Supreme Court confirms: No late amendments to an auxiliary request

Supreme Court
Case No. 4A_543/2017 | Decision of 08 May 2018 | ‘Appeal against decision O2015_012 of 29 August 2017

As to the background of this decision, I suggest to first have a look at the review of the first instance judgment on this Blog here.

AZ’s Faslodex

In (very) brief, AstraZeneca’s EP(CH) 1 250 138 B2 had been revoked for lack of inventive step over Howell in view of McLeskey. At the main hearing, AZ had further limited its third auxiliary request with an additional feature (marked-up below) as follows:

Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of breast cancer by intra-muscular administration to human patients, […] wherein […] the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ng ml-1 for at least two weeks.

AZ had argued that this further limitation was a partial acknowledgment of the complaint which is possible at any stage of the proceedings; Art. 241 CPC. The FPC did not agree.  The further limitation only concerned an auxiliary request, i.e. it only came into play when the court had already decided on the main request, i.e. denial of the complaint without any amendments to the claims. At that stage, there is no room anymore for a partial acknowledgment of the complaint. The FPC held that it was faced with new facts to be considered as an auxiliary measure. This is possible in general, but only within the time limits for submission of novae; Art. 229 CPC. Consequently, the FPC had not admitted the newly drafted auxiliary request into the proceedings.

On appeal, AZ requested that the decision be set aside and the patent maintained on the basis of the amended third auxiliary request.

The Supreme Court did not agree, either. Whether or not an additional feature in a claim is an allowable limitation is not just a question of law. It rather requires a factual assessment of whether (or not) the application as filed provides sufficient basis for the amendment. This assessment had not been made in first instance proceedings. The Supreme Court further notes that even further factual assessment may be necessary, e.g. whether further prior art might be cited against the reformulated claim.

All requests on file!

The Supreme Court thus held that the FPC correctly did not admit the reformulated auxiliary request into the proceedings for being belated, and dismissed the appeal.

it remains to be seen how parties will adapt their course of action in the future. But I would not be surprised if defendants in nullity cases (and plaintiffs in infringement cases when faced with a plea for nullity in defense) will submit a lot more auxiliary requests at early stages of the proceedings.

Reported by Martin WILMING

BIBLIOGRAPHY

Supreme Court
Case No. 4A_543/2017 | Decision of 08 May 2018 | ‘Appeal against decision O2015_012 of 29 August 2017

AstraZeneca AB
./.
Actavis Switzerland AG

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL
    • Dr. Martha NIQUILLE
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Appellant / Defendant:

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

Representative(s) of Respondent / Plaintiff:

SUPREME COURT DECISION

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BREAKING: Non-enabling disclosure as closest prior art

Supreme Court
Case No. 4A_541/2017 | Decision of 08 May 2018 | ‘Appeal against decision O2015_011 of 29 August 2017

As to the background of this decision, I suggest to first have a look at the review of the first instance judgment on this Blog here.

In (very) brief, AstraZeneca’s EP(CH) 2 266 573 B1 had been revoked for lack of inventive step over Howell in view of McLeskey. The parties heavily dissented on whether or not Howell contained an enabling disclosure or not. The FPC held that it did, and that the objective technical problem to be solved in accordance with the problem-and-solution approach was only to provide an alternative formulation for sustained release.

AZ appealed and essentially argued that the FPC erroneously assumed a (concrete) pharmaceutical formulation in Howell, thus incorrectly defined the distinguishing features and the (objective) technical problem, and then wrongly concluded for lack of inventive step.

The Supreme Court indeed agreed and remitted the case for re-assessment of inventive step on the basis of an ‘objectively correct’ definition of the problem to be solved; see ¶2.3.5. Further, the Supreme Court notes in ¶2.3.3 that a correct definition is:

Provision of a castor oil-based formulation (i.e. a formulation consisting of castor oil and known suitable solvents and adjuvants in a certain composition and amount) for the administration of up to 250 mg fulvestrant for the treatment of breast cancer, which is well tolerated, has a uniform release profile and achieves the therapeutically decisive concentration of fulvestrant in the blood plasma over a longer period of time.

It is rare (to say the least) that the Supreme Court re-defines the objective technical problem to be solved in the assessment of inventive step. It did so here because the FPC got the meaning of an enabling disclosure wrong:

[…] weil [die Vorinstanz] von einem unzutreffenden Begriff der Ausführbarkeit der Lehre ausgegangen ist […]

What the heck …?!

Really? The FPC got such a fundamental point of law just wrong!?

This demands for a closer look!

The Supreme Court holds that the FPC failed to recognize the concept of feasibility or sufficient disclosure with the conclusion that ‘the technical teaching of [Howell] could basically be reworked.’ For a technical teaching consists not only of the problem but also of the solution.

Die Vorinstanz hat den Begriff der Ausführbarkeit oder der hinreichenden Offenbarung verkannt mit dem Schluss, dass ‘die Lehre [in Howell] grundsätzlich nacharbeitbar war’. Denn eine technische Lehre besteht nicht nur aus dem Problem, sondern auch aus der Lösung.

However, Howell only suggests that there was a compatible and pharmaceutically effective depot formulation available — but the actual composition of this formulation is not disclosed.

Further, the Supreme Court holds that the FPC did not expand on which concrete formulation the skilled person(s) would have found on the basis of the information in Howell without undue burden and without involvement of an inventive step. The general knowledge that steroids such as fulvestrant can be dissolved in castor oil with certain excipients and solvents in such a way that compatible injections can be produced is not sufficient for the feasibility of a technical teaching, in the Supreme Courts’ view.

In sum, the Supreme Court thus holds that the FPC applied an incorrect legal concept of feasibility with the assumption that no concrete technical formulation was required in order to affirm that there well is a technical teaching in Howell; ¶2.2.4.

Die Beschwerdeführerin rügt im Ergebnis zu Recht, dass die Vorinstanz von einem unzutreffenden Rechtsbegriff der Ausführbarkeit ausgegangen ist mit der Annahme, es bedürfe keiner konkreten technischen Formulierung, um die Offenbarung der technischen Lehre — d.h. hier der in [Howell] beschriebenen Depot-Formulierung — bejahen zu können. […] Die Vorinstanz hat die Offenbarung einer technischen Lehre durch [Howell] zu Unrecht bejaht.

Further down the road, the Supreme Court concluded that the FPC failed in the identification of the differentiating features. It just could not do it correctly because there is no specific disclosure in Howell.

But still, Howell undoubtedly is pre-published. Now, what to do with it?

The FPC had left it undecided whether or not a non-enabling disclosure is ‘prior art’ under Art. 54(2) EPC. But the Supreme Court took over — and answered even more than that. The Supreme Court holds that Howell belongs to the state of the art (contrary to what the EPO typically does, i.e. to just ignore it in toto; see Guidelines, G-IV, 2). But, in the Supreme Court’s view, such a piece of prior art cannot be assessed with the problem-and-solution approach because the objective technical problem is then just to find a working solution to what is insufficiently disclosed therein, and there is an inherent motivation to search for that solution; ¶2.3.2.

Der Beschwerdegegnerin ist zwar zuzustimmen, dass die Information von [Howell], in der das Problem formuliert und Ansätze für die Lösung mitgeteilt werden, zum Stand der Technik gehört. Wird jedoch ein Dokument als ‘nächstliegender Stand der Technik’ beigezogen, das keine technische Lösung offenbart, […]  wird der ‘Aufgabe-Lösungs-Ansatz’ verlassen. Denn die objektive technische Aufgabe ergibt sich unmittelbar aus [Howell], wenn darin dem fachkundigen Adressaten mitgeteilt wird, dass es eine Lösung für das Problem gibt […]. […] Eines Vergleichs von Merkmalen zur Ermittlung der objektiven technischen Aufgabe bedarf es in diesem Fall nicht. […] Aufgrund der Information in Howell, dass es eine Formulierung [gibt], wird das Fachteam jedenfalls dazu motiviert, geeignete Depotformulierungen zu suchen.

Frankly, it is now me who is not (yet) enabled to fully grasp the implications of this decision. Time will tell, as always.

Reported by Martin WILMING

BIBLIOGRAPHY

Supreme Court
Case No. 4A_541/2017 | Decision of 08 May 2018 | ‘Appeal against decision O2015_011 of 29 August 2017

AstraZeneca AB
./.
Actavis Switzerland AG

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL
    • Dr. Martha NIQUILLE
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Appellant / Defendant:

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

Representative(s) of Respondent / Plaintiff:

SUPREME COURT DECISION

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Hard materials, hard times …

Case No. O2016_001 ¦ Main Hearing of 3 May 2018

comadur.com

This case started off already on 27 February 2016, between Harcane and Comadur. There is not much known about the plaintiff, but the defendant is a company of the Swatch Group, specialising in hard materials. Noteworthy, the owner of Harcane, Rui Carolla, apparently had spent part of his career with Comadur; see SHAB.

Quite some background information was already included in the official announcement of the hearing. The plaintiff in first place requests that CH 707 572 B1, concerning a binder for an injection molding composition, be declared null and void. As an auxiliary measure, it is requested that the patent be assigned to the plaintiff. Allegedly, the patent lacks novelty over US 5,266,264, several PhD theses and the sale of a certain “feedstock” including the patented binder. The defendant had allegedly been provided with it back in November 2012. Further, the plaintiff alleges that the mixture according to CH 707 572 B1 had in fact been invented by Mr. Lestarquit, who was at the time an employee of the Plaintiff.

The defendant holds the view that the claimed subject-matter is new and inventive. All the compositions had been developed by Mr. Cartier, an employee of the defendant since 1999. The “mix sheets” developed by Mr. Cartier allegedly have only been put into practice by employees of the plaintiff, including Mr. Lestarquit. The defendant thus requests that the case should be dismissed in its entirety.

In the hearing, the alleged obviousness of CH 707 572 B1 was intensely discussed. Both parties had identified the characterizing part of claim 1 as the distinguishing feature, but proposed (opposing) problem-and-solution approaches (EPO Guidelines, G-VII, 5). The expert opinion of the judge-rapporteur had apparently been in favor of the plaintiff. Further, it was discussed whether the feedstock that had been exchanged between the parties during the collaboration had become public / is part of the prior art.

Initially, the defendant had no interest in settlement discussions, in view of some parallel proceedings elsewhere. Rather, the defendant requested that the present proceedings be stayed until after such parallel proceedings are concluded. Still, the defendant finally agreed to enter into settlement discussions as a first step.

Note that CH 707 572 B1 (filed 15 July 2013) has no further family members. However, we came across patent family WO 2014/191304 A1, claiming priority of CH 01021/13, filed 28 May 2013 and published as CH 708 097 A2, which is pretty similar to the patent in suit. It remains to be seen how all this will be sorted out.

Reported by Ingo LUMMER and Martin WILMING

BIBLIOGRAPHY

Case No. O2016_001 ¦ Main Hearing of 3 May 2018

Harcane Sàrl

./.

Comadur SA

Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Tobias BREMI
  • Dr. Michael STÖRZBBACH
  • Dr. Regula RÜEDI
  • Dr. Thomas LEGLER

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

  • Jean-Claude SCHWEIZER (SLB)

Representative(s) of Defendant:

  • Dr. Nathalie TISSOT (Tissot)

ANNOUNCEMENT

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No easy way out

Case No. O2017_025 ¦ Order of 15 March 2018 ¦ ‘Eintritt der Streitberufenen’

HEADNOTE

Art. 79(1) lit. b CPC

The notified party conducting the proceedings in place of the notifying party acts as representative of the notifying party.

This order clarifies some important aspects of third party notice and third party action. The general principles are set out in Art. 78 CPC: A party may notify a third party of the dispute if, in the event of being unsuccessful, he or she might take recourse against or be subject to recourse by a third party. The notified third party may also give notice of the dispute.

In practical terms, the notified third party may, according to Art. 79(2) CPC, either

  1. intervene in favour of the notifying principal party, without further conditions; or
  2. proceed in place of the notifying principal party, with the consent of the latter.

Now, what is the standing of the notified party in case of lit. b, above?

The FPC follows the practice of the High Court of Zurich (Obergericht; PP140001-O/U) and the Commercial Court of Bern (Handelsgericht; HG 15 12) in that there is no room for an arbitrary change of parties (gewillkürter Parteiwechsel) — even though the mere wording of Art. 79(2) CPC might suggest it. The order holds that this would be too much of an intervention into the procedural rights of the counterparty, and there is no indication whatsoever that the legislator indeed had intended it to be this way.

Game of Old Maid

Thus, the approach now also taken by the FPC effectively (only) relieves the notifying party of the burden of litigation, but clarifies that the legal effects of the judgment continue to apply to him. The notified party is therefore involved as such in the proceedings without the  defendants 1 and 2 being released from the proceedings. The notified party only acts as the representative of defendants 1 and 2.

Accordingly, as is customary in the case of arbitrary representation, judicial correspondence will only be served to the notified party. Defendants 1 and 2 must have the actions and declarations of the notified party counted as their own.

In sum, Art. 79(2) CPC is anything but a comfortable ejection seat to easily get out of the danger zone.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_025 ¦ Order of 15 March 2018 ¦ ‘Eintritt der Streitberufenen’

A.

./.

B., C.
both represented by C.

EXCERPT OF THE ORDER

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Are rights re-established once and for all?

Case No. O2017_016 ¦ Main Hearing of 25 April 2018

Signpost

I have attended the hearing in this matter earlier today. Infringement of the Swiss SPC C00716606/01 concerning sevelamer is at stake; the basic patent is EP 0 716 606 B1 of Genzyme Corporation. Interim injunctive relief had been granted in earlier proceedings S2016_009; see this Blog here.

Notably, infringement per se is undisputed, as well as validity of the basic patent. However, the defendant (only) alleges that the SPC is invalid because the Office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.

The parties had been summoned to the main hearing after a single exchange of briefs; plaintiff’s reply and defendant’s rejoinder were pleaded in the hearing. Since the only question at stake is a legal one, this worked out smoothly. It was also noted that no expert opinion of the judge-rapporteur will be established.

Now, can the SPC still be challenged for wrongful reinstatement in the present civil proceedings?

Undisputedly, wrongful reinstatement is not explicitly listed as a ground for nullity in Art. 140k PatA. However, the parties dissent on whether or not the list is exhaustive.

Defendant essentially argued that the Swiss legislator voluntarily aligned the Swiss law with the respective EU regulation, and that also further developments of the EU law need to be taken into account; BGE 129 III 135, ¶6. In the view of the defendant, the ECJ in all its decisions on SPCs essentially declared SPCs invalid whenever its grant had not been objectively justified — irrespective of whether or not the ground was explicitly listed in Art. 15 of Regulation (EC) 469/2009.

Plaintiff disagreed; the ECJ never introduced additional grounds of nullity but rather only interpreted the grounds that are explicitly mentioned. Further, the nullity grounds referred to in Art. 140k(1) lit a PatA explicitly only refer to Art. 146(1). However, the time limit for filing the SPC request is defined in Art. 146(2). The plaintiff noted that this focus only on paragraph 1 underlines the legislator’s intent to not include paragraph 2 into the list of grounds for nullity. Plaintiff further argued that any interested third party could well have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but the defendant failed to do so. See also the summary judgment in ¶3.5 in this respect. The decision on reinstatement is thus formally final, and the defendant has to live with it. Plaintiff further referred to BGE 90 I 186 (¶3) which held that re-establishment of rights according to Art. 47 PatA only concerns the relationship of the patentee to the Office; the effects on third parties are regulated exhaustively (sic!) by Article 48 PatA with the prior user right for bona fide third parties.

The later the day, the more pronounced the arguments: The parties reproached each other for having not been able to refer to a prior decision on precisely this issue to their favour. On the funny side, plaintiff noted that this is only because so far just no one has come up with this absurd idea.

So sad

The parties were then asked by the presiding judge whether they were interested in settlement discussions. Unfortunately, I cannot tell what the answer was because it was requested that the public be excluded before the question is answered, and this request was granted.

UPDATE 05 May 2018:

I meanwhile obtained the request and the grant of reinstatement.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_016 ¦ Main Hearing of 25 April 2018

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

./.

Salmon Pharma GmbH

Composition of the Board of the FPC:

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

ANNOUNCEMENT

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Struggling with the burden of proof

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

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

HEADNOTE

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

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

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

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

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

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

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

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

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

Admissibility of late requests

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

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

Allocation of the burden of proof

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

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

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

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

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

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

Authorship of draft applications does not prove (sole) inventorship

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

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

Contractual assignment?

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

The right to claim priority

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

Is the EPO doing it wrong?

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

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

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

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

UPDATE 08 May 2018:

The decision has been appealed to the Supreme Court.

Reported by Martin WILMING


BIBLIOGRAPHY

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

Marcel Riendeau
./.
Zehnder Group International AG

Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

DECISION IN FULL

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

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

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

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

Omega logo

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

The single independent claim 1 as granted reads as follows:

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

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

Tudor logo

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

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

The requests

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

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

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

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

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

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

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

Rather, the request for injunctive relief read as follows:

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

I.e., in English language:

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

Claim construction re feature #7

Now, what does it mean in French that

les masselottes sont vissées depuis l’intérieur?

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

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

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

Novelty

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

Novelty over DE 864 827 was thus acknowledged.

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

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

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

US 2,958,997 (Fig. 4)

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

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

Balance wheel ‘Jean Martin’

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

Inventive step

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

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

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

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

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

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

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

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

Late request – belated?

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

In a nutshell

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

The decision can still be appealed to the Supreme Court.

UPDATE 14 May 2018:

The decision has been appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

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

Omega S.A.

./.

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

Judge(s):

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

Judge-rapporteur:

  • Frank SCHNYDER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendants:

FULL TEXT DECISION

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An incredibly complex mechanical writing instrument not of this world

Case No. O2015_018 ¦ Main hearing of 13 March 2018

UPDATE 13 March 2018:

I have added some notes from the hearing below.

The FPC today published an announcement of the main hearing in this matter. The parties apparently have locked jaws about an invention relating to a mechanical writing instrument.

It started off with Guenat‘s request that Swiss Finest‘s CH 704 790 B1 be declared invalid; note that the patent has been limited in March 2017 and re-published as CH 704 790 C1, see Swissreg for further bibliographic details.

The plaintiff argued that the invention had been made by Frédéric Garinaud, an independent inventor who had applied for a European patent for this invention. The application has then been assigned to the plaintiff and a patent was granted; EP 2 479 648 B1, see Swissreg and European Patent Register for further bibliographic details.

Defendant countersued and requested that EP’648 be declared invalid, or assigned to the defendant. Interestingly, defendant argues that the invention had been made by Frédéric Garinaud when he had been working for the defendant. (Note, however, that Mr Garinaud is not mentioned as an inventor on CH’790.)

In addition, defendant requests injunctive relief for the product ‘Mechanical Fountain Pen RMS05‘.

Fountain Pen RMS05 by Richard Mille

This product has some amazing mechanics; see yourself:

Even more amazing is the price tag of $105,000 (as reported by Bloomberg and others).

The hearing will be in French language, and it will be a real ‘town hall’ meeting: The venue this time is not the Federal Administrative Court in St. Gallen, but rather the Hôtel de Ville de Neuchâtel.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_018 ¦ Main hearing of 13 March 2018

Guenat SA Montres Valgine ./.  Swiss Finest SA

CH 704 790 B1

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CH 704 790 C1

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EP 2 497 648 B1

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Omega ./. Tudor et al.: The aftermath of Baselworld 2015

Case No. O2015_008 ¦ Main hearing of 30 January 2018

Omega logo

The main hearing in this matter took place earlier today.

See this Blog here for a brief review of the subject-matter at stake, based on the court’s detailed announcement of the hearing.

  1. Background of the case

Infringement of Omega‘s  EP 1 837 719 B1 is at stake; see EPO Register and Swissreg for further bibliographic details.

The single independent claim 1 reads as follows:

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

This is best understood with Fig. 1 of the patent at hand:

Fig. 1 of the patent in suit

The attacked embodiments are Tudor‘s calibres MT5621 and MT5612; infringement under the Doctrine of Equivalents is alleged. The current versions of the calibres are shown below:

Interestingly, the balance wheels looked a little different when the calibre had been introduced back in 2015 at Baselworld; see here. Do you notice the different balance wheel in the top right of the calibre?

Former promotional material re Tudor’s calibre MT5621

We have found a perspective picture of the old MT5612 balance wheel on the internet here; a similar picture had been shown in the hearing.

When digging a bit deeper, we came across a report in a watch Blog suggesting that the change of the balance wheel had apparently been implemented in view of Omega’s intervention at Baselworld 2015. Indeed, that would be a perfect fit with the case number of the present matter referring back to 2015.

Now, about three years later, the case surfaces again.

Tudor logo

Defendants Tudor and Detech deny infringement under the DoE and countersued for invalidity in view of DE 864 827US 759,914US 2,958,997, ROLEX calibres and the common general knowledge of the skilled person.

  1. Learnings from the hearing
UPDATE Feb 1, 2018:

The first version of this post indicated that the expert opinion of the judge-rapporteur had already addressed infringement. I have been informed by plaintiff’s counsel that this is not the case. Accordingly, this has been corrected below. /MW

Based on what  can be concluded from the pleadings, plaintiff is on the defensive. The expert opinion of the judge-rapporteur had apparently held that the claimed subject-matter (to the extent invoked) was novel, but not inventive. However, the judge-rapporteur had not yet assessed infringement in his expert opinion.

Most of the discussion was about fulfilment the feature

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

Evidently, the parties disagree on whether or not this feature is fulfilled in the attacked embodiment(s). Is it sufficient for infringement to be ruled out if the inertia blocks are screwed into the threaded hole from the outside? It remains to bee seen whether fixation from the outside might constitute infringement under the DoE. In particular, plaintiff argued that there was no indication whatsoever in the patent in suit that the direction of fixation was of any relevance. Guess which way the wind is blowing: Pemetrexed.

The final judgment needs to be awaited, to fully understand how the inertia blocks in the attacked embodiments are actually fixed.

The value in dispute is CHF 1M. The parties did not enter into settlement discussions today.

Reported by Jolanda MINDER and Martin WILMING

BIBLIOGRAPHY

Case No. O2015_008 ¦ Main hearing of 30 January 2018

Omega S.A.

./.

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

Judge(s):

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendants:

PATENT IN SUIT

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HEARING NOTES

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It Ain’t Over ’til It’s Over

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

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

Pemetrexed revisited, once again:

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

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

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

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

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

Aus diesen Gründen ist eine Gleichwirkung für Pemetrexeddikalium gegeben ist.

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

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

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

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

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

Reported by Martin WILMING

BIBLIOGRAPHY

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

Actavis Switzerland AG

./.

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

Composition of the Board of the FPC:

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

Judge-rapporteur:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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PATENT IN SUIT

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Omega ./. Tudor et al.: The next decision on the DoE approaching?

Case No. O2015_008 ¦ Main hearing of 30 January 2018

Omega logo

The FPC today published an announcement of the main hearing in this matter. Infringement of Omega‘s  EP 1 837 719 B1 is at stake; see EPO Register and Swissreg for further bibliographic details.

The single independent claim 1 reads as follows:

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

The attacked embodiments are Tudor‘s calibres MT5621 and MT5612; infringement under the Doctrine of Equivalents is alleged.

Defendants Tudor and Detech deny infringement under the DoE and countersued for invalidity in view of DE 864 827US 759,914US 2,958,997, ROLEX calibres and the common general knowledge of the skilled person.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_008 ¦ Main hearing of 30 January 2018

Omega S.A.

./.

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

PATENT IN SUIT

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ANNOUNCEMENT

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Swiss Supreme Court sides with German and UK courts re Pemetrexed, O2015_004 lifted

Case No. 4A_208/2017 (Supreme Court) ¦ Decision of 20 October 2017 ¦ “Pemetrexed; O2015_004”

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

The decision has not yet been officially published as per today (Nov 2), but has been published already on EPLAW Blog on Nov 1.

Little time? Read the summary.

If this is the first time that you read about the pemetrexed litigation saga, please see this Blog here for a review of the decision O2015_004 under appeal and some further background information.

The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. It’s all about a generic version of Lilly’s Alimta®, i.e. Actavis’ Amtiris®. While the claims of EP’508 specifically require  pemetrexed disodium, Amtiris® comprises pemetrexed diacid.

In a nutshell, the FPC had taken a stepwise approach in O2015_004. In first place, it was held that limitation from antifolate to pemetrexed disodium during prosecution constitutes an abandonment of subject-matter. In an auxiliary assessment, i.e. if one were to consider the limitation not as an abandonment, the FPC denied an infringement under the Doctrine of Equivalents (DoE) since the skilled person would have understood the wording pemetrexed disodium as a strict limitation, in view of the claims and in further consideration of the specification.

As you were! The Supreme Court did not agree with either of these two findings.

1.   Abandonment of subject-matter

The wording of the claims had been narrowed down during prosecution: The broad term antifolate had been amended in the claims to pemtrexed in first place and finally to pemetrexed disodium, to restore novelty while at the same time complying with Art. 123(2) EPC.

This limitation is also reflected in the description. The definition in paragraph [0022] of EP’508 had only been introduced during prosecution:

Amended description during prosecution (mark-up)

The FPC had held that the patentee is bound by the limitation that he had accepted during prosecution in order to obtain the patent, and that he is therefore prevented under principles of good faith (Art. 2 CC) to now circumvent this limitation by asserting equivalence as if the limitation had not  been made.

