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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Infringement proceedings re injector pens derailed, Supreme Court holds that appearence of bias has to be re-assessed

Reading time: 18 minutes

Case No. 4A_243/2020 (Supreme Court) | Decision of 5 November 2020 on appeal against O2017_022 | Order of 8 April 2020 (unpublished)

The defendant / respondent in this matter had been sued for infringement of three patents by certain injector pens back in November 2017 at the FPC. The case number is O2017_022; nothing has surfaced about this case by now. The panel of judges is Dr. Christoph Gasser (presiding judge), Dr. Tobias Bremi (judge-rapporteur) and Dr. Kurt Sutter. Judge Bremi’s expert opinion was sent to the parties for comment on 7 January 2020. In the expert opinion, judge Bremi inter alia held that one of the three patents was valid and infringed. 

Less than a week later, on 13 January 2020, yet another party sued the very same defendant for infringement of its patent by the very same injector pens which are at stake in O2017_022. This second case is referred to as O2020_001. From the details reveiled in the Supreme Court decision, it is clear that the plaintiff in the second proceedings is represented by MLL.

Nothing out of the ordinary this far. But the defendant then requested that judge-rapporteur Bremi recuse himself from the first proceedings O2017_022. The defendant argued that judge Bremi’s employer, the patent attorney firm I&P of which he is a partner, was registered as the representative of patents of the plaintiff in the second proceedings O2020_001 before the Swiss IPI, including the patent-in-suit in that case. The second action O2020_001 was directed against the same injector pens of the defendant as in O2017_022, which was why the outcome in O2017_022 had considerable prejudicial significance for O2020_001.

You cannot make this up. Here is the factual setup again, in short:

Factual setup

With decision of 8 April 2020, the Administrative Commission (AC) of the FPC dismissed the request for recusal. In sum, the AC held that a part-time judge who is an employee of a firm that only performs administrative support tasks for a third party who brings an action on a different legal basis against the defendant cannot objectively give rise to any mistrust in the impartiality of the part-time judge in proceedings in which the employee is acting as a part-time judge.

The Supreme Court did not agree. At least not for now, and not so easy. Rather, it depends. But the facts have not (yet) been sufficiently established by the FPC’s AC for the Supreme Court to decide.

But first things first. Let’s have a closer look at some of the extensive case law that is referred to by the Supreme Court about cases in which a part-time judge (or arbitrator) was particularly connected to a litigant because of his activity in a law firm. If you are only interested in the case-specific issues, feel free to jump here.

Case law review

In general terms, the Supreme Court held that the guarantee of a constitutional judge applies equally to full-time and part-time judges. The fact that the use of part-time judges increases the likelihood of professional relations with one of the parties to the proceedings compared to full-time judges who do not pursue any other gainful activity does not justify a less stringent application of the constitutional requirements (139 III 433, ¶ 2.1.3).

In the interest of the credibility of the FPC with only two full-time judges and a vast majority of part-time judges particular attention must be paid to judicial independence. Still, the legislator deliberately set up a specialised court for patent law and staffed it with specialised judges whose main profession is also related to patent law. The Supreme Court held that this must also be taken into account.

According to settled case law of the Supreme Court, a lawyer acting as a judge appears to be biased if there is an outstanding mandate with a party or if he has acted as a lawyer for a party several times in the sense that there is a kind of permanent relationship between them. This applies irrespective of whether the mandate has a factual connection with the subject matter of the dispute or not (140 III 221, ¶ 4.3.1; 139 III 433, ¶ 2.1.4; 138 I 406, ¶ 5.3; 135 I 14, ¶ 4.1). In such a situation, the lawyer acting as judge may be tempted, even if unconsciously, not to want to alienate his client by making a decision that is unfavourable to him (135 I 14, ¶ 4.3).

