of the Federal Council when the SPCs had been enacted, i.e. the note that Art. 140k is to define the grounds for nullity:

Artikel 140k Nichtigkeit: Absatz 1: Neben dem Erlöschen bzw. der Sistierung des Zertifikats müssen auch die Gründe festgelegt werden, sie seine Nichtigkeit herbeiführen.

CJEU’s logo

Further, the decision reviews the CJEU’s case law and notes that the grounds for nullity according to Art. 15 of the EU SPC Regulation 469/2009 have never been held to be an open list. Rather, the CJEU only interpreted Art. 3, violation of which is referred to as a ground for nullity in Art. 15 of the EU SPC Regulation.

The FPC notes that the defendant could 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 failed to do so. The decision is thus formally final, and the defendant has to live with it.

If there is a take away message for practitioners in this decision, then it is surely to watch out for fresh grants (not only of SPCs, but also patents, trademarks, designs, etc.), to not miss the 30 days(!) time limit for an appeal; Art. 50(1) APA. This will be the only chance to fight against e.g. a wrongful reinstatement — which is more than you will ever get e.g. at the EPO where there is no such chance at all; but still, you need to act quickly.

Yet another interesting aspect of the decision is the assessment of the value in dispute. The parties heavily disagreed. Plaintiffs had considered it to be CHF 5m, while the defendant only estimated it to be CHF 500k. The FPC had thus to decide on this issue, too; Art. 91(2) CPC. Towards this end, it relied on some interesting rules of thumb:

  1. one third of the turnover of the originator’s product is replaced by the generic within about 2 years;
  2. the profit margin of a generic is 50%.

Based on these rules of thumb, and the plaintiffs’ own statement of an annual turnover in Switzerland of CHF 2.25m p.a., the FPC considered the the value in dispute as CHF 750k, for the roughly two years of protection at stake before the SPC will finally lapse in February 2019.

UPDATE 18 July 2018:

The decision has been appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_016 ¦ Decision of 12 June 2018 ¦ “Verletzung Ergänzendes Schutzzertifikat; Sevelamer”

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

./.

Salmon Pharma GmbH

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

DECISION IN FULL

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BASIC PATENT

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Amlodipine / Valsartan: Controlling blood pressure while assessing obviousness

Case No. S2018_002 | Decision of 07 June 2018 | ‘Abweisung vorsorgliche Massnahme; Fachrichtervotum im parallelen Nichtigkeitsverfahren kein Grund für die Abänderung einer Massnahme; fehlende relative Dringlichkeit’

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

The patent in suit is EP 2 322 174 B1; see EPO Register and Swissreg for further details. It relates to a fixed dose combined unit dose form of two active ingredients for effective control of blood pressure, i.e. amlodipine and valsartan. The former is a dihydropyridine calcium-channel blocker, the latter is an angiotensin II antagonist.

Déjà-vu, you think? Indeed!

A first request for interim injunctive relief had been dismissed with decision of June 1, 2017; see S2017_001. At that time, the claimed subject-matter had been held obvious over Corea in further view of the skilled person’s knowledge. Separately, nullity proceedings had been pending at that time — and they are still pending now; O2016_006. The main hearing is scheduled for August 21, 2018; see here.

What has changed since then is that the patent has been maintained by an Opposition Division of the EPO in first instance at the end of a hearing on December 6-7, 2017. The reasoned decision has been issued on February 8, 2018; see here. Appeal proceedings are still pending at the EPO.

Wind of change?

In the aftermath of the EPO’s first instance decision, the wind has somewhat changed: While the Düsseldorf Regional Court had initially dismissed the request for injunctive relief (decision 4c O 6/17 of April 10, 2017, the Higher Regional Court overturned the decision of the Regional Court and granted interim injunctive relief (decision I - 2 U 18/17 of December 14, 2017), in consideration of the decision of the EPO’s OD. But it is not only that the wind has changed in Düsseldorf from the first to the second instance. Even the judge-rapporteur in both the first summary proceedings and the nullity proceedings at the FPC has changed his mind and gave an expert opinion in parallel nullity proceedings that the claimed subject-matter was non-obvious. The prior art and the arguments on file are still essentially the same, and it remains to be seen how the panel of five judges will actually decide.

In view of the above, Novartis again requested interim injunctive relief. The FPC noted that a second request for interim injunctive relief is possible in general, but only when the circumstances have changed. And even though this is the case here in view of the parallel decisions elsewhere, the FPC still denied the request. It did so because the facts (i.e. the relevant prior art documents) have not changed, but rather only the legal assessment thereof; ¶4.3.

Vorliegend ist […] zu berücksichtigen, dass die von den Klägerinnen genannten Parallelurteile nicht neuen Stand der Technik behandeln, sondern den schon im ersten Massnahmeverfahren bekannten Stand der Technik anders würdigen.

The FPC held that assessment of validity of the patent in suit apparently is a borderline case which requires in-depth assessment in main proceedings; ¶4.4.

Vielmehr bedarf die Klärung der Frage der Rechtsbeständigkeit des Klagepatents einer eingehenderen Prüfung im ordentlichen Verfahren.

Moreover, the FPC held that there was no urgency anymore. A decision in the present summary proceedings could not be expected substantially earlier than a decision in parallel nullity proceedings, if earlier at all.


Further, the FPC noted that Novartis could have well initiated main proceedings for infringement at any time since defendant’s product launch in January 2017, and now has to live with the consequences of not having done so.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2018_002 | Decision of 07 June 2018 | ‘Abweisung vorsorgliche Massnahme; Fachrichtervotum im parallelen Nichtigkeitsverfahren kein Grund für die Abänderung einer Massnahme; fehlende relative Dringlichkeit’

  1. Novartis Pharma AG
  2. Novartis Pharma Schweiz AG

./.

