Fulvestrant, the never-ending story(?)

Reading time: 9 minutes

Case No. O2017_014 | Hearing of 20 January 2020

Fulvestrant, a breast cancer medication of the class of antiestrogens, is probably the most frequently appearing bone of contention at the FPC to date.

Fulvestrant (aka ICI 182,780), the active ingredient of AZ's Faslodex®
Fulvestrant (aka ICI 182,780), the active ingredient of AZ’s Faslodex®

Fulvestrant per se is generic since about 2004 (EP 138 504 B1). However, patents relating to certain second-medical uses of fulvestrant are still in force today.

The St Gall’ish part of the story
AZ logo

AstraZeneca asserts that EP(CH) 1 272 195 (see EPO Register and Swissreg for further information) is infringed by Sandoz’s generic version of AZ’s Faslodex®, i.e. Fulvestrant Sandoz 250 mg/5ml (Swissmedic approval no. 56778).

KSSG logo

The FPC’s seat is in St. Gall — you knew this. But this time, even the inventor is based in St. Gall: Prof. Dr. Beat THÜRLIMANN, chief physician at the breast center of the St. Gall cantonal hospital. A very St. Gall’ish part of the complex portfolio of fulvestrant patents and litigation in Switzerland and beyond, isn’t it?

Sandoz logo

Note that Sandoz’s generic has been on the market in Switzerland ever since 26 July 2016, despite various attempts of AZ to stop this; see this Blog here (PI proceedings, based on EP 2 266 573 B1) and here (PI proceedings, based on EP 1 250 138 B2). Yet further proceedings between AZ and Sandoz are currently co-pending at the FPC (O2018_010), with AZ asserting infringement of EP 2 266 573 B1 in main proceedings. I understood from the pleadings that AZ’s reply (incl. the first counter to Sandoz’s nullity plea in defense) was due only after this hearing, i.e. on 23 January 2020.

A quick recap of the procedural history

It all started off with a pretty standard exchange of briefs in infringement proceedings (AZ’s submissions in red; Sandoz’s submissions in blue; court interventions in yellow):

10 Jul 2017 Stmt of claim
11 Oct 2017 Stmt of defense w plea for nullity
8 Dec 2017 Partial reply re validity
4 Sep 2018 Preparatory hearing
22 Oct 2018 Full reply
6 Dec 2018 Rejoinder
11 Dec 2018 Closure of the file
18 Jan 2019 Comments on rejoinder
12 Mar 2019 Expert opinion of judge-rapporteur
5 Apr 2019 Summons for main hearing (28 Aug 2019)
10 May 2019 Cmt on expert opinion Cmt on expert opinion

The judge-rapporteur’s expert opinion had been unfavorable for AZ: In the judge-rapporteur’s view, EP 195 as granted was neither valid nor infringed.

I understood from the pleadings that AZ had apparently asserted EP 195 as granted only, without any ‘verbal limitation’ inter partes, neither as a main request nor as an auxiliary request. Later, proceedings ran off the rails (as defendant put it):

29 Jul 2019 Advance notice, patent will be partially waived
8 Aug 2019 Notice that partial waiver has been filed
12 Aug 2019 Main hearing cancelled; defendant to comment on partially waived patent
11 Sep 2019 Request that deadline be lifted
13 Sep 2019 Setting deadline for defendant
11 Oct 2019 Comments on partially waived patent
15 Oct 2019 Publication of the partially waived patent

I understood from the pleadings that the actual subject-matter of the partially waived patent had never been pleaded by AZ, neither with respect to validity nor infringement. Apparently, it was only at the main hearing that AZ did so — partially due to the fact that the FPC had ordered AZ to respond to defendant’s submission of 11 October 2019 at the main hearing.

the leftovers of the patent in suit after the partial waiver

Claim 1 of EP 195 as granted and maintained in EPO opposition/appeal proceedings was quite concise, a straight-forward second medical use claim:

Use of fulvestrant in the preparation of a medicament for the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment.

The partial waiver in accordance with Art. 24 PatA added quite a lot to this (marked-up):

Additional features in claim 1, by way of a partial waiver
The pleadings in a nutshell

AZ argued that validity of the partially waived patent had essentially already been decided by the FPC, in proceedings O2018_009 with decision of 27 May 2019 (in line with T 1680/17 of an EPO Board of Appeal), with only the target patient group being now even more more precisely defined. AZ emphasized that this was the trigger for the partial waiver that had been filed only shortly therafter, on 30 July 2019; not defendant’s nullity plea in defense and/or the judge-rapporteur’s expert opinion.