Furthermore, the Supreme Court repeatedly held that a lawyer acting as judge or arbitrator does not only appear to be biased if he represents or has represented one of the litigants in another proceeding shortly before, but also if such a representation relationship exists or has existed with the opposing party of one of the litigants in the other proceeding (139 III 433 , ¶ 2.1.4;  138 I 406, ¶ 5.3; 135 I 14, ¶4.1-4.3; 139 I 121, ¶ 5.1; 139 III 120, ¶ 3.2.1). There is an appearance of bias insofar as the litigant could objectively fear that the judge might not want to rule in his favour because he was acting for the opposing party of his client in the other proceedings. A litigant often transfers his or her negative feelings towards the opposing party to the latter’s legal representative, as the latter supports the opposing party in the dispute. For many parties, the lawyer of the opposing party is considered as much an adversary as the opposing party itself, all the more so as he is perceived as the actual strategist. It is therefore understandable that a party does not expect a judge who is fighting against it in other proceedings as a representative of the opposing party and who — from its point of view — will possibly deprive it of its rights or has deprived it of its rights, to suddenly face it with complete impartiality (138 I 406, ¶ 5.3; 135 I 14, ¶ 4.3). This applied irrespective of whether or not the lawyer’s mandate had a factual connection with the subject matter of the dispute (138 I 406, ¶ 5.4.1). In such cases, the Supreme Court regularly assumes a prima facie case of bias irrespective of the further concrete circumstances (139 III 433, ¶ 2.1.4; 138 I 406, ¶ 5.4.1). In particular, in the case of an ongoing relationship with a party to the proceedings, it cannot matter whether the mandate exercised is considered important or less important by the party or the lawyer (139 III 433, ¶ 2.1.4).

Further, the Supreme Court had held that an appearance of bias also arises from the fact that it is not the part-time judge himself, but another lawyer in his firm who has a mandate with a litigant or who has had such a mandate several times before or in the sense of a permanent relationship. The client expects loyalty not only from his contact person within the law firm, but from the entire firm. The uniform approach is also in line with the law governing the legal profession, which treats all lawyers in a law firm as one lawyer with regard to a conflict of interest (140 III 221, ¶ 4.3.2; 139 III 433, ¶ 2.1.5).

The Supreme Court has also held that it is inadmissible for a lawyer to participate as a judge in a case that may have significant prejudicial significance for a similar proceeding in which he is representing a third party as a lawyer (139 III 433, ¶ 2.1.6). Thus, there would be a prima facie case of bias if a part-time judge was appointed to rule in a case in which the same legal questions arose as in another pending case in which he or she was acting as counsel (128 V 82, ¶¶ 2a and 3d; 124 I 121, ¶ 3). With reference to these two decisions, the Federal Supreme Court later considered that the question of recusal could arise if a judge represented a third party in parallel proceedings who pursued the same interests as one of the parties to the proceedings. This was to avoid the judge deciding on a dispute in a way that could improve his or her position as a lawyer in the parallel proceedings (133 I 1, ¶ 6.4.3).

Even purely administrative activities of a lawyer acting as a part-time judge or of his law firm are not per se unobjectionable. But not every relationship of any kind of an economic, professional or personal nature in itself gives rise to the appearance of bias (125 II 541, ¶ 4b). For such a relationship to give rise to concerns of bias, objective circumstances must indicate a certain intensity of the relationship (9C_257/2016, ¶ 4.2.1; 8C_467/2014, ¶ 4; 4A_256/2010 ¶ 2.4). Whether a relationship reaches this degree of intensity is assessed on the basis of the specific circumstances of the individual case. See, for example, 4A_256/2010 ¶ 2.5 regarding a patent application. If the objected relationship is not with a party to the proceedings but with its opposing party or a third party in another proceeding, the effect of the two proceedings on each other must also be taken into account when deciding on the recusal.

The case at hand

In its internal Guidelines on Independence, the FPC does not equate purely administrative activities and the provision of an address for service with (patent) attorney activities. However, the FPC also does not assume that such activities are unproblematic with regard to the appearance of bias in every case. According to Art. 4 lit. f of the Guidelines, a judge shall recuse if he (or the company for which he works) is or was acting as addressee for service of the patent-in-suit. According to Art. 4 lit. g, the judge shall also recuse if he (or his company) is or has been directly mandated by the party to the dispute as addressee for service and to maintain the validity of its IP rights within the year or on a regular basis.