Mepha Pharma AG

Panel of Judges:

  • Dr. Daniel KRAUS
  • Dr. Tobias BREMI
  • Prisca VON BALLMOOS

Reporting Judge:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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PATENT IN SUIT

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Multicasting and Software: Too soft to be described?

Case No. S2018_001 | Decision of 23 May 2018 | ‘Vorsorgliche Massnahmen / Beschreibung’

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

The plaintiff Two-Way Media requested that, in accordance with Art. 77(1) lit. b PatA, a precise description be made of certain infrastructure and processes relating to Swisscom’s internet-based televion (IPTV) products Swisscom TV 1.0, Swisscom TV 2.0 and TV Air. Swisscom was one of the first providers worldwide of IPTV, with about 1m customers already in 2013; see here.

Screenshot www.swisscom.ch
Screenshot www.swisscom.ch; see live here
  1. What the patents are all about

The two patents in suit are EP 2 323 333 B1 (see the EPO Register and Swissreg for further information) and EP 2 278 775 B1 (see the EPO Register and Swissreg for further information). Both patents have already lapsed in May 2017.

The patents generally relate to the communication of audio or video content over a network, such as the Internet. More specifically, certain processes and products for the provision of real-time audio and/or video communication services to a wide range of users are concerned.

The patents propose a multi-casting system with a scalable distribution architecture and a scalable control architecture that provides for superior management and administration of users who are to receive the information. In addition to the provision of real-time audio and/or video communication services to a large number of users, the operator can also provide related follow-on offerings based on the behaviour of a user who has registered and authenticated himself in advance.

  1. Parallel proceedings elsewhere

The defendant inter alia argued that validity of the patents was doubtful, with reference to a decision of the CAFC in the U.S. and the fact, that infringement proceedings based on validations of both European Patents in Germany are stayed while nullity proceedings are pending.

However, the reasoning from the U.S. could not be applied to the present matter, and the defendant did not provide any material arguments for invalidty. The decision thus holds that invalidity has not been sufficiently substantiated.

Eine materiell-inhaltlich begründete Auseinandersetzung zur Nichtigkeit der hier massgeblichen Streitpatente wird von den Beklagten nicht vorgetragen und eine solche ist daher nicht glaubhaft gemacht.

  1. Legitimate interest

The decision holds that the requests at least partially pertain to facts which are accessible to the plaintiff even without judicial intervention, and that it therefore is questionable whether there is a legitimate interest to that extent; Art. 59(2) lit. a CPC.

Further, the decision holds that it was not clear to what extent the current state of affairs could allow conclusions to be drawn for a possible patent infringement before May 2017. The plaintiff could and should have argued that the current system of the defendant corresponds to the system in place at the time before the expiry of the patents, or to what extent which current facts allow conclusions to be drawn about the system in place at that time.

  1. Financial claims

As mentioned above, the patents in suit have already lapsed. Thus, only infringment in the past is at stake — incl. compensation for damages, and the right to information.

The decision holds that a description according to Art. 77(1) PatA indeed is possible even after a patent has lapsed.

Wenn eine Beschreibung auch dazu dienen kann, um Beweismittel zu beschaffen bzw. um die Prozessaussichten für Verletzungshandlungen während der Wirksamkeit bzw. der Gültigkeitsdauer eines Patents abzuklären […], dann muss sie grundsätzlich auch nach Erlöschen des Patents möglich sein. […] Es genügt, wenn ein der Klägerin zustehender Anspruch verletzt ist. Demnach schliesst Art. 77 PatG die Anrufung eines bloss finanziellen Anspruchs nicht aus.

However, the decision further holds that the plaintiff has to substantiate his financial claims with the request for description, but did not do so.

Allerdings ist […] der der Klägerin zustehende finanzielle Anspruch, resultierend aus einer in der Vergangenheit erfolgten Patentverletzung, zu substantiieren und glaubhaft zu machen. Zu Schaden, Widerrechtlichkeit und Kausalität eines konkreten Schadens äussert sich die Klägerin jedoch nicht; ein ihr zustehender Anspruch wurde damit nicht einmal substantiiert behauptet.

On a personal note: Isn’t that at odds with the hn and reasons of O2013_008?

  1. How to describe software-implemented processes

The defendant argued that software-implemented processes were not accessible to sensual perception and could therefore not be the subject of a precise description within the meaning of Art. 77(1) lit. b PatA.

The FPC did not agree. Rather, everything that can be described technically in the context of an inspection is accessible to a precise description. But when the target of the description cannot be directly assessed, then it is the plaintiff’s task to to give precise instructions how to obtain specific findings so that the software-implemented processes can be concluded from such findings.

Die Klägerin hätte, um ihrer Substantiierungspflicht nachzukommen, mit ihrem Gesuch konkret angeben müssen, wie was wo genau beschrieben werden kann und soll bzw. welche angeblich gespeicherten Informationen wie angezeigt und betrachtet werden können.

Welcome to the jungle

The decision gives some examples of how software-implemented processes could be indirectly described, e.g. by measuring temperatures in a software-controlled manufacturing process. But how would you do that when only data is concerned, and you cannot know how the data is actually handled by the defendant? Is a description then really available? Reading between the lines of the decision, I have my doubts. The decision suggests that there may well be situations where a plaintiff just cannot meet his burden of substantiation.

Kann oder will der Antragsteller seiner diesbezüglichen Substantiierungslast nicht nachkommen, kann ihm das Gericht dies nicht abnehmen ohne die Dispositionsmaxime zu verletzen (Art. 55 Abs. 1 ZPO).