It was also referred to decision X ZR 59/17 of the German Supreme Court, revoking EP 1 250 138 B2 within the same patent family. In AZ’s view, this was due to an incorrect formulation of the technical problem, disregarding the problem-solution approach; and with the threshold for a reasonable expectation of success being set much too low.

Both parties disagreed on what ‘failure with a treatment’ means; see ¶ [0018] of EP 195 for a definition. In AZ’s view, this covers both adjuvant and palliative therapy. Defendant pointed out that switching therapy does not necessarily mean that the first therapy had failed. Rather, therapy is frequently switched before resistance occurs; thus, therapy has not yet failed.

Defendant pointed out that no substantiated assertions had been on file until the day before the hearing concerning the actual scope of the partially waived patent, as well as validity and infringement thereof.

Further, admissibility of the partial waiver after formal closure of the file was a big issue. Note that this has also been at stake in the recent decision O2016_012, where the panel of judges had been split 3:2 in favor of admissibility. However, defendant noted that the factual setup was very different. Contrary to the present matter, the partial waiver in O2016_012 did not require any new pleadings or assertions:

In O2016_012, the partially waived patent integrated smoothly into the proceedings as pleaded beforhand. This was of great importance ('von ganz wesentlicher Bedeutung') for admissiblity in that case.

In any event, defendant apparently considers the partial waiver after formal closure of the file as an improper novum (‘gewillkürtes Novum’; ‘Potestativ-Novum’), contrary to what had been held in O2016_012. Defendant referred to a decision of the Cantonal Court Zug in this respect, i.e. ES 2018 449. This decision is totally unrelated to patents. But it has been held that a document that has only been created after closure of the file cannot be admitted anymore into the proceedings when the respective assertion of the counterparty had already been made in the statement of defense, i.e. when the document could well have been created and submitted before closure of the file; see ¶2.7:

A document that had only been created after closure of the file, even though the respective assertion that the document was meant to counter had already been made in the statement of defense, is belated.
UPDATE 30 January 2020:

I have obtained a copy of this decision only yesterday. Accordingly, this post has been updated today with some more information about the actual content of the decision.

Finally, defendant placed the procedural request that a deadline be set for a written response to AZ’s validity arguments presented at the hearing, should the court admit them into the proceedings.

Please find some quick notes from the hearing below this post.

A hot potato?

The presiding judge made an opening remark that ‘contrary to what defendant  apparently assumed the court has not yet decided on the admissiblity of the partial waiver after closure of the file.’ That was not much of a surprise. However, the presiding judge further noted that the court is not inclined to decide on that issue while the appeal in case O2016_012 is still pending.

I was flabbergasted. I understood from the later pleadings that admissibility of the partial waiver after formal closure of the file might not necessarily be the decisive issue in this case. But let’s assume it was: Is an informal stay of proceedings appropriate? I have my doubts. It might easily take the Supreme Court six months or more to decide on that issue, which is (much) longer than what it normally takes from the main hearing to the decision being handed down.

Meanwhile in Germany

A PI request of AZ based on EP 195 has been rejected by the Regional Court Dusseldorf (4C O 10/18, 5 July 2018). Likewise, AZ’s appeal failed at the Higher Regional Court (2 U 28/18, 9 January 2018). In a nutshell, AZ could not establish that the treatment regime as claimed had actually been used to an extent that could not remain unnoticed by the defendant (if it had been used at all in more recent times).

Nullity proceedings re EP 195 are pending at the FPC since 14 August 2017, with case no. 3Ni32/17(EP).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_014 | Hearing of 20 January 2020

AstraZeneca AB
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

    • Prof. Dr. Daniel KRAUS
    • Prisca VON BALLMOOS
    • Marco ZARDI

Judge-rapporteur:

    • Prisca VON BALLMOOS

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Michael RITSCHER (MLL)
    • Dr. Kilian SCHÄRLI (MLL)
    • Andreas BRAUN (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant / Patentee:

    • Dr. Andri HESS (Homburger)
    • Julian SCHWALLER (Homburger)
    • Dr. Elisabeth GREINER (df-mp), assisting in patent matters

ANNOUNCEMENT

PATENT IN SUIT

EP 195 as granted by the EPO:

 

