A quick recap: Actavis had challenged validity of AZ’s Swiss part of EP 2 266 573 back in 2015, and the FPC had indeed held in 2017 that EP 573 was invalid for lack of inventive step; see this Blog here. However, the Supreme Court overruled that decision and remitted the case back to the FPC for re-assessment of obviousness; see this Blog here. In the second round, the FPC held that the subject-matter of EP 573 did involve an iventive step; see the decision O2018_009 of 27 May 2019. In brief, the FPC held that neither
Howell (referred to as D15) in further view of McLeskey (referred to as D13); nor
rendered the claimed subject-matter obvious. That decision was again appealed to the Supreme Court, and I have been eagerly awaiting a good read. But nothing like that. The Supreme Court only published a dismissal order. The parties have apparently reached an amicable settlement; court fees are shared.
As discussed a while ago on this Blog here, the settlement discussion at the occasion of a main hearing is non-public at the FPC. I trust that this will not change any time soon, in view of a decision of the Supreme Court that has been published earlier this week (4A_179/2019 of 24 September 2019). In that case, an accredited court reporter of the Republik had been asked to leave the room for the settlement discussion at the end of a main hearing in proceedings at the Zurich labor court. Ultimately, the Supreme Court has now endorsed this exclusion of the public from the settlement discussion:
Die Bemühungen des Gerichts, zwischen den Parteien zu vermitteln, gelten nicht als Gerichtsverhandlung respektive Verhandlung und unterstehen nicht dem Grundsatz der Justizöffentlichkeit.
Maybe, the Supreme Court telegraphed a message by explicitly saying nothing (emphasis added):
Demgegenüber ist hier nicht zu beurteilen, ob es zulässig wäre, die Öffentlichkeit über die Vergleichsgespräche hinaus generell von Instruktionsverhandlungen auszuschliessen, zumal an solchen nach Art. 226 Abs. 2 ZPO unter anderem auch der Sachverhalt ergänzt und die Hauptverhandlung vorbereitet werden kann ([…]).
In English (emphasis added):
On the other hand, it is not necessary here to assess whether it would be permissible to generally exclude the public from instruction hearings beyond the settlement discussions, especially since, according to Art. 226 para. 2 CPC, the facts of the case can be supplemented and the main hearing can be prepared in the instruction hearings ([…]).
The FPC took note. Here is the FPC’s tweet of earlier today:
BGer vom 24. September 2019: Gericht darf Öffentlichkeit, inkl. Medien, von informellen Vergleichsgesprächen ausschliessen; offen gelassen, ob das auch für den formellen Teil der Instruktionsverhandlung gilt; https://t.co/3bkf7ZyXiTpic.twitter.com/0zi1jYGjNp
Indeed, the Supreme Court did leave it undecided whether the public could also be excluded from the formal part of an instruction hearing. Still, the Supreme Court made it crystal clear that it does not want to see its judgement being read on instruction hearings in general, in view of what is (or maybe) going on in (the formal part of) an instruction hearing — contrary to mere settlement discussions, be it during a main hearing or an instruction hearing.
In my perception, that’s a somewhat deafening silence on this issue, isn’t it?
I have reported about the first instance decision of the FPC on this Blog here.
Frankly, I did not see this coming:
With the present decision the Supreme Court quashes the FPC’s decision of 18 December 2018 in case O2016_009.
Do you remember the hn of that decision? Here it is again:
If in a patent infringement proceeding the plaintiff files before the instructional hearing a reply limited to the defense of the validity and no pleadings take place at the instructional hearing, the plaintiff may submit new allegations of fact, and therefore also amended patent claims, in the completed reply filed after the instructional hearing without having to meet the requirements of art. 229 para. 1 CPC.
Well, and now: Forget it! The Supreme Court turned the hn upside down, in no uncertain terms.
The FPC had held that there was no reason for a plaintiff bringing a claim for infringement to address nullity of his patent. The Supreme Court does not agree and holds that the plaintiff could well have addressed potential nullity arguments already in the statement of claim, even though he might not yet know the potential nullity arguments for sure at that time. Thus, the plaintiff in the case at hand actually had three chances to submits new facts and evidence before closure of the file, constrary to the meanwhile established case law of the Supreme Court; see e.g. BGE 144 III 117.
As if this was not enough, the Supreme Court apparently even has doubts as to whether a thematic split of the reply is admissible and sensible at all.
Ob eine thematische Aufteilung der Replik zulässig ist, erscheint fraglich ([…]). Es ist ausserdem zweifelhaft, ob eine derartige Vorgehensweise überhaupt sinnvoll ist, setzt sie doch mindestens voraus, dass sich die vorweggenommene Frage klar vom übrigen Prozessstoff abgrenzen lässt, was die Beschwerdegegnerin mit guten Gründen für die Frage der Patentnichtigkeit im Verhältnis zur Frage der Verletzung bestreitet.
Accordingly, the FPC’s recent note on Twitter mentioned that this decision puts the practice of a split reply in question:
#bger_CH heisst Beschwerde gegen Teilurteil i.S. Hamilton Medical AG v. imtmedical AG vom 18. Dezember 2018 wegen Verstoss gegen Art. 229 Abs. 1 #ZPO (Novenrecht) gut; Praxis der zweigeteilten Replik in Frage gestellt, https://t.co/l1PlBjdC1X
In my perception, this puts more than just the split reply at question. The split reply was to ensure that the instructional hearing could efficiently be held after a first round of submissions by both parties on all aspects of the case, and to bring about a settlement; and the FPC has been pretty successful at this over the years. See e.g. the FPC’s Annual Report 2018 (p. 8):
The high ratio of cases settled is due to the practice of holding an instructional hearing at a relatively early stage of the procedure, during which a court delegation provides the parties with a preliminary legal and technical assessment of the dispute and tries to foster a settlement.