The FPC thus dismissed the request for a precise description.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2018_001 | Decision of 23 May 2018 | ‘Vorsorgliche Massnahmen / Beschreibung’

Two-Way Media Ltd.

./.

  1. Swisscom (Schweiz) AG
  2. Swisscom AG

Panel of Judges:

  • Dr. Rudolf RENTSCH
  • Peter RIGLING
  • Frank SCHNYDER

Judge-rapporteur:

  • Peter RIGLING

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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EP 2 323 333 B1

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EP 2 278 775 B1

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Struggling with the burden of proof

Case No. O2015_009 ¦ Decision of 21 March 2018 ¦ ‘Wärmeaustauschelement: Feststellung der gemeinsamen Berechtigung an der Anmeldung’

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

HEADNOTE

Art. 58(1) CPC
Binding nature of prayers for relief, principle of party disposition

The request that the court should find the plaintiff to be solely entitled to a patent or patent application includes a maiore minus the request that the court should find the plaintiff to be entitled to the patent or patent application together with another party (see r. 2.3).

This case is an assignment action of Marcel Riendeau against Zehnder Group International AG. Some background information on this case can be found on this Blog here.

Two European patent applications are concerned, i.e.:

Both EP2 and EP3 had been filed in Zehnder’s name only; the plaintiff had been designated only as inventor.

Independent claims 1 of both EP2 and EP3 are all about methods for the production of enthalpy heat exchanger elements; they read as follows:

EP2 EP3
1. Method for the production of enthalpy exchanger elements comprising steps of:
a perforating a flat plate element (1) according to a predetermined perforation pattern within the plate outer dimensions; perforating a flat plate element (1) according to a predetermined perforation pattern (2, 2, …) within the plate outer dimensions;
b forming the plate element (1) into a desired embossing pattern and geometrical shape; and applying to at least one side (1a) of the plate element (1) a thin polymer film (3) with water vapor transmission characteristics […];
c applying to at least one side (1a) of the plate element (1) a polymer film (3) with water vapor permeation characteristics […]. forming the plate element (1) into a desired shape exhibiting a corrugation pattern (4, 4, …), whereby the polymer film (3) is formed into the same corrugation pattern shape as that of the plate element (1).

This can be best understood with the following figures at hand:

The decision is pretty exhaustive; I feel the most relevant issues of potentially broader interest are the following:

Admissibility of late requests

The plaintiff had requested with the rejoinder that his sole ownership of the patent applications be declared. An explicit auxiliary request for declaration of co-ownership was submitted in reply to the expert opinion of the judge-rapporteur. This request was not admitted into the proceedings anymore, with reference to O2015_009.  However, the decision holds that the request for sole ownership includes a majore minus the request that the plaintiff is not the sole owner but rather only co-owner together with others (see hn). In contrast to a new version of the patent applications like in O2015_009, this does not constitute a new issue.

This finding is in-line with how such situations are addressed in Germany; see the German Supreme Court decision X ZR 139/03 'Schneidbrennerdüse'.

Allocation of the burden of proof

The person who claims to derive rights from it must prove the existence of an alleged fact; Art. 8 CC. The decision thus holds that it is up to the plaintiff to prove all elements of the test outlined in O2012_001 (r. 27), i.e.

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

It is reiterated again that dependent claims and even the specification have to be dealt with. Only subordinate and routine details can be ignored.

Eine Patentanmeldung umfasst regelmässig technische Lehren, die über den Gegenstand der unabhängigen Ansprüche hinausgehen respektive diesen wesentlich weiter konkretisieren. Solche Gegenstände können sich in den abhängigen Ansprüchen, aber auch in der Beschreibung finden. Wer behauptet, alleiniger Erfinder der in einer Patentanmeldung offenbarten Lehre zu sein, muss daher darlegen, dass er der geistige Urheber aller darin der Fachperson unmittelbar und eindeutig offenbarten Lehren ist, soweit es sich bei den offenbarten technischen Details nicht um untergeordnete, bloss handwerkliche Details handelt.

The decision does not expand further on how to assess whether a certain feature or technical detail is merely a subordinate element / routine detail or not. This still remains to be seen in cases to come.

Further, the plaintiff needs to prove that no rights had been assigned to the defendant; see below. However, this is an indefinite negative fact and the defendant is thus required to at least substantiatedly assert why he believes that the right had been assigned; see BGE 119 II 305, r. 1b; 4C.64/2003, r. 4.

Authorship of draft applications does not prove (sole) inventorship

The decision holds that the mere fact that the plaintiff had (undisputedly) drafted first versions of the patent application(s) does not yet prove that he had invented the respective subject-matter solely on his own. In the view of the defendant, the draft patent application(s) only summarized the results of the joint development. Since the burden of proof lies with the plaintiff in this respect, the decision holds that he has to bear the consequences of the remaining doubt.

In any event, it remained undisputed that the plaintiff is one of the inventors of the subject-matter of EP2 and EP3.

Contractual assignment?

The parties have agreed in the main hearing to submit their contractual relationship to Swiss law. In an overall assessment of the allegations and evidence, the decision holds that the parties could neither agree on a written consultancy agreement which would have provided for an explicit transfer of rights, nor did they live it unconditionally. The oral work order to the plaintiff did not clearly include the task of making inventions. The defendant is therefore not the legal successor of the plaintiff with regard to the rights to the patents to which he is entitled on the basis of his position as (co-)inventor.

