The first enforcement decision of the FPC — but there is nothing to enforce (yet)

Reading time: 7 minutes

Case No. S2020_001 | Decision of 25 August 2020 | ‘Enforcement request’

HEADNOTE

Art. 26(2) PatCA, Art. 339 CPC; jurisdiction for execution.

The Federal Patent Court is competent for the enforcement of its judgments rendered in concurrent jurisdiction.

We have reported about this matter on this Blog already here and here.

The parties had come to a settlement in their patent ownership dispute in proceedings O2017_026 at the FPC. But, clearly, the parties do not get along well with each other. The former plaintiff now tried to enforce the settlement decision.

Competency of the FPC

This is what the hn is all about. Art. 339(1) CPC provides for mandatory jurisdiction to order measures of enforcement. For disputes falling under the exclusive subject-matter jurisdiction of the FPC (Art. 26(1) PatCA), enforcement is explicitly reserved exclusively to the Federal Patent Court because of the primacy of the PatCA (Art. 27 PatCA) for such disputes.

For disputes falling under concurrent subject-matter jurisdiction (Art. 26(2) PatCA), the place of jurisdiction for enforcement is not governed by Art. 339(1) CPC, insofar as the FPC has ruled on the merits of the case; the FPC is competent to enforce its decisions for the whole of Switzerland also in this concurrent subject-matter jurisdiction. The place of jurisdiction is determined by Art. 339(1) CPC only to the extent that a competent cantonal court has ruled on the case in disputes falling under the concurrent jurisdiction of the FPC (Art. 26(2) PatCA).

A request for enforcement of a decision concerning the entitlement to patent applications is a civil action within the meaning of Art. 26(2) PatCA. If the underlying judgment is patent-related, which always applies to substantive judgments rendered by the FPC, then the enforcement of that judgment is also patent-related. The Federal Patent Court is therefore competent to enforce such judgments.

No manifest abuse

The FPC held that the defendant’s position is erroneous that, in enforcement proceedings, the court is not competent to interpret the judgment to be enforced. The mere fact that the judgment contains language that requires interpretation does not make a motion for enforcement abusive.

But it’s a different topic whether the alleged obligations of the defendant actually flow from the judgment. This question must be addressed when assessing the merits of the motion for enforcement. It is possible that the plaintiff’s motion may not succeed because the obligations to be enforced do not in fact arise from the judgment, as the defendant claims. But not every unsuccessful motion is in itself abusive.

In substance, the defendant essentially argued that the request for execution was abusive because it would be unsuccessful — which is insufficient.

time is not yet ripe

The defendant had argued that all of its obligations to pay a share of the license fees received under the license agreements for the assigned patents are subject to the plaintiff’s obligation to take all necessary steps to assign the patent applications to the plaintiff. On the contrary, the applicant argued that there is no subordination between its obligation to take all necessary steps to assign the patent applications and the payment of a share of the license royalties generated.

Apparently, there is a license contract in place between ROCK dental and Sulzer Mixpac AG, dated 23 January 2017. I have not been able to spot a corresponding product on the market, though. But Sulzer Mixpac is pursuing a related patent application, WO 2020/083841 A1.

Anyway, according to the plain language of the settlement, there is an exchange between the transfer of the applicant’s share in the patents and the compensation due under Art. 3 of the settlement:

The compensation under Art. 3 of the settlement is therefore effectively subject to the obligation of the applicant to take all necessary steps for the transfer of his share in the patents (or patent applications). However, it is not necessary that the applicant’s share in the patents (or patent applications) be actually transferred. All that is required under Art. 2 of the settlement is that the applicant takes all necessary steps for the transfer of his share in the patents / patent applications. If the effective transfer fails, for example because the defendant does not take the necessary steps, the claimant has fulfilled his obligations as the performance has been duly offered within the meaning of Art. 342 CPC.

It was undisputed that the patent application US 2017/325923 filed by the applicant and specifically mentioned in Art. 2 of the settlement has not been formally transferred to the defendant, i.e. the defendant is not yet registered as the sole owner of this application in the US Patent Register (and no assignment has been recorded to date).

The parties did not agree on the reasons why the transfer of this patent application has not been made. The applicant argued that he had undertaken all that was necessary for a transfer, namely that he has signed all the required documents. According to him, the non-registration of the transfer was attributable to the defendant, who refused to cooperate with the assignment. On the other hand, the defendant argued that the plaintiff did not sign all the required documents and that he himself diligently and fully complied with his obligations, in particular the various requests made by the plaintiff’s patent attorneys, who systematically answered all enquiries with considerable delay and in an incomplete or incomprehensible manner.

The FPC held that the applicant failed to show that the fault for the non-assignment of the patent(s) lies with the defendant. The file revealed that the applicant’s patent attorneys had often acted with a considerable delay and demanded documents that were not necessary for a transfer of patent applications. It therefore appears that the failure to register the transfer of the US patent application US 2017/325923 to the defendant is the responsibility of either the plaintiff or the plaintiff’s patent attorneys (acting as plaintiff’s associate), who was in possession of the documents necessary to execute the registration of the transfer on 14 August 2019. As the applicant is liable for the acts and omissions of his associate (Art. 101 CO), the failure to get the transfer registered must be considered a fault of the applicant.

Joh 8:7

In summary, the FPC held that the applicant had failed to prove that it has taken all necessary steps to assign the U.S. patent application to the defendant. Notably, the FPC held tha it may well be that the defendant has also failed to take certain steps. However, until plaintiff has taken all necessary steps to transfer his rights, plaintiff is prohibited from seeking performance of defendant’s outstanding obligations.

Well,

[h]e who is without sin among you, let him throw the first stone at her.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2020_001 | Decision of 25 August 2020 | ‘Enforcement request’

Dr. David BENSOUSSAN
./.
ROCK dental AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Lara DORIGO

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

SETTLEMENT

PATENT FAMILY IN SUIT

See the consolidated patent family in the European Patent Register.

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A partial waiver that did not do the trick

Reading time: 8 minutes

Case No. 4A_583/2019 (Supreme Court) | Decision of 19 August 2020 on appeal against O2016_012 (FPC) | Decision of 28 October 2019 | ‘Einschlagbarer Hüftgelenkprothesengrundkörper’

I have reported about the first instance decision in this matter on this Blog here. It was a controversially discussed decision — not only by practitioners after publication, but already in the making: It was a split decision, with a dissenting opinion supported by two of the five judges.

A quick recap
Implantec’s logo

The patent in suit is EP 1 411 869 B1; see Swissreg and EPO Register for further information. Stemcup asserted that Implantec‘s ANA.NOVA® hybrid socket infringes the patent.

Stemcup’s logo

Stemcup had partially waived EP 869 at the IPI, to overcome the judge-rapporteur’s finding in his expert opinion with respect to a presumably undue extension of subject-matter. The partial waiver had thus been filed at a very late stage of the proceedings, i.e. only after formal closure of the file and only about nine months after the defendant’s rejoinder wherein the undue extension of subject-matter had first been asserted.

The partial waiver has been published on 15 August 2018. Independent claims 1 and 2 now read as follows (inofficially translated; changes marked-up):


Claim 1

A joint prosthesis (1) with a base body (10) for knocking into a bone, characterised in that there are arranged at least two locking elements (20) on the outer side of the base body (10) which in each case comprise at least one 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°.

Claim 2

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°.

On the merits, this was no big deal. The FPC had emphasized that the patent after the partial waiver fits smoothly into the subject-matter as it had been already discussed in the proceedings, and the parties’ right to be heard had well been observed.

The FPC had further held that the plaintiff made use of a possibility that is explicitly provided for in Art. 24 PatA, and that this partial waiver is effective ex tunc, i.e. the patent is treated as if it had been granted only to that extent right from the outset. This is a new fact within the meaning of Art. 229(1) lit. a CPC (proper novum), because the patent in that limited form was only created after the formal closure of the file. The FPC had held that the fact that the plaintiff could have requested the partial waiver with the IPI well before the closure of the file, or that the partial waiver represents a new fact created by the plaintiff himself, does not change anything in this respect.

Further, the FPC had held that the proceedings have not become devoid of purpose, as the defendants had argued; this would only be the case if no patent existed at all anymore. 