Apart from the split reply with the instructional hearing in between, I do not yet see a different way to bring the parties willingly at the table at an early point of time in the proceedings, to talk settlement.
Despite the potential impact on any future case at the FPC, it remains to be seen whether this win will actually carry the day for the defendant / appellant in the case at hand: The Supreme Court formally submitted the case back to the FPC to assess whether the submission of new claims by the plaintiff with the second reply was admissible under Art. 229(1) lit. b CPC (improper novum) — but it is already explicitly held in the decision that there is some indication that filing of these claims was occasioned by the defendant’s submission of a particular prior art document (¶2.5.3-2.5.4).
The Supreme Court had to deal with an appeal against an (unpublished) order issued by the Administrative Commission (AC) of the FPC in case no. O2017_024, by which order the requested recusal of the judge-rapporteur had been denied. Defendant / appellant felt that some statements of the judge-rapporteur at the occasion of the instruction hearing (Art. 226 CPC) gave rise to the appearance of bias. It is important to understand that the instruction hearing at the FPC consists of two parts (Art. 8(4) of the Guidelines on Proceedings before the Federal Patent Court), i.e.:
a) The court delegation discusses with the parties the matter at issue, asks questions where the party submissions are unclear, and provides substantiation advice. Evidence may also be accepted. This first part is transcribed.
b) The court delegation explains its preliminary assessment of the matter in dispute off the record and attempts to bring about a settlement between the parties. The parties and the Court are prohibited from subsequently invoking any submissions made during this second part of the hearing; it serves exclusively to bring about a settlement.
Notably, the appellant did not object to the formal part a) of the instruction hearing (where the judicial duty to ask and inform applies), but rather to the informal part b) which serves exclusively to bring about a settlement.
After having read the first lines of the decision, I so much hoped that this decision would finally help me understand the metes and bounds of the informal part of the instruction hearing, and maybe even the formal part. Unfortunately, it doesn’t. The Supreme Court did not even assess the issue on the merits, but rather dismissed the appeal for formal reasons. What a pitty.
First, the Supreme Court holds that the appellant raised the objection belatedly, i.e. only 24 days after the instruction hearing. The Supreme Court did not buy into the argument that the procedural violations had only been noticed well after the instruction hearing (¶4.3):
It is not convincing that the appellant has only gained knowledge of the (alleged) ground for recusal until two weeks after the hearing, since the appellant does not object to a single error in the conduct of the proceedings, which may not be discernible at first sight, but «a large number of inadmissible statements by the judge-rapporteur», which «substantiated a serious violation of the duties of the judge by the disregard of fundamental principles of civil procedure.»
BGer, Urteil 4A_56/2019 vom 27. Mai 2019: ein Ausstandsgesuch, das 24 Tage nach Kenntnis des Ausstandsgrunds eingereicht wurde, ist verspätet, https://t.co/j1IlfSEuWB
Further, the appellant criticised a statement made by the judge-rapporteur in his opinion of 26 September 2018, which the appellant considered would in itself give rise to the appearance of bias, and which should have been taken into account by the FPC’s AC ex officio. This statement is literally recited in the decision in ¶5.2, as follows (jump here for an English translation):
Die Instruktionsverhandlung dient gemäss Art. 226 ZPO unter anderem der freien Erörterung des Streitgegenstandes und dem Versuch einer Einigung. Um eine Einigung zu ermöglichen, nimmt der Instruktionsrichter eine vorläufige und unpräjudizielle Einschätzung der Sach- und Rechtslage vor. Dass es sich dabei um eine vorläufige Einschätzung handelt, die sich im Laufe des weiteren Verfahrens ändern kann und von den weiteren Mitgliedern des Spruchkörpers nicht geteilt werden muss, wird den Parteien klar kommuniziert. Die genannten Zwecke der Instruktionsverhandlung können nur erreicht werden, wenn sich der Instruktionsrichter – im Rahmen des von den Parteivorträgen umrissenen Streitgegenstandes – frei äussern kann. Eine strikte Bindung an einzelne Tatsachenbehauptungen ist in diesem frühen Verfahrensstadium, in dem das Behauptungsverfahren noch nicht abgeschlossen ist, nicht möglich und nicht zielführend.
According to Art. 226 CPC, the instruction hearing serves, among other things, the free discussion of the subject matter in dispute and the attempt to reach an agreement. In order to enable an agreement to be reached, the judge-rapporteur makes a preliminary and unprejudiced assessment of the factual and legal situation. The parties are clearly informed that this is a preliminary assessment, which may change in the course of further proceedings and need not be shared by the other members of the panel. The stated purposes of the instruction hearing can only be achieved if the judge-rapporteur can freely express himself within the framework of the subject matter of the dispute outlined by the party submissions. A strict link to individual factual assertions is not possible and not expedient at this early stage of the proceedings, at which the assertion proceedings have not yet been concluded.
The FPC’s AC did not see any reason for recusal in the above statements. But still, and ‘for the sake of completeness’, the FPC’s AC addressed the opinion of the judge-rapporteur and concluded — in general terms, detached from the case at hand — that ‘there was no basis for supplementing the relevant alleged facts by the judge, neither outside nor within settlement discussions.’
[…] keine Grundlage für eine Ergänzung des relevanten behaupteten Sachverhalts durch den Richter, weder ausserhalb noch innerhalb von Vergleichsgesprächen.
