Claim dismissed, counterclaim dismissed: Huge expense, no recompense

Case No. O2015_018 | Decision of 15 June 2018 | ‘Instrument d’écriture’

The FPC handed down the decision in this remarkable litigation about a highly complex mechanical writing system. Please see this Blog here for a report about the main hearing and some background information.

What follows is a rather lengthy post, but this is due to the complexity of the case, both procedurally and technically.

  1. Party positions in a nutshell

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. Guenat argued that the invention had been made by Frédéric Garinaud, an independent inventor who is quite renown for being the mastermind behind the Harry Winston Opus 8. Frédéric Garinaud had filed a patent application for a writing instrument; this patent application has then been assigned to Guenat and a patent was granted; EP 2 479 648 B1, see Swissreg and European Patent Register for further bibliographic details.

In Guenat’s view, the subject-matter of the Swiss Patent was invented by Frédéric Garinaud before it was used by Swiss Finest, and Frédéric Garinaud never transferred his patent rights to Swiss Finest. Guenat further argued that the invention of the Swiss Patent is obvious in view of a PowerPoint Presentation which had been sent to a third party without confidentiality obligation. Frédéric Garinaud being the only creator of the technical teachings contained in Garinaud’s European Patent and having transferred his patent rights to the plaintiff, Guenat argues that the defendant has no right to the Swiss Patent.

Swiss Finest countersued and requested that Guenat’s EP’648 be declared invalid, or assigned to Swiss Finest. Swiss Finest argued that in autumn 2010, Frédéric Garinaud had only a vague idea but had not yet completed an invention at that time. The invention was only made later with the substantial contribution of Swiss Finest’s employees after Frédéric Garinaud’s appointment as Creative Director, and any rights in the invention had been assigned to the defendant by employment contract.

Later, Swiss Finest argued that if Frédéric Garinaud was nevertheless considered to have already conceived the invention in the fall of 2010, the patent rights in this invention had been transferred to a simple partnership founded by Fabrice Thueler (owner of Swiss Finest) and Frédéric Garinaud in the preparation of a company ‘Garinaud SA’ which was foreseen to exploit the invention in dispute. Swiss Finest held thus to be the legitimate owner of the rights in the invention which is the subject of the Swiss Patent and, since the invention of the European Patent is the same, it is also entitled to the European Patent. Further, the subject-matter of the Swiss Patent was new and inventive in Swiss Finest’s view, since the PowerPoint presentation had not become publicly available because it had been sent only under an implicit confidentiality obligation. Even if one were to consider that the presentation was to be considered as prior art, the subject-matter of the Swiss patent is nonetheless inventive.

As if all this was not confusing enough, the case was spiced up further with Swiss Finest’s counterclaim for infringement by the Mechanical Fountain Pen RMS05:

Fountain Pen RMS05 by Richard Mille

This product has some amazing mechanics; see yourself:

In brief:

It’s complicated. Very complicated.

  1. The parties’ requests — and why they failed

The stage is set with a rather complicated factual situation. But at least some of the request could be dealt with quite straight forward by the court:

  1. Nullity for lack of entitlement

Guenat had requested that Swiss Finest’s Swiss patent be annulled based on Art. 26(1) lit. d PatA, i.e. for lack of entitlement. However, such request can only be brought by the entitled person; Art. 28 PatA. Guenat alleged that Frédéric Garinaud transferred ‘full and complete ownership’ of the European patent application to Guenat. Even though the inventions in both (Guenat’s) European and (Swiss Finest’s) Swiss patent may well be the same, this did not help. Frédéric Garinaud specifically assigned only the European patent application to Guenat, but not to the invention itself.

Guenat’s request for declaration of nullity based on Art. 26(1) lit. d PatA was thus held inadmissible for lack of standing.

  1. Nullity for lack of inventive step

Novelty of Swiss Finest’s Swiss patent after partial surrender was not contested anymore. But Guenat alleged obviousness over the PowerPoint presentation that had been sent to Hamdi Chatti of Louis Vuitton in 2010, in further view of i) F. Lecoultre, Les Montres Compliquées, 3ème éd. Neuchâtel 1985; ii) Huguenin / Guye / Gauchat, Les Echappements, 2ème éd. Neuchâtel 1974; and/or EP 1 221 383 A1.

Louis Vuitton logo

With respect to the PowerPoint presentation, the parties dissented whether or not it had been sent to Hamdi Chatti with an implied confidentiality obligation. The last page of the PowerPoint presentation mentioned ‘breveté’ (‘patented’), even though the Swiss patent application had not yet been filed. Frédéric Garinaud was apparently aware of this faux-pas; he wrote to his patent attorney:

I confess I anticipated the patent application.

The decision holds that under the specific circumstances there was no implicit confidentiality obligation associated with the PowerPoint presentation.

It then remained undisputed that the PowerPoint presentation was the closest prior art. However, quite a lot of differentiating features were missing. The missing features could be grouped into three aspects, and three partial problems are dealt with in the decision:

amovibilité the removable endpiece allows wide access to the pen holder, and indirectly to the other components housed in the front part of the writing instrument, avoiding manipulation by the writing tip;
échappement the choice of an escapement as a control mechanism offering a simple and proven solution to control energy release, while producing an audible indication;
verrouillage cooperation between the actuator and the locking system to unlock the power source to release the writing tip when the actuator is actuated, without additional action.

This is the only picture from the PowerPoint presentation in the decision:

PowerPoint presentation

As to the locking system (‘verrouillage‘), the decision holds that this was readily obvious (if not implicitly disclosed already in the PowerPoint presentation). Likewise, the escapement (‘échappement‘) is held obvious in further view of Lecoultre:

Lecoultre, p. 113

However, the removable endpiece (‘amovibilité‘) was more tricky, and the decision holds that this was not obvious from the cited prior art. When seeking a solution to the problem of replacing the ink cartridge, the skilled person would not have thought of a removable endpiece. Instead, he would have e.g. made a pen in which the writing tip as such is detachably mounted on the body or tip, like e.g. in EP'383:

EP 1 221 383 A1, Fig. 1

Thus, the subject-matter claimed in Swiss Finest’s Swiss patent was held to be non-obvious over the cited prior art.

  1. Nullity for yet further reasons

Guenat argued for nullity of Swiss Finest’s Swiss patent for yet further reasons.

First, an alleged undue extension of subject-matter (Art. 26(1) lit. c PatA) in the course of the partial surrender according to Art. 24 PatA; see the B1 and the C1 version of the Swiss patent below.

Second, Guenat alleged a lack of enabling disclosure; Art. 26(1) lit. b PatA.

Without setting out all the details here, both these alleged grounds of nullity failed for apparently straight forward reasons.

  1. Entitlement to Guenat’s European patent

The invention disclosed in the European Patent was already disclosed or was obvious to a large extent from the PowerPoint Presentation prepared and sent by Mr. Garinaud on November 17, 2010; see above — with the only exception of the removable endpiece. This removable endpiece was first mentioned by Frédéric Garinaud’s patent attorney François-Régis Richard (e-patent). In an email dated December 9, 2010, he wrote to Frédéric Garinaud:

I am also realizing that for the change of the cartridge, it would probably be simpler to disassemble the pen by its front part to avoid exposing the watch mechanism in the back.

This undisputedly was the first note of the removable endpiece. Whether the rights to this creative contribution were transferred to Frédéric Garinaud, as alleged by Guenat, could remain open. In any event, it had not been alleged that François-Régis Richard transferred the rights to Swiss Finest. Rather, Swiss Finest only held that the invention was made by Frédéric Garinaud when he was employed at Swiss Finest — which could not be true given the PowerPoint presentation and the email of December 9, 2010.

The decision thus holds that the subject-matter of claim 1 of the Swiss patent was created by Frédéric Garinaud before its use by Swiss Finest — with the exception of the removable endpiece which was proposed by François-Régis Richard without having assigned his rights in this contribution to the defendant.

In anticipation of this outcome, Swiss Finest apparently modified its position later and alleged that it had obtained rights in the European Patent by virtue of a simple partnership agreed between Frédéric Garinaud and Fabrice Thueler in preparation of a company ‘Garinaud SA’ to be established.

However, this was not convincing, either. The decision holds that it is unclear how the right to the patent, even if it had been transferred to the simple partnership, should finally reside with Swiss Finest. Members of a simple partnership are joint owners of the assets, with the consequence that they can only dispose of them jointly. In any event, according to the defendant’s allegations, Frédéric Garinaud and Fabrice Thueler were the partners of the simple partnership. A patent right could therefore only belong to them jointly. However, the defendant did not allege that Frédéric Garinaud agreed to transfer the right to the patent to it.

  1. Injunctive relief

Swiss Finest’s request for injunctive relief in respect of the ‘Mechanical Fountain Pen RMS05’ failed for a lack of concreteness of the attacked embodiment. See e.g. this Blog here (O2012_004, ‘Leichtbeton’) for further information on the necessary concreteness of a request for injunctive relief.

Swiss Finest did not argue for literal infringement, but rather only for infringement under the Doctrine of Equivalents (DoE); see below. Still, the request for injunctive relief merely recited the wording of the claims, and was thus held inadmissible.

  1. Infringement by the Mechanical Fountain Pen RMS05
RMS05 (annotated)

Even though the request for injunctive relief was held inadmissible, the court still dealt with had to assess whether or not the RMS05 was infringing. Confused? I will clarify this later; see below.

It was undisputed that the RMS05 did not comprise a removable endpiece (’embout amovible’). However, Swiss Finest alleged that the function of the removable endpiece is to allow the writing tip to be removed from the pen body to allow an ink cartridge to be inserted or replaced. Swiss Finest further alleged that the fountain pen holder (indicated by the white arrow in the annotated figure) can be unscrewed and removed from the body using a wrench formed in the cap of the pen to place and replace an ink cartridge. In Swiss Finest’s view, the removable fountain pen holder inserted into the endpiece of the RMS05 amounts to an infringement under the DoE.

First, the court carefully defined the function of the removable endpiece in the context of the invention and reverted to ¶ [0015] of the Swiss patent:

It can still be noted that, to have access to the pen holder, the endpiece is screwed on the body and can therefore be unscrewed. The ink supply can then be changed by disassembling the pen holder and the intermediate holder.

The decision holds that this function does not exist in the RMS05. The endpiece is not removable and the disadvantage of the access to the fountain pen holder still remains in the RMS05. The fact that the fountain pen holder of the attacked embodiment can be removed does not change anything in this respect, because according to the Swiss Patent, after unscrewing the endpiece and facilitating access, the fountain pen holder is also removed to replace the cartridge.

As can be seen in the below screenshot of this video on YouTube, the fountain pen holder can be gripped with the cap and removed to replace the ink cartridge. However, the endpiece is fixed (indicated by the white arrow in the screenshot below).

RMS05, replacement of ink cartridge

Therefore, there is no removable endpiece in the RMS05, neither literally nor under the DoE, because the function of the removable endpiece is not realized in this pen. Thus, already the first question of the questionnaire established with O2014_002 was denied.

In sum, neither party succeeded with any attack. This somehow reminds me of the ‘Hornberg salute’:

‘Hornberger Schiessen’
  1. What the decision might be cited for
  1. Competency for assignment of all national validations of a European patent

Swiss Finest had requested that Guenat’s European patent be assigned to them. This was interpreted by the court as to concern all national validations of the meanwhile granted patent. To the best of my knowledge, it had been mentioned for the first time in O2015_009, ¶ 2.1, that the FPC is competent to decide also on ownership of foreign rights — without any in-depth discussion because it had not been decisive anymore in that case.

Not so here. The court now took the chance to set out its reasoning in any detail in ¶ 10 of the decision. The question of ownership of IP rights does not fall within the exclusive jurisdiction under Art. 22(4) of the Lugano Convention; see decision C-288/82 of the ECJ, Ferdinand M.J.J. Duijnstee ./. Ludowijk Goderbauer and further literature in fn 1 of the decision. Under Swiss national law, international jurisdiction for disputes relating to intellectual property rights is governed by Art. 109 CPIL. However, only validity and infringement actions are mentioned, but not assignment actions. Jurisdiction for actions for the assignment of an IP right, in particular a patent, is therefore determined in accordance with the general rule of Art. 2 CPIL, according to which the Swiss judicial or administrative authorities of the defendant’s domicile are competent. As the plaintiff (defendant of the counterclaim) is domiciled in Switzerland, the FPC is also competent for counterclaims relating to the transfer of foreign patents.

  1. Right to accounting

The court re-visited the right to accounting based on Art. 66 lit. b PatA in view of critical voices in the aftermath of O2013_008; see ¶ 58 of the decision (note that fn 33 erroneously refers to O2012_008). However, the decision explicitly confirms the FPC’s practice that in case the court finds infringement there is a substantive entitlement to information and accounting based on Art. 66 lit. b PatA.

  1. Request for accounting with reference to a trademark / product name

As mentioned above, the request for injunctive relief was held inadmissible for lack of concreteness. Still, the court did the whole exercise of infringement analysis. It had to because of the request for accounting. The request for accounting referred to the ‘Mechanical Fountain Pen RMS05’. Such a description would be perfectly inadmissible in a request for injunctive relief, because the product name could be changed at any time. But not so in a request for accounting. The name of a product that has been sold in the past cannot be changed anymore:

However, in the case of conduct that has taken place in the past, it is permissible to specify the allegedly infringing object by means of a type designation or trademark. Such a designation cannot be changed for the past and one therefore knows exactly which product — namely in this case the product previously offered under the designation ‘Mechanical Fountain Pen RMS05’ — is the subject of the information request.

I guess we will see more such simplified requests for accounting in the future.

  1. No mixing-up of functions of features in the test for infringement under the DoE

There is an interesting general remark in ¶ 63 of the decision, i.e.:

One cannot reasonably expand the function of a claim feature and argue that this expanded function is fulfilled by another feature of the attacked embodiment, when the same element (penholder) with the same functionality (can be dismantled to replace the cartridge) is found in the invoked patent in parallel to claimed features, and independently of it (removable endpiece).

Reported by Martin WILMING

IMAGE CREDIT

Header image (Hôtel de Ville de Neuchâtel, Salle du Conseil Général) courtesy of Lucas Vuitel – ArcInfo.

BIBLIOGRAPHY

Case No. O2015_018 | Decision of 15 June 2018 | ‘Instrument d’écriture’

Guenat SA Montres Valgine
./.
Swiss Finest SA

Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Tobias BREMI
  • Dr. Philippe DUCOR
  • Christoph MÜLLER
  • Dr. Ralph SCHLOSSER

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Nathalie TISSOT (Etude Tissot)
  • Christophe SAAM (P&TS), assisting in patent matters

Representative(s) of Defendant:

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

DECISION IN FULL

Fullscreen view (new tab)

CH 704 790 B1

Fullscreen view (new tab)

CH 704 790 C1

Fullscreen view (new tab)

EP 2 497 648 B1

Fullscreen view (new tab)

FRÉDÉRIC GARINAUD

Harry Winston Opus 8

Frédéric Garinaud apparently is a master of complicated mechanics. He developed the Harry Winston Opus 8, a manually-wound watch with a ‘digital’ display of the hours and minutes.

The numbers appear only on demand, when a slide on the right side of the watch is activated. I could not help but do some further research on the Opus 8. It was a limited edition of 50 pieces only, on 9 July 2018 seen at luxurybazaar.com with a price tag of US$ 350’125,–. A somewhat fair deal in view of a purported retail price of US$ 449’700,–.

www.luxurybazaar.com; July 9, 2018

Get to know Mr Garinaud in this video, talking about the Opus 8:

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

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

Download (PDF, 192KB)

PATENT IN SUIT

Download (PDF, 878KB)

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

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

Download (PDF, 205KB)

PATENT IN SUIT

Download (PDF, 878KB)

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Some recent case law revisited

VESPA’s annual evening conference earlier this week shed light on some key aspects of recent case law of the FPC.

Discussion centred on the following topics:

i)   Protective letters

Protective letters are frequently used. See the most important do’s and don’ts here. In addition, note that protective letters can be filed by a legal representative or the party itself, but not by a patent attorney.

The audience unanimously critcized decisions D2015_035 of 08 March 2016 (hn: A protective letter may not be withdrawn) and, to less extent, D2015_035 of 09 February 2016 (no later addendum to a protective letter, except for proper and improper novae).

By the way: A protective letter may not only be useful in anticipation of a request for ex parte interim injunctive relief, but also in anticipation of a request for preliminary measures to secure evidence like this one here.

ii)   Ex parte interim measures

Decisions S2016_007 (“don’t play games”) and S2017_001 were only briefly touched.

S2017_002 and S2017_003 made clear which requirements are to be fulfilled for an ex parte register ban to be successful; the former failed, the latter has been successful.

It became clear in the discussion that the surprising effect is not the only motivation for practitioners to request ex parte interim measures. Actually, ex parte interim measures are perceived by some as the only way to get speedy relief. Interim measures typically take seven to twelve months if they really dive deep into the subject-matter at stake (which is more the rule rather than the exception). Some participants questioned whether there is actually any difference to main proceedings, besides the fact that judicial vacations are not applicable. Sure, court fees are reduced — but so is the party compensation. On the other hand, parties typically do not perceive that the reasonable effort in summary proceedings is reduced by half.

iii)   Service of process

Two Swiss parts of European patents have been recently revoked by the FPC in judgements rendered in absentia; O2015_007 and O2015_017. The patentees / defendants did not respond at all. At least for O2015_007, it is clear meanwhile that this happened by accident; see the detailed discussion here. In both cases, the U.S. patentee / defendant had been directly served with the writ in accordance with the Hague Convention and Art. 137 CPC. In accordance with U.S. rules, the Swiss embassy in the U.S. thus served the writ to the patentees / defendants by registered letter. In the absence of any reaction, the FPC had published subsequent notifications to the patentees / defendants only in the Swiss Official Gazette of Commerce; Art. 141 CPC.

It has been proposed that the FPC could at least bring the subsequent publications in the Swiss Official Gazette of Commerce also to the attention of the representative on file at the Swiss Federal Institute of Intellectual Property for the patent in suit.

On a personal note: I have my doubts. (I have been involved in O2015_007, but this case is finally concluded now.) It may well appear formalistic to only publish a notification in the Swiss Official Gazette of Commerce when contact details of a representative of the patent are available from Swissreg. As a patent attorney on file in Swissreg, one may easily find it unsatisfactory to just be ignored. But it’s the law. Even if such an additional notification would not constitute a breach of judicial confidentiality: It surely is more than what is required by law. Nota bene: In inter-partes proceedings. Any assistance by a court for the potential benefit of one party is of potential disadvantage for the respective other party; and I cannot see any superordinated public interest, either. This is why I am hesitant. But may the lawyers have their say on this.

iv)   Doctrine of Equivalents

Discussion of decision 4A_131/2016 of the Supreme Court highlighted the apparent gap in the assessment of literal infringement and infringement under the DoE; see this Blog here. But let’s focus on the positive: The three-step questionnaire for the assessment of infringement under the DoE is approved. Let’s await the next decision(s) of the Supreme Court which hopefully provide further guidance.

As to the assessement of the third question in O2015_004, it has been discussed whether the actual wording of a claim is more binding if the alternatives are readily apparent — both for the person skilled in the art reading the patent, as well as for the patentee when drafting the application. (Note that Hepp Wenger Ryffel is involved in this matter, and the decision is not yet final. It can thus not yet be discussed in detail here.)

v)   Abandonment of subject-matter

A further interesting aspect of O2015_004 surely is the issue of abandonment of subject matter; see this Blog here for further details. (Note that Hepp Wenger Ryffel is involved in this matter, and the decision is not yet final. It can thus not yet be discussed in detail here.)

vi)   Miscellaneous

Discussion briefly touched decisions 4A_427/2016 of the Supreme Court with respect to the legal standard of implied confidentiality (see this Blog here) and S2016_002 with respect to the admitted prior art as supporting basis for claim construction (see this Blog here).

Reported by Martin WILMING

BE ON THE KNOW

You liked this? And you would like to be notified of new posts? Here you go.

Pemetrexed: It’s the counterion that counts

Case No. S2016_004 ¦ Decision of 06 December 2016 ¦ “Abweisung Massnahmebegehren; Bindung an Einschränkung aus Erteilungsverfahren”

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

Little time? Read the summary.

Lilly and CompanyThe patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. EP’508 is heavily litigated in many countries. The present decision in Switzerland concerns Lilly’s request for interim injunctive relief in summary proceedings. Main proceedings are still pending (O2105_004).

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.

Pemetrexed disodium (see structural formula below) is marketed by Lilly under the trademark Alimta®. Stakes are high for Lilly: Alimta® generated a worldwide revenue of $2,493 million in 2015; see Lilly’s Annual Report 2015, p F31. The drug is used as a cancer medication that interferes with the growth and spread of cancer cells in the body; see drugs.com for further information.

ActavisThe attacked embodiment is Actavis‘ Amtiris® which makes use of pemetrexed diacid instead of pemetrexed disodium (see structural formula above). Amtiris® had been approved by Swissmedic on 23 March 2016; see Swissmedic Journal 03/2016. Please refer to the interactive 3D structure below to get an idea of how pemetrexed dicacid actually looks like:

Literal infringement was not an issue. The present decision is all about the question of whether or not the use of pemetrexed diacid might constitute an infringement under the Doctrine of Equivalents (DoE).

Note that the wording of the claim had been narrowed down during prosecution in order to overcome the examiner’s objections and to proceed to grant: The broad term antifolate had been more precisely defined as pemetrexed in first place, and finally even further as pemetrexed disodium. 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 limitations 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 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.

The FPC consequently held that the request for interim injunctive relief had to be dismissed for this reason alone.

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 patent refers to antifolates in paragaph [0022] as follows (emphasis added):

The terms “antifolate” and “antifolate drug” generally refer to a chemical compound which inhibits at least one key folate-requiring enzyme of the thymidine or purine biosynthetic pathways, preferably thymidylate synthase (“TS”), dihydrofolate reductase (“DHFR”), or glycinamide ribonucleotide formyltransferase (“GARFT”), by competing with reduced folates for binding sites of these enzymes. The “antifolate” or “antifolate drug” for use in this invention is Pemetrexed Disodium (ALIMTA®), as manufactured by Eli Lilly & Co.

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.

The FPC thus dismissed Lilly’s request for interim injunctive relief in summary proceedings. Main proceedings are still pending (O2015_004).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2016_004 ¦ Decision of 06 December 2016 ¦ “Abweisung Massnahmebegehren; Bindung an Einschränkung aus Erteilungsverfahren”

Eli Lilly and Company ./. Actavis Switzerland AG

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

Download (PDF, 212KB)

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-Q (3/2016); see p 24-25.

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.

SUMMARY

The FPC dismissed Lilly’s request for interim injunctive relief in summary proceedings concerning a generic version of Lilly’s Alimta®, ie Actavis’ Amtiris®. While the claims of Lilly’s EP 1 313 508 B1 specifically require pemetrexed disodium, Amtiris® comprises pemetrexed diacid. The FPC 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 since the skilled person would have understood the wording pemetrexed disodium as a strict limitation, in view of the claims in view of the specification. Main proceedings are still pending (O2015_004).

BE ON THE KNOW

You liked this? And you would like to be notified of new posts? Here you go.

Doctrine of Equivalents: It’s not only about asking the right questions

Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”

Little time? Read the summary.

I have reported on the main hearing before the FPC on this Blog here. For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here.

boy-214906_960_720Long awaited, now here it is: The first decision of the Supreme Court on the Doctrine of Equivalents since ages; see fulltext below. You hoped for a ready-mix for assessment of equivalency? I’m sorry, there is none.

But let’s have a look at the very basic facts first.

The patent in suit is EP 1 579 133 B1 (embedded below), and it’s all about a non-return valve for a urinal. The independent claim reads as follows (mark-up added):

A non-return valve (3), comprising an inlet section (5) in the form of a self-supporting trough-shaped section and an outlet section, the outlet section being made of a flexible resilient material connected to the inlet section (5), whereby the outlet section comprises a flat flexible resilient strip (6) with a high inherent degree of flexibility, the strip (6) being connected with the inlet section (5) at its upper edge; and further comprising a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal.

The technology is not difficult to understand: The strip (6) and the ‘component with a complementary surface’ — actually, yet another strip — are arranged in a way as to allow fluid passing through the valve in the one direction of the valve. The valve closes when the fluid has passed, to prevent unpleasant odor from rising up. Flattened tubes instead of separate strips had been known in the prior art for the same purpose; see D1, US 3 835 857).

LITERAL INFRINGEMENT

The million dollar word is “separate”. What does the feature

[…] a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal

actually mean? There is no explicit definition of “separate” in the patent. Actually, the word as such was not even used in the application as filed at all. It had been introduced during prosecution, based on the overall specification and figures which all show (completely) separate strips; see figures 1 and 2, above.

On the other hand, the two strips are interconnected by lateral connectors in the attacked embodiment. Noteworthy, this configuration is protected by EP 2 553 299 B1 of the defendant (embedded below; EP’299 explicitly acknowledges the patent in suit as closest prior art in para. [0003]-[0005]).

attacked embodiment
attacked embodiment

The assessment of the Supreme Court is straight forward — and in line with the decision of the FPC. In light of the figures, the description and in differentiation over the prior art (flattened tube) the feature is construed to imply a full-length separation. The Supreme Court explicitly holds that the embodiment with loose ends is not merely a preferred embodiment:

Die Ausführungsbeispiele weisen auf dieses Verständnis eindeutig hin, ohne dass Anhaltspunkte für ein weiteres Verständnis von ‘separate’ in dem Sinne bestehen würden, dass das Ausführungsbeispiel mit den losen Enden nur als eine – wie die Beschwerdeführerin behauptet, bevorzugte – Ausführung erschiene.

Thus, no literal infringement.

INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS

Almost no decision on equivalency is uncontroversial, and people mostly have a very firm opinion pro or contra infringement under the Doctrine of Equivalents. So do I. But I feel there are plausible arguments for both views in the present matter, and I won’t take position for either side. No use crying over spilt milk anyway; this case has been finally decided now.

But let’s have a closer look at what can be learned about how the Supreme Court nowadays assesses infringement under the Doctrine of Equivalents on the basis of the three-step questionnaire as defined by the FPC (see S2013_001).

THE FIRST QUESTION

Do the replaced features have the same objective function? (same effect / “Gleichwirkung”)

Erfüllen die ersetzten Merkmale [Austauschmerkmale] die objektiv gleiche Funktion? (Gleichwirkung)

First of all, what is the replacing feature? The Supreme Court identifies the replacing feature essentially as follows:

[…] component and the strip (6) are separate for a sufficient length to allow for a sealing effect when a fluid has passed.

The first question is a no-brainer here: Fulfilment of the same function has been beyond dispute.

THE SECOND QUESTION

Are the replaced features and their same objective function made obvious to the skilled person by the teaching of the patent? (accessibility / “Auffindbarkeit”)

Werden die ersetzten Merkmale [Austauschmerkmale] und deren objektiv gleiche Funktion dem Fachmann durch die Lehre des Patentes nahe gelegt? (Auffindbarkeit)

This question had unfortunately been left undecided by the FPC (since the third question was answered in the negative). Nevertheless, the FPC had clarified in the headnote of the underlying decision how it expects this question to be addressed; see this Blog here. This hn 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)

The reasons 6.5.2.4 referred to in the hn read as follows:

It is to be determined whether, once the features are replaced, the same effect is evident for the person of skill in the art when objectively assessed in consideration of the teaching of the patent.

Zu beurteilen ist, ob, wenn die Merkmale ausgetauscht sind, die Gleichwirkung für den Fachmann bei objektiver Betrachtung unter Berücksichtigung der Lehre des Patents offensichtlich ist.

According to the hn in light of the reasons, this test compares two already given situations (one with the replaced/claimed feature and another one with the replacing feature) and only then asks whether the same effect is evident. As I have outlined earlier, this really makes a big difference.

Now, this is what the Supreme Court asked (mark-up added):

[…], whether the skilled person who intends to add a fixation at the lower end of the strips instead of the loose ends will readily understand that the strips have to be separate at a length which is sufficient to achieve the effect which the patent intends to achieve.

[…], ob der Fachmann, der statt der losen Enden der Streifen am unteren Ende der Streifen eine Befestigung anbringen will, ohne weiteres erkennt, dass die Streifen auf einer hinreichenden Länge getrennt werden müssen, um die mit dem Patent angestrebte Wirkung zu erreichen.

I don’t think that this is what the FPC had in mind when drafting the hn and r. 6.5.2.4. In the assessment of the FPC, there is no need at all for a skilled person intending to add a fixation. The skilled person rather only compares two given scenarios, i.e. the claimed solution and the attacked embodiment. If the same effect of these two embodiments is evident, the question is to be answered in the affirmative. Else, it’s not. Frankly speaking, I just cannot say whether the Supreme Court is supportive of this approach or not.

THE THIRD QUESTION

With due consideration of the wording of the claim in the light of the description, would the skilled person have considered the replacing features as a solution of equal value? (equal value / “Gleichwertigkeit”)

Hätte der Fachmann bei Orientierung am Anspruchswortlaut im Lichte der Beschreibung die ersetzten Merkmale [Austauschmerkmale] als gleichwertige Lösung in Betracht gezogen? (Gleichwertigkeit)

Assessment of this question by the Supreme Court in r. 6.3.2 starts with a summary of what the FPC had held, i.e. that the skilled person would not have considered the replacing features as an equivalent solution, with due consideration of the claim. Really? Is that it? I feel the FPC did more than that — and there is more to do according to the wording of the third question recited above, i.e. to give due consideration to the claim wording in view of the description. And it had been the description and the figures which strictly limited the term “separate” to only cover loose ends. Consequently, the FPC had discussed the actual meaning of the claim wording (see section 6.5.2.5 of the underlying decision O2014_002):

Thus, it is not apparent for the skilled person in view of the claim construction that the claimed subject-matter (separately) could equivalently be replaced with a modification of this feature (lateral connectors).

So ist in diesem Fall für den Fachmann bei Orientierung am ausgelegten Anspruchswortlaut auch nicht erkennbar, dass die anspruchsgemässe Lehre (separat) mit einer Abwandlung des betroffenen Merkmals (Verbindungsstege) gleichwertig realisiert werden kann.

From the decision as such, it is not clear to me whether (or to which extent) the Supreme Court has paid attention to the description when answering the third question. The meaning of “separate” is interpreted more broadly again, based only on the wording of the claim as such:

Actually, a complete separation […] with loose ends is not required by the wording of the claim as such.

Eine vollständige Trennung […] mit losen Enden wird vom Anspruchswortlaut für sich genommen gerade nicht verlangt.

If that was indeed the case, then why is there no literal infringement?

The Supreme Court finally holds:

Thus, the loose end of the strips can equally be replaced by a fixation.

Danach lässt sich das lose Ende der Streifen gleichwertig durch eine Befestigung ersetzen.

In my perception, the great achievement of the third question reaches far beyond that. It had been intended to be all about providing a reasonable degree of legal certainty for third parties, i.e. to reasonably confine the potential scope under the Doctrine of Equivalents. Therefore, it essentially asks whether the skilled person would really have considered the replacing feature as an equivalent, with due consideration of the claim and the description — not merely whether it objectively is an equivalent replacement.

The Supreme Court notes in passing that the attacked embodiment has been patented (explicitly over the patent in suit as prior art), but holds that this does not change the fact that it still makes use of the patent in suit. The bottom line of the decision is a reference to a famous Swiss legal scholar:

Subsequent inventions are directly covered by the scope of the prior teaching if this prior teaching is fully embodied while providing for an improved, non-obvious variant; and inventions which make use of the core of the inventions that has been patented earlier (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Art. 36(1) PatA provides for a non-exclusive license in such cases (cf decision 4C.502/1997 of April 20, 1998, r. 5b).

Vom Schutzbereich der älteren Lehre direkt umfasst sind spätere Erfindungen, wenn sie die ältere Lehre vollständig anwenden, aber eine verbesserte, nicht naheliegende Ausführung lehren, und ebenso Erfindungen, bei deren Anwendung der Kern der früher patentierten Erfindung mitverwendet wird (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Dafür sieht Art. 36 Abs. 1 PatG eine nicht ausschliessliche Lizenz vor (vgl. Urteil 4C.502/1997 vom 20. April 1998 E. 5b).

Reference to Art. 36(1) PatA looks like an easy way out, but the right to be granted a non-exclusive license is explicitly only given by law if the invention represents an important technical advance of considerable economic significance in relation to the invention that is the subject-matter of the prior patent. It will not necessarily be easy to meet this precondition.

I hope we will see further decisions of the Supreme Court in the near future which provide some more guidance on the actual interpretation of the second question and how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question. Addressing infringement under the Doctrine of Equivalents with a set of three questions that somehow resemble the questionnaires used in the U.K. and Germany surely is an achievement of harmonization. But I do not yet see much harmony in how the questions are interpreted and answered.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”

Daspaco AG ./. Von Allmen AG

Composition of the Board of the Supreme Court:

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Gilbert KOLLY
  • Dr. Fabienne HOHL
  • Dr. Martha NIQUILLE

Court Clerk:

  •  Dr. Christoph HURNI

Representative(s) of Appellant / Patentee:

Representative(s) of Defendant:

DECISION IN FULL

Download (PDF, 694KB)

PATENT IN SUIT

Download (PDF, 303KB)

DEFENDANT’S PATENT

Download (PDF, 437KB)

SUMMARY

The good news from the first decision of the Supreme Court on the Doctrine of Equivalents since ages: The third question of the FPC’s questionnaire is approved. The sad news: There is little to no guidance in the decision with respect to how the second and the third question are to be interpreted. In particular, it still remains unclear how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question.

BE ON THE KNOW

You liked this? And you would like to be notified of new posts? Here you go.

Supreme Court decision on Doctrine of Equivalents

Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”

For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here. The decision of the Supreme Court has been published today.

An important take-away message is: The third question (which has been applied by the FPC for the first time in S2013_001, somewhat similar to Schneidmesser in Germany and Improver in the UK) has now been approved by the Supreme Court. Welcome!

With due consideration of the claim wording in view of the description: Would the person skilled in the art have taken the replacing features into account as being an equivalent solution? (“Gleichwertigkeit”)

On the merits of the case, the Supreme Court overruled the FPC’s decision on equivalence. It will take me a few days to digest the decision and to put it into perspective. Asking three questions is a first step; the devil surely is in the detail of the answers. Stay tuned.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”

Daspaco AG ./. Von Allmen AG

Composition of the Board of the Supreme Court:

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Gilbert KOLLY
  • Dr. Fabienne HOHL
  • Dr. Martha NIQUILLE

Court Clerk:

  •  Dr. Christoph HURNI

Representative(s) of Appellant / Patentee:

Representative(s) of Defendant:

DECISION IN FULL

Download (PDF, 694KB)

BE ON THE KNOW

You liked this? And you would like to be notified of new posts? Here you go.

Some thoughts on the urinal question (O2014_002)

Case No. O2014_002 ¦ Decision of 25 January 2016 ¦ “Urinalventil: Teilweise Gutheissung Patentverletzung, Äquivalenz, Auskunft und Rechnungslegung, Verjährung”

HEADNOTE

Art. 109 PatA; Art. 69 EPC; Protocol on the Interpretation of Article 69 EPC of 05 October 1973 as revised by the Act revising the EPC of 29 November 2000; Art. 66 para. 1 lit. a PatA: imitation (equivalence), accessibility.

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)

The decision is a booklet of 82 pages and it will take me some more time to finish a post on all aspects of the decision. The main hearing took place on 14 September 2015; see this Blog here for some background information on the subject-matter at stake. But the highlight for sure is the headnote which is meant to clarify an important issue in the assessment of equivalence, i.e. the second question relating to accessibility (Auffindbarkeit). So I bring forward this part of the story.

The plain wording of the second question outlined in the hn of S2013_001 may well have caused some confusion. It reads as follows:

Werden die ersetzten Merkmale und deren objektiv gleiche Funktion dem Fachmann durch die Lehre des Patentes nahe gelegt?

Literally (and inofficially) translated:

Are the replaced features and their objectively same function rendered obvious by the teaching of the patent to the person of skill in the art?

Obviousness is a word that practitioners readily associate with assessment of inventive step. In any event, the FPC has now clarified that this must not be mixed up. According to the hn, the following is to be assessed instead (in the official English translation of the hn):

Starting from the teaching of the patent in suit, is it evident for the skilled person that the replaced feature has the same effect?

In the German language of the proceedings, the relevant section of the hn reads as follows:

Ist bei ausgetauschten Merkmalen die Gleichwirkung für den Fachmann bei objektiver Betrachtung ausgehend von der Lehre des Patents offensichtlich?

My first reaction was ‘Alright, got it, that’s the 2nd Schneidmesser question as applied in Germany, with mild Swiss tones.’ On a second thought, I do not think it is. It is a Urinal question. The reasons of the decision even make this clearer (r. 6.5.2.4, referred to in the hn; emphasis added):

Zu beurteilen ist, ob, wenn die Merkmale ausgetauscht sind, die Gleichwirkung für den Fachmann bei objektiver Betrachtung unter Berücksichtigung der Lehre des Patents offensichtlich ist.

Inofficially translated into English:

It is to be determined whether, once the features are replaced, the same effect is evident for the person of skill in the art when objectively assessed in consideration of the teaching of the patent.

While the hn requires “starting from the teaching of the patent” (“ausgehend von der Lehre des Patents”), the reasons only take the teaching of the patent into consideration (“unter Berücksichtigung der Lehre des Patents”). But when doing what? In light of the reasons, this test compares two already given situations (one with the replaced/claimed feature and another one with the replacing feature) and only then asks whether the same effect is evident. To the contrary, the wording of the concise, yet finely chiselled second question in Germany is (see Schneidmesser I, BGH X ZR 168/00, r. 3a, emphasis added):

Was the person skilled in the art enabled by his expertise to find the modified means as having the same effect?

Haben seine Fachkenntnisse den Fachmann befähigt, die abgewandelten Mittel als gleichwirkend aufzufinden?

This clearly asks for the capability of the person of skill in the art to actually find the replacing means (in their capacity to have the same effect). Schneidmesser does not make a comparison of two already given scenarios and – only based theron – an assessment of whether or not the same effect is evident. And Prof. Dr. Meier-Beck (a member of the panel of judges that has issued the Schneidmesser decision) emphasizes that this is intentional:

This question is all about excluding those cases in which an inventive step was necessary to find the modified means as having the same effect. If that is the case, i.e. if the means having the same effect were not obvious to the person skilled in the art, they are outside the scope of the patent (BGH Oct. 24, 1986, Case No. X ZR 45/85, (Befestigungsvorrichtung [Fixing Device])). Because what the person skilled in the art is not able to find and to do based on the patent and helped by his or her knowledge in the art, is not to be granted to the patentee (BGH May 15, 1975, Case No. X ZR 35/72, (Ski-Absatzbefestigung [Ski Heel Attachment])). Else, the fundamental bargain underlying most patent regimes is violated — i.e. that a patent is an exclusive right granted for a limited period in exchange for certain technical teaching made available by the patentee to the public, by publication of the patent.

(Meier-Beck in Pumfrey, Nicholas; Adelman, Martin J.; Basheer, Shamnad; Dave, Raj S.; Meier-Beck, Peter; Nagasawa, Yukio; Rospatt, Maximilian; and Sulsky, Martin (2009) “THE DOCTRINE OF EQUIVALENTS IN VARIOUS PATENT REGIMES — DOES ANYBODY HAVE IT RIGHT?”, Yale Journal of Law and Technology: Vol. 11: Iss. 1, Article 9. Available here.)

But let’s again have a look at the reasons of the decision S2013_001, r. 17.2: In light of various Supreme Court decisions (BGE 97 II 85, r. 1; BGE 125 III 29, r. 3b; BGE 115 II 490, r. 2a), it was held that it has to be asked whether the replacing means are rendered obvious by the teaching of the patent for the person of routine skill in art, “henceforth referred to as the second question” (“nachstehend als zweite Frage bezeichnet”). In the next paragraph, the second Schneidmesser question is recited and it was held, that this question equates with the aforementioned second question (“entspricht obiger zweiter Frage”). This is why I felt that the Swiss approach to the second question actually resembles Schneidmesser. With the reasons of the present decision at hand, I doubt that this is the case.

It may well be that the answers to the second Schneidmesser question and the Urinal question are the same in some situations. But in my perception this is not necessarily the case. Assume that the replacing feature is taken from a completely different field of technology. Once it is on the table, it may well be the case that the same effect is evident for the person of routine skill in the art, in consideration of the teaching of the patent. But would he ever have actually found it (not only as having the same effect, but maybe even at all)? I do not think that the Urinal question clearly addresses this. Instead, it seems to me that the Urinal question is more along the lines of the second Improver question in the U.K. ([1990] F.S.R. 181; Chancery Division (Patents Court), 16 May 1989), which reads as follows:

Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art?

I remain keen to learn how the Urinal question will henceforth be applied in practice.

Reported by Martin WILMING (to be cont’d)

— BIBLIOGRAPHY —

Case No. O2014_002 ¦ Decision of 25 January 2016 ¦ “Urinalventil: Teilweise Gutheissung Patentverletzung, Äquivalenz, Auskunft und Rechnungslegung, Verjährung”

Daspaco AG ./. Von Allmen AG

Board of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Dr. Ralph SCHLOSSER
  • Werner ROSHARDT

Court Clerk

  • Susanne ANDERHALDEN

Reporting Judge:

  • Dr. Tobias BREMI

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Matthias STÄDELI (Rentsch)
  • Dr. Demian STAUBER (Rentsch)
  • Dr. Jens OTTOW (Rentsch), assisting in patent matters
  • Dr. Alfred KÖPF (Rentsch), assisting in patent matters

— FULLTEXT —

Download (PDF, 802KB)

— BE ON THE KNOW —

You liked this? And you would like to be notified of new posts? Here you go.

Non-return valve for urinals: Does it stink up to the sky? Or is it gas-tight?

Case No. O2014_002 ¦ Main Hearing of 14 September 2015

The patent in suit is EP 1 579 133 B1; plaintiff and currently registered owner of the patent in Swissreg is Daspaco AG.

Independent claim 1 of EP’133 reads as follows:

A non-return valve (3), comprising an inlet section (5) in the form of a self-supporting trough-shaped section and an outlet section, the outlet section being made of a flexible resilient material connected to the inlet section (5), whereby the outlet section comprises a flat flexible resilient strip (6) with a high inherent degree of flexibility, the strip (6) being connected with the inlet section (5) at its upper edge; and further comprising a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal.

Defendant (1) is Enswico AG. More precisely, it was. Enswico AG has recently sold its operative business, according to information on their website (screenshot below taken today). Bankruptcy proceedings have been opened with decision of 31 August 2015; see Commercial Register. Thus, proceedings have been split and today’s hearing in the matter O2014_002 only concerned the second defendant, Van Allmen AG. Separate proceedings against Enswico AG (in liquidation) will be continued, too (O2015_013). The attacked product is Enswico’s valve used in waterless urinal systems:

This video (see https://youtu.be/-JzslgVMzvI) helps to understand how the valve works:

The second defendant, Von Allmen AG, apparently produced the valves for Enswico AG. Two embodiments of the valve are at stake: A first generation embodiment where the flaps were not connected at the lower end; and a second generation where the two flaps are interconnected by connectors. It has been argued that the second generation embodiment is subject of granted EP 2 553 299 B1 (see characterizing part of claim 1 and Fig. 8 ff).

From what has been argued I conclude that the preliminary assessment of the reporting judge must have been in favour of the plaintiff’s position, i.e. that the patent is infringed (by both embodiments) and valid. Accordingly, the plaintiff’s opening pleadings were succinct, fully supporting the assessment of the reporting judge. Not so the defendant’s reply. In brief, four major issues were adressed in subsequent pleadings of the parties:

i)    (Lack of) distinctiveness of the request

From what has been argued I tend to assume that the claim language “high inherent degree of flexibility” is literally recited in the plaintiff’s request for injunctive relief. Parties dissented on the question of whether or not this wording is specific enough in order to meet the legal requirements as definied e.g. in the decision BGE 131 III 70 E3.3 of the Supreme Court. Defendant insisted that the case should not be considered in view of the improper request.

ii)    Claim construction by the reporting judge

Fig. 3 of D1
Fig. 3 of D1

I understood from the plaintiff’s pleadings that the reporting judge had interpreted a non-return valve according to the patent as a valve which is gas-tight when it is slack, without special outer influences. It was disputed that a gas-tight closure is achieved in the dry state, at least for the second generation embodiment. In a nutshell, defendant argued that if the reporting judge’s assessment were correct, then at least the second generation embodiment cannot infringe since it is not gas-tight without special outer influences. Else, if the construction of this feature was not correct, at least the prior art document D1 (US 3 835 857) would be novelty-destroying for the patent in suit.

Next, the inlet section (5) in the form of a self-supporting trough-shaped section has been discussed. Defendant argued that if in D1 the inlet section was not self-supporting since it is made from the same material as the flaps, then both the first and second generation could not infringe — because the same material is used for both elements.

iii)    Undue extension of subject-matter

Defendant raised various objections in this respect. First, the documents as filed allegedly only disclosed a valve that “has a component (4) having a flat strip (6).” Defendant argued that this implies a one-piece construction, in light of the whole specification (e.g. manufactured in an injection moulding process). To the contrary, claim 1 as recited above requires a connection (of two parts?). Defendant argued that this constitutes an undue extension of subject-matter.

Second, defendant alleged a shift from a complementary component to (only) a complementary surface of such component in the granted claim.

iv)    Equivalency

From the discussion at the hearing, I conclude that two features of the claim were held to be not literally fulfilled by the attacked embodiments, but rather only under the doctrine of equivalents. Interestingly, the features at stake are marked-up as amendments in the DREX, i.e. were at least not irrelevant for the patent to proceed to grant: First, that the component is separate from the strip. Note that the second generation embodiment has connectors (which, in turn, is a patented embodiment; see above). And second, that it is (only?) the lower end of the flexible strip that seals.

Parties finally entered into non-public settlement negotiations.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. O2014_002 ¦ Main Hearing of 14 September 2015

Daspaco AG
./.
(1) Enswico AG
(2) Von Allmen AG

Board of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Dr. Ralph SCHLOSSER
  • Werner ROSHARDT

Court Clerk

  • Susanne ANDERHALDEN

Reporting Judge:

  • Dr. Tobias BREMI

Representative(s) of Plaintiff:

Representative(s) of Defendant (2):

  • Dr. Demian STAUBER (Rentsch)
  • Dr. Alfred KÖPF (Rentsch), assisting in patent matters
  • Dr. Andri HESS (Homburger), “supporting the team”

— PATENT IN SUIT —

Download (PDF, 303KB)

— BE ON THE KNOW —

You liked this? And you would like to be notified of new posts? Here you go.

Brief report on the main hearing in O2013_009 — “Drospirenone”

Case No. O2013_009 ¦ Main Hearing of 09 December 2014

ContraceptiveThe FPC has already issued a landmark decision Drospirenone in summary proceedings last year. Drospirenone is a compound used in contraceptives (birth control pills). This first decision S2013_001 mainly dealt with the doctrine of equivalents; please refer to the earlier post for all the technical matters that are at stake.

Later on, a procedural decision on the non-consideration of a late filed subsidiary request has been issued.

In a nutshell, infringement of EP 1 149 840 B2 is at stake. It is to be decided whether dehydration in the presence of pyridine/water as the replacing feature is an equivalent to p-toluenesulfonic acid (which is the claimed feature).

I have attended the main hearing yesterday. The parties had already been provided with the preliminary written assessment of a technically qualified judge. This assessment held that the use of pyridine/water infringes the claim under the doctrine of equivalents, in confirmation of the outcome of the summary proceeding S2013_001. The parties referred to sections of this written assessment at page numbers > 30; it is thus reasonable to assume that it already contains an exhaustive discussion of the technical matter at stake.

Thus, it was an uphill struggle for the defendant in the hearing, but it was fought well. The defendant pointed to alleged inconsistencies in the chain of arguments of the written assessment, and I have heard prima facie convincing arguments of both parties. I am keen to read the final decision, to cross-check whether and how yesterday’s hearing changes any of the conclusions of the preliminary assessment. But the parties finally entered into non-public settlement negotiations and it remains to be seen if a final decision will be issued.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2013_009 ¦ Main Hearing of 09 December 2014

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE (President; Judge)
  • Dr. Tobias BREMI (Reporting Judge)
  • Dr. Erich WÄCKERLIN (Judge)
  • Dr. Roland DUX (Judge)
  • Dr. Thomas LEGLER (Judge)

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Gregor S. KÖNIG (KSVR), assisting in patent matters

Representative(s) of Defendant:

  • Dr. Christoph WILLI (Streichenberg)
  • Dr. Rainer FRIEDRICH (df-mp), assisting in patent matters

Drospirenone: A masterclass in equivalents

Case No. S2013_001 ¦ Decision of 21 March 2013 (excerpt) ¦ “Auszug aus dem Urteil Nachahmung (Äquivalenz)”

This post has been updated on 02/15/2016 with a more literal translation of the second question, in light of O2014_002.

HEADNOTE

Art. 109 PatA; Art. 69 EPC, Protocol on the Interpretation of Article 69 EPC; Art. 66(1) lit. a PatA:

When an allegedly infringing method or device does not literally fulfil one or more features of the claim but comprises replacing features instead, the following three questions need to be answered in the affirmative in order to conclude that the allegedly infringing method or device is within the scope of the claim:

(1.) Does the replacing feature objectively fulfil the same function? (“Gleichwirkung”)

(2.) Was the person skilled in the art enabled to find the replacing feature as having the same effect? Are the replaced features and their objectively same function rendered obvious by the teaching of the patent to the person of skill in the art? (“Auffindbarkeit”)

(3.) With due consideration of the claim wording in view of the description: Would the person skilled in the art have taken the replacing features into account as being an equivalent solution? (“Gleichwertigkeit”) (r. 17.2)

(Non-official translation from German into English language)

We already catched a glimpse of what was going on earlier this year; see the post on ex-parte injunctions of 26 May 2013. Now, we get some deeper insight into the subject-matter at stake. At first, I felt the take-away message is clear-cut: The FPC assess infringement under the doctrine of equivalents using essentially the Schneidmesser questionnaire established in Germany. That’s it. But this would have been too narrowly considered. On closer scrutiny, things are (much) more difficult. In fact, this case might turn out to be a masterclass in assessment of equivalents in various countries.

1.  Background of the case

Drospirenone
Drospirenone (DRSP; click to enlarge)

The plaintiff sought for preliminary injunctive relief and invoked two European patents: EP 0 918 791 B3 (hereinafter the ‘791 patent; see the European patent register for further details) and EP 1 149 840 B2 (which is a divisional of the ‘791 patent; hereinafter the ‘840 patent); see the European patent register for further details. Both patents relate to methods for the production of drospirenone (DRSP), a compound used in contraceptives (birth control pills).

Drospirenone closely resembles natural progesterone. Drospirenone-containing pills are presumably the most widely prescribed hormonal contraceptives in the world today. Proprietor of both European patents is Bayer Pharma AG, according to Swissreg (cf. here and here). Drospirenone-containing pills are one of the – if not the – best selling product of Bayer Pharma AG; see some further information directly on the website of Bayer Pharma AG. Thus, it’s reasonable to assume that Bayer Pharma AG or a connected undertaking is the plaintiff. The situation is not that clear to me with respect to the defendant(s), and I am not going to speculate.

2. The decision of the FPC

i)  Ex-parte interim measures

As already outlined in an earlier post, the ex-parte injunction in this case was not granted without any prior hearing of the defendant. In fact, the parties had already presented their case in writing, and a hearing with oral reply and rejoinder had already taken place on 31 January 2013. Moreover, the reporting judge had already presented his preliminary opinion on the merits of the case — presumably essentially in the sense of the present decision. Only shortly thereafter, on 7 February 2013, the plaintiff noticed that not all allegedly infringing products were withheld at the customs but that some appeared on the market in Switzerland. Under these circumstances, the FPC granted an ex-parte injunction.

ii)  Rectification of the record

The record of the hearing is quite lengthy (49 p.), and both parties requested rectifications of the record. The plaintiff did so within three days, pointed to five specific issues and indicated precisely what the correction should be. All these rectifications were accordingly made by the FPC.

The defendant filed his request for rectification only after seventeen days. The FPC held that this request was filed too late and thus already failed for this reason. Moreover, the defendant did not indicate what the correction should be, but rather requested the correction to be made on the basis of the tape. The FPC reminded the parties that the record is to contain the overall content of the submissions, but needs not to be a literal transcript (Art. 235(2) CPC; note that the non-official English translation of the CPC fails to properly recite the German wording “dem wesentlichen Inhalt nach“).

iii)  Value in dispute

The plaintiff had estimated the value in dispute to about CHF 500’000,– and indicated that this is a common value in summary proceedings pertaining to patents in the pharaceutical field. On the other hand, the defendant provided a reasoned estimation of the value in dispute to exceed CHF 1’000’000,– . The FPC agreed with the defendant. “Common values” are irrelevant. What counts is the individual assessment of each case.

iv)  Assessment of equivalents

Here we are at the very core of the dispute. A little bit of chemistry is no longer avoidable. Let’s have a look at the final steps in synthesis of drospirenone (DRSP; click to enlarge):

Final steps in synthesis of drospirenone (DRSP)

The starting molecule is the alkine ZK 34506 which is hydrated to form the compound ZK 92836 (step A). Next, ZK 92836 is oxidised to form the cyclic lactone ZK 90965 (step B). Finally, water is eliminated from ZK 90965 to form the enone DRSP (step C).

In simple terms, claim 1 of EP’791 protects the reaction scheme as outlined above, wherein step B is carried out in the presence of a ruthenium salt as a catalyst. Step C is not specified any further.

On the other hand, the only claim 1 of EP’840 specifically pertains to step C only and requires that dehydration is carried out through addition of p-toluenesulfonic acid.

Apparently, the plaintiff sought for injunctive relief with respect to two different methods. With respect to a “first method”, the FPC held that the plaintiff had not credibly shown that this method is effectively used by the (supplier of the) defendant, in particular in view of the injunction issued with decision 4a O 49/12 – Drospirenon of the Dusseldorf regional court; cf. r. 16. This Dusseldorf decision specifically pertains to the dehydration through addition of p-toluenesulfonic acid and refers to WO 2006/061309 A1 in this respect (more specifically to example 7, relating to a method of manufacturing DRSP that does not rely on a ruthenium salt as catalyst in step B, but still uses p-toluenesulfonic acid in step C). Even the plaintiff seemingly suspected that p-toluenesulfonic acid is not used by the defendant (anymore).

The “second method” is the more interesting one. The defendant did not dispute that the “second method” is used. Apparently, the following features were not literally fulfilled:

  • With respect to EP’791, step B is not carried out in the presence of a ruthenium salt as a catalyst, but rather in the presence of TEMPO in combination with Ca(OCl)2.
  • With respect to EP’840, dehydration is not carried out through addition of p-toluenesulfonic acid, but rather in the presence of pyridine/water.

Assessment of infringement of EP’791

The FPC concluded that both the ruthenium salt on the one hand and TEMPO in combination with Ca(OCl)2 on the other hand objectively fulfil the same function (catalysis), in the absence of any further limitation with respect to the specific mechanism of catalysis in the patent in suit (“Gleichwirkung”). The FPC then briefly discussed whether the person skilled in the art was enabled to find TEMPO in combination with Ca(OCl)2 as having the same effect, but finally left this undecided (“Auffindbarkeit”). Rather, the FPC held that the person skilled in the art would not have taken TEMPO in combination with Ca(OCl)2 into account as being an equivalent solution, with due consideration of the claim wording in view of the description (“Gleichwertigkeit”), for the following reasons: First, EP’791 explicitly aims to replace toxic chromium compounds with catalytic amounts of a metal compound. The ruthenium salt catalyis is said to be the key reaction in EP’791 (cf. para.  [0012]). The FPC thus held that this does not suggest the applicability of an organic radical like TEMPO, and EP’791 is not infringed (r. 17.4-17.8).

Apparently, courts in the Netherlands (Rechtsbank Den Haag, C/09/432919 / KG ZA 12-1391), Germany (Dusseldorf regional court, 4a O 190/12 and 4a O 192/12; both confirmed by the higher regional court with decisions 2 U 26/13 and 2 U 25/13, respectively) and Italy (Corto di Appello di Torino) have also issued decisions on this topic. Of course, the final outcome in main proceedings is to be awaited, but this is where we stand today, to the best of my knowledge:

TEMPO / Ca(OCl)2 replacing a ruthenium salt (EP’791) is held to be …
an infringement in … no infringement in …
IT* x
NL x
CH x
DE x

* From what is discussed in the Dusseldorf decisions, I conclude that the Italian decision relies on an opinion of a court-appointed expert. Unfortunately, I could not yet retrieve a copy of this decision.

Assessment of infringement of EP’840

With p-toluenesulfonic acid, step C of the above reaction scheme is an acid-catalysed elimination of water. On the other hand, pyridine/water is a weakly basic system, relying on a different reaction mechanism. Nevertheless, the result (elimination of water) is the same. The FPC thus held that both reagents fulfill the same function (“Gleichwirkung”). Since both acid- and base-catalysed  elimination reactions are very basic reactions in organic chemistry, the FPC held that the person of skill in the art was enabled to find an appropriate base in general. Moreover, she/he would have also considered pyridine/water in particular since there is a pointer in the introductory part of the patent in suit, i.e. the discussion of the prior art. Therefore, the FPC held that the person of skill in the art was enabled to find pyridine/water as having the same effect (“Auffindbarkeit”). Finally, the FPC held that the person of skill in the art would also have taken pyridine/water into account as an equivalent means, since this reagent is known to her/him (as is evident from the discussion of the prior art in the patent in suit).

Concluding, the FPC held that EP’840 is infringed under the doctrine of equivalents and granted a preliminary injunction.

Again, what’s going on elsewhere? Note that the FPC was aware of the fact that the Rechtsbank Den Haag (C/09/432919 / KG ZA 12-1391) had decided the same question differently (r. 18.3, last para.). Later, the Dusseldorf court in the decisions 4a O 193/12 – Drospirenon II and 4a O 191/12 explicitly took the decision of the FPC into account — and decided for non-infringement. This was confirmed by the Dusseldorf higher regional court in decisions 2 U 23/13 and 2 U 24/13, respectively. To the contrary, the appelate court of Brussels (Belgium) decided for infringement (decision of March 25, 2013 — 2012/KR/127; unfortunately, I could not yet retrieve a copy of this decision). Of course, the final outcome in main proceedings is to be awaited, but this is where we stand today, to the best of my knowledge:

Pyridine/water replacing p-toluenesulfonic acid (EP’840) is held to be …
an infringement in … no infringement in …
NL x
BE x
CH x
DE x

3.  The decision of the Supreme Court

In summary proceedings, the Supreme Court does not examine the case on the merits again. Generally speaking, only violations of the law are reviewed, but not the discretionary adjudication of the first instance. The defendant referred to the decisions of the Dusseldorf regional court; see above. However, this was not considered by the Supreme Court for that it was only lately filed. It would have been interesting to learn more about the Supreme Court’s view on the merits of the case already now, but it’s not much of a surprise that the Supreme Court dismissed the appeal (4A_160/2013).

4.  Remarks

i)  What is not claimed, is disclaimed(?)

Perhaps the best-known statement of the status of the claims in UK law is by Lord Russell of Killowen in Electric and Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23, 39 (emphasis added):

The function of the claims is to define clearly and with precision the monopoly claimed, so that others may know the exact boundary of the area within which they will be trespassers. Their primary object is to limit and not to extend the monopoly. What is not claimed is disclaimed. The claims must undoubtedly be read as part of the entire document and not as a separate document; but the forbidden field must be found in the language of the claims and not elsewhere.

So, how to deal with the following situation:
The claim requires a feature (A). A variant (B) is outlined in the description of the patent, but not in the claims. Is there any room for equivalency, i.e. to cover embodiments with variant (B) under the doctrine of equivalents?

After the decision Okklusionsvorrichtung of the Federal Supreme Court in Germany, some practitioners feared (and some hoped) that the answer might be a clear “No”. In the meantime, the decision Diglycidylverbindung of the Federal Supreme Court provided some further guidance on the assessment in such cases. In a first step, the specific technical effect of the claimed feature (A) has to be determined in order to differentiate it from the alternative feature (B) mentioned in the description but not included in the claim. Second, it has to be established whether the allegedly infringing means provides for the specific technical effect of the claimed feature (A) and thus differs from the alternative feature (B) mentioned only in the description in the same way as the claimed feature (A).

It will be interesting to read a decision of the FPC in such a situation (in the present matter, the pointer to pyridine/water in the introductory part of EP’840 was apparently not held to preclude equivalency). In an obiter dictum, the FPC seemingly tends to assess such situations in line with the Federal Supreme Court in Germany: It is likely that variants explicitly outlined in the description but not in the claims cannot be considered to be covered under the doctrine of equivalents but rather are waived (r. 17.1, last para.).

Wäre das Mittel nämlich in der Beschreibung aufgeführt, aber nicht im Anspruch, müsste daraus voraussichtlich geschlossen werden, dass der Anmelder auf dessen Beanspruchung verzichtet hat und die betreffende Ausführungsart nicht unter Schutz stellen wollte.

ii)  Questionaires for assessement of equivalents – a broader European picture

In order to assess equivalency, the landmark decision in UK is Improver Corporation v Remington Consumer Products Limited (1990) FSR 181, 189. Questions to be answered in the assessement of equivalency are frequently referred to as Improver questions:

(1) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no-

(2) Would this (i.e. that the variant had no material effect) have been obvious at the date of the publication of the patent to a reader skilled in the art. If no, the variant is outside the claim. If yes –

(3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention. If yes, the variant is outside the claim. On the other hand, a negative answer to the last question would lead to the conclusion that the patentee was intending the word or phrase to have not a literal but a figurative meaning (the figure being a form of synecdoche or metonymy) denoting a class of things which included the variant and the literal meaning, the latter meaning, the latter being perhaps the most perfect, best-known or striking example of the class.

In Germany, the Federal Supreme Court (BGH) took over a similar schedule of assessment in the decisions Schneidmesser I and Schneidmesser II:

(1) Does the modified embodiment solve the problem underlying the invention by means which have objectively the same technical effect?

(2) Was the person skilled in the art enabled by his expertise on the priority date to find the modified means as having the same effect?

(3) While answering question two, are the considerations that the person skilled in the art applies drawn from the technical teaching of the patent claim (so that the person skilled in the art took the modified embodiment into account as being an equivalent solution)?

And, finally, the test known from the Formstein decision (X ZR 28/85) of the German Federal Supreme Court (a kind of litmus test to preclude that a claim is construed overly broad, i.e. covering prior art):

(4) Is the modified embodiment anticipated or made obvious by the state of the art?

(A more detailed analysis of the doctrine of equivalents in various jurisdictions can be found in Yale Journal of Law and Technology.)

How was this dealt with in Switzerland by now? Well, questions (1) and (2) were already in use (BGE 97 II 85, r. 2; BGE 97 II 85, r. 1; BGE 125 III 29, r. 3b; BGE 115 II 490, r. 2a.), but a third question was missing — until now. However, the present case strikingly shows that similar questionnaires do not necessarily result in similar decisions. Hopefully, there is no revival of Epilady® or Spannschraube on the rise.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2013_001 ¦ Decision of 21 March 2013 (excerpt) ¦ “Auszug aus dem Urteil Nachahmung (Äquivalenz)”

(not identified) ./. (not identified)

Subject(s):

  • Infringement

Composition of the Board of the FPC:

  • (not identified)

Representative(s) of Plaintiff:

Representative(s) of Defendant:

Full text of the decision right here:

Download (PDF, 128KB)