And now … forget all of that!

The Supreme Court disagreed, entirely.

A strictly literal interpretation of Art. 229(1) CPC does not sufficiently take account of the fact that all party submissions must be made within a certain stage of the proceedings, i.e. one must not conveniently hold back facts and only submit them later (‘Eventualmaxime’). There are two aspects to that: On the one hand, facts must be presented in a concentrated manner; and on the other hand they can — in the interest of material truth — still be submitted later, under certain circumstances. The Supreme Court holds that it would contradict the first aspect if facts that are subsequently created by a party, which — depending on the decision of this party — could have already existed before the closure of the file, would qualify as proper nova. Further, it is not that the second aspect would require that the belated fact be taken into account.

The admissibility of new facts, the creation of which depend on the will of a party, is thus governed by Art. 229(1) lit. b CPC, i.e. it has to be shown that they could not have been submitted earlier, despite reasonable diligence.

This is essentially as has been argued in O2017_014 (see this Blog here), with reference to the decision ES 2018 449 of the Cantonal Court Zug.

In the case at hand now, the undue extension of subject-matter had first been alleged by the defendant already with the rejoinder. The Supreme Court holds that this should have prompted the plaintiff / patentee to fix it. Reacting only after receipt of the judge-rapporteur’s expert opinion was belated.

Finally, the Supreme Court holds that the patentee has no legal interest in a judgment on the patent as initially granted, since it does not exist anymore after the partial waiver. Note that the legal interest has to be examined ex officio. On the other hand, the partially waived patent cannot be admitted into the proceedings, as outlined above. Acordingly, the case has to be dismissed as devoid of purpose.

Thus, the Supreme Court lifted the FPC’s decision and dismissed the case as devoid of purpose. The case has been remitted to the FPC, to decide on the costs.

Now we know … what we don’t know

It is perfectly clear now that a partial waiver after closure of the file, to react on the judge-rapporteur’s expert opinion, does not generally do the trick. At least not in those cases where one could — and should — have reacted earlier. It won’t work anymore for a patentee to just wait and see whether the judge-rapporteur follows a nullity argument, and to only react with a partial waiver when needed in view of the expert opinion.

But what if the judge-rapporteur comes up with a certain reasoning in respect of an issue that is to be examined ex officio (e.g. a clarity issue in an amended claim in nullity proceedings), without it having been pleaded by the other party? Perhaps, one might still argue that one could not have submitted the partial waiver earlier, despite reasonable diligence in such cases?

Further, I wonder what happens when a plaintiff failed with his complaint for some validity issues, he then partially waives the patent later-on and sues the same defendant for the same attacked embodiment again. It’s not the same patent anymore, in my reading of the present decision. Thus, it is not yet res iudicata(?).

Patent litigation will surely remain exciting.

Oh, and I feel that the present decision might have a huge impact on some pending cases. For instance, the plaintiff / patentee in O2018_004 has partially waived the patent after receipt of the judge-rapporteur’s expert opinion. The main hearing is scheduled for 3 September 2020; see this Blog here. Maybe, we will see some creative lawyering as to why this partial waiver could not have been made earlier, despite reasonable diligence.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_583/2019 (Supreme Court) | Decision of 19 August 2020 on appeal against O2016_012 (FPC) | Decision of 28 October 2019 | ‘Einschlagbarer Hüftgelenkprothesengrundkörper’

(1) Implantec GmbH Appellants / Defendants
(2) Endoprothetik Schweiz GmbH
(formerly ImplanTec Schweiz GmbH)
./.
Stemcup Medical Products AG Respondent  / Plaintiff

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Fabienne HOHL
      • Dr. Martha NIQUILLE
      • Dr. Yves RÜEDI
      • Marie-Chantal MAY-CANNELLAS

Court Clerk:

    • Nicolas CURCHOD

Representative(s) of Appellants / Defendants:

    • Dr. Michael RITSCHER (MLL)
    • Noëlle STALDER (MLL)

Representative(s) of Respondent / Plaintiff :

SUPREME COURT DECISION

FPC DECISION

PATENT IN SUIT

EP 1 411 869 B1 (as initially granted):

 

EP(CH) 1 411 869 H1 (after partial waiver):

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There is an end to everything, even a flow sensor

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Case No. 4A_77/2020 (Supreme Court) | Decision of 17 June 2020 » on appeal against O2019_008 (FPC) | Decision of 17 December 2019 » | ‘Flow sensor II’

This is the second time that the Supreme Court had to deal with the ‘flow sensor’ litigation between Hamilton Medical and imtmedical. We had reported already on this Blog about the main hearing of 29 October 2018, the first decision of the FPC (case O2016_009 of 18 December 2018) and the first Supreme Court decision (case 4A_70/2019 of 6 August 2019). The latter decision has apparently been acknowledged «Impact Case of the Year 2020 – Switzerland» at the MIP Awards in March 2020. The Supreme Court had remitted the case to the FPC, to assess one specific issue; see 4A_70/2019, ¶2.5.4:

... for which the Supreme Court had remitted the case back to the FPC.

Inofficially translated:

[The FPC] did not examine whether there was a causal connection between the improper novum [document E10] in the rejoinder and the verbal limitation of the patent claim, i.e. whether the limitation was specifically occasioned by [E10]. The case must thus be remitted to [the FPC] for assessment of this issue.

Well, in the second FPC decision it had been held that the limitation was indeed specifically occasioned by E10; see this Blog here. imtmedical appealed again, but the Supreme Court has dismissed the appeal with decision of 17 June 2020.

A procedural issue is probably the most interesting aspect of the Supreme Court decision: As long as there is still a deadline pending for a party to make a submission on the merits, no separate (immediate) submission on a novum is necessary in the meantime.

As long as there is still a deadline pending for a submission on the merits, no separate reaction on the novum is necessary beforehand.

On the merits, the Supreme Court strictly focused to the only issue that had still been at stake — and did not actually address imtmedical’s arguments on various other issues (which the Supreme Court evidently did not appreciate).

Now that the partial decision on infringement and injunctive relief is final, it remains to be seen how this litigation continues when imtmedical has provided the information and accounting, as ordered.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_77/2020 (Supreme Court) | Decision of 17 June 2020 » on appeal against O2019_008 (FPC) | Decision of 17 December 2019 » | ‘Flow sensor II’

Hamilton Medical AG (Respondent / Plaintiff)
./.
imtmedical AG (Appellant / Defendant)

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Martha NIQUILLE
      • Marie-Chantal MAY-CANNELLAS

Court Clerk:

    • Nicolas CURCHOD

Representative(s) of Appellant / Defendant:

Representative(s) of Respondent / Plaintiff:

2nd SUPREME COURT DECISION 

on appeal against O2019_008 | Decision of 17 December 2019:
4A_77/2020 17 June 2019

2nd FPC DECISION

on remittal of 4A_70/2019 | Decision of 6 August 2019:
O2019_008 17 December 2019

1st SUPREME COURT DECISION 

on appeal against O2016_009 | Decision of 18 December 2018:
4A_70/2019 6 August 2019

1st FPC DECISION 

O2016_009 18 December 2018

CH 701 755 B1


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Of course I am in shape: Round is a shape …

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Case No. O2017_002 | Decision of 8 May 2020 » | ‘Freiform-Schneidverfahren’

We have reported about the main hearing on this Blog here ». From the pleadings at the hearing, I had expected a pretty straight-forward outcome. But when I had downloaded the decision, I panicked: 110 pages(!), a decision of epic length. When will I ever find time to read all this? But in the end it was not half as bad: One can thumb through more than half of the decision without missing much: It takes essentially the first 65(!) pages to recite the various requests of the parties during the proceedings.

The mountain in labour

Against the background of the pleadings at the main hearing, the conclusions of the decision indeed do not come as a big surprise anymore: EP(CH) 864 » is declared null and void; Bystronic’s further requests are dismissed, as well as Tomologic’s counterclaim for infringement. Appeal proceedings are currently pending at the Supreme Court.