I am not fully sure what is meant with ‘no basis’. If this is to be understood in a sense that supplementing the alleged facts (within or beyond ‘the framework of the subject matter of the dispute outlined by the party submissions’) is a clear no-go, then I could not agree more. It may be a tough exercise for a judge-rapporteur to stick to the facts as they have been asserted after only a single exchange of briefs, in particular when the forthcoming further assertions are all too obvious. But still, parties sometimes just do not make even the most obvious next assertion (intentionally or unintentionally), and any helping hand for a potentially negligent or ignorant party would be to the disadvantage of the respective other party.
But in the matter at hand, the Supreme Court did not need to deal with this issue on the merits. The decision holds that the appellant’s criticism misses the point: Procedural errors (as well as a decision that is potentially wrong on the merits) cannot in themselves justify the appearance of bias. The situation is different only if there are particularly blatant or repeated errors which must be assessed as a serious violation of the duties of the judge. Consequently, the request for recusal of a judge cannot normally serve to assess alleged procedural or other errors of the judge. Such complaints must be raised on appeal; see 4A_149/2018 in ¶5.2. Accordingly, the Supreme Court did expressly not assess to what extent the statements made by the judge-rapporteur — in particular the last two sentences — are in conformity with the law. The only decisive point is, in the Supreme Court’s view, that this statement was not a particularly blatant error of such a kind that would make the rejected judge appear almost biased. Thus, also appellant’s second criticism failed.
Now, what can be learned from this decision?
Unfortunately, not too much for the time being, because the Supreme Court took a formal shortcut. But, in my perception, there is some handwriting on the wall, isnt’t it? And, maybe, we will see the appellant’s second criticism being raised again on appeal if this case moves on and the appellant / defendant is unsuccessful in first instance proceedings on the merits.
Please see this Blog here for a detailed review of the first instance decision S2018_004 of the FPC in this matter, granting interim injunctive relief against Sandoz’s generic Kivexa®.
An appeal against a decision in summary proceedings is not so easy anymore as it used to be. In former times, a not easily repairable harm had routinely be assumed on appeal against decisions concerning interim injunctive relief (see BGE 134 I 83, ¶3.1, with further reference). However, the more recent case law requires that the appellant is threatened by a not easily repairable harm (in legal terms) in the specific case at hand; see BGE 144 III 475, ¶1.2, with further reference). In the case at hand, the Supreme Court left it undecided whether the loss of the first mover advantage or reputational damages would be sufficient to meet the threshold. But the Supreme Court noted that the interim injunctive relief also prohibited possession and storage, and the defendant would thus have to destroy all products on stock. The Supreme Court held that this constitutes a not easily repairable harm in the sense of Art. 93(1) lit. a SCA, and the appeal was admissible already for this reason. This surely is lawyer’s playground; but I am wondering why the loss of stock was considered a not easily repairable harm? It surely is a harm. But wouldn’t it be one of the kind that is quite easy to repair?
Further, Sandoz had argued that the plaintiff was not actually at risk of a ‘not easily repairable harm’ as required by Art. 261(1) lit. b CPC.
The FPC had held that a not easily repairable harm was sufficiently credible; it was ‘obvious and notorious’ that in such group structures of pharmaceutical companies a disadvantage that cannot be easily repaired arises for the group and thus at least indirectly also for the formal holder of the SPC. The FPC failed to see why / to what extent this should not be the case in the present setup.
Es ist offensichtlich und notorisch, dass in derartigen Gruppenkonstellationen von pharmazeutischen Konzernen ein nicht leicht wiedergutzumachender Nachteil bei der Gruppe anfällt und damit wenigstens indirekt auch bei der formellen Inhaberin des Schutzrechts. Inwiefern dies in der vorliegenden Konstellation nicht der Fall sein sollte, ist nicht ersichtlich.
The Supreme Court essentially confirmed this reasoning.
The decision also discusses the dispatch of the Federal Council on the Civil Procedure Code and holds that any impairment of the execution of absolute rights constitutes a not easily repairable harm; BBl 2006, ¶5.19, p. 7354:
[…], wird in der Botschaft zur ZPO ausgeführt, jede Beeinträchtigung in der Ausübung absoluter Rechte bedeute einen nicht leicht wieder gutzumachenden Nachteil ([…]).
Frankly, I don’t see that in the dispatch. In my reading, the dispatch only holds that any impairment of the execution of absolute rights constitutes a harm, but it does not say that this harm is automatically not easily repairable:
Als Nachteil gilt beispielsweise eine Beeinträchtigung der Ausübung absoluter Rechte (z.B. Störung des Eigentums).
As to the alleged lack of novelty over D1 (WO 96/06844), the Supreme Court held that the FPC did not arbitrarily acknowledge novelty based on multiple selections from lists. In my perception, the Supreme Court suggests that the standard established by the case law of the Boards of Appeal of the EPO in relation to selections from multiple lists of certain length shall be applicable:
Die Beschwerdeführerin stellt zu Recht nicht in Frage, dass auf die Praxis der Beschwerdekammern des EPA abgestellt werden kann.
Thus, let’s do it. Here is the critical paragraph of D1:
[Abacavir] may be administered alone or in combination with […] Nucleoside Reverse Transcriptase Inhibitors (NRTIs) for example zidovudine, zalcitabine, lamivudine, didanosine, stavudine, 5-chloro-2′,3′-dideoxy-3′-fluorouridine and (2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine; non-NRTIs for example nevirapine and α-APA; HIV protease inhibitors for example saquinavir; other anti-HIV agents for example soluble CD4; immune modulators for example interleukin II, erythyropoetin, tucaresol; and interferons for example a-interferon.
Now, does it require a multiple selection from two lists of certain lengths to arrive at the combination of abacavir and lamivudine, in accordance with the established case-law of the Boards of Appeal of the EPO? Does one have to first choose a generic class (NRTIs) and then lamivudine within that class — or does one just have to pick one compound from a single (structured) list of compounds? A decision on that question could have been a very interesting read. But the Supreme Court merely held that the FPC could well assume, without becoming arbitrary, that it would still require a twofold choice and thus a multiple selection from D1.
