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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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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ViiV seeking injunctive relief against Sandoz’s generic Kivexa®

Reading time: 5 minutes

Case No. S2018_004 | Hearing of 10 September 2018

ViiV logo

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

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

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

For the chemists out there, these are the molecules:

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

ViiV’s Kivexa®

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

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

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

Sandoz logo

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

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

The following issues have been discussed:

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

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

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

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

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

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

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

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

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

UPDATE 12 September 2018:

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

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

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

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

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

Loosely translated:

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

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

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

ViiV corporate tree (section), as illustrated by respondent

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

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

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

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

Reported by Martin WILMING

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

BIBLIOGRAPHY

Case No. S2018_004 | Hearing of 10 September 2018

ViiV Healthcare UK Ltd.
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

PATENT IN SUIT

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ANNOUNCEMENT

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Laurastar and Innosteam Swiss working flat out

Case No. S2018_003 | Hearing of 28 June 2018

UPDATE 14 July 2018:

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

Laurastar logo

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

Innosteam logo

The patent applications are about devices and methods for producing instant steam (WO’994) and instant hot water (WO’653), for use e.g. in devices for ironing.

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

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

The hearing was remarkable for some procedural reasons.

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

Not yet done …

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

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

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

Reported by Leila MÜLLER and Martin WILMING

BIBLIOGRAPHY

Case No. S2018_003 | Hearing of 28 June 2018

Laurastar SA
./.
Innosteam Swiss SA

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Giovanni GERVASIO

Court Clerk:

  • Agniezka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Jacy PILLONEL (BCP)

ANNOUNCEMENT

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WO 2018/006994 A1

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WO 2018/036653 A1

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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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Act quickly when it’s urgent

Case No. S2018_002 ¦ Decision of 5 April 2018 ¦ ‘Abweisung superprovisorische Massnahme; fehlende besondere Dringlichkeit’

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

The plaintiffs requested ex parte interim injunctive relief, i.e. without hearing the defendant beforehand. In principle, this is possible in cases of special urgency; Art. 265 CPC. It goes without saying that a plaintiff should act quickly in a case of special urgency. But how quickly does one need to take action so that it is not considered (too) late? The present decision provides further guidance in this respect.

In cases of alleged urgency, the court examines whether the request has not obviously been delayed or could reasonably have been and should have been filed earlier. If this is the case, it is no longer justified to not hear the defendant beforehand. If a plaintiff waits considerably longer after a triggering event than the time limit that is typically set for the defendant to respond in summary proceedings, the case can hardly be assumed to be particularly urgent.

[B]eim Fall der zeitlichen Dringlichkeit ist weiter zu prüfen, ob das Gesuch nicht offensichtlich hinausgezögert worden ist respektive vernünftigerweise früher hätte gestellt werden können und müssen, mithin das Weglassen der Anhörung der Gegenseite nicht mehr gerechtfertigt ist. Die relevante Zeitskala bemisst sich dabei unter anderem an der Zeit, die typischerweise der Gegenseite zur Stellungnahme eingeräumt wird. Wartet die Gesuchstellerin ohne erkennbare Gründe mit der Einreichung des superprovisorischen Gesuchs nach einem auslösenden Ereignis deutlich länger zu, als der Gegenseite in einem Massnahmeverfahren zur Stellungnahme eingeräumt wird, kann schwerlich von besonderer Dringlichkeit im Sinne von Art. 265 ZPO ausgegangen werden, die ein Weglassen der Anhörung der Gegenseite rechtfertigt.

Plaintiffs argued that the defendant had already ample opportunity in prior / parallel proceedings to provide comments. Accordingly, new arguments were not to be reckoned with. The decision holds that this has nothing to do with the alleged urgency, and that there may well be new arguments since parallel proceedings are pending elsewhere.

Further, plaintiffs argued that the expected delay in co-pending nullity proceedings caused urgency of the present request for injunctive relief. However, the decision holds that the course of the parallel nullity proceedings is not out of the ordinary, and plaintiffs could have lodged a claim for infringement in main proceedings since more than a year ago – but did not do so.

time is running …

Note that the request for ex parte interim measures had been filed more than one month after the parties had been informed about availability of hearing dates in parallel nullity proceedings no earlier than end of August 2018, and the plaintiff indicated one of these dates as ‘suitable and preferred’ (‘geeignet und bevorzugt’). Only later, plaintiffs requested an earlier hearing date – which could not be arranged anymore.

Moreover, the present request was filed more than two months after receipt of the opinion of the judge-rapporteur. If this was considered as the triggering event (in view of a changed opinion of the judge-rapporteur), the request could and should have been filed much earlier.

Finally, plaintiffs noted that previous summary proceedings took about six months to conclude. A similar duration in the present proceedings would result in a decision only after the hearing date in parallel nullity proceedings. The decision holds that this, again, has nothing to do with the required urgency.

The request for ex parte interim injunctive relief was thus dismissed, and inter partes summary proceedings are now ongoing.