The Supreme Court notes that behavior in contradiction to one’s prior acts is not generally prohibited under the principle of good faith, but only if the prior act gave rise to a legitimate trust of others which then is frustrated by the later act (BGE 125 III 257, r. 2a). The Supreme Court further holds that the limitation of a claim feature does not readily constitute an abandonment of the protection against infringement under the DoE for that feature without taking the reasons of the limitation into account.

Die Einschränkung eines Merkmals stellt nicht ohne weiteres und unbesehen des Grundes für diese Einschränkung eine Erklärung des Verzichts auf den Schutz gegen Nachahmung dar.

The Supreme Court did not identify any special circumstances that would justify the use of the makeshift of Art. 2 CC to prevent gross injustice, either.

2.   Infringement under the DoE

The Supreme Court held that the pemetrexed anion is the active substance with anti-cancer effect and agreed with the FPC’s finding that the diacid and the disodium salt objectively fulfil the same function.

The second question (accessibility / ‘Auffindbarkeit’) is somewhat tricky, again. The Supreme Court recites the FPC in that accessibility of the replacing feature had been answered in the affirmative; ¶5.4.

Die Vorinstanz hat die Auffindbarkeit der abgewandelten Form für den Fachmann bejaht.

This is not very precise. The second question, in the FPC’s approach, asks for the accessibility of the same effect when the skilled person is confronted with both the claimed variant and the replacing variant. The FPC’s second question is not about how to get to the replacing variant; it’s already there.

Anyway, the Supreme Court held that the skilled person had a reasonable expectation that the replacing variant would work. The necessity of some routine experiments to confirm this expectiation is of no avail. Accessibility was thus confirmed, too.

The Supreme Court also answered the third question (same value / ‘Gleichwertigkeit’) in the affirmative. The skilled person had no reason to believe that the patentee had only intended protection for the literal meaning of the claim, i.e. pemetrexed disodium.

Der Fachmann […] hatte keinen Grund zur Annahme, die Patentinhaberin habe Schutz nur für die wortsinngemässe Ausführung beansprucht.

Even though it is noted in paragraph [0022] of the patent (see marked-up excerpt above) that

[t]he ‘antifolate’ or ‘antifolate drug’ for use in this invention is Pemetrexed disodium (ALIMTA®), as manufactured by Eli Lilly & Co.

the Supreme Court held that there is no apparent reason why the patent would expand on the properties and ways of action of antifolates in general if it was intended to limit the claimed scope to the product manufacted by the patentee; ¶5.5.6.

Wenn zudem in der Beschreibung erklärt wird, das für die Erfindung verwendete Antifolat sei das von der Patentinhaberin hergestellte Pemetrexed-Dinatrium der Marke ‘Alimta’, so ergibt sich daraus bei objektiver Betrachtung eine Beschränkung ausschliesslich auf dieses Antifolat im Gesamtzusammenhang der Beschreibung nicht. Denn es ist nicht erkennbar, weshalb im Patent die Eigenschaften und die Wirkungsweise von Antifolaten allgemein beschrieben werden sollte, wenn das von der Erfindung beanspruchte tumorhemmende Produkt ausschliesslich das von der Patentinhaberin hergestellte Markenprodukt sein sollte.

Concluding, the Supreme Court held that use of pemetrexed diacid instead of pemetrexed disodium infringes the patent under the DoE.

The case has been remitted to the FPC with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.

Reported by Martin WILMING

CORRESPONDING DECISIONS

For ease of reference, here is a list of some corresponding decisions of highest instance available elsewhere, based on the same European patent:

U.K. (Supreme Court) 2017 UKSC 48
Germany (Supreme Court)  X ZR 16/09
Germany (HRC Munich)  6 U 3039/16
Italy (TO Milano)  54470/2016
The Netherlands (Rechtbank Den Haag) C/09/538525 / KG ZA 17-1159

I will update the list when more decisions are available.

COMMENTS

Attorney’s dilemma

Lawyers and patent attorneys are having a hard time nowadays when advising clients on infringment under the DoE.

Maybe it should not be me to overly analyse this decision since my firm has been involved in this matter, as noted above. But I was taken aback by some key elements of the decision which are of relevance far beyond the subject-matter at stake in the present matter, and I will briefly address those aspects on a general level only, to the extent possible. 

So, here is some food for further thought:

i)   The gist of the DoE?

The Supreme Court comes up with a very pronounced gist of the DoE; see ¶5.5.3:

Der Schutzbereich wird – mit Ausnahme der nachfolgend zu erörternden bewusst gewählten Beschränkung – über die genaue wörtliche Anwendung der Patentansprüche hinaus gewährt in der Erkenntnis, dass es auch bei sorgfältiger und umsichtiger Redaktion unmöglich ist, in einer technischen Anleitung alle möglichen Ausführungen zu benennen. Der Schutz soll daher auch gewährt werden, wenn die technische Anleitung den Fachmann über den zu engen Wortsinn hinaus anweist, wie die Erfindung zu verwirklichen ist.

This can be loosely translated as follows:

With the exception of a deliberately chosen limitation the scope of protection shall extend beyond the literal meaning, in appreciation of the fact that it is not possible to specify all potential embodiments even when the text is redacted with all due care and diligence. Protection shall thus also be granted when the technical teaching instructs the skilled person how to work the invention beyond the overly limited literal meaning.

I do not agree.

This rationale would actually excuse each and every mishap in drafting / prosecution of an application, be it a minor negligence, a gross error or just blatant foolery. All of this could not reasonably be considered deliberately chosen (‘bewusst gewählt’) and would thus not be covered by the exception.

Now, as long as the skilled person nevertheless understands that the teaching of the patent is applicable beyond the literal meaning, it shall still be covered by the scope of the claim under the DoE?

Finding balance

Is this the right balance between legal certainty for the public and forgiveness of drafting / prosecution failures?

The Protocol on Interpretation of Art. 69 is not that strict. It only requires that due account shall be taken of any element which is equivalent to an element specified in the claims when determining the scope of protection. Does ‘due account’ really mean that the only exception is an express and deliberatly chosen limitation?

I am in doubt.

One of the best pieces on the various situations where the DoE is typically invoked that I have come across still is in Arnold J’s judgment at the High Court of Justice in the corresponding matter in the U.K., [2014] EWHC 1511 (Pat), in ¶104 ff.:

[E]xperience shows that patentees resort to arguments about equivalents in three main classes of case. The first is where, with the benefit of hindsight, it can be seen that the patent was unfortunately drafted, whether because of poor instructions from the inventor or poor drafting by his patent attorney or a combination of these things. […] The second class is where technology has moved on since the priority or filing date of the patent. […] The third class is where the patentee now regrets a decision taken during the course of prosecution of the patent application, whether by himself or by the examiner, and is trying to avoid the consequences of that decision.

Arnold J went on in his assessment of the first and the third class of cases in ¶105 and ¶107, respectively:

In the first class of case, the law recognises that drafting patent claims is a difficult and imprecise art and that third parties should not be allowed to exploit infelicities of drafting where it is reasonably clear that those infelicities should not affect the scope of the claim. This is in order to provide ‘fair protection for the patent proprietor’. The law also recognises, however, the countervailing consideration that third parties are entitled to rely on the drafting of the claim when deciding on a commercial course of action. There is no tort of avoiding a patent claim. Thus it is also necessary to provide ‘a reasonable degree of legal certainty for third parties’. The problem, of course, is that what is fair protection to one person is legal uncertainty to another. Conversely, what is reasonable legal certainty to the second person is a denial of protection to the first. The courts have to strike a balance. […]

In the third class of case, there is no reason why the law should be sympathetic to the patentee. Not only do applicants generally rely on skilled professional advice, but also they can appeal against adverse decisions of examiners during the course of prosecution if they consider that those decisions are wrong. If the courts allow decisions as to claim scope made by the examiner during the course of prosecution which have not been successfully appealed effectively to be overturned by decisions on claim construction, the courts undermine the important role of the examiner. This is still more so if the courts allow decisions as to claim scope made by the applicant during the course of prosecution effectively to be reversed by decisions on claim construction.

ii)  The more apparent the replacing feature (but not too much, please!), the more likely the third question would be answered in the affirmative?

There has been a guiding principle in the assessment of equivalents according to the German Federal Supreme Court since the ‘Okklusionsvorrichtung‘ decision (X ZR 16/09):

If the description discloses several possibilities regarding how a specific technical effect can be attained but only one possibility has been included in the patent claim, the use of the other possibilities generally does not constitute an infringement under the doctrine of equivalence.

So, an explicit mentioning of two alternatives in the specification while only one of these alternatives is recited in the claim rules out an infringement under the DoE. Fine.

But what if there is explicit disclosure of a generic class of compounds (‘antifolate’) and only a single specific variant (‘pemetrexed disodium’) in the claims and specification? Luckily, the German Federal Supreme Court had to assess the parallel case in Germany, too (X ZR 29/15): It concluded that this is not sufficient per se. But if there were further indications that the skilled person reads the other variants along in his head (‘unmittelbar mitlesen’), then ‘Okklusionvorrichtung’ might well be applicable. Fine, too.

Now, this is the chemist in me speaking to the other chemists out there: Imagine you readily appreciate the below as a preferred embodiment of a group of compounds (¶5.5.7), can you avoid reading along in your head some very close relatives of this compound?

Pemetrexed disodium
Pemetrexed disodium

The chemist in me has a hard time to not think of some close relatives in the upper right of the molecule. 

Safeguarding legal certainty for the public has always been an issue. The following is taken from Miller v. Bridgeport Brass Co. of ancient 1881:

[I]t must be remembered that the claim of a specific device or combination, and an omission to claim other devices or combinations apparent on the face of the patent, are, in law, a dedication to the public of that which is not claimed. It is a declaration that that which is not claimed is either not the patentee’s invention, or, if his, he dedicates it to the public.

In my perception, this still holds true nowadays; equivalence must not extend to what is apparent on the face of the patent, but remained unclaimed.

I have been a strong believer in the power of the questionnaires. But, frankly, I am getting more and more frustrated. When cases come up where the result based on just two questions appears to be inappropriate, a third one is added (Germany and Switzerland). If the result with three questions appears to be inappropriate, the questions are amended (UK). Still, judgments on equivalence are frequently reversed even in one and the same jurisdiction, and are rarely consistent across jurisdictions. So, what is it all worth? The questionnaires apparently only provide an illusion of certainty, don’t they? And they are not the law. (If you catch me red-handed when using the questionnaire nevertheless, don’t blame me for this paragraph. I am just conforming with the landmark case law …)

iii)   What about inventive equivalents?

The Supreme Court elaborates on the second criterion (accessibility / ‘Auffindbarkeit’) in the assessment of equivalents in ¶5.4 ff. It is held in ¶5.4.1:

Der Fachmann […] muss aufgrund seines Allgemeinwissens durch die patentierte Erfindung zur Abwandlung angeregt werden; beruht die Abwandlung ihrerseits auf erfinderischer Tätigkeit, ist die Auffindbarkeit ausgeschlossen (vgl. BGE 125 III 29 E. 3b S. 32 mit Verweisen).

Loosely translated as follows:

The skilled person must be prompted to the replaced feature by his common general knowledge and based on the patented invention; accessibility is ruled out if the replacing feature itself is based on an inventive step ([…]).

The decision suggests in ¶5.4.1 that this is common ground for the Supreme Courts of the UK, Germany and Switzerland.

I don’t think that this is correct. Lord Neuberger in the corresponding decision in the UK explicitly held in ¶64:

The second test applied by the German courts, as I understand it, at least sometimes appears to require the variation not to be inventive, but I am not sure that that is an appropriate requirement, although it is unnecessary to decide that point on this appeal. If the variation represents an inventive step, while it may render it less likely that the patentee will succeed on the second reformulated question, I find it hard to see why that alone should prevent the resultant variant from infringing the original invention. It may entitle the infringer to a new patent, in the same way as the invention of a novel use for a patented invention can itself be patented, but like such a novel use I see no reason why the variant should not infringe the original patent.

I am not even sure if this holds true for Switzerland. The Supreme Court’s own landmark ruling ‘Urinalventil’ (4A_131/2016) marches to a different drummer, in my perception. In that later case, the replacing feature in the attacked embodiment was in fact patented by the EPO, with the patent in suit being explicitly acknowledged as closest prior art. The attacked embodiment had nevertheless been held to infringe the patent in suit under the DoE. See this Blog here for a detailed review of the ‘Urinalventil’ case.

Moreover, the second question in the FPC’s questionnaire in no way excludes inventive equivalents; see this Blog here. The headnote in O2014_002 reads as follows:

The assessment of accessibility is not to be confused with the assessment of inventiveness. Starting point for the assessment of accessibility is not the general state of the art, but the patent in suit. Therefore it is not to be assessed whether the replaced feature is inventive in view of the state of the art. It is rather to be assessed whether, starting from the teaching of the patent in suit, it is evident for the skilled person that the replaced feature has the same effect (r. 6.5.2.4).
(Clarification of the case law with respect to S2013_001, decision dated 21. März 2013)

iv)   Should one care (more) about the title?

There are multiple references to the title of the patent in particular in the reasons of the Supreme Court’s decision (p. 2, section A; ¶5.5.5; ¶5.5.6:

[…] Patent[s] […] dessen Gegenstand umschrieben ist als “Combination containing an antifolate and methylmalonic acid lowering agent” […];

In der Beschreibung ist – wie im Titel des Patents – allgemein von Antifolaten die Rede.

This emphasis on the title puzzles me. It is required by the EPC that the title of the invention must be contained in the request for grant form and that it shall clearly and concisely state the technical designation of the invention (R. 41(2) lit. b EPC), no doubt about it. However, the title is not part of the description (R. 42 EPC) which shall be used to interpret the claims (Art. 69(1) EPC) in accordance with the Protocol on Interpretation of Art. 69.

I am not aware of any relevant decision on equivalents that has put this much emphasis on the title. On a personal note, I couldn’t have cared less about the title by now. A negligence?

v)   Final thoughts

There were times (in particular in Germany after introduction of the third criterion (‘Gleichwertigkeit’)) when the DoE effectively was dead. In my perception, the pendulum now swings back and we see decisions more to the contrary. Over time, the ‘truth’ will be somewhere in between. Hopefully.

Exhausted from equivalents, I remain
Martin WILMING

SUMMARY

If you came here on a shortcut, you missed a lot. Anyway, I will assume this was your ‘delibarately chosen limitation’ of information. The decision holds:

  • Limitation of ‘antifolate’ to ‘pemetrexed disodium’ during prosecution did not constitute an abandonment of subject-matter.
  • A composition comprising pemetrexed diacid infringes a claim specifying pemetrexed disodium under the DoE. 
  • The case is remitted to the FPC to with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.

BIBLIOGRAPHY

Case No. 4A_208/2017 (Supreme Court) ¦ Decision of 20 October 2017 ¦ “Pemetrexed; O2015_004”

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

./.

Actavis Switzerland AG

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL
    • Dr. Martha NIQUILLE
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Appellant / Defendant:

Representative(s) of Respondent / Plaintiff:

DECISION IN FULL

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PATENT IN SUIT

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