Selbst wenn daher die Rüge der Beschwerdeführerin begründet wäre (was offen bleiben kann), dass die im angefochtenen Entscheid genannte erste Auswahl keine relevante Wahl im Sinne der Rechtsprechung sein sollte [Anm.: Mono- bzw. Kombinationstherapie], konnte die Vorinstanz ohne in Willkür zu verfallen davon ausgehen, es erfordere immer noch eine zweifache Wahl und damit eine Mehrfachauswahl aus [D1], um zum Gegenstand des Patents der Beschwerdegegnerin zu gelangen.
Now, what? Does any ‘twofold selection’ whatsoever create novelty? I don’t think so. What about the requirement of the Boards of Appeal that the lists have a ‘certain length’? And what about the argument that the above is only a single, yet structured list? While the FPC clearly intended to follow the EPO’s approach, I am not so sure about the Supreme Court’s view on this. Anyway, time will tell …
Both parties had lodged an appeal — but the Supreme Court dismissed both appeals. While the FPC’s judgement was quite a booklet of 50+ pages, it took the Supreme Court only 7 pages to deal with both appeals. Most of the judgment indeed is pretty straight forward. Still, the judgment has quite some interesting aspects, in my perception:
Assignment of a patent does not imply assignment of the universal right to the invention per se
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. But that did not help. Frédéric Garinaud specifically assigned the European patent application to Guenat, but not the universal rights in 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.
On appeal, Guenat criticises the FPC’s ‘artificial dichotomy’ between the invention and the related patent application, and claims complete control over the invention in dispute. The Supreme Court didn’t buy into that. The decision holds in ¶3.2 that Guenat’s argument is based on an assumption about the parties’ intention in respect of the transfer agreement of April 2013. This is not a question of law, but of fact. But the FPC had not found that the real and common intention the parties had been to assign all intellectual property rights to the invention and the right to be granted all related patents. On the contrary, according to the FPC, the agreement in question ‘clearly refers only to the European patent application and the resulting European patent, and not to the invention as such’ — which finding is binding on the Supreme Court since it is not ‘arbitrary.’
Thus, the Supreme Court apparently had no doubt that the assignment of a specific patent does not necessarily imply the assignment of the universal rights in the invention itself.
Assessment of inventive step is a question of law, but …
Guenat argued on appeal that the FPC had violated the principle of party disposition because it took facts into account that had not been alleged by the defendant.
Now, what had happened?
The FPC had held that a specific feature (C3-1) was not disclosed in the closest prior art document. Guenat had a different understanding of the specific feature, and had argued that based on a ‘correct’ understanding of the feature it had well been disclosed in the closest prior art.
On appeal, Guenat argued that Swiss Finest had not even alleged that feature C3-1 was not disclosed in that document. Unfortunately, it is not readily clear from the decision to which version of feature C3-1 that allegation pertained: The feature as construed by the Guenat, or the feature as construed by the FPC?
The Supreme Court held that it had not been disputed that all the factual elements necessary for the analysis of obviousness had been brought on file by the parties. Further, the Supreme Court held that Guenat had not asserted that the FPC had to supplement the facts on its own, and that such conduct was also not apparent from the file. In the Supreme Court’s view, the FPC was thus in a position to assess obviousness, which is a question of law. It is irrelevant in this respect that the presence or absence of specific features in the prior art and/or the patent have been alleged by the defendant or the plaintiff. On the basis of the facts gathered by the parties in order to consider a question of law, the court did not violate the principle of party disposition.
Without any in-depth knowledge of what had or had not been argued by the parties, I just cannot say whether I would agree with the assessment on the merits of the case. But the Supreme Court’s general considerations on questions of law vs. questions of fact trigger some further thoughts.
Clearly, assessment of obviousness is a question of law — but the underlying factual elements still need to be asserted by the parties. But what are the ‘factual elements’? They must be something more specific than just ‘the patent in suit’, ‘D1’ or the like. Else, a court could just combine whatever is on file in its assessment of obviousness, fully detached from the pleadings. This cannot be it. Now, let’s assume that both parties come up with a somewhat strange claim construction, and base all their obviousness attacks / defenses on a wrongly construed claim. In my understanding, claim construction clearly is a question of law, too (see e.g. X ZR 255/01 – ‘Bodenseitige Vereinzelungseinrichtung’ of the German Federal Supreme Court in ¶5, with further reference). But what if no party ever pointed to the relevant underlying ‘factual elements’ (i.e. specific sections of the patent in suit) that support the ‘correct’ claim construction? May the court then even come up with a different / the ‘correct’ claim construction at all?
UPDATE 21 March 2019:
Note that the FPC had held in the recent decision S2018_006 that claim construction is a question of law. In that case, both parties had not construed the feature in question at all, and the FPC came up with a construction on its own:
Wie der Begriff korrekt auszulegen ist, tragen die Beklagten hingegen ebenso wenig wie die Klägerin vor. Da die Auslegung des Patentanspruchs eine Rechtsfrage ist,15 geht die Annahme der Beklagten fehl, das Gericht dürfe den Anspruch mangels entsprechenden Vortrags der Klägerin nicht so auslegen, dass er auch etwas anderes als einen Schneidprozess erfasst.
But, again, what if both parties came up with a claim construction mutually agreed upon — but which, in the courts view, is just wrong? Or, what if both parties come up with different constructions which are both wrong in the court’s view? Can the court then correct such (a) construction(s) if it would have to rely on ‘factual elements’ that have never been pointed at by the parties, just because it is a question of law? And if that was the case, then where is the limit in the assessment of obviousness — which is a question of law, too?