The right to claim priority

The plaintiff had requested that the claims to priority of EP2 and EP3 in the corresponding PCT applications WO’544 and WO’543 were to be deleted. Towards this end, the decision holds that for a valid priority claim only formal identity of the applicant(s) at the time of filing of the applictions is required; it is referred to T1201/14 (r. 3.2.1.1 ff.), T5/05 and T788/05 in this respect. In the case at hand, identity of the applicant of both the PCT applicantions and the EP priority applications had been the same (Zehnder). On the other hand, the decision also holds that even if one would assume that the legally correct ownership would be decisive, the result would have been the same since both parties are jointly entitled to both the priority applications and the PCT applications. The request was thus dismissed.

Is the EPO doing it wrong?

That could have been it. But in a surprisingly clear-cut obiter dictum the decision holds that the EPO constantly gets priority issues wrong. It is held that contrary to the case law of the Boards of Appeal of the EPO (e.g. T788/05 (r. 2) and T382/07 (r. 9)), it is sufficient for the priority claim under Art. 87(1) EPC to be valid if at least one of the applicants of the prior application and one of the applicants of the subsequent application are identical. Note that this is the approach taken e.g. in the U.S., see MPEP. If a person that is no longer named as applicant in the subsequent application wishes to assert substantive claims to the patent, he may do so before court.

Entgegen der Rechtsprechung der Beschwerdekammern des EPA genügt es […], wenn wenigstens einer der Anmelder der Voranmeldung und einer der Anmelder der Nachanmeldung identisch sind. […] Soweit in der Nachanmeldung nicht mehr als Anmelder genannte Personen materielle Ansprüche auf das Patent geltend machen wollen, können sie das auf dem Wege der Abtretungsklage tun.

Making a long story short, the decision holds that the parties are jointly entitled to both patent applications.

The decision is not yet final / still open for appeal to the Supreme Court.

UPDATE 08 May 2018:

The decision has been appealed to the Supreme Court.

UPDATE 04 October 2018:

The appeal has been dismissed by the Supreme Court (4A_277/2018; reasons not yet available).

Reported by Martin WILMING


BIBLIOGRAPHY

Case No. O2015_009 ¦ Decision of 21 March 2018 ¦ ‘Wärmeaustauschelement: Feststellung der gemeinsamen Berechtigung an der Anmeldung’

Marcel Riendeau
./.
Zehnder Group International AG

Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Tobias BREMI
  • Dr. Philipp RÜFENACHT
  • Dr. Ralph SCHLOSSER
  • Dr. Christoph WILLI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Stefan KOHLER (Vischer)
  • Delia FEHR-BOSSHARD (Vischer)
  • Benoit YELLE (Gowling), assisting in patent matters
  • Matthew FINN (Gowling), assisting in patent matters
  • Dr. Martin WILMING (Hepp Wenger Ryffel), assisting in patent matters

Representative(s) of Defendant:

DECISION IN FULL

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EP 2 829 834 A1
(referred to as EP2 in the decision)

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EP 2 829 836 A1
(referred to as EP3 in the decision)

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Omega ./. Montres Tudor et al. — Finding balance …

Case No. O2015_008 ¦ Decision of 14 March 2018 ¦ ‘Balancier de montre’

Omega logo

We have reported on the background of this case and the main hearing on this Blog here. In brief, infringement of Omega‘s EP 1 837 719 B1 is at stake; see EPO Register and Swissreg for further bibliographic details.

The single independent claim 1 as granted reads as follows:

Balance for a timepiece movement including a felloe (3), arms (4) connecting the felloe (3) to the balance staff and inertia blocks (11) for adjusting the unbalance and regulating the moment of inertia, characterized in that the felloe (3) includes studs (7) directed inwards, a threaded hole (9) into which said inertia blocks (11) are screwed from the inside, passing through said felloe (3) and said studs (7).

This is best understood with the figures of the patent at hand:

Tudor logo

The attacked embodiments are Tudor‘s calibres MT5621 and MT5612. Defendants Tudor and Detech denied infringement and countersued for invalidity.

Let’s get to the details now, at least to some extent. The decision is a booklet of 58 pages, and I will thus only comment on what I believe are the most relevant issues of the case.

The requests

Faced with a counterclaim for invalidity, Omega defended the patent substantially as granted as the main request (MR; see the slight amendment in feature #5, below), and with two auxiliary requests (AR1 and AR2) to a more limited extent only. In the feature analysis below, claim 1 according to the MR is structured into features 1-7. Claim 1 according to AR1 comprises features 1-8, and AR2 comprises features 1-9, respectively.

FR EN
1 Balancier pour mouvement d’horlogerie Balance for a timepiece movement
2 comportant une serge (3) including a felloe (3)
3 des bras (4) reliant la serge (3) à l’axe de balancier arms (4) connecting the felloe (3) to the balance staff
4 et des masselottes (11) permettant d’ajuster le balourd et de régler le moment d’inertie and inertia blocks (11) for adjusting the unbalance and regulating the moment of inertia
5 caractérisé en ce que la serge (3)  comporte des plots (7) dirigés radialement1 vers l’intérieur characterized in that the felloe (3) includes studs (7) directed radially1 inwards
6 ladite serge (3) et lesdits plots (7) étant traversés par un trou taraudé (9) a threaded hole (9) passing through said felloe (3) and said studs (7)
7 dans lequel lesdites masselottes (11) sont vissées depuis l’intérieur into which said inertia blocks (11) are screwed from the inside
8 les masselottes peuvent être mues indépendamment les unes des autres2 the inertia blocks can be moved independently of each other2
9 le serge présente unse surface externe de diamètre constant sur tout son pourtour3 the felloe has an external surface of constant diameter all around its circumference3

1 Note that ‘radialement’ / ‘radially’ is not included in claim 1 as granted.
2 Additional feature of claim 1 in AR1 vis-à-vis the MR.
3 Additional feature of claim 1 in AR2 vis-à-vis AR1.