EP 195 after partial waiver in Switzerland:

T 0108/09 – 3.3.02

Maintenance of EP 195 as granted by a BoA of the EPO:

SOME LIVE NOTES FROM THE HEARING

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

Reading time: 8 minutes

Case No. O2016_012 | Hearing of 29 May 2019

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

Implantec’s ANA.NOVA® hybrid socket website

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

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

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

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

ANA.NOVA® hybrid socket

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

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

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

The hearing

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

Closed docket

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

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

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

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

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

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

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

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

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

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

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

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

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_012 | Hearing of 29 May 2019

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

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Stemcup :

Representative(s) of Implantec:

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

ANNOUNCEMENTS

Main hearing of 29 May 2019:

Fullscreen view (new tab)

Main hearing of 3 October 2018 (cancelled):

Fullscreen view (new tab)

The FPC’s cancellation note:



PATENT IN SUIT

EP 1 411 869 B1 (as initially granted):

Fullscreen view (new tab)

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

Fullscreen view (new tab)

NOTES FROM THE HEARING

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Litigation on clamping systems: Matter fixed?

Case No. O2012_016 ¦ Main Hearing of 03 December 2014

This case pertains to clamping systems for compacting of metal and ceramic powder. Parties to the proceedings are Erowa AG as the plaintiff and ProGrit GmbH as the defendant.

The allegedly infringing devices of the defendant are abbreviated as RCS (roller clamping system) and SCS (segmented clamping system). Screenshots taken on 06 January 2015 from the defendant’s website are embedded below.

Note that the roller clamping system RCS is not available in Germany and Austria, but rather only a

new version RCS II without heightended surface sections at the chuck.

From the hearing, it became evident that this suit had been lodged already more than 5 years ago; it had thus been transferred to the FPC from a formerly competent cantonal court. Moreover, the parties have been before courts in other jurisdictions on this matter, too (see references below for each of the patents in dispute). Noteworthy, Progrit’s managing partner Dietmar Walter Kramer had been Head R&D at Erowa until 2004 (cf. CV, as found online on December 24, 2014; markup added).

1.  THE PATENTS IN SUIT

i)  The Swiss part of EP 1 068 918 B1

The first patent in suit is the Swiss part of EP 1 068 918 B1. Please see Swissreg for the bibliographic details.

As indicated above, this matter was also litigated elsewhere, e.g. in Germany. Please see DPMAregister for bibliographic details of the German part of the European patent. In Germany, the patent has most recently been upheld in amended form, published as DE 500 08 295 C5; see the decision 4 Ni 43/10 (EP) of the German Federal Patent Court (issued 08 November 2012) and the decision X Zr 148/12 of the German Supreme Court (issued 29 July 2014); and a correction thereof.

The courts in Dusseldorf dealt with the corresponding infringment proceedings; see decision 4a O 270/09 of the Dusseldorf Regional Court (LG) and decision 2 U 29/13 of the Dusseldorf Higher Regional Court (OLG). The decision of the OLG already takes into account the amended wording of the patent as upheld by the Supreme Court with decision X Zr 148/12 (see above).

ii)  The Swiss part of EP 1 068 919 B1

The second patent in suit is the Swiss part of EP 1 068 919 B1. Please see Swissreg for the bibliographic details.

The German counterpart was also litigated in Germany. Please see DPMAregister for bibliographic details. In first instance, the German Federal Patent Court decided to maintain the patent in amended form; see decision 4 Ni 20/11 (EP) of 24 September 2013 (the decision is res judicata).

Again, corresponding infringement proceedings were dealt with by the Dusseldorf courts; see decision 4a O 84/10 of the Dusseldorf Regional Court (LG) and decision 2 U 58/11 of the Dusseldorf Higher Regional Court (OLG).

iii)  CH 699 547 B1

The third patent in suit is CH 699 547 B1; see Swissreg for the bibliographic details.

2.  WHAT THE HEARING WAS ALL ABOUT

The hearing was somewhat exceptional in that the discussion did not concern technical matters at all. Rather, pleadings revolved around highly interesting points of law.

i)  Allowable submissions after closure of the file

last chance
Not always that clear

A first issue relates to the restriction of the request for injunctive relief. It was undisputed that a restriction of the request for injunctive relief constitutes a limitation of the claim which is explicitly permitted at any time; see Art. 227(3) CPC. However, the right of the plaintiff to present new facts in support of such a restricted request was under dispute. Note that the amendment(s) to the requests were made only after the second round of written submissions, i.e. when the closure of the file (“Aktenschluss”) had already occured; see Art. 229(2) CPC and the decision 4A_73/2014 (r. 6.3.2.3) of the Supreme Court. Go figure: Being allowed to limit your request for injunctive relief, but not being allowed to freely argue in support of this limited request? That’s a nasty situation for a plaintiff!