The theory of separating questions of law from questions of fact is simple. But life is complicated …
On a sidenote: Wouldn’t it be good to establish common ground on what the claim actually is all about before diving any deeper? This is what a Markman hearing in the U.S. is all about. Even though I am not overly enthusiastic about quite some aspects of patent litigation in the U.S., this one certainly is useful.
Salmon Pharma as the defendant in SPC infringement proceedings neither disputed validity of the basic patent EP 0 716 606 B1 of Genzyme Corporation, nor that the subject-matter of the SPC C00716606/01 is actually covered by the basic patent or that the attacked embodiment (sevelamer carbonate) is covered by the SPC. Rather, the defendant (only) alleged that the SPC was invalid because the IPI wrongfully allowed re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.
The question as to whether the lists of grounds for nullity in Art. 26 and Art. 140k PatA are exhaustive had indeed not yet been explicitly decided by the Supreme Court before. However, the present judgment refers to an indication in 4A_52/2008, ¶2.2, according to which the grounds for invalidity for the certificate are listed in Art. 140k PatA. Furthermore, in application of the Patent Act of 1888, the Federal Supreme Court had already held that the grounds for invalidity of patents were exhaustively listed therein (28 II 309, ¶5). I just love to read such old decisions. Amazingly straight to the point; and the type face is so stylish:
Unsurprisingly, the Supreme Court takes the case-law of the Court of Justice of the European Union (ECJ) on Art. 15 of Regulation (EC) No 469/2009 (or Regulation (EEC) No 1768/92) into account, in view of the legislator’s explicit intent to bring the Swiss rules into line with European law.
However, the Supreme Court could not infer anything from the ECJ’s case-law in support of Salmon’s position. Rather, the Supreme Court confirms the FPC’s reasoning: The ECJ only affirmed the nullity of certificates due to the non-observance of standards which are not explicitly mentioned in Art. 15 of Regulation No 1768/92 by referring to Art. 15 as interpreted in view of Art. 3.
For example, in C-127/00 — Hässle ./. Ratiopharm, the ECJ held that failure to comply with the transitional regime of Art. 19 of Regulation No 1768/92 may result in the certificate being invalid. The requirement under Art. 19 is to be understood as an implicit substantive requirement additional to the conditions laid down in Art. 3 of the Regulation. A certificate which was granted even though an initial marketing authorisation had already been granted before the date laid down in Article 19 of the Regulation is therefore null and void; ¶¶84-92).
Likewise, in C-195/09 — Synthon ./. Merz Pharma, the ECJ held that Art. 3 of Regulation No 1768/92 necessarily referred to a product falling within the scope of that regulation within the meaning of Art. 2 thereof. A certificate granted for a product falling outside the material scope of the Regulation should be considered null and void; ¶56.
It cannot be inferred from these judgments that the list of grounds for nullity in accordance with Art. 15 of the Regulation is not to be understood as exhaustive. On the contrary, the ECJ stated that it could not be inferred from either the wording or the history of Art. 15 of the Regulation that the list of grounds for nullity of the certificate referred to therein was not exhaustive (Synthon, ¶55; Hässle, ¶¶90-91).
The Supreme Court thus held that the lists of grounds for invalidity of both Art. 26 and Art. 140k PatA cannot be supplemented. Consequently, in the context of a patent nullity action or a nullity action relating to an SPC, only the grounds provided for in these provisions may be invoked. The Supreme Court notes in passing that legal certainty demands for this, too.
Angesichts dessen, dass es sich bei der Nichtigkeit eines Patents bzw. Zertifikats um eine schwerwiegende Folge handelt, entspricht dies dem Gebot der Rechtssicherheit.
Next, the Supreme Court assessed whether non-compliance with the deadline for filing the request pursuant to Art. 140f PatA or wrongful reinstatement pursuant to Art. 47 PatA, could be subsumed under a ground for invalidity pursuant to Art. 140k PatA. However, this is neither apparent nor does it result from the relevant case-law of the ECJ.
Finally, the Supreme Court notes that SPCs and patents are granted by order of the IGE (144 III 285, ¶3.2). Nullity under Art. 26 and Art. 140k PatA is not to be mixed up with the administrative contestability or nullity of the dispositions of the IPI on which the grant of a patent or SPC is based. In other words, the fact that the catalogues of grounds for invalidity under the PatA are exhaustive does not mean that these dispositions cannot be contestable or void, which must be assessed according to general principles of administrative law.
Dass die Kataloge der patentrechtlichen Nichtigkeitsgründe abschliessend sind, bedeutet […] nicht, dass diese Verfügungen nicht anfechtbar bzw. nichtig sein können, was nach allgemeinen verwaltungsrechtlichen Grundsätzen zu beurteilen ist.
Interestingly, the Supreme Court explicitly left the question open whether the decision of grant of the SPC (or the earlier decision of 4 April 2005 concerning reinstatement) could have been challenged by the appellant, as the FPC had assumed: Any relevant time limit had expired since long, anyway. On the other hand, the nullity of a decision must be observed by all authorities applying the law at all times (137 I 273, ¶3.1; 133 II 366, ¶¶3.1-3.2; 132 II 342, ¶2.1; 129 I 361, ¶2; each with further references to case-law).
