Supreme Court confirms FPC’s decision O2015_008 — Omega’s appeal dismissed

Case No. 4A_282/2018 ¦ Decision of 4 October 2018 (Supreme Court) on appeal against O2015_008 ¦ Decision of 14 March 2018 (FPC)¦ ‘Balancier de montre’

Reading time: 4 minutes

As to the background of this matter, please see the report about the main hearing on this Blog here and the discussion of the first instance decision of the FPC on this Blog here.

In brief, Omega had alleged infringement of its EP 1 837 719 B1; see the EPO Register and Swissreg for further bibliographic details of the patent in suit. With decision of 14 March 2018, the FPC had rejected Omega’s claim for infringement while Tudor’s / Detech’s counterclaim for invalidity had been allowed; EP(CH) 1 837 719 B1 had been declared invalid.

The Supreme Court now dismissed Omega’s appeal, i.e. confirmed the FPC’s decision. EP(CH) 1 837 719 B1 is thus finally declared invalid.

The issues dealt with by the Supreme Court in the decision, in brief:

  1. Age of a prior art document 

On appeal, Omega has argued that the FPC took an unrealistic piece of prior art into account in the assessment of inventive step. Indeed, the FPC had considered a document that was published already about a century ago, i.e. US 759,914. In view of the evolution of watchmaking since then, Omega considered it unrealistic that such a document was actually considered as a starting point in the assessment of inventive step. Consequently, Omega alleged a violation of Art. 56 EPC.

The Supreme Court did not buy this argument. It is held in no uncertain terms that everything that had been made publicly available — including old documents — forms part of the prior art. One cannot exclude a document from consideration in the assessment of inventive step just because of its age; see ¶3.1.3.

Écarter un document de ceux que consulterait l’homme de métier en raison de son ancienneté reviendrait à priver les brevets ayant dépasé un certain âge de toute valeur dans le cadre de l’analyse de l’effet invenif. Un telle pratique ne saurait être déduite de l’art. 65 CBE.

Reference to some case-law of the Boards of Appeal of the EPO did not help either: The mere age of a document has not been decisive in T 479/00, T 366/89, T 1000/92 and T 334/92. The Supreme Court notes that the obsolescence or outdatedness of a technology had been the key issue in these decisions, which excluded the respective documents from consideration by the skilled person. Apparently, no such case had been established by the appellant in the present matter.

  1. Incompatibility of technical teachings

The balance wheel of US 759,914 has inertia blocks that must have been placed from the inside, as claimed by the patent in suit; see the screw head on the inner side of the felloe in the figures below.

But what is still missing here is the stud (‘plot’) according according to the patent in suit. Omega argued that the skilled person would not have added studs to the balance of US 759,914 in view of the risk to impair the automatic adjustment of its temperature dependent moment of inertia, which is the sole purpose of this invention. However, the Supreme Court holds that this is not in agreement with the fact findings of the FPC, and thus did not consider this argument any further.

  1. Choice of the closest prior art

The FPC had not explicitly motivated its choice of US 759,914 as the closest prior art in the assessment of inventive step in accordance with the problem-and-solution approach.

Kind reminder …

And the Supreme Court indeed acknowledges that it would have been desirable if it had done so.

Ainsi, il eût été souhaitable que la juridiction précédente détaille la première étape de l’approche problème-solution comme elle l’a fait pour les autres étapes de son examen.

But still, in view of the FPC’s detailed discussion of how the skilled person had arrived at the invention starting from US 759,914 without inventive merit, it became sufficiently clear how close both inventions actually are, and why US’914 thus is a reasonably chosen closest prior art.

  1. Late filed auxiliary requests / claim limitations

Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. The FPC had not admitted this request into the proceedings anymore, with reference to O2015_012.

Omega had challenged this on appeal. But while this appeal has been pending, the Supreme Court ruled on the appeal against O2015_012 — and backed the practice of the FPC in this respect; decision 4A_543/2017 of 08 May 2018, see this Blog here. Accordingly, Omega did not succeed with this argument, either.

In sum, Omega’s appeal was dismissed and EP(CH) 1 837 719 B1 is now finally declared invalid.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_282/2018 ¦ Decision of 4 October 2018 (Supreme Court) on appeal against O2015_008 ¦ Decision of 14 March 2018 (FPC) ¦ ‘Balancier de montre’

Omega S.A.

./.

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

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Nicolas CURCHOD

Representative(s) of appellant / plaintiff:

Representative(s) of defendants / respondents:

SUPREME COURT DECISION 

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No further grounds for nullity of an SPC beyond Art. 140k of the Patent Act

Case No. O2017_016 ¦ Decision of 12 June 2018 ¦ “Verletzung Ergänzendes Schutzzertifikat; Sevelamer”

Following-up on a decision granting interim injunctive relief (reported here), the present decision in main proceedings now confirms this outcome. I have reported about the hearing in main proceedings on this Blog here.

As indicated earlier, the defendant neither disputed validity of the basic patent EP 0 716 606 B1 of Genzyme Corporation, nor that the subject-matter of the SPC C00716606/01 is covered by the basic patent or that the attacked embodiment (sevelamer carbonate) is covered by the SPC. Rather, the defendant (only) alleged that the SPC is invalid because the office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.

The FPC now confirms that the list of grounds for nullity of an SPC as set forth in Art. 140k PatA is exhaustive. The alleged wrongful reinstatement is thus no valid ground of nullity. In particular, the decision refers to the dispatch of the Federal Council when the SPCs had been enacted, i.e. the note that Art. 140k is to define the grounds for nullity:

Artikel 140k Nichtigkeit: Absatz 1: Neben dem Erlöschen bzw. der Sistierung des Zertifikats müssen auch die Gründe festgelegt werden, sie seine Nichtigkeit herbeiführen.

CJEU’s logo

Further, the decision reviews the CJEU’s case law and notes that the grounds for nullity according to Art. 15 of the EU SPC Regulation 469/2009 have never been held to be an open list. Rather, the CJEU only interpreted Art. 3, violation of which is referred to as a ground for nullity in Art. 15 of the EU SPC Regulation.

The FPC notes that the defendant could have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but failed to do so. The decision is thus formally final, and the defendant has to live with it.

If there is a take away message for practitioners in this decision, then it is surely to watch out for fresh grants (not only of SPCs, but also patents, trademarks, designs, etc.), to not miss the 30 days(!) time limit for an appeal; Art. 50(1) APA. This will be the only chance to fight against e.g. a wrongful reinstatement — which is more than you will ever get e.g. at the EPO where there is no such chance at all; but still, you need to act quickly.

Yet another interesting aspect of the decision is the assessment of the value in dispute. The parties heavily disagreed. Plaintiffs had considered it to be CHF 5m, while the defendant only estimated it to be CHF 500k. The FPC had thus to decide on this issue, too; Art. 91(2) CPC. Towards this end, it relied on some interesting rules of thumb:

  1. one third of the turnover of the originator’s product is replaced by the generic within about 2 years;
  2. the profit margin of a generic is 50%.

Based on these rules of thumb, and the plaintiffs’ own statement of an annual turnover in Switzerland of CHF 2.25m p.a., the FPC considered the the value in dispute as CHF 750k, for the roughly two years of protection at stake before the SPC will finally lapse in February 2019.

UPDATE 18 July 2018:

The decision has been appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_016 ¦ Decision of 12 June 2018 ¦ “Verletzung Ergänzendes Schutzzertifikat; Sevelamer”

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

./.

Salmon Pharma GmbH

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

DECISION IN FULL

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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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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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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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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.

UPDATE 22 October 2018:

The appeal has been dismissed by the Supreme Court (4A_282/2018; reasons not yet available).

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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ANNOUNCEMENT

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NOTES FROM THE HEARING

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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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AZ’s Faslodex®: EP(CH) 2 266 573 and EP(CH) 1 250 138 revoked

Case No. O2015_011 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage”

Case No. O2015_012 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage; Nichtzulassung verspäteter Einschränkung”

We have reported on the combined main hearing in these nullity cases on this Blog here. In brief:

As could be expected after the main hearing, assessement of inventive step in view of McLeskey and Howell was key. The panel of judges essentially followed the expert opinion of the judge-rapporteur and denied patentability for lack of an inventive step in both cases. Besides the (always) very case-specific assessment of inventive step, I feel that some other aspects of these decisions are of more general interest.

  1. Partial priorities / ‘self-collision’

Plaintiff argued that the divisional application EP 1 669 073 A2 is novelty-destroying for its parent, EP’138. With reference to the decision G 1/15 of the Enlarged Board of Appeal (EPO), the FPC did not buy the self-collision argument.

No more poison!

In principle, the claims at stake could well be split into parts that did / did not enjoy priority (‘generic or’-claims) – even though that might well be a challenging task. However, since there was no intervening prior art on file, there was no need to go through that academic exercise. Partial priority was acknowledged, ruling out any self-collision issue.

Es scheint aber insbesondere im Hinblick auf die Entscheidung G 1/15 angebracht, im vorliegenden Fall Teilprioritäten grundsätzlich anzuerkennen und zwar selbst dann, wenn keine explizite Aufteilung der Patentansprüche in die Prioritäten gültig beanspruchende bzw. nicht gültig beanspruchende Teilbereiche vorliegt.

The ‘self-collision genie’ is pushed back in the bottle.

  1. Prior public use / clinical studies

It was beyond dispute that Faslodex® had been in phase-III clinical study in 1998, well before the earliest priority date. The decisions refer to the study as 9338IL/0020, but this appears to be a typo. I trust it should read 9238IL/0020; see EMA ‘Assessment Report for Faslodex’ of 2010, at the bottom of p 29.

Plaintiff argued that clinical studies would generally make the pharmaceuticals publicly available, in the absence of any proof to the contrary. It was referred to T 0007/07 in this respect. Further, it was argued that the patients must have been informed about the exact formulation; and even if this had not been the case, the formulation could have been identified / analysed with ease.

The FPC did not agree. In the case at hand, two ‘Clinical Trial Agreements’ from this study contained confidentiality clauses, and the ‘Written Informed Consent Form’ apparently did not reveal details as to the exact formulation. Finally, the patients got a monthly injection into the gluteal muscle. This is unlikely being done by the patient herself, and thus it is unlikely that the patient ever had access to the pharmaceutical for further investigation of the formulation.

Under the given circumstances, the clinical study was thus held to not constitute a public prior use. Novelty was acknowledged.

  1. Insufficient disclosure to be considered as prior art?

Howell discloses a dosage of 250 mg fulvestrant and mentions an injection volume of 5 ml. Plaintiff argued the this results in a solution with a concentration of 50 mg/ml. Defendant disagreed: The solubility of fulvestrant would be too low to obtain a solution in castor oil. Rather, a dispersion would be obtained. Further additives would be necessary to obtain a solution with such a high concentration of fulvestrant. But there is no indication of any such additives in Howell. Defendant thus argued that Howell must not be considered as prior art, for lack of an enabling disclosure.

This argument is in line with the EPO Guidelines (G-IV, 2) and some BoA decisions referred to therein:

Subject-matter can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Art. 54(1), if the information given to the skilled person is sufficient to enable him, at the relevant date (see G‑VI, 3), to practise the technical teaching which is the subject of the disclosure, taking into account also the general knowledge at that time in the field to be expected of him (see T 26/85T 206/83 and T 491/99).

Where a prior art document discloses subject-matter which is relevant to the novelty and/or inventive step of the claimed invention, the disclosure of that document must be such that the skilled person can reproduce that subject-matter using common general knowledge (see G‑VII, 3.1).

This appears to be a sensible approach at first sight. But is it really in line with the definition of ‘the state of the art’ codified in Art. 54(2) EPC?

The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.

Frankly, I am not conviced. What is published, is just out there as-is. What the skilled person actually can do based on a specific publication at a given point in time, that’s a different story to me.  Anyway, the FPC did not need to decide on this issue; but I catch the notion between the lines that it is not carved in stone that the FPC would follow the EPO’s approach.

Lässt man die Praxis des EPA unberücksichtigt, ist die D15 vollumfänglich dem Stand der Technik zuzurechnen. […] Ob der erwähnten Praxis des EPA zu folgen ist, kann deshalb hier offen bleiben.

In the case at hand, the  FPC held that Howell did contain an enabling disclosure for the skilled person, and it was considered as prior art.

  1. Belated limitation not admitted into the proceedings

Defendant limited one of his auxiliary requests in O2015_012 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.

Defendant 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 requests of the defendant: Denial of the complaint, without any amendments to the claims. At that stage, there is no room anymore for a partical acknowledgment of the complaint. The FPC held that the defendant in fact present the court 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 newly drafted auxiliary request was not admitted into the proceedings.

UPDATE October 17, 2017:

The patentee has lodged an appeal to the Supreme Court in both cases.

UPDATE May 30, 2018:

AZ’s appeal re O2015_012 has apparently been dismissed, and the appeal re O2015_011 partially approved. No more information available, for the time being.

UPDATE June 5, 2018:

The Supreme Court has published decisions 4A_541/2017 (appeal against O2015_011) and 4A_543/2017 (appeal against O2015_012) on its website earlier today. Further, 4A_541/2017 is scheduled for publication in the official collection.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_011 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage”

Case No. O2015_012 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage; Nichtzulassung verspäteter Einschränkung”

Actavis Switzerland AG ./. AstraZeneca AB

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Hannes SPILLMANN
  • Dr. Daniel ALDER
  • Dr. Hanny KJELLSAA-BERGER
  • Dr. Prisca VON BALLMOOS

Judge-rapporteur:

  • Dr. Hannes SPILLMANN

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters

DECISION O2015_011

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THE ‘573 PATENT IN SUIT IN O2015_011

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DECISION O2015_012

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THE ‘138 PATENT IN SUIT IN O2015_012

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Ex parte interim injunctive relief granted based on an SPC

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

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

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

Reported by Martin WILMING

BIBLIOGRAPHY

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

Judge(s):

  • Dr. Dieter BRÄNDLE

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

DECISION IN FULL

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

Case No. O2107_001 ¦ Main hearing of 21 August 2017

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

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

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

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

Gilead's Truvada
Gilead’s Truvada®

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

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

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

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

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

The parties did not enter into settlement discussions.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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NOTES BEFORE AND FROM THE HEARING

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Fulvestrant, reloaded (and still to be continued)

Case Nos. O2105_011 and O2015_012 ¦ Main hearing of 13 June 2017

A first glimpse of these disputes could be catched in parallel proceedings O2015_010 concerning nullity of AstraZeneca’s CH 696 260 A5 (commented on this Blog here). From r 4 of this decision, it has been evident that nullity proceedings are pending at the FPC for the two corresponding European patents in the same patent family:

The only independent claim 1 of EP’573 reads as follows (emphasis added):

A pharmaceutical formulation for use in the treatment of breast cancer by intra-muscular injection, wherein the pharmaceutical formulation comprises fulvestrant, a pharmaceutically-acceptable alcohol being a mixture of 10 % weight of ethanol per volume of formulation and 10 % weight of benzyl alcohol per volume of formulation, and the formulation contains 15 % weight of benzyl benzoate per volume of formulation and a sufficient amount of a ricinoleate vehicle so as to prepare a formulation of at least 45 mgml-1 of fulvestrant, wherein the ricinoleate vehicle is castor oil, and wherein the total volume of the formulation is 6 ml or less.

EP’138 B2 comprises various independent claims; only claim 1 is given below for illustrative purposes:

Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of a benign or malignant disease of the breast or reproductive tract by intra-muscular administration, wherein the formulation comprises fulvestrant in a ricinoleate vehicle, a pharmaceutically acceptable non-aqueous ester solvent, and a pharmaceutically acceptable alcohol, and wherein the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration for at least 2 weeks.

 

The main hearing covered both cases. We concluded from what has been discussed that  the assessment of inventive step in view of McLeskey and Howell will be key. It would be inappropriate for us to judge on the prospects based on the limited information at hand. But from the pleadings, it became clear that the expert opinion of the judge-rapporteur must have been disadvantageous for the patentee / defendant.

EP’573 has been fully revoked by an OD of the EPO in a hearing of May 8, 2017. The reasoned decision is not yet available, but the President of the FPC pushes for it, repeatedly.

UPDATE Sep 4, 2017:

The OD’s decision is published meanwhile. Appeal proceedings are pending.

Likewise, EP’138 has been fully revoked in Germany, in line with the interim assessment of the German FPC. But the reasoned decision had not been available until Friday before the hearing (Tuesday). The FPC was informed therof by the defendant / patentee in the hearing, and it turned out that the plaintiff’s representatives had not been aware of this at all. The parties will be given the opportunity to comment on this decision in writing.

The patentee / defendant also requested during the hearing that one of his auxiliary requests be amended by addition of yet another feature. The parties disagreed on whether this was admissible at this stage of the proceedings. The President noted that an order or a decision will be issued on this aspect.

If you are interested in what has happened elsewhere, these are corresponding decisions we got get a hand on from public files:

This list surely is incomplete. If you have further references to be included here, please send them in and we will accordingly update the list.

Reported by Ingo LUMMER and Martin WILMING

BIBLIOGRAPHY

Case Nos. O2105_011 and O2015_012 ¦ Main hearing of 13 June 2017

Actavis Switzerland AG ./. AstraZeneca AB

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Hanny KJELLSAA-BERGER
  • Dr. Prisca VON BALLMOOS
  • Dr. Hannes SPILLMANN
  • Dr. Daniel ALDER

Judge-rapporteur:

  • n/a
    (most likely Dr. Hannes SPILLMANN since the judge-rapporteur has always been referred to by the parties in the male form)

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters
  • Dr. Ulrike CIESLA (Hoffmann Eitle), assisting in patent matters

THE ‘138 PATENT IN SUIT

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THE ‘573 PATENT IN SUIT

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PREPARATORY NOTES BEFORE THE HEARING

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