Omega’s requests for injunctive relief are adapted accordingly in MR, AR1 and AR2, to conform with the respective requests to maintain the patent. The requests for injunctive relief additionally refer to an illustration of the attacked embodiment that is reproduced below. However, I have amended the reference numbers in accordance with those used in the patent.

Illustration of the claim features included in the requests for injunctive relief

The element marked-up with ‘Δ’ in the above illustration refers to a feature which was not literally fulfilled by the attacked embodiment, but for which infringement under the DoE was alleged, i.e. feature #7 in the table above:

the inertia blocks (11) are screwed [into the threaded hole (9)] from the inside

Rather, the request for injunctive relief read as follows:

les masselottes sont dépourvues de tête et dotées de lobes internes permettant leur vissage depuis l’extérieur de la serge

I.e., in English language:

the inertia blocks are headless and equipped with internal lobes allowing them to be screwed from outside the felloe

Claim construction re feature #7

Now, what does it mean in French that

les masselottes sont vissées depuis l’intérieur?

Does it only require that the inertia blocks can be adjusted from the inside, irrespective of how / from which direction they had been initially placed in the hole, i.e. from the inside or outside of the felloe? Or is it mandatory that the inertia blocks at least could have been placed in the hole from inside of the felloe? Note that EP’719  only discloses inertia blocks with heads (13) that cannot go through the hole, i.e. they must be / have been placed from inside of the felloe; see e.g. ¶[0010].

Anyway, I leave this tricky linguistic question to the francophones to decide for themselves. The decision holds that this feature #7 only requires that the inertia blocks could have been inserted and screwed from the inside during the assembly of the balance wheel (by an access between the serge and the centre of the serge) in the hole traversing the stud and the felloe.

Consequently, feature #7 does not cover inertia blocks which, already present in the tapped holes of the serge and the studs, can be screwed from the inside for the purpose of adjusting the inertia and unbalance, but which would not have previously been inserted and screwed into the corresponding hole from the inside of the felloe.

Novelty

The balance wheel in DE 864 827 comprises a stud (‘plot’) in the sense of feature #5; see the section 1g in the figures below . But since the screws with the inertia blocks have a head on the outside of the felloe, they do not meet the definition of feature #7 as construed above.

Novelty over DE 864 827 was thus acknowledged.

On the other hand, the balance wheel of US 759,914 has inertia blocks must have been placed from the inside; see the screw head on the inner side of the felloe in the figures below.

But what is missing here is the stud (‘plot’) according to feature #5. Thus, novelty was acknowledged over US 759,914.

The balance wheel of US 2,958,997 has some axial screws (21) which are not inertia blocks. On the other hand, it is not possible that the inertia blocks (3) have been placed from the inside since the screw head is outside of the felloe.

US 2,958,997 (Fig. 4)

Features #6 and #7 were not considered anticipated, and novelty was thus acknowledged.

Finally, novelty over the balance wheel ‘Jean Martin’ is discussed, a photograph of which is reproduced in the decision (don’t blame me for the poor quality, it’s in the original):

Balance wheel ‘Jean Martin’

Here, the studs are arranged axially on top of the felloe. The hole thus only passes through the stud, not through the felloe. Features #6 and #7 were not considered anticipated, and novelty was thus acknowledged.

Inventive step

Inventive step has been assessed on the basis of US 759,914 as closest prior art; see figures above. The distinguishing features are #6 and #7, i.e. the studs (which are directed inwards), and the inertia blocks arrangeable in a hole through the stud (and the felloe) from the inside.

Following Omega’s proposal, the objective technical problem has been defined as follows:

Increasing the diameter of a balance wheel without modifying its inertia.

Now, here is the definition of a stud (‘plot’) according to Berner (FR/EN):

Petite pièce métallique, généralement cylindrique qui sert de butée ou qui renforce la partie d’une pièce qui doit recevoir une goupille ou une vis.

Small metal part, usually cylindrical, used as a stop or as a means of strengthening a part that takes a pin or screw.

It is held in the decision that, with this skilled person’s knowledge in mind, it was obvious to arrange studs on the felloe to reinforce the holes. But on which side? On the inside or the outside of the felloe? When placed on the inside, the diameter of the felloe can be larger. Anyway, with reference to T107/02 and T739/08, it is held that a choice from a very limited number of alternatives without an unexpected effect cannot be considered inventive.

The auxiliary requests did not succeed, either. As to AR1, the inertia blocks can be moved independently of each other already in US 759,914. As to AR2, the felloe has an external surface of constant diameter all around its circumference already in US 759,914.

Late request – belated?

Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. This request was not admitted into the proceedings anymore, with reference to O2015_012. In particular, the decision holds that the expert opinion did not contain new facts or arguments of a technical nature which had not been argued by the parties.

In a nutshell

Omega’s claim for infringement has been rejected, Tudor’s / Detech’s counterclaim for invalidity has been allowed and EP(CH) 1 837 719 B1 declared invalid.

The decision can still be appealed to the Supreme Court.

UPDATE 14 May 2018:

The decision has been appealed to the Supreme Court.

UPDATE 22 October 2018:

The appeal has been dismissed by the Supreme Court (4A_282/2018; reasons not yet available).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_008 ¦ Decision of 14 March 2018 ¦ ‘Balancier de montre’

Omega S.A.

./.

  1. Montres Tudor S.A.
  2. Detech S.A.

Judge(s):

  • Dr. Mark SCHWEIZER
  • Frank SCHNYDER
  • Dr. Tobias BREMI
  • Dr. Philippe DUCOR
  • Christoph MÜLLER

Judge-rapporteur:

  • Frank SCHNYDER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendants:

FULL TEXT DECISION

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PATENT IN SUIT

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Whose invention is it?