Incorrect administrative acts are usually not null and void, but only contestable; and they become legally effective when not challenged. Invalidity, i.e. absolute ineffectiveness, of an order is only accepted if it is afflicted with a profound and substantial defect, if this serious defect is obvious or at least easily recognisable and if the legal certainty is not seriously jeopardised by the acceptance of invalidity. Deficiencies in content only rarely result in the nullity of an order, in exceptional cases; this requires an extraordinarily serious deficiency. The main grounds for invalidity are the functional and factual lack of competence of an authority and serious procedural irregularities (such as the fact that the person concerned did not have the opportunity to participate in the proceedings). If an order is not legally binding in this sense, any authority dealing with the matter must comply with it at all times and ex officio (see, inter alia, 138_II_501, ¶3.1; 137 I 273, ¶3.1; 136_II_489, ¶3.3).
Salmon had argued that reinstatement was granted ‘arbitrarily and contrary to the clear and decades-long practice’ of the IPI. Again, the Supreme Court left undecided whether the IPI indeed wrongly allowed reinstatement because the alleged misjudgment could not be a defect that leads to the nullity of the decision. In particular, the Supreme Court held that any such deficiency would be neither obvious nor easily recognisable: By definition, reinstatement is a remedy when something went wrong, i.e. in the event that a time limit prescribed by the law was not observed.
Finally, in simple terms, the Supreme Court notes: The IPI had come to the conclusion that the conditions for reinstatement pursuant to Art. 47 PatA were met. The appellant may not share this view, but the administrative act is still not null and void.
Das IGE ist zum Schluss gekommen, dass die Voraussetzungen für die Wiedereinsetzung gemäss Art. 47 PatG gegeben waren. Die Beschwerdeführerin mag diese Einschätzung nicht teilen; ein nichtiger Verwaltungsakt liegt jedoch nicht vor.
Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff / appellant.
Please see this Blog here for a discussion of the underlying decision of the FPC. In brief, it is all about an assignment action of Marcel Riendeau against Zehnder Group International AG, concerning two European patent applications, i.e.:
Both EP2 and EP3 had been filed in Zehnder’s name only; the plaintiff had been designated as inventor. The plaintiff had partially suceeded in first instance when the FPC held that the parties are jointly entitled to both patent applications.
On appeal, the plaintiff objected that the facts had been wrongly established in the first instance decision in various aspects, that the burden of proof had been incorrectly allocated and that the FPC had not dealt with the plaintiff’s entitlement to a transfer of the patent applications based on a contractual undertaking.
To cut a long(er) story short: The Supreme Court did not agree and dismissed the appeal. The FPC’s decision is thus final now, and it remains to be seen how the parties get along with their joint entitlement to both EP2 and EP3.
The Supreme Court now dismissed Omega’s appeal, i.e. confirmed the FPC’s decision. EP(CH) 1 837 719 B1 is thus finally declared invalid.
The issues dealt with by the Supreme Court in the decision, in brief:
Age of a prior art document
On appeal, Omega has argued that the FPC took an unrealistic piece of prior art into account in the assessment of inventive step. Indeed, the FPC had considered a document that was published already about a century ago, i.e. US 759,914. In view of the evolution of watchmaking since then, Omega considered it unrealistic that such a document was actually considered as a starting point in the assessment of inventive step. Consequently, Omega alleged a violation of Art. 56 EPC.
The Supreme Court did not buy this argument. It is held in no uncertain terms that everything that had been made publicly available — including old documents — forms part of the prior art. One cannot exclude a document from consideration in the assessment of inventive step just because of its age; see ¶3.1.3.
Écarter un document de ceux que consulterait l’homme de métier en raison de son ancienneté reviendrait à priver les brevets ayant dépasé un certain âge de toute valeur dans le cadre de l’analyse de l’effet invenif. Un telle pratique ne saurait être déduite de l’art. 65 CBE.
Reference to some case-law of the Boards of Appeal of the EPO did not help either: The mere age of a document has not been decisive in T 479/00, T 366/89, T 1000/92 and T 334/92. The Supreme Court notes that the obsolescence or outdatedness of a technology had been the key issue in these decisions, which excluded the respective documents from consideration by the skilled person. Apparently, no such case had been established by the appellant in the present matter.
Incompatibility of technical teachings
The balance wheel of US 759,914 has inertia blocks that must have been placed from the inside, as claimed by the patent in suit; see the screw head on the inner side of the felloe in the figures below.
But what is still missing here is the stud (‘plot’) according according to the patent in suit. Omega argued that the skilled person would not have added studs to the balance of US 759,914 in view of the risk to impair the automatic adjustment of its temperature dependent moment of inertia, which is the sole purpose of this invention. However, the Supreme Court holds that this is not in agreement with the fact findings of the FPC, and thus did not consider this argument any further.
And the Supreme Court indeed acknowledges that it would have been desirable if it had done so.
Ainsi, il eût été souhaitable que la juridiction précédente détaille la première étape de l’approche problème-solution comme elle l’a fait pour les autres étapes de son examen.
But still, in view of the FPC’s detailed discussion of how the skilled person had arrived at the invention starting from US 759,914 without inventive merit, it became sufficiently clear how close both inventions actually are, and why US’914 thus is a reasonably chosen closest prior art.
Late filed auxiliary requests / claim limitations
Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. The FPC had not admitted this request into the proceedings anymore, with reference to O2015_012.
Omega had challenged this on appeal. But while this appeal has been pending, the Supreme Court ruled on the appeal against O2015_012 — and backed the practice of the FPC in this respect; decision 4A_543/2017 of 08 May 2018, see this Blog here. Accordingly, Omega did not succeed with this argument, either.
It was beyond dispute between the parties that the subject-matter of the SPC (tenofovir disoproxilfumarat + emtricitabin) is covered by the basic patent EP’894. The so-called ‘infringement test’ that had been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met. However, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and the plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland, either.
The FPC had held that it is not appropriate to change the practice. On the contrary, the Supreme Court did now exactly that.