Besides EP(CH) 864 », the further members of this patent family in other jurisdictions had also been at stake: Bystronic had requested assignment to co-ownership. Yet another patent family was at stake with respect to co-ownership, i.e WO 2012/136262 A1; grant of a European patent had already been intended, but proceedings at the EPO have been stayed in view of the entitlement proceedings at the FPC.

Now that the outcome is essentially in line with what we had learned in the main hearing », let’s have a look at some procedural aspects, and some issues of potentially more general interest.

Competency of the FPC

Competency of the FPC to hear all aspects of the case was not a given, since e.g. Bystronic had requested that foreign members of the patent families were assigned to co-ownership. It was only due to a Service Agreement between the parties, i.e. a choice of forum clause contained therein, that the FPC’s competency was acknowledged in toto.

based on a choice of forum agreement between the parties.
the judge-rapporteur’s expert opinion

Parties sometimes feel that the judge-rapporteur’s expert opinion should have dealt with yet further aspects of the case: Why didn’t he/she take a deep(er) dive? The decision holds that the parties do not have the right to have all the questions which might arise and which concern technical issues be dealt with in a specialised judge’s opinion; see ¶ 32. This is even more so in cases like the present one when more than 20 auxiliary requests are pending (which ultimately all failed for clarity issues and insufficiency of disclosure of a feature that was contained in all requests). It is at the judge-rapporteur’s discretion to make a reasonable choice of aspects to be dealt with in the expert opinion:

Do the examples have to be covered by the claim?

In general terms with respect to claim construction, the decision holds in ¶ 43 that a claim shall be read in such a way that the embodiments disclosed in the patent are literally covered. Applying this to the case at hand, the decision holds in ¶ 46, that one has to arrive at a certain conclusion since the embodiments disclosed in the specification must be covered (literally):

I have stumbled over the same wording several times in recent decisions of the FPC — and I am still not really comfy with it. My experience as a patent attorney is different: It frequently happens during prosecution that claims are amended in such a way that specific examples (only some or even all) disclosed in the specification are not covered anymore by the amended claim. Clearly, both the attorney and the examiner should spot and remove such inconsistencies before grant. But it just doesn’t happen, quite often.

By way of example, if a claim is amended during prosecution by specifying that a certain element is circular, and the patent as granted contains various embodiments of circular shape and still an embodiment where that element is rectangular, there is no way in my perception that circular in the claim should be construed such that it covers a rectangle.

On the other a hand, when the claim says round and the embodiments disclose only various polygons, chances are that polygons might well read on round(?). Subject to discussion, of course. But I feel that it is in no way a universal truth that a claim has to be construed in a way that it literally covers the disclosed embodiments, no matter what. Rather, it depends.

Accordingly, the German Supreme Court has held several times that the correct claim construction may well lead to a situation where only some or, in exceptional cases, even no embodiment at all is covered by the claim (see e.g.  X ZR 43/13Rotorblätter (¶ 16) and X ZR 35/11Zugriffsrechte (¶ 26)):

Eine Auslegung des Patentanspruchs, die zur Folge hätte, dass keines der […] geschilderten Ausführungsbeispiele vom Gegenstand des Patents erfasst würde, kommt […] nur in Betracht, wenn andere Auslegungsmöglichkeiten, die zumindest zur Einbeziehung eines Teils der Ausführungsbeispiele führen, zwingend ausscheiden oder wenn sich aus dem Patentanspruch hinreichend deutliche Anhaltspunkte dafür entnehmen lassen, dass tatsächlich etwas beansprucht wird, das so weitgehend von der Beschreibung abweicht.

In English:

A claim construction which would have the consequence that none of the described embodiments would be covered by the patent is only possible if other ways of claim construction which lead to the coverage of at least some of the embodiments are definitely ruled out or if there are sufficiently clear indications from the patent claim that something is actually claimed which deviates so widely from the description.

Co-inventorship

What’s the threshold for someone’s contribution to be considered relevant enough to give rise to co-inventorship?

The decision holds in ¶ 62 that a co-inventor is someone who has participated creatively in the development of the invention. Mere workmanship is not sufficient to be a co-inventor, but it is not required that the contribution in itself is inventive or even that it fulfils the conditions for patentability in itself.

mere constructional conribution does not suffice.

In the case at hand, the decision holds that mere evaluation of an invention-in-progress is not a creative / substantial input to the invention per se:

is not a creative / substantial contribution to the invention per se.

This example appears straight-forward to me. On the other side of the threshold, an input that is more than standard workmanship (or which is substantial; see ¶ 69) but not yet inventive in itself is sufficient for someone to be a co-inventor. Again, there may well be clear cases, e.g. when a car is claimed and the invention is all about an engine for the car, and someone only contributes to the subject-matter of the claim that the car has wheels (guess what!). But most cases won’t be this easy to decide.

On a sidenote, the decision also holds that the inventor has to be a human. Well, that is the current mainstream approach, see e.g. the EPO’s DABUS decisions and a recent report from the Five IP Offices:

ManMachine

But there are certainly AI-generated inventions around; see e.g. The Artificial Inventor Project, and it is a pity that the law — at least as it stands and as it is currently interpreted by the offices and courts(?) — deprives AI-generated inventions from patent protection. But the discussion about this and further AI-related aspects has only just begun.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_002 | Decision of 8 May 2020 » | ‘Freiform-Schneidverfahren’

Bystronic Laser AG
./.
Tomologic AB

Panel of Judges:

    • Dr. Thomas LEGLER
    • Dr. Tobias BREMI
    • Christoph MÜLLER
    • Christophe SAAM
    • Dr. Rudolf RENTSCH

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Markus FRICK (Walder Wyss)
    • Manuel BIGLER (Walder Wyss)
    • Dr. Peter WALSER (Frei), assisting in patent matters
    • Dr. Markus MÜLLER (Frei), assisting in patent matters

Former representative(s) of Plaintiff:

    • Catherine WEISSER
    • Paul ROSENICH (PPR), assisting in patent matters

Representative(s) of Defendant / Counterclaimant:

    • Dr. Simon HOLZER (MLL)
    • Martin TOLETI (Blum), assisting in patent matters
    • Dr. Christoph ENGELBRECHT (Blum), assisting in patent matters

DECISION

PATENT IN SUIT

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No cherry-picking: Supreme Court endorses EPO case-law re singling out

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Case No. 4A_613/2019 (Supreme Court) | Decision of 11 May 2020 on appeal against O2017_009 (FPC) | Decision of 7 November 2019

MundiPharma’s EP(CH) 2 425 821 B1 and EP(CH) 2 425 824 B1 had been revoked by the FPC with decision of 7 November 2019; O2017_009. Accordingly, MundiPharma’s counterclaim for infringement failed. A detailed comment on that decision is available on this Blog here.

MundiPharma had appealed the decision, but only with respect to EP(CH) 821:

The decision of the Supreme Court gives an overview of some relevant decisions of the Boards of Appeal of the EPO concerning Art. 123(2) EPC in ¶ 3.2, which the Supreme Court apparently endorses without hesitation. As to the matter at hand, the Supreme Court confirms that the FPC had correctly applied these principles and that the subject-matter of EP(CH) 821 is the result of an unallowable singling out of at least two features from different lists. The resulting combination of features, i.e. the weight ratio of oxycodone to naloxone of 2:1 in combination with the reduction of obstipation, is not directly and unambiguously disclosed in the application as originally filed; see ¶¶ 3.3 and 3.4. In particular, MundiPharma could not establish how the skilled person would have derived the specific weight ratio and the reduction of obstipation in combination from the application as filed:

Further, the Supreme Court did not spot a violation of MundiPharma’s right to be heard because the FPC allegedly did not take the skilled person’s knowledge into account. The Supreme Court holds that the FPC in fact did take it into account, and that MundiPharma essentially only argues that it had a different opinion of how the law and case-law should be applied to the case at hand:

Finally, the Supreme Court dealt with MundiPharma’s objection concerning the apportionment of costs. It may well be that in a nullity case the necessary expenses incurred by the assisting patent attorney exceeds the amount that can be refunded for legal representation according to the tariff:

Oral proceedings before a Board of Appeal in co-pending proceedings at the EPO are scheduled for 23 September 2021, to be continued on 24 September 2021 if necessary. No preliminary opinion of the Board is available yet.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_613/2019 (Supreme Court) | Decision of 11 May 2020 on appeal against O2017_009 (FPC) | Decision of 7 November 2019