Reported by Martin WILMING


BIBLIOGRAPHY

Case No. S2018_002 ¦ Decision of 5 April 2018 ¦ ‘Abweisung superprovisorische Massnahme; fehlende besondere Dringlichkeit’

  1. A. AG
  2. B. AG

./.

C. AG

Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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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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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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Does the wording of an SPC matter?

Case No. S2107_006 ¦ Hearing of 9 October 2017

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

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

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

tenofovir disoproxilfumarat + emtricitabin

Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

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

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

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

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

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

Reported by Martin WILMING

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

BIBLIOGRAPHY

Case No. O2107_001 ¦ Hearing of 9 October 2017

Gilead Sciences Inc. ./. Mepha Pharma AG

Panel of Judges:

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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Ex parte interim injunctive relief granted based on an SPC

Case No. S2017_006 ¦ Decision of 30 August 2017 ¦ “Gutheissung superprovisorische Massnahme”

The defendant in this matter had notified the SPC holder of the imminent launch of its generic product in Switzerland, before a decision in parallel nullity proceedings was available. The validity of the SPC had been challenged in parallel nullity proceedings based on the SPC case law of the CJEU and an accordingly to be revised Swiss practice.

The plaintiff sought for interim injunctive relief without hearing the defendant beforehand. Since the critical issue had not yet been decided in parallel nullity proceedings, interim injunctive relief has provisionally been granted. The defendant has been invited to file a response.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2017_006 ¦ Decision of 30 August 2017 ¦ “Gutheissung superprovisorische Massnahme”

Judge(s):

  • Dr. Dieter BRÄNDLE

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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Wrongful reinstatement is no ground for nullity of an SPC

Case No. S2016_009 ¦ Decision of 04 July 2017 ¦ “ESZ / Nichtigkeitsgründe”

The decision grants interim injunctive relief in summary proceedings based on an SPC.

Notably, the defendant neither disputed validity of the basic patent, nor that the subject-matter of the SPC is covered by the basic patent or that the attacked embodiment 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.

Publications in the Patent Bulletin and Swissreg as to the actual filing date of the SPC application are indeed confusing, to say the least. The (belated) filing date of 13 December 2014 has not been published at all, nor has the re-establishment of rights. Anyway, the FPC holds that in view of the apparent inconsistency between a belated filing date and the fact that the SPC had been granted anyway should have prompted a check of the dossier. The defendant would then have noticed the re-establishment of rights.

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.

The FPC further holds 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.

It was undisputed that the defendant had advertised the attacked embodiment at a congress in December 2016, and had actually sold products already in September 2016. However, the defendant argued that there was no threat of any further infringing acts: The defandant would stick to his affirmation to give notice to the patentee a month before commercialising the product again (the patentee demanded for an advance notice of at least 6 months). The FPC held that an advance notice of 1 month clearly is insufficient: One cannot expect injunctive relief to be granted within a month; the advance notice (at least this short one) does not preclude the threat of a further infringement.

The FPC also confirmed the threat of an irreparable harm, with a straight-forward reasoning. Interim injunctive relief was thus granted.

FROM A MARKET PERSPECTIVE

Infringement of the Swiss SPC C00716606/01 concerning sevelamer is at stake; the basic patent is EP 0 716 606 B1 of Genzyme Corporation.

Sevelamer is a phosphate binding drug used to treat hyperphosphatemia in patients with chronic kidney disease; it binds to dietary phosphate and prevents its absorption. Sevelamer is legally marketed in Switzerland under the trade names Renagel® (sevelamer hydrochloride) and Renvela® (sevelamer carbonate).

Sevelamer consists of polyallylamine that is crosslinked with epichlorohydrin. Sevelamer carbonate is a partial carbonate salt. The amine groups of sevelamer become partially protonated in the intestine and interact with phosphate ions through ionic and hydrogen bonding.

Structural formula of sevelamer carbonate
Structural formula of sevelamer carbonate

The confusing publications in the Swiss Patent Bulletin are +pat+ 08/2005, p 1317-1318 and 06/2006, p 1058. The publication in Swissreg is not of much help, either; it rather adds to the confusion:

Dass das IGE schliesslich am 8. Dezember 2016 noch zu guter Letzt als neues – nicht erklärbares – Datum der Berichtigung den 7. April 2005 einführte, komplettierte den Zahlensalat.

The market authorisations for the active ingredient sevelamer are listed in Compendium and the ‘Spezialitätenliste‘; this reveals the parties involved: Genzyme Corporation (SPC holder) and Sanofi-Aventis (Suisse) SA (exclusive licensee and market authorisation holder) as the plaintiffs. The defendant apparently is Salmon Pharma GmbH since it is the only other holder of a market authorisation for a product containing sevelamer, ie the product Sevelamercarbonate Salmon Pharma.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2016_009 ¦ Decision of 04 July 2017 ¦ “ESZ / Nichtigkeitsgründe”

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

./.

Salmon Pharma GmbH

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Andreas SCHÖLLHORN SAVARY
  • Dr. Ralph SCHLOSSER

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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