Case No. S2017_008 ¦ Decision of 29 December 2017 ¦ “Abweisung vorsorgliche Massnahme, Abtretungsanspruch nicht glaubhaft”

Yet another ownership dispute:

Fig. 1b of WO’036

PCT application WO 2016/125036 A1 is at stake; the national phase has already been entered in Switzerland, China, South Korea, USA and at the European Patent Office; please find further information about the patent family here.

The present decision pertains to some interim measures. Inter alia, the plaintiff had requested that an order be issued to the defendant to not dispose of the applications in suit in any way, or to let them lapse. Main proceedings to actually sort out the right in the invention are still pending; O2017_026. See the full complaint below.

The plaintiff had initially been named as an inventor and is still listed on the title page of the PCT application as published, but has later been deleted on request of the applicant while still in the international phase.

The plaintiff essentially relied on an SMS and MMS that he had submitted to the defendant on 6 November 2013:

Bei der PCT-Anmeldung […] handelt es sich um die dargestellte Erfindung des Klägers, die dieser […] am 6. November 2013 D. bzw. der Beklagten mitgeteilt hat; es liegt technische Übereinstimmung vor. Weitere Ausführungen im Bestreitungsfalle bleiben vorbehalten.

MMS and SMS of November 6, 2013

The decision holds that this is obviously not sufficient to establish a prima facie case of entitlement to a patent application of 13 pages, 17 figures and 13 claims. The (then) President notes that the plaintiff failed to show that the three necessary elements (in particular the last one) are met, i.e.

  • that he actually made the invention (what exactly, when, where and how);
  • how the defendant has been made aware of this invention; and
  • how the subject-matter claimed by the defendant actually corresponds to this invention.

For the sake of completeness, the decision also recites two features from claim 1 of the PCT application which cannot be derived from the MMS and SMS. The plaintiff thus failed to show by prima facie evidence that he has any right in the invention at stake.

Further, there was no indication of any urgency on file, i.e. that the defendant might actually undertake any of the actions that were sought to be forbidden. The requested interim measures were denied also for this reason.

UPDATE 10 March 2018:

I just noticed that actually two applications are pending in the U.S., i.e. a continuation application of the PCT application in the name of the plaintiff (US 2017 / 0325923 A1) and a further national phase entry based on the same PCT application in the name of the defendant (US 2018 / 0000560 A1). It remains to be seen how these two applications will interfere with each other during prosecution.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2017_008 ¦ Decision of 29 December 2017 ¦ “Abweisung vorsorgliche Massnahme, Abtretungsanspruch nicht glaubhaft”

David Bensoussan ./. ROCK dental AG

Judge(s):

  • Dr. Dieter BRÄNDLE

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • n/a

DECISION IN FULL

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The correct case no. is S2017_008, as indicated on the title page. Don’t be misled by case no. S2017_002 in the header of pages 2 ff of the decision; that’s a typo.

COMPLAINT AS FILED

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UPDATE 07 March 2018:

Upon intervention of plaintiff’s counsel, I have deliberately redacted plaintiff’s private address and the signatures of plaintiff’s counsel from the complaint, without acknowledging any legal obligation to do so. The writ is freely available in unredacted form in the European Patent Register since 29 December 2017.

PATENT APPLICATION IN SUIT

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It Ain’t Over ’til It’s Over

Case No. O2017_019 ¦ Decision of 21 December 2017 ¦ “Pemetrexed: Abweisung der Feststellungsklage auf Nichtverletzung (Rückweisung O2015_004)”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.
Lenny Kravitz; (c) Gage Skidmore, CC BY-SA 3.0
“It Ain’t Over ’til It’s Over” (Lenny Kravitz; © Gage Skidmore, CC BY-SA 3.0 license)

Pemetrexed revisited, once again:

As reported earlier on this Blog here, the Supreme Court had remitted the case to the FPC with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.

Well, the first part is a no-brainer. The FPC is bound to the legal assessment of the Supreme Court, and it thus dismissed the suit with respect to the diacid.

As to the two other salts, i.e. pemetrexed dipotassium and pemetrexed ditromethamine, the FPC briefly assessed infringement under the doctrine of equivalents.

The first question to be answered in the assessment of infringement under the DoE is whether the replaced feature and the replacing feature have the same objective function. The decision holds that it is only the cation that is different, and that the dianion is the same in any event. Further, it is held that both the dipotassium and the ditromethamine salt will be dissociated under physiological conditions, and everything suggests that the mode of action is determined by the dianion.

Pemetrexeddikalium unterscheidet sich von Pemetrexeddinatrium bzw. Pemetrexeddisäure lediglich durch das Kation. Das Dianion ist in allen Fällen identisch. Pemetrexeddikalium liegt bei physiologischem pH dissoziiert in Kation und Dianion vor. Es spricht alles dafür, dass die Wirkungsweise durch das Pemetrexed-Dianion gegeben ist.

Aus diesen Gründen ist eine Gleichwirkung für Pemetrexeddikalium gegeben ist.

One may like or dislike the outcome as it is. Be this as it may. What is troubling me is that this reasoning is only focused on the mode of action of the dianion. Note that the dianion neither is the replaced feature nor the replacing feature. Does this reasoning actually address the first question of the FPC’s questionnaire for the assessment under the DoE at all?

Does the replacing feature objectively fulfil the same function? (‘Gleichwirkung’)

Is there a need to rephrase the first question? Time will show, I guess.

The FPC answered the second and third question in the affirmative, too. It did so by mere reference to the considerations of the Supreme Court.

In sum, all three pemetrexed forms (diacid, dipotassium and ditromethamine) are held to infringe the patent in suit.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_019 ¦ Decision of 21 December 2017 ¦ “Pemetrexed: Abweisung der Feststellungsklage auf Nichtverletzung (Rückweisung O2015_004)”

Actavis Switzerland AG

./.