MundiPharma Medical Company (Appellant / Defendant)
./.
Develco Pharma Schweiz AG (Respondent / Plaintiff)

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Fabienne HOHL
      • Dr. Martha NIQUILLE
      • Dr. Yves RÜEDI
      • Marie-Chantal MAY-CANNELLAS

Court Clerk:

    • Christian STÄHLE

Representative(s) of Appellant / Defendant:

    • Dr. Simon HOLZER (MLL)
    • Louisa GALBRAITH (MLL)

Representative(s) of Respondent / Plaintiff:

DECISION OF THE SUPREME COURT
→ appeal against FPC decision to revoke EP(CH) 2 425 821 B1
Case no.: 4A_613/2019
Decision of: 11 May 2020
The unredacted decision had been submitted by the Respondent / Plaintiff in the co-pending opposition / appeal proceedings at the EPO:

DECISION OF THE FPC
→ Revocation of EP(CH) 2 425 821 B1
Case no.: O2017_009
Decision of: 7 November 2020

PATENT IN SUIT

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Fulvestrant, again

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Case No. O2017_014 | Decision of 10 March 2020 | ‘Fulvestrant use’

When you have read the report about the main hearing of 20 January 2020 on this Blog here, you probably won’t be overly surprised by the outcome: AZ’s complaint has been dismissed.

In brief, AstraZeneca asserted 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). The patent has been partially waived after closure of the file, in accordance with Art. 24 PatA (newly added features marked-up):

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

Here are my take-away messages from the decision:

Expert opinion

The decision clarifies in no uncertain terms the nature of the judge-rapporteur’s expert opinion (EO):

... is a legal assessment of the facts as pleaded before closure of the file.

Loose translation to English:

The [EO] is established after closure of the file, and it is the judge-rapporteur’s legal assessment of the facts put forward by the parties. It provides a contribution to the discussion for the purpose of rendering a judgment. The [EO] can therefore only deal with questions of law, but not with questions of fact. Accordingly, [an EO] cannot entitle the submission of new facts from the outset. Certainly, a party cannot use [the EO] as a trigger to remedy incomplete factual allegations.

Admissibility of partial waiver

Nosy? Me too. But it’s not yet time. Admissibility of the partial waiver after closure of the file is left undecided, in view of the appeal in case O2016_012 that is currently still pending at the Supreme Court. Irrespective of the answer to this highly interesting question, the complaint had to be dismissed for other reasons; see below.

Belated and insufficient factual allegations re infringement of the partially waived patent

A partial waiver after closure of the file per se cannot carry the day.

The decision holds that AZ’s pleadings re infringement of the partially waived patent — for the first time at the hearing — were belated and insufficiently substantiated:

... and insufficiently substantiated pleadings re infringement of the partially waived patent.

Accordingly, the complaint was dismissed.

How to (formally correctly) introduce a partially waived patent into the proceedings

AZ had submitted the partially waived patent to the court with letter of 8 August 2019, and Sandoz had been given the opportunity to comment thereon. The decision holds:

... and how it had been introduced into the proceedings.

Loose translation to English:

In this respect, it is not clear to the Court what the defendant means when asserting that the partially waived patent has not yet been asserted or formally correctly introduced into the proceedings.

Frankly, I am confused. My understanding from what had been pleaded at the hearing was that AZ had indeed submitted the partially waived patent — but merely as an annex, i.e. without asserting the substance of the partially waived patent in the submission itself. That could have been an interesting issue, somewhat similar to the situation that gave rise to the order of 3 May 2012 in O2012_022; see ¶¶ 10.4 et seqq. But, maybe, I just got it wrong. Anyway, that’s not the decisive issue here.

UPDATE 27 May 2020:

According to an update on the FPC’s website earlier today, the decision has not been appealed / is final.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_014 | Decision of 10 March 2020 | ‘Fulvestrant use’

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. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters

Representative(s) of Defendant / Patentee:

DECISION IN FULL

PATENT IN SUIT

EP 195 as granted by the EPO:

 

EP 195 after partial waiver in Switzerland:

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How many deaths can one die?

Reading time: 11 minutes

Case No. O2017_015 | Decision of 7 November 2019 | ‘Rame ferroviaire modulaire’

HEADNOTE

Art. 56 EPC, Art. 1(2) PatA: Inventive step and technical disadvantages in the event of a change in the teaching of the state of the art.

If an obvious technical disadvantage for the skilled person results from a change of the teaching of a prior art leading to the claimed invention, it cannot be asserted, that the skilled person would not seriously consider such a change of the teaching of the prior art, if at the same time the claimed invention does not remedy that disadvantage in an unexpected manner, but merely accepts it.

Alstom’s logo

The patent at stake in this infringement case is Alstom‘s EP 1 024 070 B1; see EPO Register and Swissreg for further bibliographic information. We have reported about the main hearing in this matter on this Blog here.

Alstom alleged that Bombardier‘s Twindexx train in the IR100 (SBB RABe 502) configuration infringes EP’070:

The IR100 configuration of Bombardier’s Twindexx train
SBB logo

Please find some further information about the Twindexx train on SBB’s website, and on Bombardier’s swissdosto.ch website and fact sheet. The video below is embedded from swissdosto.ch, for amusement of the railway enthusiasts out there before we are going to have a closer look at the more legal issues of the case …

Promo video, embedded from swissdosto.ch (Bombardier)

The relevant claims are the independent claim 1 and its dependent claim 7 (emphasis added), as asserted by Alstom:


Claim 1:

A modular railway rake formed of at least two vehicles (1, 2) with two superposed levels, including at least one bogie (10) including at least one driving axle, at least one bogie (11) including at least one carrying axle, and on-board equipment including at least one power supply electronic unit (19) for supplying motive power to one or more traction motors, at least one motive power supply unit (22, 25) for supplying power to the electronic unit (19), at least one auxiliary power supply unit (30) for supplying power to auxiliary equipment, and at least one device (21) for connection to an overhead power supply network, in which rake the motive power factor of a vehicle or a group of vehicles is defined as the ratio of the number of driving axles to the total number of axles of the vehicle or group, the rake being characterized in that at least one vehicle (1) includes at least one bogie (10) including at least one driving axle and at least one bogie (11) including at least one carrying axle, at least one bogie (11) of the rake including at least one carrying axle is associated with at least one of said on-board equipment items (19; 22, 25; 30; 21) disposed approximately over that bogie, and the ratio between the respective motive power factors of any two groups of two vehicles of the rake is not less than 1/3 and not more than 3.

Claim 7:

A railway rake according to claim 1, characterized in that at least one power supply unit (22, 25; 30) is disposed approximately over a bogie (11) including at least one carrying axle.
Bombardier Logo

Bombardier took the position that the IR100 did not make use of the features as marked-up in bold above; in particular, that the IR100 was not modular and did not have two superposed levels in the sense of EP’070.

Alstom had amended the request for injunctive relief after the instructional hearing in that the term ‘modular’ was replaced by the following:

What ‘modular’ means, in Alstom’s view

With regard to modularity, the court came to the conclusion that only a modularity could be meant which allows the train operator to react on momentary needs, by way of adding vehicles to preexisting train compositions. The decision refers to ¶¶[0002]-[0003] of the general specification of EP’070, as well as the explanations with respect to specific embodiments:

Alstom had argued that also modifications in medium and long term would be covered by the term ‘modular’ when properly construed. This, however, did not convince the judges because such broad reading would cover virtually any system composed of a plurality of parts. The term must necessarily have a (more narrow) meaning. Otherwise, so the decision, it would not have been used (¶19):

Par conséquent, étant donné que la rame ferroviaire est définie dans la revendication comme etant «modulaire», ce terme doit nécessairement avoir une signification particulière, sinon il n’aurauit pas été spécifié dans la revendication.

That’s pretty catchy, isn’t it? I would not be surprised if (mis?)use of this reasoning will become somewhat popular in response to an invalidity challenge:

Uuhu, hold on, the feature is in the claim, it must have a very specific meaning, else it wouldn’t be there.

