ViiV seeking injunctive relief against Sandoz’s generic Kivexa®

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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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LIVE NOTES


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Does the wording of an SPC matter?

Case No. S2107_006 ¦ Hearing of 9 October 2017

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

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

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

tenofovir disoproxilfumarat + emtricitabin

Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

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

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

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

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

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

Reported by Martin WILMING

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

BIBLIOGRAPHY

Case No. O2107_001 ¦ Hearing of 9 October 2017

Gilead Sciences Inc. ./. Mepha Pharma AG

Panel of Judges:

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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

Case No. O2107_001 ¦ Main hearing of 21 August 2017

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

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

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

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

Gilead's Truvada
Gilead’s Truvada®

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

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

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

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

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

The parties did not enter into settlement discussions.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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NOTES BEFORE AND FROM THE HEARING

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Applied Nanostructures, Inc. ./. Nanoworld AG

Case No. O2013_013 ¦ Main hearing of 23 June 2016

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

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

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

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

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

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

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

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

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

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

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

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. O2013_013 ¦ Main hearing of 23 June 2016

Applied NanoStructures, Inc ./. Nanoworld AG

Subject(s):

  • Nullity

Board of Judges:

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

Reporting Judge:

  • (not identified)

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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

— PATENT IN SUIT —

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Lässer ./. Saurer, reloaded

Case No. O2014_009 ¦ Hearing of 27 January 2016

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

Independent claim 1 of EP’083 reads as follows:

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

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

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

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

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

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

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

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

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

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

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

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

Reported by Susanna RUDER and Martin WILMING

— BIBLIOGRAPHY —

Case No. O2014_009 ¦ Hearing of 27 January 2016

Lässer AG Stickmaschinen ./. Oerlikon Saurer Arbon AG

Subject(s):

  • Infringement
  • Plea of nullity

Composition of the Board of the FPC:

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

Representative(s) of claimant:

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

Representative(s) of defendant:

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

— PATENT IN SUIT —

EP 1 983 083 B1:

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Nordson EFD ./. Gema Switzerland

Case No. O2013_008 ¦ Main Hearing of 15 June 2015

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

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

The only independent claim 1 reads as follows:

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

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

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

Reported by Ingo LUMMER and Martin WILMING

— BIBLIOGRAPHY —

Case No. O2013_008 ¦ Main Hearing of 15 June 2015

Nordson EFD ./. GEMA Switzerland GmbH

Composition of the Board of the FPC:

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

Court Clerk

  • Susanne ANDERHALDEN

Reporting Judge:

  • [unknown]

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

— PATENT IN SUIT —

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

Case No. O2013_009 ¦ Main Hearing of 09 December 2014

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

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

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

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

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

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2013_009 ¦ Main Hearing of 09 December 2014

Composition of the Board of the FPC:

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

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

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

“HeatCut” technology of embroidery machines litigated again

Case No. S2014_004 ¦ Hearing of 05 June 2014

The parties know each other from an earlier case at the FPC: Lässer and Oerlikon Saurer Arbon were already litigating in the matter S2012_004; see a post commenting on that case here. From my understanding during the course of the hearing, EP 1 983 083 B1 might be at stake now (to be confirmed). Note that this is a patent within the patent family of EP 1 985 736 B1 that had been litigated before.

The claimant asked for interim injunctive relief. At the beginning of the hearing, the claimant had distributed a written statement and used this as the basis for his plea. But only selected parts of the written statement were orally presented. Consequently, it was not clear for the defendant what the basis for his reply should be. The defendant disputed any infringment and insisted on neither using the protected device nor the method according to the patent-in-suit.

In the claimant’s view, interim measures were justified since the (allegedly infringing) “HeatCut” system is excessively used in marketing activities by the defendant and can be used to upgrade existing machines (see e.g. brochure below). It was argued that this would constitute an irreparable harm for the claimant.

As outlined by the defendant, the allegedly infringing device is already on the market since 2011. In fact, it was argued that it is still the same device as in the matter S2012_004 (it was also referred to a parallel law suit in Taiwan). Thus, the defendant argued that no interim measures are to be granted for lack of urgency. 

Both parties agreed to enter into the non-public part of the hearing / settlement negotiations, but the defendant pointed out that taking a license is no option for him.

Reported by Susanna RUDER and Martin WILMING

— BIBLIOGRAPHY —

Case No. S2014_004 ¦ Hearing of 05 June 2014

Lässer AG Stickmaschinen ./. Oerlikon Saurer Arbon AG

Subject(s):

  • Infringement
  • Interim measures

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Judge)
  • Dr. sc. nat. Tobias BREMI (Judge)
  • Frank SCHNYDER (Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of claimant:

Representative(s) of defendant:

  • Dr. Stefan KOHLER (Vischer AG)
  • Roland HÜTHER (TMP), assisting in patent matters

— TECHNICAL BACKGROUND —

A brochure on the “HeatCut” technology of the defendant, for ease of understanding of the general technology:

Download (PDF, 4.34MB)

Lundbeck ./. Sandoz settled (S2014_002)

Case No. S2014_002 ¦ Settlement

Last week I have reported on the oral hearing in this matter; see here.

We won’t see a decision of the FPC on the plaintiff’s request to impose a prohibition of sales as an interim measure in extension of the term of the SPC. In the meantime, I have been informed by Simon HOLZER (representative of the plaintiff) that the parties have settled, essentially as follows:

  1. The defendant has accepted to abstain from advertising / offering Escitalopram Sandoz® until May 31, 2014 (lapse of the SPC).
  2. The plaintiff has withdrawn the request to impose a prohibition of promotion / sales / distribution as an interim measure, in extension of the term of the SPC.
  3. Court fees are borne by the defendant.
  4. The defendant has accepted to pay the plaintiff a reasonable compensation.
  5. By fulfilling the settlement both parties agree to have settled all mutual claims resulting from that case.