In first place, the Supreme Court reviewed the practice of the CJEU which initially left it to the national courts to decide on what it meant to be protected by a basic patent. Essentially two lines of jurisprudence developed thereafter, i.e. the disclosure theory (‘Offenbarungstheorie’) and the infringement test (‘Verletzungstest’). Only later, the CJEU disapproved the ‘infringement test’; CJEU C-322/10 – Medeva.
The Supreme Court noted that the Swiss SPC legislation had been enacted with the explicit aim to make it materially the same as in the European Union. The ‘infringement test’ cannot achieve this aim anymore, and it thus cannot be maintained; ¶2.2.5-2.2.6:
Die Auslegung […] weicht konzeptionell ab von der Auslegung durch den EuGH. […] Das vom schweizerischen Gesetzgeber angestrebte Zeil, das Schutzniveau für das Institut der ergänzenden Schutzzertifikate mit demjenigen im benachbarten Ausland in Einklang zu bringen, wird damit verfehlt. […] An BGE 124 III 375 kann nicht festgehalten werden.
Supreme Court dismisses appeal against judgment of 3 Oct 2017 in the matter of Mepha Pharma AG v Gilead Sciences, Inc., re Supplementary Protection Certificate (SPC); but in the future, Switzerland will apply the ECJ’s “Medeva” case law to SPC’s, https://t.co/tdY0t602LG
Noteworthy, the Supreme Court also briefly touched the IPI’s prior initiative to amend its SPC granting practice in light of the CJEU’s Medeva case law, and the positive feedback that had been received from (at least some of) the interested circles. The Supreme Court notes that this was a strong indication that the Swiss practice should indeed be changed, and the IPI’s initiative thus paid off. Still, it was good that the IPI’s initiative had been put on hold in view of the present proceedings. In my humble opinion, any change of practice while BGE 124 III 375 – Fosinopril was still formally applicable would have been premature. Just imagine the consequences if the granting practice had been changed and the Supreme Court later did not abstain from the ‘infringement test'(!), for any reason whatsoever. Dreadful.
Now, what is the test instead? Practitioners are familiar with the subtle twists in the various decisions of the CJEU. This is not further clarified in the present decision. Unsurprisingly, the Swiss Supreme Court essentially only summarizes the criteria of these decisions, ¶2.2.6:
Bezeichnet ein Grundpatent nur einen von zwei Wirkstoffen, kann ein Erzeugnis […] nicht als ergänzendes Schutzzertifikat beanspruch werden, wenn es aus zwei Wirkstoffen zusammengesetzt ist. Art. 140b PatG ist vielmehr […] so auszulegen, dass die Wirkstoffe des Erzeugnisses im Grundpatent beansprucht werden müssen, indem sie in den Patentansprüchen benannt werden, oder indem sich die Patentansprüche – im Lichte der Beschreibung ([…]) ausgelegt – zumindest stillschweigend, aber notwendigerweise auf diese Wirkstoffe beziehen, und zwar in spezifischer Art und Weise.
But the Supreme Court did not just change the practice. It did so with a smooth ‘Swiss touch’: Already granted SPCs shall not be affected by the change of practice. The Supreme Court held that, as a rule, formally final administrative decisions cannot be reconsidered or reversed on the basis of a change in case law. In the Supreme Court’s view, the public interest in equal treatment hardly exists in the context of an SPC, contrary to e.g. in social insurance issues. Apart from the fact that the number of SPCs — irrespective of their economic importance — is rather small, the purpose of granting them is precisely to grant privileges to their owners. If a change of the case law now restricts the conditions for granting SPCs in certain cases, the interests of the other market participants are given a higher weighting and the interests — including public interests in health care — are weighed up differently. However, this change in valuation and consideration of the interests involved does not justify the withdrawal of acquired legal positions, in the Supreme Court’s view; see ¶3.6. No national court in the European Union took this approach when the ‘infringement test’ had been abandoned, to the best of my knowledge.
Now, what is next? Respondent’s counsel already noted on Kluwer Patent Blog that it remains unclear how pending SPC applications shall be dealt with, but they suggested that the infringement test should also apply in these cases. I feel this could well be handled differently. No subjective right has yet been granted in these cases, and I cannot readily see an overriding interest of the applicants to still get SPCs granted contrary to the changed practice. To strike a balance, one might as well just give applicants a chance to amend their pending applications in view of the changed practice instead.
In (very) brief, AstraZeneca’s EP(CH) 1 250 138 B2 had been revoked for lack of inventive step over Howell in view of McLeskey. At the main hearing, AZ had further limited its third auxiliary request with an additional feature (marked-up below) as follows:
Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of breast cancer by intra-muscular administration to human patients, […] wherein […] the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ng ml-1for at least two weeks.
AZ had argued that this further limitation was a partial acknowledgment of the complaint which is possible at any stage of the proceedings; Art. 241 CPC. The FPC did not agree. The further limitation only concerned an auxiliary request, i.e. it only came into play when the court had already decided on the main request, i.e. denial of the complaint without any amendments to the claims. At that stage, there is no room anymore for a partial acknowledgment of the complaint. The FPC held that it was faced with new facts to be considered as an auxiliary measure. This is possible in general, but only within the time limits for submission of novae; Art. 229 CPC. Consequently, the FPC had not admitted the newly drafted auxiliary request into the proceedings.
On appeal, AZ requested that the decision be set aside and the patent maintained on the basis of the amended third auxiliary request.
The Supreme Court did not agree, either. Whether or not an additional feature in a claim is an allowable limitation is not just a question of law. It rather requires a factual assessment of whether (or not) the application as filed provides sufficient basis for the amendment. This assessment had not been made in first instance proceedings. The Supreme Court further notes that even further factual assessment may be necessary, e.g. whether further prior art might be cited against the reformulated claim.