(1) Eli Lilly and Company
(2) Eli Lilly (Suisse) SA

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Roland DUX
  • Prisca VON BALLMOOS

Judge-rapporteur:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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PATENT IN SUIT

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The wording of a Swiss SPC does not (really) matter … (?)

Case No. S2017_006 ¦ Decision of 12 October 2017 ¦ “Gutheissung vorsorgliche Massnahme, ESZ Kombinationspräparat”

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

Infringement of a supplementary protection certificate (SPC) is at stake again. The FPC had granted ex parte interim injunctive relief; see this Blog here. Interim injunctive relief has now been confirmed.

The SPC concerns (emphasis added)

SD.-fumarat + T.

On the contrary, defendant’s attacked embodiment comprises SD.-phosphate and T.

The FPC held that this is still ‘the product’ in the sense of Art. 140d PatA, with reasons essentially as follows:

The codified definition of ‘product’ is ‘active ingredient or combinations of active ingredients’; Art. 140a(2) PatA. According to the Federal Council Dispatch (p. 729), this refers to the active ingredient or combination of active ingredients that is used in the medicament.

[Bei Erzeugnissen] handelt es sich […] nicht um das (Human- oder Tier-)Arzneimittel, so wie es als pharmazeutische Spezialität genehmigt wird, sondern um den Wirkstoff oder die Wirkstoffzusammensetzung, welche(r) in einem solchen Arzneimittel Anwendung findet.

IPI
IPI

The FPC holds that the term ‘product’ shall be construed consistently in the registration process and when it comes to assessment of the scope of protection. The FPC then refered to the Guidenlines on Examination of the IPI. The Guidelines hold that different salts or esters of an active ingredient are regarded as one and the same chemical substance / product, unless the specific salt or ester has an influence on the pharmacological effect (which would then need to be derivable from the patent).

Liegen für einen Wirkstoff mehrere Genehmigungen für jeweils unterschiedliche Salzformen oder Ester vor, so werden diese grundsätzlich als ein und dieselbe chemische Verbindung respektive als ein und dasselbe Erzeugnis betrachtet. Diese Salze bzw. Ester dienen der Handhabung bei der Herstellung, Verarbeitung oder Verabreichung (z.B. Verbesserung der Löslichkeit) oder Stabilisierung des Wirkstoffs. Ist beispielsweise eine Carbonsäure je separat als freie Säure, als Natrium- und Kaliumsalz zugelassen worden, so ist die früheste dieser drei Genehmigungen massgebend.

Hat jedoch die Salzform (bzw. das Gegenion) oder die Estergruppe einen Einfluss auf die pharmakologische Wirkung im Körper, handelt es sich um eine neue Erfindung. Die durch die spezielle Salz- oder Esterform veränderte Wirkung muss aus dem Patent hervorgehen.

The FPC thus concluded that a proper construction of the wording of the SPC in the case at hand is

T. plus SD.-Fumarat incl. all derivatives therof (i.e. in particular all other salts), provided that they have the same pharmacological effect and are protected by the basic patent

The FPC in particular noted that the specific wording of the SPC (‘fumarate’) is not a differentiation over the prior art, but rather is dictated by the wording of the underlying market authorisation. In the FPC’s assesement, it would not have been possible for the plaintiff to obtain a SPC that did not mention the fumarate. The wording of the SPC shall thus not limit the scope of protection, provided that the pharmacological effect of the ‘phosphate’ is the same (and the attacked embodiment is covered by the basic patent).

Die spezifische Formulierung des ESZ ist damit keine Abgrenzung vom Stand der Technik durch die Schutzrechtsinhaberin, sondern vielmehr bestimmt durch den Wortlaut der arzneimittelrechtlichen Zulassung. Damit ist glaubhaft, dass die Klägerin gar kein Schutzzertifikat gestützt auf die Zulassung […] hätte erhalten können, bei welchem […] und nicht […] Fumarat genannt wird. Eine Beschränkung des patentrechtlichen Schutzbereichs kann daraus deshalb auch nicht abgeleitet werden, vorausgesetzt dass, wie hier unbestritten, die gleiche pharmakologische Wirkung beim anderen Salz als Fumarat gegeben ist.

Swissmedic
Swissmedic

The FPC then took the fact that the attacked embodiment had been registered by Swissmedic essentially based on the plaintiff’s prior market authorisation as prima facie evidence of the same pharmacological effect of the fumarate and the phosphate.

It was beyond dispute that the attacked embodiment was covered by the basic patent, and that the attacked embodiment had a market authorisation by Swissmedic. Thus, the FPC held that all elements of an infringement of the SPC had been fulfilled.

The decision is not yet final.

UPDATE 01 December 2017:

The decision has not been appealed.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2017_006 ¦ Decision of 12 October 2017 ¦ “Gutheissung vorsorgliche Massnahme, ESZ Kombinationspräparat”

n/a  ./.  n/a

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

DECISION IN FULL

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The ‘infringement test’ is (still) alive in Switzerland, surrounded by post-Medeva EU

Case No. O2017_001 ¦ Decision of 3 October 2017 ¦ “Nichtigkeit eines ESZ; Überprüfung der bisherigen Rechtsprechung zu Kombinationspräparaten; Klageabweisung”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.
Gilead's Truvada
Gilead’s Truvada®

Nullity of the supplementary protection certificate C00915894 has been at stake; see this Blog here and here for some background information. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

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

It was beyond dispute between the parties that the subject-matter of the SPC (Tenofovir Disoproxilfumarat + Emtricitabin) is protected by the basic patent EP’894. The so-called ‘infringement test’ that has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met.