Accordingly, judge Bremi may not participate as a judge in the second case O2020_001 due to the administrative relationship of I&P with the plaintiff in the second case. The Supreme Court holds that on the other hand, according to the Guidelines, there is no bias («besteht keine Befangenheit») on the part of judge Bremi for the first patent infringement case, as his law firm was not mandated by a «party to the dispute directly» as an addressee for service and to maintain its IP rights. The firm was rather mandated by a third party, namely the plaintiff in the second case O2020_001, which is not a party to the first case O2017_022.

I respectfully disagree with the Supreme Court in this respect. Art. 4 of the Guidelines is an open list of grounds for recusal («insbesondere»). Accordingly, it cannot be said that the Guidelines hold that there is no bias in the situation at hand. Anyway, the Supreme Court rightly emphasises that the Guidelines can help judges to better assess their potential bias in the specific case. But what ultimatley counts is the law itself (139 III 433, ¶ 2.2). In particular, the Guidelines must not lead to the conclusion that a judge can in no way be biased by administrative work, apart from the specific situations governed by Art. 4 lit. f and g. Whether a reason for recusal exists has to be assessed according to Art. 47 CPC (to which the Guidelines refer to in the general clause of Art. 3), taking into account the principles flowing from Art. 30(1) FC (to which the Guidelines do not explicitly refer to), according to the specific circumstances of the individual case. Accordingly, even in the case of purely administrative activities, a concrete and case-specific assessment must be carried out to determine whether there is an appearance of bias.

Now, does the relationship between I&P and the plaintiff in the second patent infringement proceedings reach such an intensity under the specific circumstances for judge Bremi to appear to be biased in the first patent infringement proceeding?

To answer this question, the Supreme Court held that two aspects need to looked at more closely:

    1. The extent of the relationship between I&P and the plaintiff in the second proceedings; and
    2. the effect of the outcome of the first proceedings on the second proceedings.

As to the first aspect, i.e. the relationship between I&P and the plaintiff in the second proceedings, the contested decision of the FPC’s AC only stated that I&P’s activities were limited to purely administrative representation at the IPI. The appellant argued that it is not clear from the contested decision how the FPC could even know this. Indeed, the Supreme Court held that the FPC merely stated that I&P’s activities for the plaintiff in the second proceedings were limited to purely administrative representation. But there was no evidence for this statement, which the appellant rightly complains about. It was not baseless from the outset when the appeallant argued that in a business relationship lasting more than 15 years, it cannot be assumed without further clarification that I&P does not represent any interests of that party other than receiving mail from the IPI. Accordingly, the Supreme Court held that the FPC’s AC should have clarified the nature, scope and duration of the specific business relationship between I&P and the plaintiff in the second proceedings and, in particular, the FPC should have verified whether I&P did not provide the plaintiff in the second proceedings with more extensive (patent) legal advice, as the appellant suspects.

As to the second aspect, i.e. the effect of the first proceedings on the second one, the FPC only stated that in the second proceedings an unnamed third party asserts infringement of a not specifically identified patent by the same injector pens of the appellant. Further details are missing; not even the name of the plaintiff in the second proceedings is known (what a pity, indeed). Further, it is not known whether the two actions are directed against the same embodiment of the (type of) injector pen. Nor is it known whether the plaintiff in the second action is a competitor of the appellant who could benefit from the first action being upheld.

The Supreme Court acknowledged that due to the different patents-in-suit, the second proceedings against the appellant presumably raise different technical and legal questions than the first proceedings. Still, there may be delicate interferences. For instance, according to the appellant’s submissions, which have yet to be established in evidence by the FPC, the plaintiff in the second proceedings could pursue the same interests as the plaintiff respondent in the first proceedings, namely a ban on the manufacture and distribution of the attacked injector pens. Accordingly, such a ban in the first proceedings would also serve the plaintiff in the second proceedings. Further, the Supreme Court did note that, if the respondent’s action were to be upheld, the appellant could well come up with a workaround that lies outside the scope of protection of the patents asserted in proceedings O2017_022. However the Supreme Court held that, as the appellant rightly argued, it is generally known that medical products cannot be adapted and brought to market overnight, but are regulated products, so that the plaintiff in the second proceedings may well have an interest in the respondent’s complaint to succeed.

In this factual situation, the FPC’s AC should have clarified the concrete effects of the two pending patent infringement proceedings for the question of judge Bremi’s recusal in the first proceedings. Based solely on the factual elements established in the contested decision, it was not possible for the Supreme Court to conclusively examine the concrete effects of the first proceedings O2017_022 on the second proceedings O2020_001. The FPC’s AC has thus not established all the relevant facts, which prevented the Supreme Court from correctly applying the rules on recusal.

A contingent reasoning of the FPC’s Administrative Commission did not convince the Supreme Court, either. The FPC had concluded that even if one were to assume that the facts of the case objectively gave rise to the appearance of bias, the appellant could not invoke it in view of a violation of the requirement to act in good faith in the proceedings (Art. 52 CPC), because the appellant had created the ground for recusal itself with the request for recusal and the facts and arguments contained therein. In the FPC’s view, as judge Bremi was not involved in the second proceedings O2020_001, he had not been aware of anything from these proceedings apart from the names of the parties involved. His employer I&P was not involved in the second proceedings. In particular, judge Bremi had not been aware until the appellant’s request for recusal that the second proceedings were directed against the same injector pens as in O2017_022. The FPC had held that it was against the requirement of acting in good faith to provide a judge with the very knowledge that allegedly made him appear biased: If the appellant had not filed a request to recuse herself, no appearance of bias could have arisen because judge Bremi would simply not have known that his employer (allegedly) had an interest in him ruling against the complainant in proceedings O2017_022. The complainant could therefore not invoke the ground for recusal even if it existed.

The Supreme Court held that this line of reasoning is mistaken. Since it is not important for the appearance of bias of a judge whether he is actually biased, it cannot be decisive for the assessment of the reason for recusal whether the judge had already been aware at the time of filing the request for recusal request whether a certain reason for recusal existed, or whether a party first made him aware of such a reason. The Supreme Court notes that, ultimately, the FPC’s contingent reasoning would mean that wherever a judge is not (yet) aware of an existing ground for recusal, no request for recusal could be made because the party would otherwise be violating the good faith principle by making the judge aware of the ground for recusal. This would contravene the very essence of the rules on recusal.

Accordingly, the FPC’s contingent reasoning did not hold, either.

In sum, the Federal Supreme Court could not finally assess whether judge Bremi is biased in the first patent infringement proceedings O2017_022 because the facts have not yet been sufficiently established. The case has accordingly been remitted to the FPC to completely establish the facts and to render a new decision.

Full stop!

That’s a harsh stop to O2017_022 at a very late stage of the proceedings, well after the expert opinion of judge-rapporteur Bremi had been established and most likely only shortly before the main hearing. It will be interesting to see how the FPC deals with the remittal. In particular, I wonder how to properly and openly assess the potential cross-contamination between the two proceedings, while at the same time not to disclose otherwise non-public information of both plaintiffs to each other. They are most likely competitors, and would not normally know about particulars of the respective other proceedings.

Now, who are the parties?

I feel ashamed but I do not feel confident enough (yet) to come up with an educated guess here. But, clearly, there is only a limited number of high-stake companies that could be involved:

Injector pen key market players (see here)

Any one of these companies being sued by two others for infringement of their respective patent(s) by one and the same injector pen will be an interesting setup from a market perspective. We shall see.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_243/2020 (Supreme Court) | Decision of 5 November 2020 on appeal against O2017_022 | Order of 8 April 2020 (unpublished)

n/a (Appellant / Defendant)
./.
n/a (Respondent / Plaintiff)

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Fabienne HOHL
      • Dr. Martha NIQUILLE
      • Dr. Yves RÜEDI
      • Marie-Chantal MAY-CANELLAS

Court Clerk:

    • Daniel BRUGGER

Representative(s) of Respondent / Plaintiff:

    • Dr. Andri HESS (Homburger)
    • Dr. Roman BAECHLER (Homburger)

Representative(s) of Appellant / Defendant:

    • Dr. Christian HILTI (Rentsch)
    • Dr. Demian STAUBER (Rentsch)

SUPREME COURT DECISION
Appeal against the order of the FPC’s Administrative Commission of 8 April 2020 (unpublished) in case O2017_022, rejecting the request for recusal of judge-rapporteuer Tobias Bremi
Case no.: 4A_243/2020
Decision of: 5 November 2020

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