The Supreme Court thus held that the FPC correctly did not admit the reformulated auxiliary request into the proceedings for being belated, and dismissed the appeal.
it remains to be seen how parties will adapt their course of action in the future. But I would not be surprised if defendants in nullity cases (and plaintiffs in infringement cases when faced with a plea for nullity in defense) will submit a lot more auxiliary requests at early stages of the proceedings.
In (very) brief, AstraZeneca’s EP(CH) 2 266 573 B1 had been revoked for lack of inventive step over Howell in view of McLeskey. The parties heavily dissented on whether or not Howell contained an enabling disclosure or not. The FPC held that it did, and that the objective technical problem to be solved in accordance with the problem-and-solution approach was only to provide an alternative formulation for sustained release.
AZ appealed and essentially argued that the FPC erroneously assumed a (concrete) pharmaceutical formulation in Howell, thus incorrectly defined the distinguishing features and the (objective) technical problem, and then wrongly concluded for lack of inventive step.
The Supreme Court indeed agreed and remitted the case for re-assessment of inventive step on the basis of an ‘objectively correct’ definition of the problem to be solved; see ¶2.3.5. Further, the Supreme Court notes in ¶2.3.3 that a correct definition is:
Provision of a castor oil-based formulation (i.e. a formulation consisting of castor oil and known suitable solvents and adjuvants in a certain composition and amount) for the administration of up to 250 mg fulvestrant for the treatment of breast cancer, which is well tolerated, has a uniform release profile and achieves the therapeutically decisive concentration of fulvestrant in the blood plasma over a longer period of time.
It is rare (to say the least) that the Supreme Court re-defines the objective technical problem to be solved in the assessment of inventive step. It did so here because the FPC got the meaning of an enabling disclosure wrong:
[…] weil [die Vorinstanz] von einem unzutreffenden Begriff der Ausführbarkeit der Lehre ausgegangen ist […]
Really? The FPC got such a fundamental point of law just wrong!?
This demands for a closer look!
The Supreme Court holds that the FPC failed to recognize the concept of feasibility or sufficient disclosure with the conclusion that ‘the technical teaching of [Howell] could basically be reworked.’ For a technical teaching consists not only of the problem but also of the solution.
Die Vorinstanz hat den Begriff der Ausführbarkeit oder der hinreichenden Offenbarung verkannt mit dem Schluss, dass ‘die Lehre [in Howell] grundsätzlich nacharbeitbar war’. Denn eine technische Lehre besteht nicht nur aus dem Problem, sondern auch aus der Lösung.
However, Howell only suggests that there was a compatible and pharmaceutically effective depot formulation available — but the actual composition of this formulation is not disclosed.
Further, the Supreme Court holds that the FPC did not expand on which concrete formulation the skilled person(s) would have found on the basis of the information in Howell without undue burden and without involvement of an inventive step. The general knowledge that steroids such as fulvestrant can be dissolved in castor oil with certain excipients and solvents in such a way that compatible injections can be produced is not sufficient for the feasibility of a technical teaching, in the Supreme Courts’ view.
In sum, the Supreme Court thus holds that the FPC applied an incorrect legal concept of feasibility with the assumption that no concrete technical formulation was required in order to affirm that there well is a technical teaching in Howell; ¶2.2.4.
Die Beschwerdeführerin rügt im Ergebnis zu Recht, dass die Vorinstanz von einem unzutreffenden Rechtsbegriff der Ausführbarkeit ausgegangen ist mit der Annahme, es bedürfe keiner konkreten technischen Formulierung, um die Offenbarung der technischen Lehre — d.h. hier der in [Howell] beschriebenen Depot-Formulierung — bejahen zu können. […] Die Vorinstanz hat die Offenbarung einer technischen Lehre durch [Howell] zu Unrecht bejaht.
Further down the road, the Supreme Court concluded that the FPC failed in the identification of the differentiating features. It just could not do it correctly because there is no specific disclosure in Howell.
But still, Howell undoubtedly is pre-published. Now, what to do with it?
The FPC had left it undecided whether or not a non-enabling disclosure is ‘prior art’ under Art. 54(2) EPC. But the Supreme Court took over — and answered even more than that. The Supreme Court holds that Howell belongs to the state of the art (contrary to what the EPO typically does, i.e. to just ignore it in toto; see Guidelines, G-IV, 2). But, in the Supreme Court’s view, such a piece of prior art cannot be assessed with the problem-and-solution approach because the objective technical problem is then just to find a working solution to what is insufficiently disclosed therein, and there is an inherent motivation to search for that solution; ¶2.3.2.
Der Beschwerdegegnerin ist zwar zuzustimmen, dass die Information von [Howell], in der das Problem formuliert und Ansätze für die Lösung mitgeteilt werden, zum Stand der Technik gehört. Wird jedoch ein Dokument als ‘nächstliegender Stand der Technik’ beigezogen, das keine technische Lösung offenbart, […] wird der ‘Aufgabe-Lösungs-Ansatz’ verlassen. Denn die objektive technische Aufgabe ergibt sich unmittelbar aus [Howell], wenn darin dem fachkundigen Adressaten mitgeteilt wird, dass es eine Lösung für das Problem gibt […]. […] Eines Vergleichs von Merkmalen zur Ermittlung der objektiven technischen Aufgabe bedarf es in diesem Fall nicht. […] Aufgrund der Information in Howell, dass es eine Formulierung [gibt], wird das Fachteam jedenfalls dazu motiviert, geeignete Depotformulierungen zu suchen.
Frankly, it is now me who is not (yet) enabled to fully grasp the implications of this decision. Time will tell, as always.