Well, not necessarily. Sometimes there are features in a claim that are just trivial — and can be (easily) challenged as such.

Anyway, the decision holds that omission of the term ‘modular’ in the plaintiff’s request for injuctive relief as amended resulted in the court’s finding that the request went beyond the scope of protection of EP’070 and that it had to be rejected already for this reason alone; ¶21. Death #1.

This could have been it. However, the decision gives even more reasons as to why the complaint had to be rejected: EP’070 was neither valid nor infringed.

After a detailed claim construction, the decision holds that EP’070 to the invoked extent was novel over the closest prior art, D1, at least for the modularity of the rake and for the positioning of heavy elements approximatively above the carrying axle bogie.

Now … what is D1?!

But … what the heck is D1?

The decision is silent on what D1 is — which is regrettable. No chance to really review the stringency of the court’s line of arguments. It can only be assumed from what had been pleaded at the main hearing and some annotations in figures reproduced in the decision that D1 is a publication about the first generation DD-IRM (1994) train of the Dutch Railways (see Wikipedia: NS_VIRM).

Anyway, the decision holds that the subject-matter of EP’070 to the invoked extent did not involve an inventive step over the teachings of D1. The differentiating features (first, the modularity; and, second, the positioning of heavy elements approximatively above the carrying axle bogie) are associated with the technical effects that the weight is distributed evenly over the length of the train rake and that train operation becomes more profitable.

As to modularity, the decision holds that the skilled person would arrive at a modular train without further ado if he/she were to develop a more flexible and hence more profitable train rake.

With regard to the positioning of heavy equipment (such as the down chopper module in D1) the judges agreed with the patentee in that such heavy equipment would intuitively be placed in the lowest possible location of the rake, e.g. at the bottom of a low voltage machine room. However, and this is where the headnote stems from, if the claimed invention merely accepts an obvious disadvantage without suggesting any remedy thereto, the unfavorable feature cannot support the finding of an inventive step.

... when an apparent technical disadvantage of a technical solution is not overcome in a non-obvious manner but merely accepted.

In consequence, EP’070 was found obvious over D1 in combination with the skilled person’s general technical knowledge. Death #2.

At the face of it, the hn makes much sense against the background of the case at hand. But is the absolute character of the statement justified? One might well think of situations, where a particular disadvantage of a feature would be merely accepted (rather than remedied), but where the choice of the feature would still be non-obvious. For example, when the commonly known and persisting drawbacks are set off by other, unrelated or indirect advantages associated with the feature. In our perception, the hn should be understood with the provision marked-up below:

[…] if at the same time the claimed invention does not remedy that disadvantage in an unexpected manner, but merely accepts it and does not compensate for it by any unexpected technical advantage.

This would actually be perfectly in line with established case law of the Boards of Appeal of the EPO; see Case Law of the Boards of Appeal (2019), I.D.9.19.1, in particular T 119/82 (hn 2).

Again, the decision could have ended at this point. But the decision also expands on the question of infringement, i.e. that Bombardier’s Twindexx IR100 was not modular in the sense as described above. In particular, it could not, due to software issues, be supplemented with additional coaches nor could coaches be removed by the train operator in the short run. Also, no equivalent feature providing such flexibility could be found in the IR100 train. Death #3.

It is remarkable that the decision gives no less than three reasons for rejecting the request for injunctive relief. This is rarely seen. Still, it may well serve procedural economy: Both the parties and the appellate body are provided with a more complete picture of the first instance’s views. This way, the unsuccessful party can make a more informed decision on whether or not to lodge an appeal; and if an appeal is lodged, the appellate body might not have to remit the case back to the first instance — hence saving time and money.

Patent Reaper

But as if three reasons were not enough, death #4 was just around the corner: EP’070 lapsed after 20y in January 2020.

The decision has not been appealed / is final.

Reported by Jolanda MINDER and Martin WILMING

BIBLIOGRAPHY

Case No. O2017_015 | Decision of 7 November 2019 | ‘Rame ferroviaire modulaire’

Alstom Transport Technologies SASU
./.
Bombardier Transportation (Switzerland) AG

Panel of Judges:

    • Dr. Philippe DUCOR
    • Dr. Tobias BREMI
    • Christophe SAAM

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

PATENT IN SUIT

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How to interpret expressions stating a purpose in a patent claim

Reading time: 10 minutes

Case No. O2018_017 | Decision of 31 January 2020

Aschwanden’s logo

F.J. Aschwanden on the one hand, and acG Holding (Anita and Clément Gutzwiller) and Andreas (André) Robert on the other hand are litigating over validity of EP 2 475 827 in Switzerland. We had reported about the main hearing in this matter on this Blog here.

Basys’ logo

From the earlier case S2018_005 it is known that Basys is the exclusive licensee of EP 827; Aschwanden’s ‘Dura Box‘ line of products had been asserted to infringe EP 827.

EP 827 pertains to reinforcing elements that can be integrated in concrete structures in order to support recesses for conduits (water, electricity, etc.).

No suspension of proceedings / the judgment

Opposition proceedings are currently pending at the EPO, and the parties have been summoned for oral proceedings on 31 March 2020. One of the two opponents is F.J. Aschwanden, i.e. the plaintiff in the present case. The second opponent is Jordahl H-Bau AG. The latter has submitted the judgment to the EPO with letter of 18 February 2020.

The FPC may suspend proceedings, and in particular defer the judgment, where a final decision has not yet been taken in EPO opposition proceedings; Art. 128 lit. b PatA. The decision holds that the timeline is decisive. If a legally binding decision is to be expected soon by the EPO, it is justified in order to avoid contradictory decisions to suspend the national proceedings, or the judgment only. However, if it is likely to take longer for the EPO to reach a final decision, the constitutional right to an assessment within a reasonable period of time will prevail.

Defendant’s request to suspend proceedings had already been dismissed with order of 30 October 2019. The request at the main hearing to only suspend the judgment was unsuccessful, either. First, a delay of at least one year could hardly be considered acceptable for the plaintiff, in view of the constitutional acceleration requirement; Art. 29(1) FC, Art. 6(1) CPHR. Second, the decision holds that there is not even a risk of conflicting decisions since the claims for which the Opposition Division provisionally indicated allowability are not to be considered in the present proceedings; see below.

Belated claim amendment

The patentee / defendant had requested twice to maintain the patent in amended form: For the first time with the rejoinder, and for the second time in an even more limited form with the comment on the expert opinion of the judge-rapporteur. Clearly, the former was still timely filed, i.e. well before closure of the file. On the other hand, the latter was filed only after closure of the file. What is more, the patentee had submitted the very same claims in EPO opposition proceedings already well before the rejoinder was filed. The decision holds that the mere fact that the Opposition Division of the EPO indicated allowability of these claims (Auxiliary Request 2) with the summons to oral proceedings in no way justifies the belated submission of the claims in proceedings at the FPC.

On the merits

The decision extensively deals with claim construction on about five pages. Clearly, this facilitates the analysis of novelty and inventive step later on.

Neither claim 1 as granted nor claim 1 as amended with the rejoinder is held to be novel over Suzuki et al. (Nippon Steel Technical Report No. 96 July 2007: High Strength Deformed Bar-in-Coil «HDC800» for Shear Reinforcement of RC Beam with Web-opening) and JP 6-32280; an automated translation of the latter (which is actually not too bad) is available via the Global Dossier.


Claim 1 as granted (EN translation)

A Device for the reinforcement of concrete structures
B which, by means of inserted structural elements, bridges weakened zones
C which are produced by recessed parts
D and which transmits the forces
E wherein in addition to the conventional design of the reinforcement (11) originally calculated by the structural engineer
F and before the concrete is cast
G  the recessed parts are surrounded by at least one structural element
H the structural element (1) comprises at least one tension element (2) in the form of a straight tension rod, a bent rod or a frame
I which is connected at both ends to an anchoring
J at least one holder (4) is provided, which is connected to the tension element (2) or to the anchoring (3) or is formed by the tension element itself
K wherein a force model is formed by the structural element
L which reinforces the local shear behavior of the statics in the region of the recessed parts
M and thus improves the concrete structure weakened by the recessed parts by transferring the forces
N and reduces or eliminates the static weaknesses of the concrete structure caused by the recessed parts
O the tension element taking over shear, compression, transverse, tensile forces and / or bending moments
P wherein force-neutral zones are formed for the recessed parts by the force model
Q the structural element surrounds these force-neutral zones at least partly on two opposite sides
R and completely on a third side connecting the two sides
S the holder is arranged to hold the recessed parts in the force-neutral zone and the recessed parts are accommodated in the force-neutral zones

Claim 1 of the Auxiliary Request (EN translation), marked-up

A Device for the reinforcement of reinforced-concrete floorsstructures
B which, by means of inserted structural elements inserted into the reinforced-concrete floor, bridges weakened zones
C which are produced by recessed parts
D and which transmits the forces
E wherein in addition to the conventional design of the reinforcement (11) originally calculated by the structural engineer
F and before the concrete is cast
G  the recessed parts are surrounded by at least one structural element
H the structural element (1) comprises at least one tension element (2) in the form of a straight tension rod, a bent rod or a frame
I which is connected at both ends to an anchoring
J at least one holder (4) is provided, which is connected to the tension element (2) or to the anchoring (3) or is formed by the tension element itself
K wherein a force model is formed by the structural element
L which reinforces the local shear behavior of the statics in the region of the recessed parts
M and thus improves the concrete structure weakened by the recessed parts by transferring the forces
N and reduces or eliminates the static weaknesses of the concrete structure caused by the recessed parts
O the tension element taking over shear, compression, transverse, tensile forces and / or bending moments
P wherein force-neutral zones are formed for the recessed parts by the force model
Q the structural element surrounds these force-neutral zones at least partly on two opposite sides
R and completely on a third side connecting the two sides
S the holder is arranged to hold the recessed parts in the force-neutral zone and the recessed parts are accommodated in the force-neutral zones

The statements in the claim that indicate a purpose are the most crucial ones for the outcome of the case; see below.

Interpretation of expressions stating a purpose

The decision holds that according to the Supreme Court (122 III 81, r. 4b), in the case of a device claim (product claim), indications of purpose, effect or function do not normally have a restrictive effect on the scope of protection. Such statements generally are only to ease understanding. The situation is different if the disclosed use is not merely a statement of purpose, but already indicates the functional suitability of the device and its physical properties by way of explanation.

According to the practice at the EPO, on the other hand, the indication of a purpose in a device claim must in principle be interpreted such that the device is suitable for the specified purpose; see Guidelines F-IV, 4.13.1 and Case Law of the Boards of Appeal, 9th ed. (2019), I.C.8.1.5.

UPDATE 09 March 2020:

I only realized now that indications of a purpose had already been at stake in S2012_004 of 24 March 2012; see this Blog here. At that time, the FPC had applied the EPO’s approach without hesitation; see ¶8.

Anyway, the decision holds that the principles of interpretation of the Supreme Court and the EPO lead to same result: A known device prejudices the subject matter of a later claim if that known device was suitable for the purpose stated in the claim.

Even though it is a non-issue for the case at hand, I am still struggling with the reasons in 122 III 81, r. 4b.

Do you get it? I don’t.

In a claim directed to a «[d]evice for [doing x], wherein the device comprises [y and z]», how would I ever know whether the indicated purpose is only meant ‘to ease understanding’ («Verständnishilfe») or whether it defines ‘the functional suitability of the device and its physical properties by way of explanation’ («die funktionelle Eignung der Vorrichtung und deren körperliche Ausgestaltung erläuternd klarstellt»). Frankly, that doesn’t make much sense to me; it is the exact opposite of legal certainty. Anyway, the decision is almost a quarter of a century old. I would assume that the Swiss Supreme Court would nowadays assess the issue similar as the German Supreme Court did in the hn of Xa Zr 140 05 of 28 May 2009:

[Purpose features] regularly have the task of defining the subject-matter protected by the patent in such a way that it does not only have to fulfil the spatial-physical features recited in the claim, but that it must also be designed in such a way that it can be used for the purpose stated in the claim.

approaches 'purpose' features in pretty much the same way as the EPO.

Well, this is it. Period.

UPDATE 12 March 2020:

The decision has not been appealed / is final now.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_017 | Hearing of 18 November 2019

F.J. Aschwanden AG

./.

  1. acG Holding AG
  2. Andreas (gen. André) ROBERT

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Natalia CLERC
    • Dr. Kurt SUTTER

Judge-rapporteur:

    • Natalia CLERC

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant / Patentee:

    • Felix GRETHER (EBD)
    • Daniel MAIER (euromaier), assisting in patent matters

DECISION IN FULL

PATENT IN SUIT

EPO SUMMONS

EPO AUXILIARY REQUEST 2

RELATED CASE S2018_005


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Oxycodone / Naloxone II, III, … and counting(?)

Reading time: 7 minutes

Case No. O2017_009 | Decision of 7 November 2019 | ‘Oxycodon und Naloxon II und III’

The patents at stake in this nullity case are MundiPharma‘s EP 2 425 821 B1 (see EPO Register and Swissreg) and EP 2 425 824 B1 (see EPO Register and Swissreg). The same parties have already litigated over EP 2 425 825 B9 in separate proceedings O2016_016; see this Blog here — and so did yet another plaintiff in O2016_017; see this Blog here.

Wondering about the color code? It is adopted from the decision itself (¶ 16), to help getting the ducks (pardon me, divisional applications) in line:

Patents in suit: EP’821 and EP’824

Yet again, it’s all about a combination of oxycodone hydrochloride and naloxone hydrochloride, in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma.

Develco sought annulment of both EP(CH)’821 and EP(CH)’824 inter alia for undue extension of subject-matter, in violation of Art. 76 and Art. 123 EPC. Note that both patents had been filed as divisional applications, without any claims in first place. However, the claims of WO’520 had been recited in the specification in ¶ [0127] of EP 821 A1 and ¶ [0131] of EP 824 A1, respectively.

As to EP 824, the decision holds that claim 1 as granted does not comply with Art. 76 and Art. 123 EPC; see the following mark-up over the first claim-like clause  in ¶ [0131] of EP 824 A1:

EP 824 as granted; mark-up over ¶ [0131] of EP 824 A1
Likewise, the first auxiliary request (AR 1) — wherein only feature 1.7 had been amended over the claims as granted — failed  for essentially the same reasons:

AR 1, mark-up over the claims as granted

Both claim 1 as granted and claim 1 of the AR 1 had also been held by an Opposition Division of the EPO to not comply with Art. 123 EPC; see the decision of 11 September 2019, ¶¶ 2.4-2.9, 6 and 8.

Finally, also AR 2 failed for essentially (some of) the same reasons as the claims as granted, and in line with the ratio decidendi of the EPO’s Opposition Division:

AR 2, mark-up over the claims as granted

As to EP 821, the decision is pretty straight forward because the specification is the same as in EP 824. Claim 1 as granted does not comply with Art. 123 EPC:

EP 821 as granted; mark-up over ¶ [0127] of EP 821 A1
The FPC comes to the same conclusion for claim 1 of AR 1:

AR 1, mark-up over the claims as granted

This finding of the FPC is in line with the decision of an Opposition Division in parallel proceedings at the EPO; see the decision of 11 September 2019 (AR 1 corresponds to AR IX in EPO opposition proceedings).

On the merits, I feel that this case is nothing out of the ordinary in terms of assessment of undue extension of subject-matter. Still, there are two statements that I find noteworthy.

First, the decision holds in ¶ 25 that, as a rule, when reading a patent application or a patent, the person skilled in the art assumes that features, if they are expressly mentioned in an independent claim, are important and not just superfluous — unless there are clear indications to the contrary. Thus, for a feature to be omitted, it is therefore not sufficient to show that it is not highlighted anywhere as important. Rather, it must be shown that the skilled person recognizes that the feature does not make a technical contribution or can be omitted. It must therefore be established that the skilled person, using common general knowledge, would regard the claimed subject-matter even without the specific feature  as — explicitly or implicitly — directly and unambiguously disclosed in the application as filed.

Grundsätzlich geht der Fachmann beim Lesen einer Patentanmeldung oder einer Patentschrift a priori zunächst einmal davon aus, dass Merkmale, wenn sie ausdrücklich in unabhängigen Patentansprüchen genannt werden, auch wichtig und nicht einfach überflüssig sind, sofern es nicht klare Hinweise für das Gegenteil gibt.

Damit ein Merkmal weggelassen werden kann, genügt es also nicht, zu zeigen, dass es nirgends als wichtig hervorgehoben wird, sondern es muss gezeigt werden, dass für den Fachmann zweifelsfrei erkennbar ist, dass das Merkmal keinen technischen Beitrag leistet oder auch weggelassen werden kann. Mithin muss gezeigt werden, dass der Fachmann unter Heranziehung des allgemeinen Fachwissens den beanspruchten Gegenstand auch ohne das Merkmal als – explizit oder implizit – unmittelbar und eindeutig in der ursprünglichen Fassung der Anmeldung offenbart ansehen würde.

In my perception, this is essentially the approach of the EPO, even though the decision does not make any reference to the EPO Guidelines or case-law of the Boards of Appeal in this respect.

Second, the decision makes a clear distinction in ¶ 44, with extensive reference to case-law of the Boards of Appeal, between mere deletion of some elements from lists of a certain length on the one hand (which may well be admissible), and so-called singling out of specific elements from a lists (which is typically not permissible).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_009 | Decision of 7 November 2019 | ‘Oxycodon und Naloxon II und III’

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

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

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Develco:

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

Representative(s) of Mundipharma:

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

DECISION IN FULL

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PATENTS IN SUIT

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The Supreme Court will not have its say on O2018_009 re Fulvestrant

Case No. 4A_332/2019 (Supreme Court) | Order of 13 November 2019, on appeal against O2018_009  (FPC) | Decision of 27 May 2019 | ‘Patentnichtigkeit Fulvestrant’

Reading time: 3 minutes

A quick recap: Actavis had challenged validity of AZ’s Swiss part of EP 2 266 573 back in 2015, and the FPC had indeed held in 2017 that EP 573 was invalid for lack of inventive step; see this Blog here. However, the Supreme Court overruled that decision and remitted the case back to the FPC for re-assessment of obviousness; see this Blog here. In the second round, the FPC held that the subject-matter of EP 573 did involve an iventive step; see the decision O2018_009 of 27 May 2019. In brief, the FPC held that neither

rendered the claimed subject-matter obvious. That decision was again appealed to the Supreme Court, and I have been eagerly awaiting a good read. But nothing like that. The Supreme Court only published a dismissal order. The parties have apparently reached an amicable settlement; court fees are shared.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_332/2019 (Supreme Court) | Order of 13 November 2019, on appeal against O2018_009  (FPC) | Decision of 27 May 2019 | ‘Patentnichtigkeit Fulvestrant’

Mepha Schweiz AG
(formerly Actavis Switzerland AG)
(Appellant / Plaintiff)
./.
AstraZeneca AB (Respondent / Defendant)

Single Judge:

    • Dr. Kathrin KLETT

Court Clerk:

    •  Dr. Thomas WIDMER

Representative(s) of Appellant / Plaintiff:

Representative(s) of Respondent / Defendant:

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

SUPREME COURT DECISION

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FPC DECISION

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EP 2 266 573 B1

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Lilly’s EP 1 313 508 on combination of pemetrexed and vitamin B12 held valid

Case No. O2018_003 | Decision of 15 October 2019 | “Patentnichtigkeit; Pemetrexed”

The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. In a nutshell, EP’508 relates to combination of pemetrexed disodium and vitamin B12. See this Blog here for a discussion about earlier infringement proceedings concerning the same patent.

Now, nullity is at stake.

An Opposition Division of the EPO had maintained the patent as granted with decision of 27 December 2010; an appeal had initially been lodged but withdrawn later. Related decisions in civil proceedings elsewhere had also addressed the validity of EP’508, e.g. in

Thus, it was an uphill fight for the plaintiff. And even though the FPC took the parallel decision of the German FPC into account, it explicitly disagreed. It is held on p 19 (penultimate and lastparagraph), that the German FPC erred with the finding that

[…] bei einer Pemetrexedgabe durch die Blockierung der drei Schlüsselenzyme Thymidylatsynthase (= TS), Dihydrofolatreduktase (= DHFR) und Glycinamidribonukleotidformyltransferase (= GARFT) im «DNA- Zyklus» nicht nur dieser Zyklus, sondern auch der «Methylierungszyklus» blockiert wird.

Consequently, the FPC did not put much weight (if any) on the parallel decision in Germany.

On the contrary, the decision holds that the claimed subject-matter was novel over Worzalla et al. since mere reference to a diet ‘Purina Chow #5001’ did not implicitly, yet clearly and unambiguously, disclose the presence of vitamin B12 (or folic acid).

Further, the decision rejects plaintiff’s argument re obviousness over Niyikiza et al. (abstract 609P bridging pages 126/127), Niyikiza et al. (abstract 2139 on the top right, referred to as act. 7_10 in the decision), the IBIS Guide to Drug-Herb and Drug Nutrient Interactions, Jackman and Calvert (which had been considered as closest prior art in EPO opposition proceedings).

The decision has been appealed to the Supreme Court.

A discussion of this decision is also available on the EPLAW Blog, provided by defendant’s counsel.

UPDATE 18 June 2020:

The Supreme Court has dismissed Sandoz’s appeal with decision of 1 May 2020 (published 17 June 2020); the full judgment is available here.

The operative part of the judgment has been published earlier by Lilly’s counsel on EPLaw Blog; available here.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_003 | Decision of 15 October 2019 | “Patentnichtigkeit; Pemetrexed”

Sandoz Pharmaceuticals AG

./.

Eli Lilly & Company

Panel of Judges:

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

Court Clerk:

    •  Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

DECISION IN FULL

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Non-official English translation (first published on the EPLAW Blog):

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PATENT IN SUIT

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Low dosage form of tadalafil held obvious, preliminary injunction denied

Reading time: 13 minutes

Case No. S2019_007 | Decision of 1 October 2019

DISCLOSURE NOTICE

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

The patent in suit is CH/EP 1 173 181 H1, after partial surrender of EP 1 173 181 B3 which itself came out of central limitation proceedings concerning EP 1 173 181 B1 before the EPO; see EPO Register and Swissreg for further information.

EP’181 is meant to protect Lilly‘s low dosage forms of tadalafil, i.e. Cialis® 2.5 mg and Cialis® 5 mg, for the treatment of erectile dysfunction. Cialis at these low dosages is sometimes referred to as the ‘weekend pill’ because it can not only be taken on demand but also once daily, without regard to timing of sexual activity. See drugs.com and Lilly’s prescribing information.

Lilly sought for a preliminary injunction against Sandoz‘s generics Tadalafil Sandoz® 2.5 mg and Tadalafil Sandoz® 5 mg.

The feature analysis of claim 1 of CH/EP’181 H1 reads as follows:

1.1 Pharmaceutical unit dosage composition
1.2 comprising a compound having the structural formula [tadalafil]
1.3 comprising 1 to 5 mg of this compound
1.4 said unit dosage form suitable for oral administration
1.5 up to a maximum total dose of 5 mg per day
1.6 for use in treating a condition where inhibition of PDE5 is desirable
1.7 wherein the condition is sexual dysfunction.

No dosage regime

Note that the claim does not address the frequency of taking of tadalafil. In accordance with feature 1.5, tadalafil could be taken once or several times per day (prophylactic or on demand, as long as the dose of 5 mg per day is not exceeded), and it is not defined that tadalafil is taken each day. Similar to the German FPC (¶ II.1), the decision holds that the claim lacks an essential element of a dosage regime, i.e. the frequency of taking tadalafil.

Claim to priority presumably valid

EP’181 is based on a national phase application of WO 00/66099 and claims priority of US 60/312,036.

The decision holds that the claim to priority is presumably valid, both formally (¶ 19) and on the merits (¶¶ 20-22).

Presumably no undue extension of subject-matter

The range of ‘1 to 20 mg’ in EP’181 B1 — with ‘5 to 20 mg’ being preferred — had been limited to ‘1 to 5 mg’ in EP’181 B3.

The decision holds that the plea in defense with respect to an undue extension of subject-matter is presumably unfounded (¶¶ 23-24), because the skilled person would still have seriously contemplated the range of 1 to 5 mg in view of dependent claim 4 (2.5 mg) and example 7 (2 mg).

Novelty acknowleged …

Since the priority claim was held presumably valid, the only remaining document to be considered with respect to novelty was WO 97/03675 A1 (Daugan). The relevant disclosure therein reads as follows (p 5, l 1-11):

For administration to man in the curative or prophylactic treatment of the disorders identified above, oral dosages of [tadalafil] will generally be in the range of from 0.5-800 mg daily for an average adult patient (70kg). Thus for a typical adult patient, individual tablets or capsules contain from 0.2 – 400 mg of active compound, in a suitable pharmaceutically acceptable vehicle or carrier, for administration in single or multiple doses, once or several times per day. […] In practice the physician will determine the actual dosing regimen which will be most suitable for an individual patient and it will wary with the age, weight and response of the particular patient.

Specific examples in Daugan make use of 50 mg of active compound in a tablet (p 12 ff).

Now, is the range of 1-5 mg novel over the broad range disclosed in Daugan?

According to the EPO Guidelines (G-VI, 8, ed. 2018), a sub-range selected from a broader numerical range of the prior art is considered novel, if each of the following three criteria is satisfied (emphasis added):

    1. the selected sub-range is narrow compared to the known range;
    2. the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art and from the end-points of the known range;
    3. the selected range is not an arbitrary specimen of the prior art, i.e. not a mere embodiment of the prior art, but another invention (purposive selection, new technical teaching).

The decision only applies criteria a. and b. for novelty, while the requirement of a purposive selection / new technical teaching (c.) is said to be related to obviousness only. Note that this criterion is also abolished with in the 2019 edition of the EPO Guidelines, entering into force on 1 November 2019.

Clearly, 1-5 mg is a narrow range compared to 0.2 – 800 mg; criterion a. is thus fulfilled.

But is the range sufficiently removed from the working example of 50 mg in Daugan? The decision holds that even though the absolute difference is only 45 mg, the absolute amounts still differ by a factor of 10. Thus, criterion b. is also considered fulfilled.

On a personal note, I doubt that time was already ripe for changing the Guidelines. The recent 2019 edition of the book ‘Case Law of the Boards of Appeal’ in chapter I.C.6.3.1 correctly holds that there are several decsions that disregard criterion c., but still there are even recent decisions that do apply criterion c. There have been constant rumors for quite a while that this might be sth for the EBoA to finally decide. I would have preferred to await final clarification on BoA level over the uncertainty of an early change in first instance proceedings that might perhaps need to be reversed again in a worst-case scenario. In my view, criterion c. when correctly applied is a test whether there is a ‘new technical teaching’ (not just a formally new numerical value); see emphasis above. I cannot see any fundamental misconception in doing so under the title of novelty. A new technical teaching must not be confused with a non-obvious technical teaching. But be this as it may, I am still hopeful that the EBoA might finally have its say.

… but the low dosage form is obvious

Actually, obviousness is at the heart of this multi-national dispute. Lilly argued that courts in strict application of the problem-solution approach had found that EP’181 B3 was valid (e.g. in DK and FI), whereas only courts that applied a somewhat different approach concluded that EP’181 B3 was invalid (e.g. in the U.K., DE and NL):

Accordingly, Lilly pushed for a strict application of the problem-solution approach in the present proceedings. The FPC indeed applied the problem-solution approach, but still concluded that EP’181 H1 was invalid.

The parties agreed on WO 97/03675 A1 (Daugan) as the closest prior art.

It’s no more than a sideshow for the outcome of the decision, but an interesting one:

The decision holds in ¶ 33 that the skilled person would understand the broad ranges in Daugan as ‘boiler plates’ which are aimed at claiming the broadest possible protection. This implies quite some knowledge of a patent practitioner. The discussion of the broad ranges is in the specification, not in the claims. What is more, the skilled person is defined earlier in the decision as follows (¶ 14):

[A] team consisting of a clinical pharmacologist (with knowledge of the pharmacokinetics of conventional medicines and biological preparations) and a clinician (with knowledge of urology, and in particular of sexual dysfunctions or erectile dysfunctions and available medicinal treatments such as sildenafil).

I wonder where any knowledge of a patent practitioner stems from in this team. When discussing patent literature in litigation, it is constantly assumed that the ‘skilled person’ just knows how to read patents, and that he is even able to understand what the drafting attorney might have had in mind and intended in legal terms when drafting the specification. This is anything but realistic, in my perception. On the contrary, the typical pharmacologist and clinician will be used to read scientific publications, and without any additional training in patent matters he will approach a patent document just like any other piece of scientific literature.

In view of WO 97/03675 A1 (Daugan) as closest prior art, the FPC defined the objective technical problem as to provide a clinically effective and safe dosage of tadalafil for the treatment of sexual dysfunction.

The decision holds that it is credible that the skilled person would always aim to find the lowest possible effective dosage of an active substance, for various reasons. First, because the skilled person knows that a lower dosage will have fewer side effects, and the avoidance of side effects is always a goal in drug research. Second, the skilled person will strive to find the lowest possible effective dosage, because it may well be that the regulatory authority asks for it. Although it is not certain that the approval authority will require this information, it is still reasonably possible. Even this possibility is a sufficient incentive to identify the lowest possible dosage: If the necessary studies would only be done at the request of the authority later on, the market authorisation would be considerably delayed.

Interestingly, the decision also expands on the ‘reasonable expectation of success’ (see this Blog here) — and its irrelevance for the case at hand. A ‘reasonable expectation of success’ is not necessary if the skilled person has an incentive for any other reason (e.g. a potential inquiry from the approval authority to specify the lowest effective dosage in the present case). The skilled person will then just take the necessary steps towards the invention unless he has to assume that this is hopeless right from the outset (¶36):

[E]ine Erfindung [ist] naheliegend, wenn der Stand der Technik […] dem Fachmann einen Anlass (“Motivation”) bietet, den nächstliegenden Stand der Technik so abzuwandeln, dass er zum beanspruchten Gegenstand gelangt. Oft wird den Fachmann eine begründete Erfolgserwartung zu der Weiterentwicklung veranlassen, d.h. wenn er aufgrund wissenschaftlicher Erwägungen annimmt, dass die Abwandung des Standes der Technik mit hoher Wahrscheinlichkeit zur Lösung der Aufgabe führt, wird er diese Abwandlung naheliegenderweise vornehmen. Eine begründete Erfolgserwartung in diesem Sinne ist aber nicht notwendig, wenn der Fachmann bereits aus anderen Gründen einen Anlass hat, den nächstliegenden Stand der Technik zum Gegenstand des geltend gemachten Anspruchs weiterzuentwickeln. Er wird diese Entwicklung dann vornehmen, wenn er nicht geradezu annehmen muss, dass sie aussichtslos ist.

The decision holds that the skilled person would  have routinely included a dose of 5 mg of tadalafil in the phase IIb clinical study to determine the dose-response curve, in particular in view of Goldstein et al. (1997) where quite some efficacy of the sildenafil, the first-in-class drug, had been reported for a dosage of as low as 5 mg.

Excerpt from Goldstein et al. (1997)

The skilled person would then inevitably have realised that tadalafil at a dose of 5 mg was still clinically effective. Thus, the decision holds that the subject-matter of EP’181 H1 was prima facie obvious.

  • The decision can still be appealed to the Supreme Court.

Reported by Martin WILMING

The ‘two bathtubs’ header image is a screenshot taken from one of Lilly’s Cialis® commercials at about 0:40 min.

BIBLIOGRAPHY

Case No. S2019_007 | Decision of 1 October 2019

(1) ICOS Corporation
(2) Eli Lilly (Suisse) SA
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Martin SPERRLE
    • Marco ZARDI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of ICOS / Eli Lilly:

    • Dr. Christian HILTI (Rentsch)
    • Dr. Demian STAUBER (Rentsch)
    • Dr. Andrea CARREIRA (Rentsch), assisting in patent matters

Representative(s) of Sandoz:

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