On the contrary, the CJEU disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland either.

The FPC held that it is not appropriate to change the practice, and affirmed the ‘infringement test’ – at least for the time being.

The FPC’s reasons are as follows:

  1. The law is clear

It is (only) required by the law that the product is protected by a patent; Art. 140b(1) lit. a PatA. The Supreme Court had held in the Fosinopril decision that it is not necessary that the product be explicitly named and described in the patent (‘ausdrücklich genannt und beschrieben’). Rather, it is decisive whether the product is covered by the scope of the basic patent. Well, that’s the ‘infringement test’.

The FPC notes in passing that the Introduction of further criteria might require a change to the law.

Die Einführung zusätzlicher, über den […] Schutz durch das Basispatent hinausgehende Anforderungen an das Basispatent für die Erteilung von Schutzzertifikaten würden wohl eine entsprechende Regelung durch den Gesetzgeber voraussetzen.

  1. The rationale of Medeva is not applicable for Switzerland

The CJEU aimed to harmonize the SPC practice in the EU in order to preclude ‘obstacles to the free movement of medical prodcuts with the EU that would affect the establishment and functioning of the internal market’; see ¶24 of Medeva.

Switzerland is not part of that internal market, in particular not for medical products with state-regulated prices. Further, the FPC notes that the EU has harmonised the grant of market authorizations by the European Medicines Agency; Regulation (EC) No 726/2004. On the contrary, Switzerland has its own market approval procedure via Swissmedic; Therapeutic Products Act, TPA. The FPC concludes that even if one were to change the Swiss pratice in accordance with Medeva, this would not result in harmonised protection by SPCs with the EU.

  1. Voluntary alignment with Medeva would not improve legal certainty and consistency

The FPC analysed the CJEU’s series of decisions dealing with SPCs, i.e.

The FPC held that the CJEU had been asked to answer essentially the very same question again and again, i.e. what exactly the criteria are to decide whether or not a product is ‘protected’ by the basic patent.

The SPC salad
The SPC salad?

In the FPC’s view, Medeva raised more questions than it answered, and this uncertainty has not yet been resolved by the CJEU’s subsequent decisions. Defendant referred to the different wording used by the CJEU as ‘salad’. The FPC notes that this might well be an oversimplification. But still, the FPC identifies a terminological muddle, or at least a substantial unclarity.

Wenn die Beklagte die Formulierungen des EuGH als ‘Salat’ bezeichnet […], greift das wohl auch zu kurz, aber ein gewisses ‘terminologisches Durcheinander’, wie die Beklagte das auch nennt, oder zumindest eine erhebliche Unklarheit, scheint durchaus vorzuliegen.

The FPC further noted that yet another referral to the CJEU has been made by Arnold J in the co-pending case in the U.K.; see [2017] EWHC 13 (Pat). Undoubtedly, Arnold J has immense knowledge and experience in SPC matters. The FPC took the fact that Arnold J again seeks advice from the CJEU on the question

What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?

as a further indication of the substantial uncertainty even in the EU. In the court’s view, an attempt to harmonise the Swiss practice in alignment with Medeva would not improve legal certainty and consistency.

  1. Application of the Medeva principles in the case at hand would not give a clear result

Finally, the FPC holds that it was unclear whether or not the unspecific reference to ‘optionally other therapeutic ingredients’ in claim 27 of the basic patent would be sufficient to meet the CJEU’s criteria, i.e. ‘specified in the wording of the claim’.

In sum:

The FPC holds that if harmonisation with the CJEU case-law should be made at all, it would be too early: In the court’s view, there is just not yet a comprehensible and practicable case-law to align with.

Sollte überhaupt eine Harmonisierung mit der EuGH-Rechtsprechung in Betracht gezogen werden, scheint deshalb auf jeden Fall der Zeitpunkt, die Schweizer Rechtsprechung anzupassen, verfrüht, solange seitens des EuGH nicht eine nachvollziehbare und eindeutig umsetzbare Rechtsprechung vorliegt. Ein Versuch der Übernahme der Rechtsprechung des EuGH im gegenwärtigen Zeitpunkt würde nur eine Erhöhung der Rechtsunsicherheit nach sich ziehen. […] Deshalb ist, jedenfalls solange keine etablierte und die Rechtssicherheit sowohl für die Antragsteller als auch für die Dritten erhöhende Rechtsprechung des EuGH vorliegt, eine Änderung der Schweizer Rechtsprechung in keiner Weise angezeigt. Die strengen Voraussetzungen für eine Praxisänderung [BGE 138 III 270 , r. 2.2.2] sind eindeutig nicht erfüllt.

Two further aspects of the decision relate to the costs:

First, the parties had agreed on the English language to be used by the parties; Art. 36(3) PatCA. The main hearing, however, was held in German on request of the defendant. This required translation at the main hearing, and the defendant has to bear the costs for the interpreter.

That’s not much …

Second, the FPC did not order any reimbursement of expenses incurred by defendant’s patent attorney. Note that expenses for assisting patent attorneys are not reimbursed  according to a tariff (unlike the compensation for legal representation); see Art. 3 lit. a and Art. 9(2) CostR-PatC.

The requested amount has to be specified and substantiated, preferably by means of a detailed debit note. This has not been done, and the FPC accordingly did not award reimbursement of such unspecified and unsubstantiated expenses for the assisting patent attorney.

The decision is not yet final.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_001 ¦ Decision of 3 October 2017 ¦ “Nichtigkeit eines ESZ; Überprüfung der bisherigen Rechtsprechung zu Kombinationspräparaten; Klageabweisung”

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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

DECISION IN FULL

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THE BASIC PATENT

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