In my perception, an outcome like this is not much of a surprise: From a business perspective, this makes perfectly sense for both parties.

Reported by Martin WILMING


BIBLIOGRAPHY

Case No. S2014_002 ¦ Settlement

Lundbeck (Schweiz) AG ./. Sandoz Pharmaceuticals AG

Subject(s):

  • Infringement

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Single Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

Lundbeck ./. Sandoz: Inquiry of (future) demand while the SPC on Escitalopram is still in force

Case No. S2014_002 ¦ Hearing of 06 March 2014

Today’s hearing was announced on the website of the FPC only on February 28, without any details on the merits of the case. In view of this very short notice, I felt that an interim measure without hearing of the defendant might be at stake. Indeed, it is. But let’s first have a look at the pharmaceutical and commercial background:

Escitalopram, the (S)-enantiomer of citalopram
Escitalopram

This case pertains to Lundbeck’s blockbuster drug escitalopram (also known under various trade names such as Lexapro® and Cipralex®). It is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class which is widely used for the treatment of adults and children over 12 years of age with major depressive disorder (MDD) and generalized anxiety disorder (GAD). Escitalopram is the (S)-enantiomer of citalopram; see the structural formula in the margin. Please revert to MedlinePlus for further information on this drug.

Escitalopram accounted for a (worldwide) revenue of DKKm 5,933 in 2013; see Lundbeck’s Annual Report 2013, p. 15 (approx. 1bn CHF).

Cipralex film-coated tablets
Cipralex® film-coated tablets

These are my personal conclusions and take-away messages from what has been argued by the parties earlier today:

Escitalopram is a mature drug. The corresponding patent EP 0 347 066 B1 was filed already back in 1989 (June 1), and even the SPC is about to lapse on May 30, 2014. According to PharmaWiki, various suppliers of generics have already obtained the market authorization in Switzerland. But, to date, Cipralex is the only available drug on the Swiss market comprising escitalopram (see the so-called Spezialitätenliste). And it is an important one for Lundbeck in Switzerland: It accounts for a turnover of CHF 3m per month which is about 80% of all sales of Lundbeck in Switzerland.

Similar to many other mature blockbuster drugs, there is a lot of litigation going on in many jurisdictions; see e.g. the EPLAW Patent Blog. But the present case is somewhat special. Apparently, sales representatives of the defendant had asked doctors for their (future) demand on escitalopram, well before the lapse of the SPC. The FPC had ordered the defendant to refrain from such activities — without hearing the defendant beforehand. Subsequently, the parties were summoned for today’s hearing.

From what has been discussed in the hearing, I understood that sales representatives of the defendant had used a kind of form for the inquiry. However, the defendant argued that this form had not been intended to be given away. Rather, it was meant as a tool for the sales representatives, i.e. for internal purposes only. Nevertheless, the plaintiff evidently got hold of a photography of such a form. The defendant neither denied authorship nor the actual use of the form. What was denied is that the inquiry of (future) demand could establish an infringement according to Art. 8 PatA. It had not been intended to enter the market before June 1, nor was this an offer. It was only aimed to streamline logistics upon market entry when the SPC will have lapsed on June 1. The defendant pointed out that this intention is underlined by the absence of any specific indication of the defendant’s (generic) product, its price and availability. Moreover, the defendant alleged that the plaintiff himself had notified the doctors of the forthcoming lapse of the SPC. This was disputed by the plaintiff.

The plaintiff argued that this inquiry was a “perfidious” marketing while the SPC is still in force: By asking the doctors for their future demand, they were made readily aware not only of the approaching lapse of the SPC, but also of the defendant as a potential future supplier of the generic version. From my understanding of what has been argued, the plaintiff had documented at least one case where a doctor refrained from immediate stock replenishing after such an inquiry and instead delayed it until the generic version(s) will be available.

Anyhow, the defendant declared to abstain from further use of the form (N.B., without acknowledging any legal obligation); all sales representatives had already been informed accordingly. Although these inquiries had triggered the dispute, a second request of the plaintiff might turn out to have severe implications: The plaintiff sought for an interim injunction being issued for a term of 2½ month after the lapse of the SPC.

The defendant essentially argued that injunctive relief would require the SPC to be still in force since this request relied on the PatA. To the contrary, the plaintiff argued that this request also relies on the law against unfair competition (UCL). Moreover, a prohibition of sales as an action for damages would not be uncommon, in connection with Art. 43 of the Code of Obligations. Inter alia, the plaintiff relied on C-316/95 of the EuC. In that case, samples of medicinal products manufactured in accordance with a patented process had been submitted to the authority competent for issuing marketing authorizations. It was held that a moratorium imposed by the court on the infringer of the patent right, in so far as it seeks to place the proprietor of the patent in the position in which it would, in principle, have been had its rights been respected, cannot in itself be held to be a disproportionate form of reparation.

The defendant emphasized that this case (and similar ones which would have to be decided differently nowadays, anyhow) were fundamentally different in that an infringing act had actually been carried out during the term of the patent or SPC.

Yet another point of discussion was the value in dispute for the moratorium. While the plaintiff argued for CHF 250’000,–, the defendant estimated the value in dispute to exceed CHF 1m.

The parties finally entered into non-public settlement negotiations.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2014_002 ¦ Hearing of 06 March 2014

Lundbeck (Schweiz) AG ./. Sandoz Pharmaceuticals AG

Subject(s):

  • Infringement

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Single Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

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

Representative(s) of Defendant: