Please welcome with me: The mind willing to understand, not desirous of misunderstanding

Reading time: 7 minutes

Case No. O2020_001 | Decision of 9 June 2021

BD logo

As mentioned earlier on this Blog here and here, Becton, Dickinson and Company had sued Ypsomed AG for infringement of EP 2 825 227 B1; see EPO Register and Swissreg for further bibliographic information.

The attacked embodiment is Ypsomed’s UnoPen™:

Ypsomed logo

The FPC’s judgment has meanwhile been published. Cutting a long story short: The FPC had to take a decision only on the unallowability of various amendments of EP 227, and dismissed BD’s complaint on this basis alone.

However, the most interesting aspect of the decision is claim construction. Accordingly, this is also mentioned in the FPC’s tweet:

Claim construction in good faith

With reference to an old Supreme Court decision, 107 II 366 (¶ 2), the jugdment holds that claims are to be construed in good faith; ¶ 24. This is what had been held in 107 II 366:

More recent judgments of the Supreme Court (in German language) did not explicitly refer to the good faith approch anymore, but rather only recited the sentence pertaining to the consequences of wrong, incomplete or contradictory definitions — which are to be borne by the patentee. However, this is apparently merely a shortened citation rather than a change of practice of the Supreme Court; a recent judgment in French language still refers to the good faith approach:

Now, what does ‘good faith’ mean when it comes to claim construction?

[drum roll]

You guessed it, didn’t you? Indeed, it’s the ‘mind willing to understand, not desirous of misunderstanding’ approach of T 190/99 to which the FPC now explicitly refers in ¶ 24 (fn 9):

T 190/99 is one of the most cited EPO decisions of all times. Sooner or later in any complex case at the EPO, the catchy headnote is cited by at least one party. Mostly, by the more desparate one.

The most interesting feature in terms of claim construction is feature 1.4.2:

According to the wording of the claim (emphasis added), the pen is configured such as

[…] to substantially prevent said driver (21) from rotating with respect to said dose set knob (2), […]

The parties fundamentally disagreed how this is to be understood. The defendant held that the claim wording is clear by and in itself; no claim construction even needed. On the other hand, the plaintiff argued that this should be understood as

[…] to substantially prevent said driver (21) from rotating with respect to said dose set knob (2), […]

in light of the specification — which is pretty much the opposite of the wording.

First, the judgment holds that feature 1.4.2 in isolation is indeed perfectly clear. However, the claim as a whole throws doubt on the linguistic interpretation of feature 1.4.2. In light of feature 1.4.3, this would mean that not only during an injection position, but also already during dose setting and dose correction a medicament would be ejected. This can’t be it; the claim as a whole would not amount to a credible technical teaching in such a reading.

Accordingly, in light of the specification, the skilled person would indeed understand feature 1.4.2 according to plaintiff’s interpretation, i.e. contrary to the mere linguistic interpretation.

Defendant further argued that one might well assume how a device with a literally interpreted feature 1.4.2 might work, e.g. with an additional (de)coupling arrangement. The FPC did not buy into that. In essence, this would mean to assume an additional feature to compensate for exactly the effect which is literally recited in the claim — which is counter-intuitive.

Finally, the judgment clarifies that this claim construction does not amount to a reduction of the scope of a claim to the disclosed embodiment(s). Rather, the claim as a whole does not provide a credible technical teaching (‘glaubhafte technische Lehre’) at all, and thus calls for proper construction in light of the specification. The proper construction of feature 1.4.2 is not narrower or broader than the literal interpretation; it is simply different.

Unallowable amendments

Allowability of amendments is always very case-specific and rarely of broader interest. This case is not an exception to the rule. However, I stumbled upon one of the various amendments that were held unallowable, i.e. the following feature (emphasis added; ¶ 49 et seq.):

[D]uring dose setting and dose correcting, stopping surfaces of said external teeth of said driver engage stopping surfaces of teeth of ratchet member to substantially prevent said driver from rotating with respect to said dose set knob.

The issue was whether there was disclosure in the application as filed for said engagement not only during dose setting, but also during dose correcting. Plaintiff argued that the feature would only mean, when properly construed in light of the specification, that during both dose setting and dose correcting the relative positions of the teeth of the driver and the teeth of the ratchet member are maintained.

The judgment holds that this is not the right approach: Allowability of amendments is all about clear and unambiguous disclosure in the application as filed, not about whether the skilled person could correctly construe or understand the feature.

On a quick read, this might be confusing. Claim construction surely matters; it has to go hand in hand with the check for proper disclosure in the application as filed; cf. e.g. Case Law of the Boards of Appeal, II.E.1.3.9. Else, the test for allowability of amendments would effectively only amount to a check for verbatim disclosure in the application as filed.

With respect to the specific feature recited above, the judgment holds that engagement of the stopping surfaces (if that may occur at all) in the correcting direction just cannot be such ‘as to substantially prevent said driver from rotating with respect to said dose set knob’:

Dies können die Stoppflächen bei einer Drehung in der entgegengesetzten Richtung als der bei der Dosiseinstellung auf keinen Fall; […]

The issue here was actually a classic non-disclosed feature: the engagement of the stopping surfaces as disclosed could not have the claimed effect; other configurations (which were not disclosed) could well have that effect, e.g. with rectangular teeth. Unlike the claim construction issue above where the claim as a whole did not make technically sense when taken literally. Accordingly, the amendment was unallowable. And, with a mind willing to understand, the judgment does not deny that claim construction matters when checking for allowability of amendments.

Expenses

The judgment is a good reminder that expenses for assisting patent attorneys have to be substantiated. Expenses of more than kEUR 30 for involvement of a patent attorney on two days is not credible from the outset.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2020_001 | Decision of 9 June 2021

Becton, Dickinson and Company
./.
Ypsomed AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Christoph MÜLLER
    • Dr. Lorenzo PARRINI

Judge-rapporteur:

    • Christoph MÜLLER

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Simon HOLZER (MLL)
    • Louisa GALBRAITH (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant:

    • Dr. Christian HILTI (Rentsch)
    • Dr. Demian STAUBER (Rentsch)
    • Dr. Alfred KÖPF (Rentsch), assisting in patent matters
    • Dr. Axel REMDE (Rentsch), assisting in patent matters
    • Markus FRANTZ (SSM), assisting in patent matters

FPC DECISION

PATENT IN SUIT

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Deriving meaning from a claim: Narrower, broader … or contrary to the wording?

Reading time: 6 minutes

Case No. O2020_001 | Hearing of 4 June 2021

BD logo

As mentioned earlier on this Blog here, Becton, Dickinson and Company has sued Ypsomed AG for infringement of EP 2 825 227 B1; see EPO Register and Swissreg for further bibliographic information.

The attacked embodiment is Ypsomed’s UnoPen™:

Ypsomed logo

It appears that BD is envoking EP 227 not as granted, but only to limited extent inter partes — presumably in accordance with the main request currently on file at the EPO in opposition proceedings. The parties used a feature analysis in accordance with the numbering in the first column of the following table (taken from the preliminary opinion of the OD):

I understand that the patentee’s amendments are addressing allegedly unallowable amendements / generalisations during prosecution. In my understanding of what has been pleaded, the juge-rapporteur had spotted multiple unallowable amendments; see also the preliminary opinion (p. 4-9) of the OD in EPO opposition proceedings in this respect.

Metes and bounds of claim construction

This is where it gets really interesting. According to the wording of the claim (emphasis added), the pen is configured such as

[…] to substantially prevent said driver (21) from rotating with respect to said dose set knob (2), […]

The parties fundamentally disagree how this is to be understood. The defendant holds that the claim wording is clear by and in itself; no claim construction even needed. On the other hand, the plaintiff argues that this should be understood as

[…] to substantially prevent said driver (21) from rotating with respect to said dose set knob (2), […]

Plaintiff submitted that in light of the claim as a whole and the embodiments outlined in detail in the specification, the skilled person would readily understand that nothing else could be meant. But isn’t that quite the contrary of what the mere wording of the feature might suggest, at least at the face of it?

There are pros and cons for both positions. The preliminary opinion (p. 10/11) of the OD in EPO opposition proceedings is in line with plaintiff’s position:

Anything else would not make sense for the man skilled in the art and would be therefore disregarded.

On the other hand, the most recent decisions of the Swiss Federal Supreme Court, i.e. 4A_581/2020 and 4A_317/2020, might arguably be more in line with defendant’s position:

convince me!

It will be interesting to see how the FPC finally decides on this issue. The judge-rapporteur apparently followed defendant’s position in his expert opinion. But the President made very clear in his opening remarks that the judges have no uniform opinion on the issue yet, and mentioned to the attorneys before the pleadings:

Bitte fühlen Sie sich dadurch nicht unter Druck gesetzt.

Even at the end of the hearing, the President said that he changed his mind at least twice during the day. This highly interesting aspect of claim construction really appears to be a close call.

Patentability

Novelty has apparently been acknowledged in the judge-rapporteur’s expert-opinion. The discussion at the hearing focused only on three documents, i.e. WO 2006/084876 A1, WO 2010/072427 A1 and WO 2021/125876 A1.

However, I understood from the pleadings that the expert-opinion had held that the claimed subject-matter was obvious in view of the prior art.

Livestream
live stream

On request of the plaintiff, a live stream of the hearing had been made available to allow foreign counsel to attend the hearing, i.e. Freshfields attorneys who are handling corresponding litigation in Munich / Germany for the plaintiff, as well as some BD personnel.

It was the very first time that the FPC provided this service; much appreciated! Even though it did not work out without hiccup (room change on the spot; no video signal anyway; sensitivity of microphones; …). Still, I hope this service is here to stay. Maybe, even for the public to attend remotely … ?

(No) Stay of proceedings / TIMING

Plaintiff had apparently requested that proceedings be stayed pending the decision in opposition proceedings at the EPO. In view of the time constraints at the hearing, defendant’s counsel enquired whether pleadings on this issue were necessary (which would have taken him about 30 min more), or whether the court was inclined to deny the request anyway. The President informed the parties after a break that the request will be denied, and defendant’s counsel omitted that part of his pleadings accordingly.

The President signaled that one might reasonably expect a decision only after judicial vacation, i.e. after 15 August 2021.

Finally, defendant’s counsel encouraged the court to consider issuing the operative part of the judgment as soon as it is available, to remove the legal uncertainty as soon as possible. The President explained that this is not possible (likely in view of the reference in Art.  239(3) CPC to the Supreme Court Act; Art. 112(1) SCC appears to rule this out).

Reported by Martin WILMING

Oh, on the funny side: When the end of the hearing was approaching and someone formally requested a restroom break, laughter broke out at the other end of the court room after a short delay. Perhaps someone imagined what would happen if this request was not granted(?).

BIBLIOGRAPHY

Case No. O2020_001 | Hearing of 4 June 2021

Becton, Dickinson and Company
./.
Ypsomed AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Christoph MÜLLER
    • Dr. Lorenzo PARRINI

Judge-rapporteur:

    • Christoph MÜLLER

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Simon HOLZER (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant:

    • Dr. Christian HILTI (Rentsch)
    • Dr. Alfred KÖPF (Rentsch), assisting in patent matters
    • Markus FRANTZ (SSM), assisting in patent matters

ANNOUNCEMENT

PATENT IN SUIT

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Ypsomed sued twice(!) for patent infringement by its UnoPen™

Reading time: 4 minutes

As noted earlier on this Blog here, we knew that a medical device company has been sued by two competitors for infringement of their respective patent(s) by one and the same injector pen.

Now we know that it’s Ypsomed’s UnoPen™ that is being haunted after:

With some further digging in the EPO dockets, I have now all the pieces together to summarize the essentials of the two cases that are pending at the FPC, as follows:

O2020_001

Becton, Dickinson and Company
./.
Ypsomed AG

Patent in suit: EP 2 825 227 B1 (limited, inter partes);
see EPO Register and Swissreg for further bibliographic information.
Main hearing: 4 June 2021, 10:00 hrs
BD logo

From Ypsomed’s acceleration request in EPO opposition proceedings, it is evident that corresponding infringement proceedings are pending before the Landgericht München I, case no. 21 O 367/20.

Oral proceedings in opposition at the EPO are scheduled for 18 October 2021. The summons came along with a preliminary opinion of the OD (cf. p. 2 et seqq.). By way of its main request, BD currently defends the patent in limited form only. However, it is currently unclear whether this wording corresponds to the limitation that has been made inter partes in the Swiss proceedings. The OD’s preliminary opinion holds that the main request is unclear and comprises unallowable amendments. Novelty / obviousness is not dealt with in-depth, for the time being.

In view of the branding on this exhibit, I feel confident enough to say that BD is represented by MLL in the Swiss proceedings.

O2017_022

Sanofi Aventis Deutschland GmbH
./.
Ypsomed AG

Patent in suit: EP 2 437 830 B2;
see EPO Register and Swissreg for further bibliographic information.
Sanofi logo

While opposition / appeal proceedings were pending at the EPO, Ypsomed interevened as an assumed infringer. From the redacted complaint it is clear that Sanofi has invoked yet two further European patents; see N 5.

Sanofi is represented by Homburger‘s Andri HESS and Roman BÄCHLER.

These proceedings have been derailed well after the expert opinion of judge-rapporteur Bremi had been established and most likely only shortly before the main hearing; see this Blog here. From the Supreme Court judgment 4A_243/2020, it is evident that Ypsomed is represented by Rentsch Partner.

A little bit of background

Ypsomed logo

It is not the first time that Ypsomed and Sanofi have locked jaws in patent infringement proceedings. They settled «all currently pending patent disputes and other litigations» in April 2008. At that time, Ypsomed had attacked Sanofi’s SoloStar®. The tables have turned now when Sanofi is seeking injunctive relief.

Noteworthy, Ypsomed’s growth in the pen business is, to large extent, attributable to the UnoPen™:

What is more, Ypsomed is being sued by a (very) good customer:

It will be interesting to see how all this finally unfolds. Stay tuned.

Reported by Martin WILMING

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