The plaintiff argued that Art. 227(3) CPC should overrule Art. 229 CPC. Otherwise, a limitation of the claim (which is explicitly permitted in Art. 227(3) CPC at any time) would be impossible in patent infringement proceedings. In practice, it is rather unlikely that a patentee would be in a position to argue in support of infringement of a limited request and validity of a limited patent claim (see below) without having to present new facts. You cannot reasonably stockpile for each and every situation that might occur, be it a decision of a foreign court in co-pending proceedings on the same patent family, or new prior art that comes to light.

Moreover, the plaintiff argued that even the requirements of Art. 229 CPC were fulfilled for all patents in suit, essentially as follows:

The decision of the German Federal Supreme Court with respect to the German counterpart of the first patent in suit (see above) constitutes proper nova; see Art. 229(1) lit. a CPC and the decision 5A_568/2012 of the Swiss Federal Supreme Court, r. 4. Moreover, the patentee / plaintiff had partially surrendered the patent vis-à-vis the Patent Office (Art. 24 PatA) to bring the wording of the claim in line with the decision of the German Supreme Court. This would also constitute a new fact and the patentee / plaintiff should be allowed to present new facts in support of validity and infringement of the limited claim (like in the corresponding proceedings in Germany, see above). Note, however, that the limitation had not yet been published at the date of the hearing, and the FPC apparently dismissed a request of the patentee to postpone the hearing until publication of the limitation.

With respect to the second and the third patent in suit, the plaintiff argued that the preliminary assessment of the reporting judge and the decision 4 Ni 20/11 (EP) of the German Federal Patent Court constitute nova according to Art. 229(1) CPC, and that it should likewise be allowed to present new facts in support of validity and infringement of correspondingly limited claims that address these newly raised issues.

In sum, this boils down to three scenarios of limitations to a patent claim / request for injunctive relief: Is it allowed to present new facts in support of a limited claim / request, when the limitation is occasioned by: –

  1. … a corresponding decision in another country?
  2. … a statement in the preliminary assessment of the reporting judge?
  3. … a partial surrender of the patent?

ii)  Limitation under Art. 24 lit. c / partial invalidity

The patentee / plaintiff asserted that the patents in suit are valid and infringed on the basis of independent patent claims that were to be limited by incorporation of features taken from the description (i.e., not a combination of an independent claim with a dependent claim).

In the present proceedings, the defendant did not lodge a counterclaim for nullity but rather argued for nullity as a mere plea in defense. Apparently, the FPC had indicated to the parties in writing beforehand that it is doubtful whether it is possible at all to limit a claim on the basis of a feature taken from the description vis-à-vis the FPC, or if this shall only be possible when a counterclaim for nullity had been lodged (see Art. 27 PatA). E. Brunner in Der Patentverletzungsprozess (SMI 1994, p 127) favours the latter. Even though the plaintiff / patentee fiercely rebutted this view, the prior information from the FPC had prompted the plaintiff / patentee to declare the partial surrender of the patents vis-à-vis the patent office before the hearing. The partial surrender had not yet been officially published when the hearing took place, but had already been approved by the patent office.

A decision of the FPC on these highly interesting points of law would definitely make a good read. However, the parties finally entered into settlement negotiations and it remains to be seen if a decision will be issued at all.

Reported by Susanna RUDER and Martin WILMING

BIBLIOGRAPHY

Case No. O2012_016 ¦ Main Hearing of 03 December 2014

Erowa AG ./. ProGrit GmbH

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE (President; Judge)
  • Dr. Tobias BREMI (Judge)
  • Dr. Kurt SUTTER (Reporting Judge)
  • Esther SCHEITLIN (Court Clerk)

Representative(s) of Plaintiff:

  • Dr. Thierry CALAME (Lenz & Staehelin)
  • René RUF (Rottmann, Zimmermann + Partner), assisting in patent matters

Representative(s) of Defendant:

  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Reinhard OERTLI (MLL)
  • Willi LUCHS (Luchs & Partner), assisting in patent matters