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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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

ANNOUNCEMENT

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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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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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The wording of a Swiss SPC does not (really) matter … (?)

Case No. S2017_006 ¦ Decision of 12 October 2017 ¦ “Gutheissung vorsorgliche Massnahme, ESZ Kombinationspräparat”

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

Infringement of a supplementary protection certificate (SPC) is at stake again. The FPC had granted ex parte interim injunctive relief; see this Blog here. Interim injunctive relief has now been confirmed.

The SPC concerns (emphasis added)

SD.-fumarat + T.

On the contrary, defendant’s attacked embodiment comprises SD.-phosphate and T.

The FPC held that this is still ‘the product’ in the sense of Art. 140d PatA, with reasons essentially as follows:

The codified definition of ‘product’ is ‘active ingredient or combinations of active ingredients’; Art. 140a(2) PatA. According to the Federal Council Dispatch (p. 729), this refers to the active ingredient or combination of active ingredients that is used in the medicament.

[Bei Erzeugnissen] handelt es sich […] nicht um das (Human- oder Tier-)Arzneimittel, so wie es als pharmazeutische Spezialität genehmigt wird, sondern um den Wirkstoff oder die Wirkstoffzusammensetzung, welche(r) in einem solchen Arzneimittel Anwendung findet.

IPI
IPI

The FPC holds that the term ‘product’ shall be construed consistently in the registration process and when it comes to assessment of the scope of protection. The FPC then refered to the Guidenlines on Examination of the IPI. The Guidelines hold that different salts or esters of an active ingredient are regarded as one and the same chemical substance / product, unless the specific salt or ester has an influence on the pharmacological effect (which would then need to be derivable from the patent).

Liegen für einen Wirkstoff mehrere Genehmigungen für jeweils unterschiedliche Salzformen oder Ester vor, so werden diese grundsätzlich als ein und dieselbe chemische Verbindung respektive als ein und dasselbe Erzeugnis betrachtet. Diese Salze bzw. Ester dienen der Handhabung bei der Herstellung, Verarbeitung oder Verabreichung (z.B. Verbesserung der Löslichkeit) oder Stabilisierung des Wirkstoffs. Ist beispielsweise eine Carbonsäure je separat als freie Säure, als Natrium- und Kaliumsalz zugelassen worden, so ist die früheste dieser drei Genehmigungen massgebend.

Hat jedoch die Salzform (bzw. das Gegenion) oder die Estergruppe einen Einfluss auf die pharmakologische Wirkung im Körper, handelt es sich um eine neue Erfindung. Die durch die spezielle Salz- oder Esterform veränderte Wirkung muss aus dem Patent hervorgehen.

The FPC thus concluded that a proper construction of the wording of the SPC in the case at hand is

T. plus SD.-Fumarat incl. all derivatives therof (i.e. in particular all other salts), provided that they have the same pharmacological effect and are protected by the basic patent

The FPC in particular noted that the specific wording of the SPC (‘fumarate’) is not a differentiation over the prior art, but rather is dictated by the wording of the underlying market authorisation. In the FPC’s assesement, it would not have been possible for the plaintiff to obtain a SPC that did not mention the fumarate. The wording of the SPC shall thus not limit the scope of protection, provided that the pharmacological effect of the ‘phosphate’ is the same (and the attacked embodiment is covered by the basic patent).

Die spezifische Formulierung des ESZ ist damit keine Abgrenzung vom Stand der Technik durch die Schutzrechtsinhaberin, sondern vielmehr bestimmt durch den Wortlaut der arzneimittelrechtlichen Zulassung. Damit ist glaubhaft, dass die Klägerin gar kein Schutzzertifikat gestützt auf die Zulassung […] hätte erhalten können, bei welchem […] und nicht […] Fumarat genannt wird. Eine Beschränkung des patentrechtlichen Schutzbereichs kann daraus deshalb auch nicht abgeleitet werden, vorausgesetzt dass, wie hier unbestritten, die gleiche pharmakologische Wirkung beim anderen Salz als Fumarat gegeben ist.

Swissmedic
Swissmedic

The FPC then took the fact that the attacked embodiment had been registered by Swissmedic essentially based on the plaintiff’s prior market authorisation as prima facie evidence of the same pharmacological effect of the fumarate and the phosphate.

It was beyond dispute that the attacked embodiment was covered by the basic patent, and that the attacked embodiment had a market authorisation by Swissmedic. Thus, the FPC held that all elements of an infringement of the SPC had been fulfilled.

The decision is not yet final.

UPDATE 01 December 2017:

The decision has not been appealed.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2017_006 ¦ Decision of 12 October 2017 ¦ “Gutheissung vorsorgliche Massnahme, ESZ Kombinationspräparat”

n/a  ./.  n/a

Panel of Judges:

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

Judge-rapporteur:

  • Dr. Tobias BREMI

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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Does the wording of an SPC matter?

Case No. S2107_006 ¦ Hearing of 9 October 2017

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

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

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

tenofovir disoproxilfumarat + emtricitabin

Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

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

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

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

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

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

Reported by Martin WILMING

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

BIBLIOGRAPHY

Case No. O2107_001 ¦ Hearing of 9 October 2017

Gilead Sciences Inc. ./. Mepha Pharma AG

Panel of Judges:

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

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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Living in a box … no more

Case No. 4A_18/2017 (Supreme Court)] ¦ Decision of 10 July 2017 ¦ ‘HIT Box’

This decision of the Supreme Court of Switzerland concerns an appeal against a decision of the Princely High Court of Liechtenstein in a patent infringement case.

This setup demands for some explanations right from the outset.

Switzerland and the Principality of Liechtenstein form a unitary territory of protection; see the Bilateral Protection Act (‘Patentschutzvertrag‘, an English translation is available here). The Princely High Court is designated as the competent court in civil cases regarding patent matters in Liechtenstein. An appeal to the Swiss Supreme Court is possible with regard to issues of substantive law (BGE 127 III 461, r 3d); the Supreme Court Act applies. On the other hand, issues of international private law (BGE 127 III 461, r 4b) and procedural law of the Principality of Liechtenstein (4A_681/2012 and 4A_683/2012) are not to be dealt with by the Swiss Supreme Court. 

All this may well add a further layer of procedural complexity on top of the inherent complexity of any patent litigation.

But at least the subject-matter at stake appears to be rather straight-forward: It’s all about a plastic container with a lid and snap closure, illustrated as follows:

The snap-mechanism can be released by pushing the nose (15) inwards and pulling the gripping member (9) outwards, illustrated by forces K3 and K2, respectively, in Fig. 4 below. The lid can then be lifted easily with force K1. However, if only the lid is lifted (force K1′) without prior release of the snap-mechanism by forces K2 and K3, the nose 15 slides to the exterior into a safety position; see Fig. 6 below.

The patent EP 0 767 106 B1 (Georg Utz Holding AG; see Swissreg and EPO Register for further bibliographic details) had been granted in 1999 with a single independent claim as follows:

A plastic Container with a lower part (1) and a lid (2) as well as at least one snapping mechanism (9-18) for attaching the lid (2) to the lower part (1), wherein the snapping mechanism comprises a first and a second member (12-15; 9, 11, 17, 18), wherein the members are snapped into each other in a closed position and resist against an opening of the lid (2) by a nose (15) of the first member abutting against a stopping surface (18) of the second member, wherein for opening the lid (2) the members can be brought into an opened position by urging the nose (15) in a first direction from the stopping surface (18) by elastic deformation of at least one of the members, and wherein by exertion of a sufficient opening force (K1′) on the lid, the nose (15) can be urged from the stopping surface (18) in a different second direction and the members can be brought from the closed position into a safety position, where they form a connection positively acting against the opening force, characterised in that an opening (11) is arranged in an edge region of the lid (2), the lower edge of which opening forms the stopping surface (18), and that the nose (15) is connected to the lower part (1).

The complaint (apparently against members of the Hilti group of companies) had been filed back in September 2012. The Princely High Court appointed a court expert to assess validity and infringement of the patent: Dr. Tobias Bremi, who is also the second ordinary judge of the Swiss Federal Patent Court. The expert held that the attacked embodiment is literally covered by claim 1 of the patent, but that the patent is invalid for lack of novelty. However, it may be concluded from the decision that the court-appointed expert somehow indicated that the subject-matter of dependent claim 10 would be valid and infringed.

Later, the patent has been limited in central EPO proceedings by addition of the following feature to claim 1:

the upper border area (3) of the lower part (1) is reinforced by a double wall

No, it’s not what you might expect: The additional feature is not the subject-matter of former claim 10, it rather has been taken from the description. The limited patent has been republished as EP 0 767 106 B3.

The expert accordingly delivered a second opinion on the limited patent in December 2015: The attacked embodiment was still covered by amended claim 1, but the claim was still not novel over the same prior art document. Even worse, the amendment was held to be in violation of Art. 123(2) EPC, i.e. that the amended claim contained subject-matter which extended beyond the content of the application as filed by way of an intermediate generalisation. 

The Princely High Court thus dismissed the complaint with decision of 24 November 2016, ie well after the patent had finally lapsed on 30 September 2016. On appeal to the Swiss Supreme Court the plaintiffs essentially requested that the decision of the Princely High Court be set aside and that the case be remanded to the Princely High Court for reappraisal. The plaintiffs / appellants apparently argued that the amendment to claim 1 was not an unallowable intermediate generalisation. Moreover, it was argued that claim 10 as such was valid and infringed.

In first place, the Supreme Court held that the plaintiffs / appellants had no legitimate interest anymore in injunctive relief since the patent had meanwhile lapsed. The appeal has not been considered to this extent.

Second, the Supreme Court dealt with the aspect of information and accounting. The Supreme Court would have been competent to decide on the merits; Art. 107(2) SCA and Annex I to the Bilateral Protection Act (‘Patentschutzvertrag’) which refers to the Swiss Code of Obligations. However, only remandment to the Princely High Court had been requested. The Supreme Court has thus not considered the appeal to this extent, either.

Finally, the Supreme Court held that partial validity of dependent claim 10 of the patent (as originally granted) had not been at stake in proceedings before the Princely High Court, and any arguments in this respect were new and inadmissible. The Supreme Court noted that the plaintiffs / appellants did not object to the finding of the lower court that claim 1 was not novel, neither in the initially granted form (EP’106 B1) nor in the subsequently limited form (EP’106 B3). However, according to the Supreme Court, already this finding justifies the decision as such.

At the face of it, the Supreme Court decision appears to be very straight-forward. But the devil may well be in the unrevealed details. E.g., it would be interesting to learn more about the reasons for the limitation, and what had actually been argued with respect to claim 10.

What is not readily clear to me is how the Supreme Court dealt with the plaintiff’s auxiliary request that had been on file before the Princely High Court. The patentee had eventualiter invoked the patent only to a limited extent, and this limitation actually reflected the additional features of dependent claims 9 and claim 10 (note that claim 10 is dependent on claim 9):

[9. …] in the closed position the nose extends from an inner side into the opening;
[10. …] in the closed position an outer side of the nose is substantially flush with an outer side of the edge region of the lid.

In my perception, validity of the combination of claims 1, 9 and 10 must have been at stake before the Princely High Court, contrary to what the Supreme Court decision suggests. When a patent is invoked only to a limited extent, validity should also be assessed to that extent; see this Blog here.

I am still trying to get a hand on the decision of the Princely High Court, to gain further insight …

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_18/2017 (Supreme Court)] ¦ Decision of 10 July 2017 ¦ ‘HIT Box’

  1. A. AG
  2. B. AG
  3. [Utz group of companies]

./.

  1. C. AG (LI)
  2. D. GmbH (DE)
  3. E. mbH (DE)
  4. [Hilti group of companies]

Judge(s):

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Fabienne HOHL

Court Clerk:

  • Dr. Matthias LEEMANN

Representative(s) of Plaintiff(s) / Appellant(s):

Representative(s) of Defendant(s):

  • Dr. Michael RITSCHER (MLL)

DECISION IN FULL

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PATENT AS GRANTED (B1)

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LIMITED PATENT (B3)

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Combining a counterclaim with a main claim against a party which hasn’t sued you?

Case No. O2016_016 ¦ Decision of 16 May 2017 ¦ “Einbezug zusätzlicher Parteien mit Widerklage”

HEADNOTE

Art. 64 CPC; Fixation of the parties to the proceedings.

Litispendence results in a fixation of the parties to the proceedings. Further parties cannot be included into pending proceedings – except for an admissible substitution of a party (Art. 83 CPC) or for other reasons provided by law.

The setup of this case is straightforward: A had sued B for nullity of the patent in suit. B lodged a counterclaim for infringement against A with his reply.

In the very same proceedings, B also sued X AG and Y GmbH for infringement. B argued that this voluntary joinder was admissible in view of Art. 71 CPC: the duties of all these parties result from similar circumstances, ie cooperation with respect to the alleged infringement of the patent in suit.

However, the President held that the parties are fixed upon litispendence; Art. 62 and Art. 64 CPC. Exceptions would only be the admissible substitution of a party (Art. 83 CPC) or other reasons provided by law — which have not been applicable here. A voluntary joinder under Art. 71 CPC would have been possible, but only in separate proceedings.

The President thus dismissed the cases against X AG and Y GmbH for lack of a procedural requirement; Art. 59(1) CPCArt. 23(1) lit. a PatCA.

Court fees of CHF 10’000,– have been imposed on B. No party compensation has been awarded: There was no need to even invite X AG and Y GmbH to file reply.

Reported by Martin WILMING

P.S.:
Admittedly, I am frustrated that I have no clue about the parties this time …

BIBLIOGRAPHY 

Case No. O2016_016 ¦ Decision of 16 May 2017 ¦ “Einbezug zusätzlicher Parteien mit Widerklage”

A AG
(Nullity claimant; defendant in countersuit re infringement)

X AG
(Defendant re infringement)

Y GmbH
(Defendant re infringement)

./.

B
(Nullity defendant; counter-claimant re infringement)

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE

Court Clerk:

  • Esther SCHEITLIN

Representative(s) of A AG:

Representative(s) of B:

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

DECISION IN FULL

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Supreme Court ruling on Ethical Coffee Company ./. Nestlé Nespresso et al.

Case No. 4A_520/2016 (Supreme Court) ¦ Decision of 07 April 2017

The patent in suit is CH 701 971 B1; see Swissreg for further details. In a nutshell, ECC claimed CH’971 is a patent for the technology it alleges Nestlé Nespresso uses to block its capsules. The suit had been flatly dismissed with decision O2015_001 of 12 July 2016. The FPC held that the phrase ‘toute capsule’ / ‘any capsule’ means (literally) any capsule that is suitable for use in the machines to prepare coffee, irrespective of whether or not the capsule is retained in the machine thereafter.

[…] l’expression «toute capsule» signifie dans le présent contexte toute capsule susceptible d’être utilisée dans le dispositif (machine à café) en question, de façon à permettre la préparation d’une boisson extraite (un café), ceci indépendamment de la question de savoir si une telle capsule est retenue dans la cage après l’extraction.

The plaintiff had admitted that ECC’s modified capsules were not retained in the attacked devices. Likewise, the defendant had submitted that not all capsules are retained in the attacked devices. Concluding, the FPC held that the attacked embodiments evidently did not retain ‘toute capsule’ / ‘any capsule’. The FPC further held that the request for injunctive relief reached beyond the scope of protection conferred by the patent, and the suit had to be dismissed for this reason, too.

For further background information and details of the underlying decision O2015_001, please see this Blog here.

It had been known since April 11 that the Supreme Court had dismissed ECC’s appeal with decision of 07 April 2017:

The Supreme Court’s decision has been published only on April 28, 2017.

ECC essentially argued that the generic term ‘any capsule’ meant ‘capsule of any kind’ or simply ‘capsule’ — and that the claim does not require that systematically all capsules deformable upon contact with hot water are retained. Rather, it would suffice if only a relatively high number of such capsules were retained. In a nutshell, the Supreme Court holds that there is apparently no specific meaning of the term ‘any capsule’ in the specific technology, and that the literal meaning is perfectly clear. The appellant did not identify any part of the specification of the patent that would allow for a different interpretation.

Consequently, ECC’s appeal has been dismissed.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_520/2016 (Supreme Court) ¦ Decision of 07 April 2017

Ethical Coffee Company SA

./.

Nestlé Nespresso SA
DKB Household Switzerland AG
Eugster/Frismag AG

Composition of the Board of the Supreme Court:

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

Court Clerk:

  •  Dr. Diane MONTI

Representative(s) of Ethical Coffee Company SA:

Representative(s) of Nestlé Nespresso SA et al.:

SUPREME COURT

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FEDERAL PATENT COURT

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Confirmed in main proceedings re Pemetrexed: The counterion matters!

Case No. O2015_004 ¦ Decision of 09 March 2017 ¦ “Pemetrexed: Feststellungsklage auf Nichtverletzung gutgeheissen, Bindung an Einschränkung im Erteilungsverfahren”

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

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

The independent claims of EP’508 read as follows (emphasis added):

1.   Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.

12.   A product containing pemetrexed disodium, vitamin B 12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.

Protection of pemetrexed diacid and the pharmaceutically acceptable salts thereof by the basic patent EP 432 677 B1 and a subsequent SPC has lapsed in December 2015.

The FPC had already dismissed Lilly’s request for interim injunctive relief in corresponding summary proceedings S2016_004; see this Blog here. In a nutshell, it had been held that limitation from antifolate to pemetrexed disodium during prosecution constitutes an abandonment of subject-matter. But even if it would not be considered 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.

The present decision now is a declaratory judgement of non-infringement in main proceedings. The reasons are essentially along the line of arguments as set forth already in summary proceedings S2016_004. But still, there are some interesting aspects beyond that:

1.   Three- vs. five-member panel of judges

As a general rule, the FPC makes its decisions as a three-member panel. However, the FPC can make its decisions as a five-member panel on the order of the President where this is in the interest of the further development of the law; Art. 21(2) PatCA.

The defendant requested that the panel of judges be extended to five members, in view of the critical legal questions at stake (equivalence; abandonment of subject-matter during prosecution and its interplay with claim construction in after-grant proceedings).

First, the FPC held that this request is belated. It has only been filed when the parties had already been served with the expert opinion of the judge-rapporteur — which has been unfavorable for the defendant. In the FPC’s view, this might well be the actual motivation of the request, not the complexity of the legal questions at stake.

Im Übrigen gibt die Tatsache, dass der Antrag der Beklagten erst auf den Erhalt des für sie negativ ausgefallenen Fachrichtervotums erfolgte, Anlass zur Frage, ob nicht eher dies — und nicht die Rechtsfragen — Anlass für den Antrag war.

On the merits, the FPC further holds that this is no case of special interest for the further development of the law. Appearance of bias due to prior involvement of the same panel of judges in corresponding summary proceedings cannot be an issue, either; Art. 47(2) lit. d CPC.

2.   The ‘core of the invention’

The defendants argued that it was only the combination with vitamin B12 that made pemetrexed reasonably usable in anti-cancer therapy, since pemetrexed alone had been too toxic. This purportedly is the ‘core of the invention’. Even though the Supreme has recently used the term ‘core of the invention’ — yet only with a reference to literature from 1985 — the FPC clearly holds that the concept of a ‘core of the invention’ (resembling the outdated concept of a ‘general gist of the invention’ / ‘allgemeiner Erfindungsgedanke’) is neither necessary nor useful at all in the assessment of infringement. There is either literal infringement or infringement under the DoE, the latter being assessed with the three-step questionnaire.

Für Überlegungen zum Kern der Erfindung bleibt da weder Raum noch Bedarf.

3.   Abandonment of subject-matter

The wording of the claims had been narrowed down during prosecution in order to overcome the examiner’s objections re novelty, and to proceed to grant: The broad term antifolate had been amended in the claims to pemetrexed in first place, and finally to pemetrexed disodium.

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 thus assessed whether the DoE is applicable at all to the feature pemetrexed disodium. The FPC notes 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 circumvent this limitation by asserting equivalence.

The FPC notes that an admissible intermediate generalisation of the term antifolate is missing in the application as filed (the FPC refers to this as the onion-shell principle); the patentee has to face the consequences thereof, not the public. The FPC refers to a decision HG060066 of the Commercial Court Zurich in this respect. This is not to be confused with the Prosecution History Estoppel known in the U.S. — it rather highlights that the prosecution history is not just irrelevant.

Für die Beurteilung der Bedeutung dieser von der Patentinhaberin im Laufe des Erteilungsverfahrens vorgenommenen Einschränkung ist davon auszugehen, dass die Schweiz, wie andere Europäische Länder auch, keine Prosecution History Estoppel, wie sie in USA angewandt wird, kennt. Das heisst aber keineswegs, dass die Erteilungsgeschichte in der Schweiz völlig ausser Acht gelassen werden kann.

4.   No infringement under the Doctrine of Equivalents

For the sake of completeness, the FPC additionally assessed infringement under the DoE. The FPC’s 3-step questionnaire has recently been approved by the Supreme Court.

The first question to be answered is whether the replaced features have the same objective function. The FPC essentially relied on the fact that the attacked embodiment is a Swissmedic approved generic version of Alimta®, ie the pemetrexed disodium containing product. The same objective function was thus held to be given.

The second question asks whether the replaced features and their same objective function are made obvious to the skilled person by the teaching of the patent. See also the clarifying headnote of O2014_002 on how the FPC expects this question to be addressed. The FPC held that the skilled person knows that pemetrexed diacid would be at least partially deprotonated under physiological conditions, and that both pemetrexed diacid and pemetrexed disodium will result in the same pemetrexed dianion. Concluding, the skilled person would thus have expected the diacid to have the same effect (based on the anion). The FPC expressly dissents with the judgement of the England and Wales Court of Appeal ([2015] EWCA Civ 555, #71) in this respect.

Finally, the third question asks whether it is evident for the skilled person that the replaced feature has the same effect, starting from the teaching of the patent in suit. Would the skilled person have understood the wording pemetrexed disodium as a strict limitation? The FPC notes that other components are defined more broadly in the claims, ie vitamin B12 or a pharmaceutical derivative thereof. Not so for pemetrexed disodium. The skilled person would thus have understood this as an intentional limitation, in further view of the specification.

The FPC thus answered the third question in the negative, expressly consenting with the judgement of the England and Wales Court of Appeal ([2015] EWCA Civ 555, #72) in this respect. The FPC also sides with the German Federal Supreme Court’s decision X ZR 29/15 in parallel proceedings in that the present matter is not an abandonment in the sense of X ZR 16/09Okklusionsvorrichtung. In Okklusionvorrichtung the replacing feature had been explicitly mentioned in the specification; not so in the present matter. However, the FPC notes that this does not automatically mean that a contrario the third question is to be answered in the affirmative.

Der BGH fokussiert sich bei der Beurteilung der dritten Äquivalenzfrage allerdings sehr auf diese Frage des Verzichts. Dem kann nicht gefolgt werden. Die Tatsache, dass kein Verzicht gemäss Okklusionsvorrichtung vorliegt, bedeutet keineswegs automatisch im Umkehrschluss, dass die 3. Äquivalenz-Frage zu bejahen ist. Das greift zu kurz.

It is highly likely that this decision will be appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_004 ¦ Decision of 09 March 2017 ¦ “Pemetrexed: Feststellungsklage auf Nichtverletzung gutgeheissen, Bindung an Einschränkung im Erteilungsverfahren”

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

Reporting Judge:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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WHAT’S GOING ON ELSEWHERE

A comprehensive summary on the current status of proceedings relating to Lilly’s Alimta® can be derived from Lilly’s Form 10-K (Annual Report); see p 93-94.

If you are interested in the fulltext decisions, there is a long series of decisions to read from the UK, ie [2012] EWHC 3316 (Pat), [2013] EWCA Civ 517, [2014] EWHC 1511 (Pat), [2015] EWCA Civ 555 and [2016] EWHC 234 (Pat).

As to Germany, there is the most recent decision X ZR 29/15 of the Federal Supreme Court. Please find the whole course of proceedings through the various instances in Germany here. Interim injunctive relief has been granted by the Regional Court Munich I in matters 21 O 22243/15 and 21 O 5583/16.

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It’s just not the right time …

Case No. O2016_012 ¦ Decision of 22 February 2017 (excerpt) ¦ “Rechtliches Gehör, unbedingtes Replikrecht, Prozessleitung, Waffengleichheit”

A previous version of this post mentioned Bruno MEYER as an assisting patent attorney on behalf of the defendant. I have been informed that this is wrong; he is actually engaged on behalf of the plaintiff. This has been corrected hereinbelow.

This procedural order is almost a blueprint of a published order in the case O2012_039; see this Blog here. Again, an alleged infringer argued for nullity as a plea in defense with his answer to the suit. Prior to the preparatory hearing, the plaintiff had been ordered and actually provided a reply only with respect to the alleged nullity, for the time being. So far so good.

But the defendant filed a factual rejoinder concerning the (in)validity of the patent in suit. This evidently frustrated the court’s intention to have one(!) reply of each party on file pertaining to the questions of infringement and nullity. Consequently, the FPC decided to not take the defendant’s submission on file at all, for the time being. The defendant may re-file the same after the preparatory hearing, with his rejoinder.

Die Prozessleitung ist Sache des Gerichts (Art. 124 Abs. 1 ZPO). Wenn die Beklagten hier nun ungefragt mit einer faktischen Duplik zur Bestandesfrage reagieren, wird das Bestreben des Gerichts, die Waffengleichheit der Parteien zu wahren, unterlaufen. Das ist zu unterbinden. Entsprechend ist die Eingabe der Beklagten (samt Beilagen) aus dem Recht zu weisen. Es steht den Beklagten frei, das Vorgebrachte (nach der Instruktionsverhandlung) im Rahmen der dann einzuholenden Duplik erneut vorzutragen.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_012 ¦ Decision of 22 February 2017 (excerpt) ¦ “Rechtliches Gehör, unbedingtes Replikrecht, Prozessleitung, Waffengleichheit”

A AG

./.

(1) B GmbH
(2) C GmbH

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI

Reporting Judge:

  • n/a

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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

DECISION (EXCERPT)

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